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1. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

4. Analysis of fatal adverse drug events recorded in several Italian emergency departments (the MEREAFaPS study)

Author

Pagani, S., Lombardi, N., Crescioli, G., Vighi, G. V., Spada, G., Romoli, I., Andreetta, P., Capuano, A., Marrazzo, E., Marra, A., Leoni, O., Vannacci, A., Venegoni, M., Vighi, G. D., Bettoni, D., Blandizzi, C., Bonaiuti, R., Borsi, V., Cecchi, E., Convertino, I., Del Lungo, M., Di Mauro, C., Farina, G., Ferraro, S., Fucile, A., Galfrascoli, E., Geninatti, E., Giovannetti, L., Leonardi, L., Liccardo, R., Monina, G., Mugelli, A., Parrilli, M., Rafaniello, C., Rossi, F., Rostan, S., Ruocco, M., Sironi, M., Sportiello, L., Tuccori, M., Pagani, S., Lombardi, N., Crescioli, G., Vighi, G. V., Spada, G., Romoli, I., Andreetta, P., Capuano, A., Marrazzo, E., Marra, A., Leoni, O., Vannacci, A., Venegoni, M., Vighi, G. D., Bettoni, D., Blandizzi, C., Bonaiuti, R., Borsi, V., Cecchi, E., Convertino, I., Del Lungo, M., Di Mauro, C., Farina, G., Ferraro, S., Fucile, A., Galfrascoli, E., Geninatti, E., Giovannetti, L., Leonardi, L., Liccardo, R., Monina, G., Mugelli, A., Parrilli, M., Rafaniello, C., Rossi, F., Rostan, S., Ruocco, M., Sironi, M., Sportiello, L., and Tuccori, M.

Subjects
Drug, Male, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, media_common.quotation_subject, Adverse drug reaction, 030204 cardiovascular system & hematology, 03 medical and health sciences, Appropriateness of drug use, Pharmacovigilance, 0302 clinical medicine, Older patients, Internal Medicine, Medicine, Humans, 030212 general & internal medicine, Adverse effect, Drug safety, media_common, Aged, Medication error, business.industry, Public health, Anticoagulants, Mean age, medicine.disease, Italy, Concomitant, Emergency medicine, Emergency Medicine, Female, business, Emergency Service, Hospital, Algorithms, Platelet Aggregation Inhibitors
Abstract

Fatal Adverse Events (FADEs) are a major public health problem, and some FADEs could be preventable. The aim of the present study is to describe the frequency, the drugs involved and the preventability in the FADEs collected through the MEREAFaPS Study between 2012 and 2018. All cases including the outcome “death” have been examined. We excluded cases with vaccine-related ADEs, overdose or suicide, and ADEs occurred during the hospitalisation. Two trained assessors evaluated all cases fulfilling the inclusion criteria. ADEs’ preventability was evaluated applying the Schumock and Thornton algorithm. During the study period, we observed 429 cases of death, 92 of which were excluded. The remaining 337 cases involved 187 women and 150 men, with a mean age of 79 and of 77years, respectively. For each report, the suspected drugs and concomitant ones were 1.26 and 4.20, respectively. Anticoagulants and antiplatelet agents account for more than 40% of FADE cases and the most frequent reactions are haemorrhages (37.5%). The 25% of the FADEs were preventable. This study confirms that FADEs are still a relevant clinical occurrence, and are often caused by widely used old drugs associated with adverse events. The death of one in four patients was preventable. Further efforts should be done to improve the appropriateness of the therapy, especially in older patients who are treated with anticoagulants.

Published
2021

5. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

Author

Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P. M., Fantini M. P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P.M., Fantini M.P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Luxi, N., Giovanazzi, A., Capuano, A., Crisafulli, S., Cutroneo, P. M., Fantini, M. P., Ferrajolo, C., Moretti, U., Poluzzi, E., Raschi, E., Ravaldi, C., Reno, C., Tuccori, M., Vannacci, A., Zanoni, G., Trifiro, G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., and Montresor V.

Subjects
Allergy, IMPACT, COVID-19 Vaccine, Breastfeeding, Review Article, Toxicology, Settore MED/42 - Igiene Generale E Applicata, CLINICAL CHARACTERISTICS, Pregnancy, Pharmacology (medical), Pregnancy Complications, Infectious, Child, OUTCOMES, education.field_of_study, CANCER, Vaccination, Europe, CORONAVIRUS DISEASE 2019, CLINICAL CHARACTERISTICS, CANCER, RECIPIENTS, SEVERITY, OUTCOMES, IMPACT, RATES, Breast Feeding, Child, Preschool, Practice Guidelines as Topic, Female, 2019-nCoV Vaccine mRNA-1273, Human, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, BNT162 Vaccine, COVID-19, ChAdOx1 nCoV-19, Humans, Infant, SARS-CoV-2, Hypersensitivity, Immunocompromised Host, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Population, MEDLINE, CORONAVIRUS DISEASE 2019, medicine, RATES, education, Pharmacology, business.industry, medicine.disease, Vaccine efficacy, RECIPIENTS, SEVERITY, Family medicine, Pregnancy Complications, Infectiou, business
Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit–risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01131-6.

Published
2021

6. Factors driving choices between types and brands of influenza vaccines in general practice in Austria, Italy, Spain and the UK

Author

Stuurman AL, Ciampini S, Vannacci A, Bella A, Rizzo C, Muñoz-Quiles C, Pandolfi E, Liyanage H, Haag M, Redlberger-Fritz M, Bonaiuti R, and Beutels P

Abstract

Influenza vaccine effectiveness (IVE) assessment is increasingly stratified by vaccine type or brand, such as done by the European network of DRIVE. In 2019/2020, eleven influenza vaccines were licensed in Europe. If more than one vaccine type is recommended or if more than one vaccine brand is available for a specific risk group, it is not clear which factors affect the choice of a specific vaccine (type or brand) by a health practitioner for individual patients. This is important for IVE assessment. A survey tailored to the 2019/20 local vaccine recommendations was conducted among GPs in four European countries (Austria, Italy, Spain, UK) to understand how influenza vaccine is offered to recommended risk groups and, if GPs have a choice between 2 or more vaccines, what factors influence their vaccine choice for patients. Overall, 360 GPs participated. In Austria, Italy and Spain GPs indicated that influenza vaccines are commonly offered when patients present for consultation, whereas in the UK all GPs indicated that all relevant patients are contacted by letter. In Austria and Italy, roughly 80% of GPs had only one vaccine type available for patients 65y in Austria (45%), Italy (70%) and Spain (79%). In this group, patient characteristics played a role in choice of vaccine, notably older age and presence of (multiple) comorbidities. Knowing that a non-patient related factor usually determines the vaccine type a patient receives in settings where more than one vaccine type is recommended for risk groups 65y.

Published
2021

7. Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug–drug interactions

Author

Crescioli, G., Brilli, V., Lanzi, C., Burgalassi, A., Ieri, A., Bonaiuti, R., Romano, E., Innocenti, R., Mannaioni, G., Vannacci, A., and Lombardi, N.

Subjects
Adverse drug reactions, COVID-19, Drug–drug interactions, Internal medicine, Pharmacovigilance, Adult, Aged, Aged, 80 and over, Comorbidity, Drug-Related Side Effects and Adverse Reactions, Female, Hospitalization, Humans, Italy, Male, Middle Aged, Polypharmacy, Prevalence, Risk Factors, SARS-CoV-2, Drug Interactions
Published
2021

9. DC-ATLAS: a systems biology resource to dissect receptor specific signal transduction in dendritic cells.

Author

Cavalieri, D., Rivero, D., Beltrame, L., Buschow, S.I., Calura, E., Rizzetto, L., Gessani, S., Gauzzi, M.C., Reith, W., Baur, A., Bonaiuti, R., Brandizi, M., Filippo, C. De, D'Oro, U., Draghici, S., Dunand-Sauthier, I., Gatti, E., Granucci, F., Gundel, M., Kramer, M., Kuka, M., Lanyi, A., Melief, C.J., Montfoort, N. van, Ostuni, R., Pierre, P., Popovici, R., Rajnavolgyi, E., Schierer, S., Schuler, G., Soumelis, V., Splendiani, A., Stefanini, I., Torcia, M.G., Zanoni, I., Zollinger, R., Figdor, C.G., Austyn, J.M., Cavalieri, D., Rivero, D., Beltrame, L., Buschow, S.I., Calura, E., Rizzetto, L., Gessani, S., Gauzzi, M.C., Reith, W., Baur, A., Bonaiuti, R., Brandizi, M., Filippo, C. De, D'Oro, U., Draghici, S., Dunand-Sauthier, I., Gatti, E., Granucci, F., Gundel, M., Kramer, M., Kuka, M., Lanyi, A., Melief, C.J., Montfoort, N. van, Ostuni, R., Pierre, P., Popovici, R., Rajnavolgyi, E., Schierer, S., Schuler, G., Soumelis, V., Splendiani, A., Stefanini, I., Torcia, M.G., Zanoni, I., Zollinger, R., Figdor, C.G., and Austyn, J.M.

Abstract

Contains fulltext : 88001.pdf (publisher's version ) (Closed access), BACKGROUND: The advent of Systems Biology has been accompanied by the blooming of pathway databases. Currently pathways are defined generically with respect to the organ or cell type where a reaction takes place. The cell type specificity of the reactions is the foundation of immunological research, and capturing this specificity is of paramount importance when using pathway-based analyses to decipher complex immunological datasets. Here, we present DC-ATLAS, a novel and versatile resource for the interpretation of high-throughput data generated perturbing the signaling network of dendritic cells (DCs). RESULTS: Pathways are annotated using a novel data model, the Biological Connection Markup Language (BCML), a SBGN-compliant data format developed to store the large amount of information collected. The application of DC-ATLAS to pathway-based analysis of the transcriptional program of DCs stimulated with agonists of the toll-like receptor family allows an integrated description of the flow of information from the cellular sensors to the functional outcome, capturing the temporal series of activation events by grouping sets of reactions that occur at different time points in well-defined functional modules. CONCLUSIONS: The initiative significantly improves our understanding of DC biology and regulatory networks. Developing a systems biology approach for immune system holds the promise of translating knowledge on the immune system into more successful immunotherapy strategies.

