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3. 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. Inappropriate pharmacological treatment in older adults affected by cardiovascular disease and other chronic comorbidities: a systematic literature review to identify potentially inappropriate prescription indicators

Author

Lucenteforte E, Lombardi N, Vetrano DL, La Carpia D, Mitrova Z, Kirchmayer U, Corrao G, Lapi F, Mugelli A, and Vannacci A

Subjects
inappropriate prescriptions, elderly, cardiovascular diseases, chronic diseases, systematic review, Geriatrics, RC952-954.6
Abstract

Ersilia Lucenteforte,1 Niccolò Lombardi,1,* Davide Liborio Vetrano,2,* Domenico La Carpia,2,* Zuzana Mitrova,3 Ursula Kirchmayer,3 Giovanni Corrao,4 Francesco Lapi,5 Alessandro Mugelli,1 Alfredo Vannacci1 On behalf of the Italian Group for Appropriate Drug prescription in the Elderly (I-GrADE) 1Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy; 2Department of Geriatrics Catholic University, Rome, Italy; 3Department of Epidemiology, ASL 1 Rome, Italy; 4Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; 5Epidemiology Unit, ARS Toscana, Florence, Italy *These authors contributed equally to this work Abstract: Avoiding medications in which the risks outweigh the benefits in the elderly patient is a challenge for physicians, and different criteria to identify inappropriate prescription (IP) exist to aid prescribers. Definition of IP indicators in the Italian geriatric population affected by cardiovascular disease and chronic comorbidities could be extremely useful for prescribers and could offer advantages from a public health perspective. The purpose of the present study was to identify IP indicators by means of a systematic literature review coupled with consensus criteria. A systematic search of PubMed, EMBASE, and CENTRAL databases was conducted, with the search structured around four themes and combining each with the Boolean operator “and”. The first regarded “prescriptions”, the second “adverse events”, the third “cardiovascular conditions”, and the last was planned to identify studies on “older people”. Two investigators independently reviewed titles, abstracts, full texts, and selected articles addressing IP in the elderly affected by cardiovascular condition using the following inclusion criteria: studies on people aged ≥65 years; studies on patients with no restriction on age but with data on subjects aged ≥65 years; and observational effectiveness studies. The database searches produced 5,742 citations. After removing duplicates, titles and abstracts of 3,880 records were reviewed, and 374 full texts were retrieved that met inclusion criteria. Thus, 49 studies reporting 32 potential IP indicators were included in the study. IP indicators regarded mainly drug–drug interactions, cardio- and cerebrovascular risk, bleeding risk, and gastrointestinal risk; among them, only 19 included at least one study that showed significant results, triggering a potential warning for a specific drug or class of drugs in a specific context. This systematic review demonstrates that both cardiovascular and non-cardiovascular drugs increase the risk of adverse drug reactions in older adults with cardiovascular diseases. Keywords: inappropriate prescriptions, elderly, cardiovascular diseases, chronic diseases, systematic review

Published
2017

10. Non-alcoholic fatty liver disease and the risk of fibrosis in Italian primary care services: GPS-NAFLD Study

Author

Miele, Luca, Grattagliano, I., Lapi, F., Dajko, M., De Magistris, A., Liguori, Antonio, De Matthaeis, Nicoletta, Rossi, A., Gasbarrini, Antonio, Cricelli, Claudio, Grieco, Antonio, Miele L. (ORCID:0000-0003-3464-0068), Liguori A., De Matthaeis N., Gasbarrini A. (ORCID:0000-0002-7278-4823), Cricelli C., Grieco A. (ORCID:0000-0002-0544-8993), Miele, Luca, Grattagliano, I., Lapi, F., Dajko, M., De Magistris, A., Liguori, Antonio, De Matthaeis, Nicoletta, Rossi, A., Gasbarrini, Antonio, Cricelli, Claudio, Grieco, Antonio, Miele L. (ORCID:0000-0003-3464-0068), Liguori A., De Matthaeis N., Gasbarrini A. (ORCID:0000-0002-7278-4823), Cricelli C., and Grieco A. (ORCID:0000-0002-0544-8993)