Published
2010

10. DC-ATLAS: a systems biology resource to dissect receptor specific signal transduction in dendritic cell

Author

Cavalieri, D, Rivero, D, Beltrame, L, Buschow, S, Calura, E, Rizzetto, L, Gessani, S, Gauzzi, M, Reith, W, Baur, A, Bonaiuti, R, Brandizi, M, De Filippo, C, D'Oro, U, Draghici, S, Dunand Sauthier, I, Gatti, E, Granucci, F, Gündel, M, Kramer, M, Kuka, M, Lanyi, A, Melief, C, Van Montfoort, N, Ostuni, R, Pierre, P, Popovici, R, Rajnavolgyi, E, Schierer, S, Schuler, G, Soumelis, V, Splendiani, A, Stefanini, I, Torcia, M, Zanoni, I, Zollinger, R, Figdor, C, Austyn, J, Buschow, SI, Melief, CJ, Torcia, MG, Figdor, CG, Austyn, JM, GRANUCCI, FRANCESCA, ZANONI, IVAN, Cavalieri, D, Rivero, D, Beltrame, L, Buschow, S, Calura, E, Rizzetto, L, Gessani, S, Gauzzi, M, Reith, W, Baur, A, Bonaiuti, R, Brandizi, M, De Filippo, C, D'Oro, U, Draghici, S, Dunand Sauthier, I, Gatti, E, Granucci, F, Gündel, M, Kramer, M, Kuka, M, Lanyi, A, Melief, C, Van Montfoort, N, Ostuni, R, Pierre, P, Popovici, R, Rajnavolgyi, E, Schierer, S, Schuler, G, Soumelis, V, Splendiani, A, Stefanini, I, Torcia, M, Zanoni, I, Zollinger, R, Figdor, C, Austyn, J, Buschow, SI, Melief, CJ, Torcia, MG, Figdor, CG, Austyn, JM, GRANUCCI, FRANCESCA, and ZANONI, IVAN

Abstract

Background: The advent of Systems Biology has been accompanied by the blooming of pathway databases. Currently pathways are defined generically with respect to the organ or cell type where a reaction takes place. The cell type specificity of the reactions is the foundation of immunological research, and capturing this specificity is of paramount importance when using pathway-based analyses to decipher complex immunological datasets. Here, we present DC-ATLAS, a novel and versatile resource for the interpretation of high-throughput data generated perturbing the signaling network of dendritic cells (DCs). Results: Pathways are annotated using a novel data model, the Biological Connection Markup Language (BCML), a SBGN-compliant data format developed to store the large amount of information collected. The application of DC-ATLAS to pathway-based analysis of the transcriptional program of DCs stimulated with agonists of the toll-like receptor family allows an integrated description of the flow of information from the cellular sensors to the functional outcome, capturing the temporal series of activation events by grouping sets of reactions that occur at different time points in well-defined functional modules. Conclusions: The initiative significantly improves our understanding of DC biology and regulatory networks. Developing a systems biology approach for immune system holds the promise of translating knowledge on the immune system into more successful immunotherapy strategies. © 2010 Cavalieri et al; licensee BioMed Central Ltd.

Published
2010

11. Drug-induced taste and smell alterations: a case/non-case evaluation of an italian database of spontaneous adverse drug reaction reporting.

Author

Tuccori M, Lapi F, Testi A, Ruggiero E, Moretti U, Vannacci A, Bonaiuti R, Antonioli L, Fornai M, Giustarini G, Scollo C, Corona T, Ferrazin F, Sottosanti L, Blandizzi C, Tuccori, Marco, Lapi, Francesco, Testi, Arianna, Ruggiero, Elisa, and Moretti, Ugo

Abstract

Background: The frequency and clinical features of drug-related taste and/or smell impairments are currently unclear.Objective: The aim of this study was to identify major drug classes associated with taste and smell alterations reported to the Italian spontaneous adverse drug reaction (ADR) reporting database.Methods: The association between drug and altered taste or smell was investigated by case/non-case methodology. The reporting odds ratio (ROR) was used as a measure of disproportionality. Cases were defined as patients with at least one ADR related to taste or smell impairments. The non-cases included all patients without any ADRs related to taste or smell alterations.Results: According to the selection criteria, 52 166 reports were included in the analysis. Overall, 182 cases of drug-related taste and/or smell dysfunctions were identified. Statistically significant unadjusted RORs were reported for macrolides (n = 31; 7.1; 95% CI 4.8, 10.5), terbinafine (the only drug reported within the group of antimycotics belonging to the Anatomical Therapeutic Chemical class D01AE) [n = 17; 76.4; 95% CI 44.0, 132.6], fluoroquinolones (n = 15; 1.7; 95% CI 1.0, 2.8) and protein kinase inhibitors (n = 10; 4.0; 95% CI 2.1, 7.7). When RORs were adjusted for sex and age category, the disproportion remained statistically significant for all of the previously mentioned drug classes.Conclusions: Taste and/or smell abnormalities are common, sometimes unexpected and often persistent complaints of patients during pharmacological treatments. Physicians should be aware of the impact of these ADRs on patients' quality of life. [ABSTRACT FROM AUTHOR]

Published
2011
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13. Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)

Author

Niccolò Lombardi, Giada Crescioli, Alessandra Bettiol, Marco Tuccori, Annalisa Capuano, Roberto Bonaiuti, Alessandro Mugelli, Mauro Venegoni, Giuseppe Danilo Vighi, Alfredo Vannacci, the MEREAFaPS Study group, Maria Luisa Aiezza, Daria Bettoni, Corrado Blandizzi, Valentina Borsi, Errica Cecchi, Irma Convertino, Martina Del Lungo, Cristina Di Mauro, Gabriella Farina, Sara Ferraro, Annamaria Fucile, Elena Galfrascoli, Elisabetta Geninatti, Linda Giovannetti, Luca Leonardi, Rosa Liccardo, Anna Marra, Eleonora Marrazzo, Giovanna Monina, Silvia Pagani, Maria Parrilli, Concetta Rafaniello, Francesco Rossi, Marco Rossi, Stefania Rostan, Marco Ruocco, Marita Sironi, Giulia Spada, Liberata Sportiello, Giuditta Violetta Vighi, Lombardi, N., Crescioli, G., Bettiol, A., Tuccori, M., Capuano, A., Bonaiuti, R., Mugelli, A., Venegoni, M., Vighi, G. D., Vannacci, A., Aiezza, M. L., Bettoni, D., Blandizzi, C., Borsi, V., Cecchi, E., Convertino, I., Del Lungo, M., Di Mauro, C., Farina, G., Ferraro, S., Fucile, A., Galfrascoli, E., Geninatti, E., Giovannetti, L., Leonardi, L., Liccardo, R., Marra, A., Marrazzo, E., Monina, G., Pagani, S., Parrilli, M., Rafaniello, C., Rossi, F., Rossi, M., Rostan, S., Ruocco, M., Sironi, M., Spada, G., and Sportiello, L.

Subjects
0301 basic medicine, medicine.medical_specialty, drug safety, emergency department, Population, Context (language use), 03 medical and health sciences, seriousness, 0302 clinical medicine, preventability, Pharmacovigilance, Medicine, Pharmacology (medical), education, adverse drug event, Original Research, Pharmacology, education.field_of_study, business.industry, lcsh:RM1-950, Retrospective cohort study, Odds ratio, Emergency department, Confidence interval, 030104 developmental biology, lcsh:Therapeutics. Pharmacology, adverse drug events, hospitalization, pharmacovigilance, 030220 oncology & carcinogenesis, Emergency medicine, Observational study, business
Abstract

Background Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. Preventing ADEs and their related ED visits in outpatients remains a public health safety challenge. In this context, the aims of the present study were to describe the frequency, seriousness and preventability of outpatients' ADE-related ED visits and hospitalizations in the Italian general population, and to identify the presence of potential predictors of ADE-related hospitalization. Methods We performed a nationwide, multicentre, observational, retrospective study based on reports of suspected ADEs collected between January 1, 2007 and December 31, 2018 in 94 EDs involved in the MEREAFaPS project. Patients' demographic characteristics, their clinical status, suspected and concomitant drugs, ADE description, and its degree of seriousness, were collected. Causality and preventability were assessed using validated algorithms, and logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization, considering the following covariates: age, sex, ethnicity, number of implicated medications, parenteral administration, presence of interaction, therapeutic error, and/or complementary and alternative medicines (CAM). Results Within 12 years, 61,855 reports of suspected ADE were collected, of which 18,918 (30.6%) resulted in hospitalization (ADE defined as serious). Patients were mostly female (56.6%) and Caucasians (87.7%), with a mean age of 57.5 ± 25.0 years. 58% of patients were treated with more than two drugs, and 47% of ADEs leading to hospitalization were preventable. Anticoagulants, antibiotics, and nonsteroidal anti-inflammatory drugs (NSAIDs) were the most frequently implicated agents for ED visits and/or hospitalization, which included clinically significant ADEs, such as haemorrhage for anticoagulants, moderate to severe allergic reactions for antibiotics, and dermatologic reactions and gastrointestinal disturbances for NSAIDs. Older age (1.54 [1.48-1.60]), higher number of concomitantly taken drugs (2.22 [2.14-2.31]), the presence of drug-drug interactions (1.52 [1.28-1.81]), and therapeutic error (1.54 [1.34-1.78]), were significantly associated with an increased risk of hospitalization. Conclusion Our long-term active pharmacovigilance study in ED provided a valid estimation of ADE-related hospitalization in a representative sample of the Italian general population and can suggest further focus on medication safety in outpatients, in order to early recognise and prevent ADEs.

Published
2020

14. Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy

Author

Domenico Motola, Anita Conforti, Alfredo Vannacci, Roberto Bonaiuti, Liberata Sportiello, Annalisa Capuano, Concetta Rafaniello, Monia Donati, Maria Carmela Lenti, Alberto Vaccheri, Ugo Moretti, Roberto Leone, Oscar Bortolami, Elena Arzenton, Donati, Monia, Conforti, Anita, Lenti, Maria Carmela, Capuano, Annalisa, Bortolami, Oscar, Motola, Domenico, Moretti, Ugo, Vannacci, Alfredo, Rafaniello, Concetta, Vaccheri, Alberto, Arzenton, Elena, Bonaiuti, Roberto, Sportiello, Liberata, Leone, Roberto, Donati, M, Conforti, A, Lenti, Mc, Capuano, A, Bortolami, O, Motola, D, Moretti, U, Vannacci, A, Rafaniello, C, Vaccheri, A, Arzenton, E, Bonaiuti, R, Sportiello, L, and Leone, R

Subjects
Ketoprofen, Adult, Male, Risk, medicine.medical_specialty, Dose, NSAIDs, DILI, case-control study, liver injury, nimesulide, Ibuprofen, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, case–control study, DILI, liver injury, nimesulid e, NSAIDs, Aged, Pharmacology, Liver injury, Sulfonamides, Dose-Response Relationship, Drug, business.industry, Pharmacoepidemiology, Anti-Inflammatory Agents, Non-Steroidal, Case-control study, case–control study, Odds ratio, Middle Aged, medicine.disease, NSAID, Confidence interval, Italy, Anesthesia, Case-Control Studies, Multivariate Analysis, 030211 gastroenterology & hepatology, Female, Chemical and Drug Induced Liver Injury, business, Nimesulide, medicine.drug
Abstract

Aim: Drug-induced liver injury is one of the most serious adverse drug reactions and the most frequent reason for restriction of indications or withdrawal of drugs. Some nonsteroidal anti-inflammatory drugs (NSAIDs) were withdrawn from the market because of serious hepatotoxicity. We estimated the risk of acute and serious liver injury associated with the use of nimesulide and other NSAIDs, with a prevalence of use greater than or equal to 5%. \ud \ud Methods: This is a multicentre case–control study carried out in nine Italian hospitals from October 2010 to January 2014. Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders not related to chronic conditions, not involving the liver. Adjusted odds ratio (ORs) with 95% confidence interval (CI) were calculated initially with a bivariate and then multivariate analysis. \ud \ud Results: We included 179 cases matched to 1770 controls. Adjusted OR for acute serious liver injury associated with all NSAIDs was 1.69, 95% CI 1.21–2.37. Thirty cases were exposed to nimesulide (adjusted OR 2.10, 95% CI 1.28–3.47); the risk increased according to the length of exposure (OR > 30 days: 12.55, 95% CI 1.73–90.88) and to higher doses (OR 10.69, 95% CI 4.02–28.44). Risk of hepatotoxicity was increased also for ibuprofen, used both at recommended dosages (OR 1.92, 95% CI 1.13–3.26) and at higher doses (OR 3.73, 95% CI 1.11–12.46) and for ketoprofen ≥ 150 mg (OR 4.65, 95% CI 1.33–10.00). \ud \ud Conclusion: Among all NSAIDs, nimesulide is associated with the higher risk, ibuprofen and high doses of ketoprofen are also associated with a modestly increased risk of hepatotoxicity.

Published
2016

15. Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database

Author

Martina Moschini, Valentina Maggini, Laura Sottosanti, Roberto Bonaiuti, Carlo Piccinni, Alfredo Vannacci, Marco Tuccori, Fernanda Ferrazin, Roberto Leone, Marco Rossi, Alessandro Mugelli, Alessandra Pugi, Francesco Lapi, Domenico Motola, Pugi A, Bonaiuti R, Maggini V, Moschini M, Tuccori M, Leone R, Rossi M, Motola D, Piccinni C, Ferrazin F, Sottosanti L, Mugelli A, Vannacci A, and Lapi F.

Subjects
Adult, Male, Adolescent, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, Anemia, Neutropenia, computer.software_genre, Antiviral Agents, Severity of Illness Index, Italian pharmacovigilance system, antiviral therapy, adverse drug reactions, Pharmacovigilance, Young Adult, Severity of illness, medicine, Adverse Drug Reaction Reporting Systems, Humans, Renal colic, Adverse effect, Child, Aged, Pharmacology, Database, business.industry, Health Policy, Infant, Newborn, Infant, Odds ratio, Middle Aged, medicine.disease, antiviral medication, Confidence interval, Logistic Models, Italy, Child, Preschool, SPONTANEOUS REPORTING DATABASE, Female, medicine.symptom, business, computer
Abstract

PURPOSE: The results of an analysis of suspected antiviral-associated adverse drug reactions (ADRs) in Italy over a 22-year period are presented. METHODS: A case/non-case analysis was conducted using ADR reports compiled in the nationwide spontaneous-reporting database through September 2010. All reported events included in the analysis were evaluated and coded by drug safety experts; causality assessments were performed according to the algorithm of Naranjo et al. The association between an adverse reaction and antiviral use was assessed by estimating the reporting odds ratio (ROR), with 95% confidence interval (CI), as a measure of disproportionality. RESULTS: Overall, 863 reports of suspected ADRs involving antivirals and 42,430 reports of adverse reactions to other drugs were identified; of those events, 3.3% and 64.3% were determined to be definite or probable ADRs, respectively, and an additional 32.4% were deemed possibly drug related. Several ADRs were disproportionately associated with antivirals relative to other drugs: renal colic (ROR, 25.5; 95% CI, 13.3-49.0), lactic acidosis (ROR, 18.6; 95% CI, 9.2-37.7), depression (ROR, 18.0; 95% CI, 11.6-27.9), anemia (ROR, 15.9; 95% CI, 12.3-20.4), hallucination (ROR, 4.3; 95% CI, 2.7-7.1), neutropenia (ROR, 4.1; 95% CI, 2.9-5.8), acute renal failure (ROR, 3.9; 95% CI, 2.3-6.4), fever (ROR, 3.8; 95% CI, 2.8-5.1), hyperpyrexia (ROR, 2.9; 95% CI, 1.7-4.9), and asthenia (ROR, 1.8; 95% CI, 1.2-2.8). CONCLUSION: Analysis of data from a large Italian database showed that, among antiviral agents, the ribavirin-interferon combination, acyclovir, valacyclovir, indinavir, and zidovudine accounted for the most serious hematologic, neuropsychiatric, and renal ADRs.

Published
2013

16. DC-ATLAS: a systems biology resource to dissect receptor specific signal transduction in dendritic cells

Author

Matthijs Kramer, Roberto Bonaiuti, Ivan Zanoni, Gerold Schuler, Walter Reith, Sorin Draghici, Damariz Rivero, Vassili Soumelis, Jonathan M. Austyn, Ugo D'Oro, Cornelis J. M. Melief, Andrea Splendiani, Carl G. Figdor, Maria Torcia, Enrica Calura, Marco Brandizi, Renato Ostuni, Sandra Gessani, Duccio Cavalieri, Francesca Granucci, Sonja I. Buschow, Maria Cristina Gauzzi, Arpad Lanyi, Stephan Schierer, Nadine van Montfoort, Éva Rajnavölgyi, Michaela Gündel, Philippe Pierre, Raphaël Zollinger, Luca Beltrame, Lisa Rizzetto, Andreas Baur, Isabelle Dunand-Sauthier, Carlotta De Filippo, Mirela Kuka, Evelina Gatti, Irene Stefanini, Razvan Popovici, Reith, Walter, Dunand-Sauthier, Isabelle, Pierre, Philippe, Università degli Studi di Firenze [Firenze], Radboud University Medical Center [Nijmegen], Istituto Superiore di Sanità, Rome (ISS), Department of Therapeutic Research and Medicines Evaluation, University of Geneva Medical School, Department of Pathology and Immunology, University of Erlangen, Department of Dermatology, Leaf Bioscience, Novartis Vaccines, Siena, Italy, Novartis Vaccines, Wayne State University [Detroit], Centre d'Immunologie de Marseille - Luminy (CIML), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), University of Milano-Bicocca (UNIMIB), Department of Biotechnology and Biosciences, University of Debrecen Egyetem [Debrecen], Leiden University Medical Center (LUMC), Miravtech Corporation, Immunité et cancer (U932), Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Curie-Université Paris Descartes - Paris 5 (UPD5), University of Oxford [Oxford], Cavalieri, D, Rivero, D, Beltrame, L, Buschow, S, Calura, E, Rizzetto, L, Gessani, S, Gauzzi, M, Reith, W, Baur, A, Bonaiuti, R, Brandizi, M, De Filippo, C, D'Oro, U, Draghici, S, Dunand Sauthier, I, Gatti, E, Granucci, F, Gündel, M, Kramer, M, Kuka, M, Lanyi, A, Melief, C, Van Montfoort, N, Ostuni, R, Pierre, P, Popovici, R, Rajnavolgyi, E, Schierer, S, Schuler, G, Soumelis, V, Splendiani, A, Stefanini, I, Torcia, M, Zanoni, I, Zollinger, R, Figdor, C, Austyn, J, Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), Friedrich-Alexander Universität Erlangen-Nürnberg (FAU), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Dipartimento di Biotecnologie e Bioscienze = Department of Biotechnology and Biosciences [Milano-Bicocca] (BTBS), Università degli Studi di Milano-Bicocca [Milano] (UNIMIB), Université Paris Descartes - Paris 5 (UPD5)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Buschow, Si, Gauzzi, Mc, Kuka, Mirela, Melief, Cj, van Montfoort, N, Torcia, Mg, Figdor, Cg, Austyn, J. M., Istituto Superiore di Sanità, Rome ( ISS ), Centre d'Immunologie de Marseille - Luminy ( CIML ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Aix Marseille Université ( AMU ) -Centre National de la Recherche Scientifique ( CNRS ), University of Milano-Bicocca ( UNIMIB ), Immunité et cancer ( U932 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut Curie, Università degli Studi di Firenze = University of Florence (UniFI), Istituto Superiore di Sanità (ISS), Università degli Studi di Milano-Bicocca = University of Milano-Bicocca (UNIMIB), Universiteit Leiden, and University of Oxford

Subjects
Cell type, Markup language, Computer science, Systems biology, medicine.medical_treatment, Immunology, Computational biology, ddc:616.07, computer.software_genre, 03 medical and health sciences, 0302 clinical medicine, Immune system, Immune Regulation [NCMLS 2], medicine, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, Elméleti orvostudományok, Molecular gastro-enterology and hepatology [IGMD 2], Molecular Biology, 030304 developmental biology, 0303 health sciences, Applied Mathematics, Research, Dendritic cells, toll like receptors, pattern recognition receptors, systems biology, Pattern recognition receptor, Immunotherapy, Orvostudományok, dendritic cells, toll-like receptors, TLR, TLR pathways, systems biology, pathway analysis, Computer Science Applications, Computational Theory and Mathematics, DECIPHER, [SDV.IMM]Life Sciences [q-bio]/Immunology, Data mining, Signal transduction, computer, 030215 immunology
Abstract

Contains fulltext : 88001.pdf (Publisher’s version ) (Closed access) BACKGROUND: The advent of Systems Biology has been accompanied by the blooming of pathway databases. Currently pathways are defined generically with respect to the organ or cell type where a reaction takes place. The cell type specificity of the reactions is the foundation of immunological research, and capturing this specificity is of paramount importance when using pathway-based analyses to decipher complex immunological datasets. Here, we present DC-ATLAS, a novel and versatile resource for the interpretation of high-throughput data generated perturbing the signaling network of dendritic cells (DCs). RESULTS: Pathways are annotated using a novel data model, the Biological Connection Markup Language (BCML), a SBGN-compliant data format developed to store the large amount of information collected. The application of DC-ATLAS to pathway-based analysis of the transcriptional program of DCs stimulated with agonists of the toll-like receptor family allows an integrated description of the flow of information from the cellular sensors to the functional outcome, capturing the temporal series of activation events by grouping sets of reactions that occur at different time points in well-defined functional modules. CONCLUSIONS: The initiative significantly improves our understanding of DC biology and regulatory networks. Developing a systems biology approach for immune system holds the promise of translating knowledge on the immune system into more successful immunotherapy strategies.

Published
2010
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17. Real-world analysis on the use of gamma-hydroxybutyric acid for alcohol withdrawal syndrome in hospitalized patients with diagnosis of cirrhosis.