Abstract

Background and aims: The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing globally. This study aimed to determine the prevalence of NAFLD and the probability of liver fibrosis in Italian primary care services. Methods: We carried out a population-based and nested case–control study including all individuals aged 18 years and above registered at Italian primary care services. Data were collected from the general practitioners' network from 2010 to 2017. NAFLD cases were identified via the ICD-9-CM and Hepatic Steatosis Index score > 36 and were matched each up to 10 controls. Other causes of liver diseases were excluded. The risk of fibrosis was assessed using the FIB-4 and NAFLD fibrosis scores (NFS). Results: NAFLD was present in 9% of the primary care population with high regional variability. Among NAFLD subjects: 25% had diabetes, 10% had chronic kidney disease, 11% had cardiovascular disease and 28% were obese. Furthermore, 30% had at least two comorbidities and 13% had cirrhosis. Once cirrhosis was excluded, the risk of any degree of fibrosis was 13.8% with NFS and 20.5% with FIB-4 in subjects <65 years. Conclusions: Even if there is an identification gap in primary care, recorded cases with NAFLD have a high frequency of associated comorbidities. Despite regional variability, a close relation between cirrhosis and NAFLD exists (OR: 3.48, 95% CI: 3.23–3.76). Therefore, the use of non-invasive tests should be promoted in primary care as a useful tool for the early identification of fibrosis risk, independently of evidence of steatosis.

Published
2022

12. All-cause mortality and antipsychotic use among elderly persons with high baseline cardiovascular and cerebrovascular risk: a multi-center retrospective cohort study in Italy

Author

Sultana J., Giorgianni F., REA, FEDERICO, Lucenteforte E., Lombardi N., Mugelli A., Vannacci A., Liperoti R., Kirchmayer U., Vitale C., Chinellato A., Roberto G., Corrao G., Trifiro G., Agabiti N., Bartolini C., Bernabei R., Bettiol A., Bonassi S., Caputi A. P., Cascini S., Cipriani F., Davoli M., Fini M., Gini R., Lapi F., Onder G., Sorge C., Tari M., Vetrano D. L., Sultana, J, Giorgianni, F, Rea, F, Lucenteforte, E, Lombardi, N, Mugelli, A, Vannacci, A, Liperoti, R, Kirchmayer, U, Vitale, C, Chinellato, A, Roberto, G, Corrao, G, Trifiro, G, Agabiti, N, Bartolini, C, Bernabei, R, Bettiol, A, Bonassi, S, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Lapi, F, Onder, G, Sorge, C, Tari, M, and Vetrano, D

Subjects
Male, Pediatrics, medicine.medical_treatment, Toxicology, 030226 pharmacology & pharmacy, Cohort Studies, Antipsychotic, 0302 clinical medicine, Retrospective Studie, Risk Factors, Cardiovascular Disease, 80 and over, Antipsychotics, Medicine, Drug Interactions, Aged, 80 and over, Incidence, Incidence (epidemiology), General Medicine, Italy, Cardiovascular Diseases, 030220 oncology & carcinogenesis, Cerebrovascular Disorder, Female, cohort study, drug interactions, elderly, mortality, Antipsychotic Agents, Human, Cohort study, medicine.medical_specialty, 03 medical and health sciences, Elderly persons, Humans, Cerebrovascular risk, Proportional Hazards Models, Retrospective Studies, Aged, Pharmacology, drug interaction, urogenital system, business.industry, Proportional hazards model, Settore MED/09 - MEDICINA INTERNA, Retrospective cohort study, equipment and supplies, Cerebrovascular Disorders, Antipsychotic Agent, Proportional Hazards Model, Cohort Studie, business, All cause mortality
Abstract

Background: Little is known about the comparative risk of death with atypical or conventional antipsychotics (APs) among persons with cardiovascular or cerebrovascular disease (CCD). Research design and methods: A cohort study was conducted using five Italian claims databases. New atypical AP users with CCD aged ≥65 (reference) were matched to new conventional AP users. Mortality per 100 person-years (PYs) and hazard ratios (HR), estimated using Cox models, were reported. Incidence and risk of death were estimated for persons having drug–drug interactions. Outcome occurrence was evaluated 180 days after AP initiation. Results: Overall 24,711 and 27,051 elderly new conventional and atypical AP users were identified. The mortality rate was 51.3 and 38.5 deaths per 100 PYs for conventional and atypical AP users. Mortality risk was 1.33 (95%CI: 1.27–1.39) for conventional APs. There was no increased mortality risk with single drug–drug interactions (DDIs) vs. no DDI. AP users with ≥1 DDI had a 29% higher mortality risk compared to no DDI in the first 90 days of treatment (HR: 1.29 (95% CI: 1.00–1.67)). Conclusions: Conventional APs had a higher risk of death than atypical APs among elderly persons with CCD. Having ≥1 DDI was associated with an increased risk of death.