Author

Salomoni M, Missanelli A, Crescioli G, Lanzi C, Totti A, Losso L, Gitto S, Bonaiuti R, Vannacci A, Lombardi N, and Mannaioni G

Abstract

The present real-world analysis aimed to evaluate and describe the use of gamma-hydroxybutyric acid (GHB) for alcohol withdrawal syndrome (AWS) in hospitalized patients with diagnosis of liver cirrhosis. An 11-year observational retrospective study on patients affected by liver cirrhosis and alcohol use disorder (AUD) was performed using data from the Medical Toxicology Unit of Careggi University Hospital in Florence (Italy). A multivariate logistic regression was performed to estimate the probability of having a CIWA-Ar Max 3-4 during hospitalization, an AWS length  > 36 h, a hospitalization > 9 days, and the probability of developing drowsiness. A total of 166 AUD patients were included, of these 77 received GHB (70.13% within the first day of hospitalization) and 89 were treated without GHB. The majority were  ≥ 40 years of age (87.35%) and males (80.12%). GHB patients were more likely to have a CIWA-Ar Max 3-4 during hospitalization (OR 3.76 [CI 95% 1.02-13.85]), and a longer hospitalization (OR 3.08 [95% CI 1.23-7.71]). Early GHB administration decreased the probability of CIWA-Ar Max worsening (OR 0.06 [95% CI 0.01-0.49]). GHB dose  ≥ 100 mg/kg was not associated with the occurrence of drowsiness. Patients exposed to other sedative agents were more likely to experience drowsiness (OR 7.22 [95% CI 1.46-35.61]). The present real-world analysis underlines that GHB could be a valuable and safe option for the management of AWS in AUD patients affected by liver cirrhosis, also when administered early and even at higher than recommended dosages., (© 2024. The Author(s).)

Published
2024
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18. Prevention, diagnosis and pharmacological treatment of infections in pregnancy: The mobile app GAIA! for healthcare providers and patients.

Author

Bonaiuti R, Zammarchi L, Giaché S, Modi G, Borchi B, Campolmi I, Trotta M, Ravaldi C, Ornaghi S, Di Tommaso M, Bartoloni A, Costa P, Lombardi N, Crescioli G, Vannacci A, and Levi M

Subjects
Humans, Pregnancy, Female, Health Personnel, Italy, Mobile Applications, Pregnancy Complications, Infectious drug therapy, Pregnancy Complications, Infectious diagnosis
Abstract

Objective: To develop and assess the GAIA! app, designed to assist pregnant women and healthcare professionals in managing infectious diseases during pregnancy, and to bridge the information gap between health professionals and expectant mothers., Study Design: This collaborative initiative in Italy involved partnerships with the University of Florence, Careggi University Hospital, and other institutions. The app, built on the Ionic framework, is available on both Apple and Google App Stores. It offers two distinct modes: "healthcare providers" and "patients." Content for the app was derived from extensive literature reviews and clinical guidelines., Results: Since its August 2022 launch, the GAIA! app has garnered over 2,500 downloads, indicating its effectiveness and acceptance within the community. The app differentiates itself from others, such as the Sanford Guide, by focusing specifically on the needs of pregnant women. It ensures cross-platform compatibility, a user-friendly interface, and offline functionality., Conclusions: The GAIA! app has successfully addressed a niche in infectious disease management for pregnant women, gaining significant traction within the community. While it has seen substantial success, challenges like continuous updates and potential language expansion remain. Future endeavors will address these challenges and further evaluate the app's impact on maternal and child health., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2024
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19. Suspected adverse reactions to medications and food supplements containing Serenoa repens: A worldwide analysis of pharmacovigilance and phytovigilance spontaneous reports.

Author

Crescioli G, Maggini V, Raschi E, Gonella LA, Luxi N, Ippoliti I, Di Giovanni V, Bonaiuti R, Firenzuoli N, Gallo E, Menniti-Ippolito F, Moretti U, Trifirò G, Vannacci A, Firenzuoli F, and Lombardi N

Subjects
Male, Humans, Aged, Female, Pharmacovigilance, Retrospective Studies, Plant Extracts adverse effects, Dietary Supplements adverse effects, Serenoa adverse effects, Prostatic Hyperplasia drug therapy
Abstract

The safety of Serenoa repens (SR)-containing products was evaluated conducting a retrospective worldwide analysis of pharmaco- and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20-2.15]), as subjects exposed to 2-5 (OR: 1. 83 [95% CI: 1.30-2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36-5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15-2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21-5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10-3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20-0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies., (© 2023 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.)

Published
2023
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21. The Emotional Landscape of Pregnancy and Postpartum during the COVID-19 Pandemic in Italy: A Mixed-Method Analysis Using Artificial Intelligence.

Author

Ravaldi C, Mosconi L, Bonaiuti R, and Vannacci A

Abstract

The COVID-19 pandemic affected the perinatal emotional landscape in Italy, a country that had high mortality and implemented a strict lockdown during the pandemic. This study explores the emotions and challenges of pregnant and postpartum women during the pandemic, using AI-based mixed methods. The study analyzed 1774 women from the national survey COVID-ASSESS: 1136 pregnant and 638 postpartum women. The survey had qualitative questions on emotions and feelings related to birth, communication with healthcare professionals, media, and peers and family. We used natural language processing and machine learning to classify emotions, identify themes, and extract citations from the data. Fear and anxiety replaced joy as dominant emotions during the pandemic: trust and joy decreased by 49.3% and 36.4%, respectively, while sadness and fear increased by 52.3% and 49.3%, respectively. The pandemic also induced loneliness, isolation, frustration, and anger. Women faced challenges related to birth, communication with HCPs, media, and peers and family. They also used coping strategies such as self-care, news limitation, and trying to cultivate gratitude and hope. This study provides a comprehensive exploration of the perinatal emotional landscape of Italian women during the pandemic. The findings underscore the significant psychological impact of the pandemic and also highlight women's resilience and coping strategies.

Published
2023
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22. Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform.

Author

Stuurman AL, Carmona A, Biccler J, Descamps A, Levi M, Baum U, Mira-Iglesias A, Bellino S, Hoang U, de Lusignan S, Bonaiuti R, Lina B, Rizzo C, Nohynek H, and Díez-Domingo J

Subjects
Adult, Aged, Child, Humans, Cohort Studies, COVID-19 Vaccines, Europe epidemiology, Seasons, Vaccine Efficacy, Male, Female, Adolescent, Young Adult, Middle Aged, COVID-19, Influenza Vaccines, Influenza, Human epidemiology, Influenza, Human prevention & control
Abstract

Introduction: Development of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public-private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017-2018 to its final season in 2021-2022., Methods: In 2021-2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis., Results: In 2021-2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%-93%) for any vaccine and 81% (22%-95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%-83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%-97%) for any vaccine in adults 18-64 years (TND hospital setting), and 38% (1%-62%) in children 6 months-6 years (population-based cohort, mixed setting)., Discussion: Over five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE., Competing Interests: AS and JB declare that they were employees of P95; P95 has held/holds contracts with Seqirus, Sanofi, GSK, and AstraZeneca. AC reports remunerated collaborations with HIPRA, GSK, and MSD for lectures and seminars. JD-D declares that FISABIO receives research grants from Sanofi, GSK, and Seqirus, that he has been principal investigator in clinical trials with influenza vaccine for GSK, SP, Abbott, and that he has acted as an advisor for Sanofi and MSD. He also declares he is a Member of Monitoring committee of clinical trials for Janssen and GSK. AD reports grants from Innovative Medicines Initiative 2 Joint Undertaking (grant agreement No 777363) and from Sanofi (outside the submitted work). SL reports that through his University he has had grants not directly relating to this work, from AstraZeneca, GSK, Sanofi, Seqirus, and Takeda for vaccine related research, and membership of advisory boards for AstraZenca Sanofi and Seqirus. CR declares that she has received funding for participating in AB from Seqirus, Sanofi and MSD. HN declares that she is an employee of the Finnish Institute for Health and Welfare, which has a major phase IV study on influenza vaccine funded by Sanofi; however, she is not personally involved in the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Stuurman, Carmona, Biccler, Descamps, Levi, Baum, Mira-Iglesias, Bellino, Hoang, Lusignan, Bonaiuti, Lina, Rizzo, Nohynek, Díez-Domingo and DRIVE Study Contributors.)

Published
2023
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23. The Interplay of Perceived Risks and Benefits in Deciding to Become Vaccinated against COVID-19 While Pregnant or Breastfeeding: A Cross-Sectional Study in Italy.

Author

Gavaruzzi T, Caserotti M, Bonaiuti R, Bonanni P, Crescioli G, Di Tommaso M, Lombardi N, Lotto L, Ravaldi C, Rubaltelli E, Tasso A, Vannacci A, and Girardi P

Abstract

The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July-September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accepting of vaccination if they were not pregnant. COVID-19 risk perception predicted intention to become vaccinated, but not behavior. In conclusion, the overall risks/benefits tradeoff is key in predicting vaccination behavior and intention, but the concerns for the baby weigh more than those for the mother in the decision, shedding light on this previously neglected aspect.

Published
2023
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24. Acute appendicitis in a patient immunised with COVID-19 vaccine: A case report with morphological analysis.

Author

Marconi E, Crescioli G, Bonaiuti R, Pugliese L, Santi R, Nesi G, Cerbai E, Vannacci A, and Lombardi N

Subjects
Humans, Child, Female, Middle Aged, COVID-19 Vaccines adverse effects, Inflammation, Acute Disease, RNA, Messenger, Appendicitis complications, Appendicitis diagnosis, Appendicitis surgery, COVID-19 diagnosis, COVID-19 prevention & control, COVID-19 complications
Abstract

Although the benefit/risk profile for mRNA COVID-19 vaccines is recognised as extremely favourable, appendicitis is currently considered an adverse event (AE) of special interest. We describe the case of a 58-year-old female who presented with signs and symptoms of appendicitis approximately 48 hours after her first injection of the Pfizer-BioNTech vaccine. Abdominal ultrasound revealed fluid collection in the right iliac fossa and cecal wall thickening. Following the surgical visit, CT scan with contrast showed a distended appendix with thickened walls, suggestive of acute appendicitis. The patient tested negative to upper respiratory COVID-19 reverse transcription-polymerase chain reaction. Clinical trials and observational studies suggest a possible association between appendicitis and COVID-19 vaccines. Th-1 driven granulomatous inflammation reported in our case represents an infrequent nonspecific chronic inflammation of the appendix, especially in the setting of delayed or interval appendectomy. In view of the current paediatric vaccination campaign, we recommend monitoring the safety profile and potential gastrointestinal AEs associated with mRNA COVID-19 vaccines to swiftly manage subjects with gastrointestinal symptoms and prevent potential complications., (© 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Published
2023
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25. Hospitalisations Related to the Combination of ACE Inhibitors and/or Angiotensin Receptor Blockers with Diuretics and NSAIDs: A Post Hoc Analysis on the Risks Associated with Triple Whammy.

Author

Mattioli I, Bettiol A, Crescioli G, Bonaiuti R, Mannaioni G, Vannacci A, and Lombardi N

Abstract

This post hoc analysis aimed to assess and characterise adverse events (AEs) related to the triple whammy (i.e., combination therapy of ACE inhibitors, ACE-I, and/or angiotensin receptor blockers, ARBs, with diuretics and non-steroidal anti-inflammatory drugs, NSAIDs) leading to emergency department (ED) visits and/or hospitalisations in the Italian setting. The MEREAFaPS database was analysed. ED visits related to co-treatment with ACE-I and/or ARBs, diuretics, and NSAIDs were considered. Information on the AE (including classification, seriousness, and outcome), suspected and concomitant drugs, and concomitant conditions was retrieved and analysed. Logistic regression was used to estimate the reporting odds ratios (RORs) of hospitalisation associated with the drugs of interest. Between 1 January 2007, and 31 December 2018, 80 patients visited the ED for AEs related to the triple whammy, and a total of 261 suspected drugs were involved. Patients were mostly Caucasian females, with a median age of 85 years, and only 9 of them had renal manifestations. In this subset, drug-drug interaction contributed to kidney injury. Most patients presented a Charlson comorbidity index of 4-5. Overall, 47 patients were hospitalised (58.75%), but no significant differences in the risk of hospitalisation were found according to demographic, clinical, or therapeutic features.

Published
2023
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26. Hospitalisations related to benzodiazepine, Z-drug, and opioid treatment in Italy: a claim on the risks associated with inappropriate use.

Author

Mattioli I, Bettiol A, Crescioli G, Bonaiuti R, Prisco D, Mannaioni G, Lombardi N, and Vannacci A

Subjects
Analgesics, Opioid adverse effects, Emergency Service, Hospital, Female, Hospitalization, Humans, Benzodiazepines adverse effects, Substance-Related Disorders drug therapy, Substance-Related Disorders epidemiology
Abstract

Purpose: Benzodiazepines (BZD), Z-drugs (ZD), and opioids share a high risk of abuse. This study assessed and characterised adverse events (AEs) related to BDZ, ZD, and opioids leading to emergency department (ED) visits in the Italian setting., Methods: ED accesses related to BDZ, ZD, and/or opioids were analysed from the MEREAFaPS database. Information on AEs, suspected and concomitant medications was retrieved. Multivariate logistic regression was used to estimate the reporting odds ratios (RORs) of hospitalisation according to the different treatments., Results: A total of 5,970 pharmacovigilance reports involving BZD/ZD (n = 3,106), opioids (n = 2,767), or their combination (n = 97) were analysed. Compared to opioids, patients with BZD/ZD-related AEs were often younger (51 vs 64 years), more frequently presented 2+ suspected medications (13 vs 3%), and often had a history of abuse (4%). Twenty-three percent of BZD/ZD-related AEs were related to drug abuse (vs 2% of opioid-related ones) and frequently required patient hospitalisation (52% vs 24%), despite the significantly lower clinical complexity of these patients as compared to those on opioids. An increased risk of hospitalisation was found for flurazepam (ROR 1.62; 95% CI, 1.18-2.22), prazepam (2.66; 1.05-6.70), lorazepam (1.26; 1.07-1.49), and morphine (1.76; 1.11-2.79)., Conclusions: These results indicate that, in Italy, the inappropriate use of BZD/ZD is a relevant heath issue, often leading to serious AEs requiring patients' ED visits and hospitalisation, especially in young women and patients with a history of substance abuse., (© 2022. The Author(s).)

Published
2022
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27. Exclusive breastfeeding and women's psychological well-being during the first wave of COVID-19 pandemic in Italy.

Author

Ravaldi C, Mosconi L, Wilson AN, Amir LH, Bonaiuti R, Ricca V, and Vannacci A

Subjects
Communicable Disease Control, Cross-Sectional Studies, Female, Humans, Infant, Pandemics, Breast Feeding, COVID-19 epidemiology
Abstract

Background: At the onset of the COVID-19 pandemic, support for breastfeeding was disrupted in many countries. Italy was severely impacted by the pandemic and is known to have the lowest exclusive breastfeeding rate of all European countries. Considering the inverse association between anxiety and breastfeeding, maternal concerns about the COVID-19 emergency could reduce breastfeeding rates. The aim of the study is to explore the association between infant feeding practices and maternal COVID-19 concerns., Methods: This paper is a secondary analysis of the cross-sectional study COVID-ASSESS conducted in Italy in 2020. The original survey was administered in two phases: during the first lockdown and during the reopening. The survey included five sections: socio-demographic, medical history, concerns about the COVID-19 pandemic, infant feeding practices and psychometric evaluation. Participants were considered eligible for the post-hoc analyses if they were exclusively breastfeeding or they were feeding with infant formula (either alone or with breastfeeding) at the time of the interview., Results: Between phase 1 and phase 2 there was a decrease in anxiety and concerns about the danger of COVID-19 to general health, except for concerns about their baby's health. Women using formula were more concerned about all the health topics investigated. Moreover, they showed higher levels of stress, state anxiety, somatization and PTSD symptoms., Conclusion: Breastfeeding during the first pandemic lockdown in Italy seems to have been an independent factor associated with lower anxiety about COVID-19, fewer psychopathological symptoms, and a positive experience of infant feeding., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Ravaldi, Mosconi, Wilson, Amir, Bonaiuti, Ricca and Vannacci.)

Published
2022
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28. Potentially inappropriate prescribing before and after nursing home admission: a retrospective observational study in a sample of Italian nursing homes.

Author

Marconi E, Crescioli G, Bonaiuti R, Lorini C, Collini F, Pepe P, Lucenteforte E, Cavallini MC, Di Bari M, Bonaccorsi G, Vannacci A, and Lombardi N

Subjects
Humans, Aged, Calcium Channel Blockers, Antidepressive Agents, Tricyclic, Warfarin, Italy epidemiology, Nursing Homes, Anti-Inflammatory Agents, Non-Steroidal, Inappropriate Prescribing prevention & control, Opiate Alkaloids
Abstract

Objectives: to assess the occurrence of potentially inappropriate prescribing (PIP) in residents of Tuscany nursing homes (NHs) and its variation before and after NH entry., Design: retrospective observational study using data from the Regional Administrative Database of Tuscany., Setting and Participants: the study involved residents of 67 Tuscan NHs identified between 2011 and 2012. To estimate PIP prevalence before and after NH, a subset of 10 indicators of the Screening Tool of Older Person's Prescriptions (STOPP) criteria were selected., Main Outcome Measures: prevalence of PIP. RESULTS: considering 2,801 NH residents, the proportion of PIP ranged from 0.0% to 55.2% and from 0.0% to 33.9% before and after the NH admission, respectively. Overall, this study showed a decrease in the occurrence of PIP after the NH admission for most of the indicators, reaching statistical significance for indicator 3 (tricyclic antidepressants in combination with an opiate or calcium channel blockers), 7 (prescription of NSAIDs in heart failure patients), and 9 (warfarin in combination with NSAIDs)., Conclusions: although the reduction of PIP after NH admission may suggest greater awareness about the appropriateness of drug use, more efforts still need to be made.

Published
2022
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30. OBSIDIAN - real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis.

Author

Maccora I, Lombardi N, Crescioli G, Bettiol A, Bonaiuti R, Pagnini I, Maniscalco V, Marrani E, Mastrolia MV, Ravaldi C, Consolini R, Cattalini M, Vannacci A, and Simonini G

Subjects
Adalimumab adverse effects, Child, Cohort Studies, Drug Substitution methods, Etanercept adverse effects, Female, Glass, Humans, Prospective Studies, Treatment Outcome, Antirheumatic Agents adverse effects, Arthritis, Juvenile drug therapy, Biosimilar Pharmaceuticals adverse effects
Abstract

Objectives: Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting., Methods: This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar., Results: A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE)., Conclusion: Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2022
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31. STOP Pain Project-Opioid Response in Pediatric Cancer Patients and Gene Polymorphisms of Cytokine Pathways.

Author

Crescioli G, Lombardi N, Vagnoli L, Bettiol A, Giunti L, Cetica V, Coniglio ML, Provenzano A, Giglio S, Bonaiuti R, Mugelli A, Aricò M, Messeri A, Vannacci A, and Maggini V

Abstract

Moderate to severe cancer pain treatment in children is based on the use of weak and strong opioids. Pharmacogenetics play a central role in developing personalized pain therapies, as well as avoiding treatment failure and/or intolerable adverse drug reactions. This observational study aimed to investigate the association between IL-6, IL-8, and TNFα genetic single nucleotide polymorphisms (SNPs) and response to opioid therapy in a cohort of pediatric cancer patients. Pain intensity before treatment (PIt0) significantly differed according to IL-6 rs1800797 SNP, with a higher PI for A/G and G/G individuals (p = 0.017), who required a higher dose of opioids (p = 0.047). Moreover, compared to G/G subjects, heterozygous or homozygous individuals for the A allele of IL-6 rs1800797 SNP had a lower risk of having a PIt0 > 4. Dose24h and Dosetot were both higher in G/G individuals for TNFα rs1800629 (p = 0.010 and p = 0.031, respectively), while risk of having a PIt0 > 4 and a ∆VAS > 2 was higher for G/G subjects for IL-6 rs1800795 SNP compared to carriers of the C allele. No statistically significant association between genotypes and safety outcomes was found. Thus, IL-6 and TNFα SNPs could be potential markers of baseline pain intensity and opioid dose requirements in pediatric cancer patients.

Published
2022
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32. The BLOSSoM study: Burnout after perinatal LOSS in Midwifery. Results of a nation-wide investigation in Italy.

Author

Ravaldi C, Carelli E, Frontini A, Mosconi L, Tagliavini S, Cossu E, Crescioli G, Lombardi N, Bonaiuti R, Bettiol A, Facchinetti F, and Vannacci A

Subjects
Adult, Humans, Pregnancy, Burnout, Psychological, Cross-Sectional Studies, Flowers, Surveys and Questionnaires, Stillbirth psychology, Female, Burnout, Professional, Midwifery
Abstract

Background: Respectful care of bereaved parents after stillbirth plays a pivotal role in enabling the grieving process and reducing the traumatic impact of this life-changing event. Unfortunately, professionals and midwives, in particular, are often emotionally unprepared and frequently left alone when dealing with these stressful events., Aim: The BLOSSoM (Burnout after perinatal LOSS in Midwifery) study aims to address the levels of professional burnout in Italian midwives and evaluate the psychological impact of bereavement care on professionals., Methods: Web-based cross-sectional study, including socio-demographic questionnaire, survey on the knowledge of guidelines for stillbirth management and two psychometric tests: Maslach Burnout Inventory (MBI) and Impact of Event Scale - Revised (IES-R)., Findings: Of 445 female midwives, mean age 35.1 (SD 9.9), working years 11.2 (SD 10.2), 149 (33.4%) reported specific training on stillbirth and 420 (94.6%) highlighted the need for further training and support. Medium to high levels of burnout (Emotional Exhaustion) were present in 65 midwives (15.9%) with a high prevalence of Reduced Personal Accomplishment (292, 64.2%). 'Communicating the diagnosis of death' was considered the hardest task, followed by 'assisting the meeting with the baby'; 109 midwives (24.5%) reported high IES-R scores (>30), suggesting symptoms of PTSD related to stillbirth events; a good level of knowledge of guidelines favoured Personal Accomplishment (OR 0.3 [0.1 - 0.6]). The number of stillbirths assisted by midwives was not associated with burnout levels., Conclusion: Midwives are particularly at risk of developing professional burnout, as early as after five years of work, with a significant association with the psychological impact exerted by stressful events (stillbirth)., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2022
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33. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments.

Author

Crescioli G, Boscia E, Bettiol A, Pagani S, Spada G, Vighi GV, Bonaiuti R, Venegoni M, Vighi GD, Vannacci A, Lombardi N, and On Behalf Of The MEREAFaPS Study Group

Abstract

This post hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visits and hospitalization in women and men. During the study period (January 2007-December 2018), 61,855 reports of ADEs leading to ED visits were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13-176), antidepressants (ROR 1.12, CI 1.03-1.23) and antidiabetics (ROR 1.13, CI 1.02-1.24). Among men, only vitamin K antagonists (ROR 1.28, CI 1.09-1.50), opioids (ROR 1.30, CI 1.06-1.60) and digitalis glycosides (ROR 1.32, CI 1.09-1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidities were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing an adverse event following immunization (ROR 0.36, CI 0.27-0.48 and 0.83, 0.42-0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

Published
2021
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34. Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug-drug interactions.

Author

Crescioli G, Brilli V, Lanzi C, Burgalassi A, Ieri A, Bonaiuti R, Romano E, Innocenti R, Mannaioni G, Vannacci A, and Lombardi N

Subjects
Adult, Aged, Aged, 80 and over, COVID-19 epidemiology, Comorbidity, Female, Hospitalization, Humans, Italy epidemiology, Male, Middle Aged, Polypharmacy, Prevalence, Risk Factors, SARS-CoV-2, Drug Interactions, Drug-Related Side Effects and Adverse Reactions epidemiology, COVID-19 Drug Treatment
Abstract

Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug-drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients' demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.

Published
2021
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35. Risk of Hospitalization Associated with Cardiovascular Medications in the Elderly Italian Population: A Nationwide Multicenter Study in Emergency Departments.

Author

Crescioli G, Bettiol A, Bonaiuti R, Tuccori M, Rossi M, Capuano A, Pagani S, Spada G, Venegoni M, Vighi GD, Mannaioni G, Vannacci A, and Lombardi N

Abstract

Background: There is a significant gap in knowledge addressing cardiovascular (CV) medications safety in elderly. In this context, our purposes were to define clinical and pharmacological characteristics of outpatients' adverse drug events (ADEs) related to CV medications leading to emergency department (ED) visits in the elderly Italian patients according to different age groups, and to evaluate the risk of hospitalization associated to ADEs in this population. Methods: A multicentre, retrospective study was performed on reports of suspected ADEs collected between 2007-2018 in 94 EDs involved in the MEREAFaPS Study. Elderly patients who experienced one or more CV medications-related ADEs leading to ED visit were selected. Patients' characteristics, suspected (ATC classes B and C) and concomitant drugs, and ADE description were collected. Elderly patients were stratified into three age groups (65-74, 75-84, and ≥85 years) and compared to adults (18-64 years). Logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization adjusting for sex, presence of two or more suspected drugs, concomitant drugs, and one or more comorbidities. Results: Among elderly, 16,926 reports of suspected ADE related to CV medications were collected, and 6,694 (39.5%) resulted in hospitalization. Patients were mostly female, Caucasians, and middle-old (75-84). 78.9% of patients were treated with only one suspected drug, and 71.9% and 47.1% reported concomitant medications and comorbidities, respectively. Compared to adults, risk of hospitalization was significantly higher for middle-old and oldest-old patients exposed to vitamin K antagonists (1.29 [1.09-1.52] and 1.56 [1.30-187]), direct thrombin inhibitors (3.41 [1.44-8.08] and 4.12 [1.67-10.17]), antiplatelets (1.51 [1.26-1.81] and 2.09 [1.71-2.57]), and beta-blockers (1.89 [1.38-2.59 and 2.31 [1.60-3.35]). Overall, a higher risk of hospitalization was observed for renin-angiotensin system inhibitors (1.32 [1.04-1.68], 1.65 [1.32-2.06], and 2.20 [1.70-2.85]), presence of two or more concomitant drugs, and concomitant conditions. Conclusion: Our real-world findings underline relevant safety aspects of CV medications in the elderly Italian population. ED clinicians must always consider the higher risk of hospitalization related to the use of CV drugs in elderly, particularly in oldest-old ones, for antiarrhythmics, beta-blocking agents, renin-angiotensin system inhibitors, antiplatelets, and anticoagulants., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Crescioli, Bettiol, Bonaiuti, Tuccori, Rossi, Capuano, Pagani, Spada, Venegoni, Vighi, Mannaioni, Vannacci and Lombardi.)

Published
2021
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36. Risk of hospitalisation associated with benzodiazepines and z-drugs in Italy: a nationwide multicentre study in emergency departments.

Author

Lombardi N, Bettiol A, Crescioli G, Ravaldi C, Bonaiuti R, Venegoni M, Vighi GD, Mugelli A, Mannaioni G, and Vannacci A

Subjects
Female, Humans, Italy epidemiology, Male, Middle Aged, Pharmacovigilance, Retrospective Studies, Risk, Benzodiazepines adverse effects, Emergency Service, Hospital, Hospitalization statistics & numerical data, Hypnotics and Sedatives adverse effects, Prescription Drug Misuse statistics & numerical data, Substance-Related Disorders epidemiology
Abstract

Benzodiazepines (BZD) and z-drugs (ZD) are a widely prescribed group of medicines. They are often used inappropriately, and this is associated with adverse events (AEs), which may cause emergency department (ED) visits. The present study aimed to describe the characteristics of BZD and ZD related AEs leading to emergency department (ED) visit and hospitalisation in Italy, considering their plasma half-life. Ninety-two Italian EDs were monitored between 2007 and 2018. Rates of ED visit and hospitalisation were calculated. Multivariate logistic regression was used to estimate the reporting odds ratios (RORs) of hospitalisation. Univariate linear regression was performed to evaluate the ROR of hospitalisation according the plasma half-life of the suspected agents. A total of 3203 AE reports were collected. Overall, multivariate logistic regression showed that the risk of hospitalisation was higher for prazepam (3.26 [1.31-8.11]), flurazepam (1.62 [1.15-2.27]), and lorazepam (1.36 [1.15-1.61]). In the elderly, this risk was higher for prazepam (3.98 [1.03-15.3]), and lorazepam (1.58 [1.19-2.11]). Parenteral and rectal formulations were associated with a lower risk of hospitalisation compared to oral formulations. Our findings underlined the dangers in the use of BZD and ZD in Italy, particularly in women and older adults. ED clinicians must always take into account that the higher risk in terms of hospitalisation related to the use of BZD and ZD can be observed in patients treated with oral formulations, in those exposed to more than one sedative-hypnotics, and in patients exposed to compounds with intermediate or long plasma half-life.

Published
2020
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37. Blood pressure and long-term mortality in older patients: results of the Fiesole Misurata Follow-up Study.

Author

Rivasi G, Lucenteforte E, Turrin G, Balzi D, Bulgaresi M, Nesti N, Giordano A, Rafanelli M, Lombardi N, Bonaiuti R, Vannacci A, Mugelli A, Di Bari M, Masud T, and Ungar A

Subjects
Aged, Antihypertensive Agents therapeutic use, Blood Pressure drug effects, Blood Pressure Determination, Follow-Up Studies, Humans, Risk Factors, Hypertension drug therapy
Abstract

Background: Optimal blood pressure (BP) control can prevent major adverse health events, but target values are still controversial, especially in older patients with comorbidities, frailty and disability., Aims: To evaluate mortality according to BP values in a cohort of older adults enrolled in the Fiesole Misurata Study, after a 6-year follow-up., Methods: Living status as of December 31, 2016 was obtained in 385 subjects participating in the Fiesole Misurata Study. Patients' characteristics were analysed to detect predictors of mortality. At baseline, all participants had undergone office BP measurement and a comprehensive geriatric assessment., Results: After a 6-year follow-up, 97 participants had died (25.2%). After adjustment for comorbidities and comprehensive geriatric assessment, mortality was significantly lower for SBP 140-159 mmHg as compared with 120-139 mmHg (HR 0.54, 95% CI 0.33-0.89). This result was also confirmed in patients aged 75 + (HR 0.49, 95% CI 0.29-0.85), and in those with disability (HR 0.36, 95% CI 0.15-0.86) or taking antihypertensive medications (HR 0.49, 95% CI 0.28-0.86)., Discussion: An intensive BP control may lead to greater harm than benefit in older adults. Indeed, the European guidelines recommend caution in BP lowering in older patients, especially if functionally compromised, to minimize the risk of hypotension-related adverse events., Conclusions: After a 6-year follow-up, mortality risk was lower in participants with SBP 140-159 mmHg as compared with SBP 120-139 mmHg, in the overall population and in the subgroups of subjects aged 75 + , with a disability or taking anti-hypertensive medications.

Published
2020
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38. Italian translation and validation of the Perinatal Grief Scale.

Author

Ravaldi C, Bettiol A, Crescioli G, Lombardi N, Biffino M, Romeo G, Levi M, Bonaiuti R, and Vannacci A

Subjects
Adult, England, Female, Humans, Italy, Pregnancy, Reproducibility of Results, Surveys and Questionnaires, Abortion, Spontaneous psychology, Adaptation, Psychological, Fetal Death, Grief, Postpartum Period psychology, Psychometrics, Translations
Abstract

Aims: The short version of the Perinatal Grief Scale (PGS) has 33 items of Likert type whose answers vary from 1 (strongly agree) to 5 (strongly disagree), and is used to assess the grief after perinatal loss and to identify women at major need of specific support. This is the first attempt to validate an Italian version of PGS., Materials and Methods: The English version of PGS by Potvin et al. was translated into Italian by a professional mother tongue English translator. The survey was administered at 3 different times (translated Italian version; original English version after 10 days; and same Italian version after other 10 days) to 16 Italian/English bilingual women who had experienced a perinatal loss. The reproducibility among the three administrations and concordance were assessed using Cronbach's alpha and Cohen's kappa, respectively., Results: Considering the PGS, median score ranged from 74.5 (58.5-94.5) to 78 (64-95), with no significant difference among the three questionnaire administrations (p = 0.616). No significant difference emerged among the three administered questionnaires for subscales (p = 0.095, 0.410 and 0.410 for 'active grief' AG, 'difficulty in coping' DC and 'despair' D scores, respectively). Concordance varied from good to very good among all questionnaire administrations., Conclusions: This Italian version of the PGS can be used by clinicians to assess Italian women's responses to stillbirth and perinatal loss, as well as by researchers for research purposes., (© 2019 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.)

Published
2020
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39. Italian Emergency Department Visits and Hospitalizations for Outpatients' Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study).

Author

Lombardi N, Crescioli G, Bettiol A, Tuccori M, Capuano A, Bonaiuti R, Mugelli A, Venegoni M, Vighi GD, and Vannacci A

Abstract

Background: Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. Preventing ADEs and their related ED visits in outpatients remains a public health safety challenge. In this context, the aims of the present study were to describe the frequency, seriousness and preventability of outpatients' ADE-related ED visits and hospitalizations in the Italian general population, and to identify the presence of potential predictors of ADE-related hospitalization., Methods: We performed a nationwide, multicentre, observational, retrospective study based on reports of suspected ADEs collected between January 1, 2007 and December 31, 2018 in 94 EDs involved in the MEREAFaPS project. Patients' demographic characteristics, their clinical status, suspected and concomitant drugs, ADE description, and its degree of seriousness, were collected. Causality and preventability were assessed using validated algorithms, and logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization, considering the following covariates: age, sex, ethnicity, number of implicated medications, parenteral administration, presence of interaction, therapeutic error, and/or complementary and alternative medicines (CAM)., Results: Within 12 years, 61,855 reports of suspected ADE were collected, of which 18,918 (30.6%) resulted in hospitalization (ADE defined as serious). Patients were mostly female (56.6%) and Caucasians (87.7%), with a mean age of 57.5 ± 25.0 years. 58% of patients were treated with more than two drugs, and 47% of ADEs leading to hospitalization were preventable. Anticoagulants, antibiotics, and nonsteroidal anti-inflammatory drugs (NSAIDs) were the most frequently implicated agents for ED visits and/or hospitalization, which included clinically significant ADEs, such as haemorrhage for anticoagulants, moderate to severe allergic reactions for antibiotics, and dermatologic reactions and gastrointestinal disturbances for NSAIDs. Older age (1.54 [1.48-1.60]), higher number of concomitantly taken drugs (2.22 [2.14-2.31]), the presence of drug-drug interactions (1.52 [1.28-1.81]), and therapeutic error (1.54 [1.34-1.78]), were significantly associated with an increased risk of hospitalization., Conclusion: Our long-term active pharmacovigilance study in ED provided a valid estimation of ADE-related hospitalization in a representative sample of the Italian general population and can suggest further focus on medication safety in outpatients, in order to early recognise and prevent ADEs., (Copyright © 2020 Lombardi, Crescioli, Bettiol, Tuccori, Capuano, Bonaiuti, Mugelli, Venegoni, Vighi, Vannacci and the MEREAFaPS Study group.)

Published
2020
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40. Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy.

Author

Lombardi N, Crescioli G, Bettiol A, Tuccori M, Rossi M, Bonaiuti R, Ravaldi C, Levi M, Mugelli A, Ricci S, Lippi F, Azzari C, Bonanni P, and Vannacci A

Abstract

Background: The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. Methods: A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients' characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. Results: A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Conclusion: Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.

Published
2019
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41. Opioid response in paediatric cancer patients and the Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene: an Italian study on 87 cancer children and a systematic review.

Author

Lucenteforte E, Vannacci A, Crescioli G, Lombardi N, Vagnoli L, Giunti L, Cetica V, Coniglio ML, Pugi A, Bonaiuti R, Aricò M, Giglio S, Messeri A, Barale R, Giovannelli L, Mugelli A, and Maggini V

Subjects
Adolescent, Analgesics, Opioid blood, Child, Child, Preschool, Cohort Studies, Dose-Response Relationship, Drug, Female, Genotype, Humans, Infant, Infant, Newborn, Italy, Male, Morphine blood, Pain Measurement statistics & numerical data, Polymorphism, Single Nucleotide, Analgesics, Opioid administration & dosage, Cancer Pain drug therapy, Cancer Pain genetics, Catechol O-Methyltransferase genetics, Morphine administration & dosage
Abstract

Background: Genetic polymorphisms in genes involved in pain modulation have been reported to be associated to opioid efficacy and safety in different clinical settings., Methods: The association between COMT Val158Met polymorphism (rs4680) and the inter-individual differences in the response to opioid analgesic therapy was investigated in a cohort of 87 Italian paediatric patients receiving opioids for cancer pain (STOP Pain study). Furthermore, a systematic review of the association between opioid response in cancer patients and the COMT polymorphism was performed in accordance with the Cochrane Handbook and the Prisma Statement., Results: In the 87 paediatric patients, pain intensity (total time needed to reach the lowest possible level) was significantly higher for G/G than A/G and A/A carriers (p-value = 0.042). In the 60 patients treated only with morphine, the mean of total dose to reach the same pain intensity was significantly higher for G/G than A/G and A/A carriers (p-value = 0.010). Systematic review identified five studies on adults, reporting that opioid dose (mg after 24 h of treatment from the first pain measurement) was higher for G/G compared to A/G and A/A carriers., Conclusions: Present research suggests that the A allele in COMT polymorphism could be a marker of opioid sensitivity in paediatric cancer patients (STOP Pain), as well as in adults (Systematic Review), indicating that the polymorphism impact could be not age-dependent in the cancer pain context., Trial Registration: Registration number: CRD42017057831 .

Published
2019
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42. The Impact of Previous Pregnancy Loss on Lactating Behaviors and Use of Herbal Medicines during Breastfeeding: A Post Hoc Analysis of the Herbal Supplements in Breastfeeding InvesTigation (HaBIT).

Author

Bettiol A, Lombardi N, Marconi E, Crescioli G, Bonaiuti R, Maggini V, Gallo E, Mugelli A, Firenzuoli F, Ravaldi C, and Vannacci A

Abstract

Introduction: Complementary and alternative medicines (CAMs) are commonly used among lactating women, despite the poor knowledge of these products and of their safety. Perception of pregnancy- and breastfeeding-related difficulties and consequent use of CAMs may differ in bereaved women, by force of the distress related to previous loss, although no literature evidence is available. This Herbal supplements in Breastfeeding InvesTigation (HaBIT) post hoc analysis explored the impact of previous pregnancy loss on lactating behaviors and on use of CAMs during breastfeeding., Methods: A web-based survey was conducted among lactating women with no previous alive child, resident in Tuscany (Italy). Data on lactating behavior and on CAMs use were collected and evaluated among women with previous pregnancy loss as compared to control women., Results: Out of 476 women answering the questionnaire, 233 lactating women with one child were considered. Of them, 80 had history of pregnancy loss. Cesarean birth was significantly more frequent among women with history of pregnancy loss as compared to controls (41% versus 22%; p=0.004 ). Proportion, length of exclusive breastfeeding, and occurrence of breastfeeding-related complications were comparable among the two cohorts. More than half of women used CAMs during breastfeeding. Use of CAMs was more frequent among women with previous pregnancy loss (54% versus 68%; p=0.050) , specifically considering herbal preparations (16% versus 30%; p=0.018 ). Major advisors for CAMs use were midwives. 18% and 23% of women without and with history of pregnancy loss declared no clear perception on CAMs efficacy and safety., Conclusion: Overcoming the social taboo of pregnancy loss and training healthcare professionals for an adequate management of the perinatal period are essential for an effective and safe care. Despite the common use and advice on CAMs use during breastfeeding, it is important to acknowledge that limited evidence supports their safety and efficacy during such critical period.

Published
2018
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43. Stillbirth and perinatal care: Are professionals trained to address parents' needs?

Author

Ravaldi C, Levi M, Angeli E, Romeo G, Biffino M, Bonaiuti R, and Vannacci A

Subjects
Adult, Cross-Sectional Studies, Education methods, Female, Grief, Humans, Italy, Middle Aged, Midwifery education, Perinatal Care methods, Pregnancy, Social Support, Surveys and Questionnaires, Clinical Competence standards, Midwifery standards, Parents psychology, Perinatal Care standards, Stillbirth psychology
Abstract

Objective: To assess current practices of health care providers (HCPs) caring for women experiencing a stillbirth and to explore their needs for training to better support bereaved families., Design: Nationwide cross-sectional survey. The main outcome measures were the evaluation of HCPs cognition, emotions and behaviours with regard to the care of women with a stillbirth care, as well as their compliance with international guidelines., Participants: 750 HCPs, in 11 Italian hospitals, were administered a multiple-choice questionnaire., Findings: The response rate was 89.9%; the majority (94.1%) were female, with a mean age of 37.6 (SD = 10.4) years. Midwives were the most represented (72.8%). Half of the respondents recommended immediate birth; only 55% routinely bathed and dressed stillborn babies for their parents to see, while 44.4% of HCPs immediately took the babies away without allowing parents to properly say goodbye to them. More than half felt inadequate and some even reported having failed to provide support to the family when caring for a woman with stillbirth in the past. The need for professional training courses was expressed by 90.2%, and three-quarters had never previously attended a course on perinatal bereavement care. When answers by Italian HCPs are systematically evaluated with reference to international guidelines, the results were very poor with only 27.9% of respondents reported having created memories of the baby and less than 3% complied with all recommendations in the areas of respect for baby and parents, appropriate birth options, and aftercare., Key Conclusions: There is a substantial gap between the standards of care defined by international guidelines and the practices currently in place in Italy. Italian HCPs feel an urgent need to be offered professional training courses to better meet the needs of grieving families., Implication for Practice: Perinatal HCPs should be aware of their pivotal role in helping bereaved parents after stillbirth and perinatal loss, and seek appropriate training., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Published
2018
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44. The use of complementary and alternative medicines during breastfeeding: results from the Herbal supplements in Breastfeeding InvesTigation (HaBIT) study.

Author

Bettiol A, Lombardi N, Marconi E, Crescioli G, Bonaiuti R, Maggini V, Gallo E, Mugelli A, Firenzuoli F, Ravaldi C, and Vannacci A

Subjects
Adult, Complementary Therapies adverse effects, Dietary Supplements adverse effects, Female, Humans, Infant, Italy, Patient Education as Topic, Pregnancy, Surveys and Questionnaires statistics & numerical data, Breast Feeding, Complementary Therapies statistics & numerical data, Dietary Supplements statistics & numerical data, Health Knowledge, Attitudes, Practice, Lactation drug effects
Abstract

Aims: The use of complementary and alternative medicines (CAMs) during breastfeeding is increasing, mainly because of their presumed greater safety compared with conventional medications. However, CAMs can cause serious adverse effects, and there is limited high-quality evidence supporting their use during lactation. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. The Herbal supplements in Breastfeeding InvesTigation (HaBIT) study aimed to explore attitudes to and knowledge on CAMs among lactating women., Methods: A web-based survey was conducted over a 6-year period among lactating women resident in Tuscany, Italy. Data on lactating behaviour, CAMs use during pregnancy or breastfeeding, and women's knowledge about the efficacy and safety of CAMs were collected., Results: A total of 388 lactating women answered the questionnaire. The majority of them were primiparae, with a high educational level. Of these, 204 women declared themselves to have used CAMs during breastfeeding. Moreover, 61% and 48% of subjects reported also using CAMs before and during pregnancy, respectively. A significant proportion of subjects were unable to identify correctly the types of CAMs they were using. Seventy-three per cent of women were convinced that CAMs were equally safe or safer than conventional medications; nevertheless, 65% of women admitted to have no scientific information about the potential risks of CAMs, and 14 CAMs users reported that they had experienced side effects., Conclusions: These results demonstrate the need for healthcare providers to increase the awareness of breastfeeding women about CAMs. Further research is needed to support the evidence base for nonpharmaceutical approaches for symptom control during breastfeeding., (© 2018 The British Pharmacological Society.)

Published
2018
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45. A systematic review of the risk factors for clinical response to opioids for all-age patients with cancer-related pain and presentation of the paediatric STOP pain study.

Author

Lucenteforte E, Vagnoli L, Pugi A, Crescioli G, Lombardi N, Bonaiuti R, Aricò M, Giglio S, Messeri A, Mugelli A, Vannacci A, and Maggini V

Subjects
Age Factors, Biological Variation, Population, Cancer Pain diagnosis, Cancer Pain etiology, Child, Humans, Longitudinal Studies, Pain Measurement, Risk Factors, Treatment Outcome, Analgesics, Opioid therapeutic use, Cancer Pain drug therapy, Neoplasms complications
Abstract

Background: Inter-patient variability in response to opioids is well known but a comprehensive definition of its pathophysiological mechanism is still lacking and, more importantly, no studies have focused on children. The STOP Pain project aimed to evaluate the risk factors that contribute to clinical response and adverse drug reactions to opioids by means of a systematic review and a clinical investigation on paediatric oncological patients., Methods: We conducted a systematic literature search in EMBASE and PubMed up to the 24th of November 2016 following Cochrane Handbook and PRISMA guidelines. Two independent reviewers screened titles and abstracts along with full-text papers; disagreements were resolved by discussion with two other independent reviewers. We used a data extraction form to provide details of the included studies, and conducted quality assessment using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies., Results: Young age, lung or gastrointestinal cancer, neuropathic or breakthrough pain and anxiety or sleep disturbance were associated to a worse response to opioid analgesia. No clear association was identified in literature regarding gender, ethnicity, weight, presence of metastases, biochemical or hematological factors. Studies in children were lacking. Between June 2011 and April 2014, the Italian STOP Pain project enrolled 87 paediatric cancer patients under treatment with opioids (morphine, codeine, oxycodone, fentanyl and tramadol)., Conclusions: Future studies on cancer pain should be designed with consideration for the highlighted factors to enhance our understanding of opioid non-response and safety. Studies in children are mandatory., Trial Registration: CRD42017057740 .

Published
2018
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46. Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study.

Author

Lombardi N, Crescioli G, Bettiol A, Marconi E, Vitiello A, Bonaiuti R, Calvani AM, Masi S, Lucenteforte E, Mugelli A, Giovannelli L, and Vannacci A

Subjects
Adolescent, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Italy epidemiology, Male, Pharmacovigilance, Retrospective Studies, Drug-Related Side Effects and Adverse Reactions epidemiology, Emergency Service, Hospital statistics & numerical data
Abstract

Background: To describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs., Methods: A retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children's Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness., Results: Within 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27-0.61] and 0.47 [0.32-0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33-2.62] and 3.01 [2.07-4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs., Conclusion: Active surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children.

Published
2018
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48. Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy.

Author

Donati M, Conforti A, Lenti MC, Capuano A, Bortolami O, Motola D, Moretti U, Vannacci A, Rafaniello C, Vaccheri A, Arzenton E, Bonaiuti R, Sportiello L, and Leone R

Subjects
Adult, Aged, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Case-Control Studies, Chemical and Drug Induced Liver Injury etiology, Dose-Response Relationship, Drug, Female, Humans, Ibuprofen administration & dosage, Ibuprofen adverse effects, Italy epidemiology, Ketoprofen administration & dosage, Ketoprofen adverse effects, Male, Middle Aged, Multivariate Analysis, Risk, Sulfonamides administration & dosage, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Chemical and Drug Induced Liver Injury epidemiology, Sulfonamides adverse effects
Abstract

Aim: Drug-induced liver injury is one of the most serious adverse drug reactions and the most frequent reason for restriction of indications or withdrawal of drugs. Some nonsteroidal anti-inflammatory drugs (NSAIDs) were withdrawn from the market because of serious hepatotoxicity. We estimated the risk of acute and serious liver injury associated with the use of nimesulide and other NSAIDs, with a prevalence of use greater than or equal to 5%., Methods: This is a multicentre case-control study carried out in nine Italian hospitals from October 2010 to January 2014. Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders not related to chronic conditions, not involving the liver. Adjusted odds ratio (ORs) with 95% confidence interval (CI) were calculated initially with a bivariate and then multivariate analysis., Results: We included 179 cases matched to 1770 controls. Adjusted OR for acute serious liver injury associated with all NSAIDs was 1.69, 95% CI 1.21-2.37. Thirty cases were exposed to nimesulide (adjusted OR 2.10, 95% CI 1.28-3.47); the risk increased according to the length of exposure (OR > 30 days: 12.55, 95% CI 1.73-90.88) and to higher doses (OR 10.69, 95% CI 4.02-28.44). Risk of hepatotoxicity was increased also for ibuprofen, used both at recommended dosages (OR 1.92, 95% CI 1.13-3.26) and at higher doses (OR 3.73, 95% CI 1.11-12.46) and for ketoprofen ≥ 150 mg (OR 4.65, 95% CI 1.33-10.00)., Conclusion: Among all NSAIDs, nimesulide is associated with the higher risk, ibuprofen and high doses of ketoprofen are also associated with a modestly increased risk of hepatotoxicity., (© 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society.)

Published
2016
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49. Representativeness of the "Fiesole Misurata" study database for use in pharmaco-epidemiological investigations on adherence to antihypertensive medications.

Author

Lapi F, Lucenteforte E, Moschini M, Bonaiuti R, Di Pirro M, Barchielli A, Benemei S, Belladonna M, Nesti N, Coppini R, Taras M, Vannacci A, Ungar A, and Mugelli A

Subjects
Aged, Aged, 80 and over, Cardiomyopathies drug therapy, Cardiomyopathies epidemiology, Cross-Sectional Studies, Databases, Factual, Heart Failure drug therapy, Heart Failure epidemiology, Hospitalization, Humans, Italy epidemiology, Pharmacoepidemiology, Prevalence, Residence Characteristics, Stroke drug therapy, Stroke epidemiology, Antihypertensive Agents administration & dosage, Medication Adherence statistics & numerical data
Abstract

Background and Aims: Poor adherence to medications is a major health concern especially among older subjects. To plan future studies to improve adherence, an epidemiological study, called "Fiesole Misurata", was conducted. The aim of the present paper was to verify the representativeness of the database in evaluating the AntiHyperTensives (AHTs)-taking behaviour., Methods: Demographic records of all subjects aged ≥65 years (n = 2,228) living in the community of Fiesole (Florence, Italy) was retrieved from the Registry Office of Fiesole Municipality. The corresponding healthcare records were obtained from administrative archives of the Local Health Authority (claim dataset). Moreover, a cohort of subjects aged ≥65 years (n = 385) living in the community was screened by means of a multidimensional geriatric evaluation (cross-sectional dataset)., Results: In claim dataset, biyearly prevalences of hospitalization for ischemic cardiomyopathy, heart failure, and stroke were 3.7, 3.0, and 3.2%, respectively. In the cross-sectional dataset, prevalences were 11.2, 6.7, and 7.1%, respectively. The most used drugs were angiotensin-converting enzyme inhibitors (43.6% in the claim dataset, 45.3% in the cross-sectional dataset) and diuretics (35.6% and 47.0%, respectively). Among the incident users of AHTs, 63.5% was highly adherent (≥80%) over the first 6 months of follow-up, while 14.3 and 22.2% were intermediate (40-79%) and low (<40%) adherent. The percentage of high adherers decreased with time and reached 31.2% at the 24th month., Conclusions: These findings indicate that "Fiesole Misurata" study database can be used to develop future strategies aimed at improving the adherence to AHTs in older individuals.

Published
2013
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50. Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women.

Author

Levi M, Bonanni P, Burroni E, Bechini A, Boccalini S, Sani C, Bonaiuti R, Indiani L, Azzari C, Lippi F, and Carozzi F

Subjects
Adult, Early Detection of Cancer, Female, Humans, Italy, Mass Screening, Papillomavirus Infections prevention & control, Papillomavirus Infections virology, Papillomavirus Vaccines adverse effects, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms diagnosis, Uterine Cervical Neoplasms prevention & control, Vaccination, Human papillomavirus 16 immunology, Human papillomavirus 18 immunology, Papillomavirus Infections immunology, Papillomavirus Vaccines therapeutic use
Abstract

The aim of this study was to gather data on the safety of the HPV-16/18 AS04-adjuvated vaccine among women aged 25, evaluating the frequency and severity of adverse events reported after vaccination and to compare the results obtained with previously published data regarding a sample of Italian preadolescents. Every woman residing in the province of Florence and in the age group targeted by the cervical cancer screening was invited to participate. Participants registered daily, for 14 d post-vaccination, solicited local and systemic reactions, as well as unsolicited adverse events in a developed ad hoc safety diary card. Data were collected in a database in Access and analyzed using STATA 11 SE statistical software. A total of 271 participants were recruited in the study group. All three diary cards were completed and delivered by 186 subjects (85.7% of participants). In all, a total of 616 diary cards were collected: 216 after the 1st dose, 209 after the 2nd dose and 191 after the 3rd dose. No severe symptoms were registered. The most frequently reported adverse reaction proved to be pain at the site of injection (83.4% of doses), followed by local swelling (20.8%) and pyrexia (14.6%). The safety and tolerability of the HPV-16/18 AS04-adjuvated vaccine in this sample of adult women aged 25 did not differ much from that previously observed in a sample of preadolescents Italian girls. Fever and local pain were however more frequently registered in our sample of adult women.

Published
2013
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