Published
2019
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14. 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

17. All-cause mortality and antipsychotic use among elderly persons with high baseline cardiovascular and cerebrovascular risk: a multi-center retrospective cohort study in Italy

Author

Sultana, J, Giorgianni, F, Rea, F, Lucenteforte, E, Lombardi, N, Mugelli, A, Vannacci, A, Liperoti, R, Kirchmayer, U, Vitale, C, Chinellato, A, Roberto, G, Corrao, G, Trifiro, G, Agabiti, N, Bartolini, C, Bernabei, R, Bettiol, A, Bonassi, S, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Lapi, F, Onder, G, Sorge, C, Tari, M, Vetrano, D, Sultana J., Giorgianni F., REA, FEDERICO, Lucenteforte E., Lombardi N., Mugelli A., Vannacci A., Liperoti R., Kirchmayer U., Vitale C., Chinellato A., Roberto G., Corrao G., Trifiro G., Agabiti N., Bartolini C., Bernabei R., Bettiol A., Bonassi S., Caputi A. P., Cascini S., Cipriani F., Davoli M., Fini M., Gini R., Lapi F., Onder G., Sorge C., Tari M., Vetrano D. L., Sultana, J, Giorgianni, F, Rea, F, Lucenteforte, E, Lombardi, N, Mugelli, A, Vannacci, A, Liperoti, R, Kirchmayer, U, Vitale, C, Chinellato, A, Roberto, G, Corrao, G, Trifiro, G, Agabiti, N, Bartolini, C, Bernabei, R, Bettiol, A, Bonassi, S, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Lapi, F, Onder, G, Sorge, C, Tari, M, Vetrano, D, Sultana J., Giorgianni F., REA, FEDERICO, Lucenteforte E., Lombardi N., Mugelli A., Vannacci A., Liperoti R., Kirchmayer U., Vitale C., Chinellato A., Roberto G., Corrao G., Trifiro G., Agabiti N., Bartolini C., Bernabei R., Bettiol A., Bonassi S., Caputi A. P., Cascini S., Cipriani F., Davoli M., Fini M., Gini R., Lapi F., Onder G., Sorge C., Tari M., and Vetrano D. L.

Abstract

Background: Little is known about the comparative risk of death with atypical or conventional antipsychotics (APs) among persons with cardiovascular or cerebrovascular disease (CCD). Research design and methods: A cohort study was conducted using five Italian claims databases. New atypical AP users with CCD aged ≥65 (reference) were matched to new conventional AP users. Mortality per 100 person-years (PYs) and hazard ratios (HR), estimated using Cox models, were reported. Incidence and risk of death were estimated for persons having drug–drug interactions. Outcome occurrence was evaluated 180 days after AP initiation. Results: Overall 24,711 and 27,051 elderly new conventional and atypical AP users were identified. The mortality rate was 51.3 and 38.5 deaths per 100 PYs for conventional and atypical AP users. Mortality risk was 1.33 (95%CI: 1.27–1.39) for conventional APs. There was no increased mortality risk with single drug–drug interactions (DDIs) vs. no DDI. AP users with ≥1 DDI had a 29% higher mortality risk compared to no DDI in the first 90 days of treatment (HR: 1.29 (95% CI: 1.00–1.67)). Conclusions: Conventional APs had a higher risk of death than atypical APs among elderly persons with CCD. Having ≥1 DDI was associated with an increased risk of death.

Published
2019

23. The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Author

Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G20, Vannacci, A, Mantovani, L, Corrao, G, Trifirò, Gianluca, Trifiro G., Gini R., Barone-Adesi F., Beghi E., Cantarutti A., Capuano A., Carnovale C., Clavenna A., Dellagiovanna M., Ferrajolo C., Franchi M., Ingrasciotta Y., Kirchmayer U., Lapi F., Leone R., Leoni O., Lucenteforte E., Moretti U., Mugelli A., Naldi L., Poluzzi E., Rafaniello C., Rea F., Sultana J., Tettamanti M., Traversa G., Vannacci A., Mantovani L., Corrao G., Trifirò, Gianluca, Gini, Rosa, Barone-Adesi, Francesco, Beghi, Ettore, Cantarutti, Anna, Capuano, Annalisa, Carnovale, Carla, Clavenna, Antonio, Dellagiovanna, Mirosa, Ferrajolo, Carmen, Franchi, Matteo, Ingrasciotta, Ylenia, Kirchmayer, Ursula, Lapi, Francesco, Leone, Roberto, Leoni, Olivia, Lucenteforte, Ersilia, Moretti, Ugo, Mugelli, Alessandro, Naldi, Luigi, Poluzzi, Elisabetta, Rafaniello, Concita, Rea, Federico, Sultana, Janet, Tettamanti, Mauro, Traversa, Giuseppe, Vannacci, Alfredo, Mantovani, Lorenzo, Corrao, Giovanni, Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G, Vannacci, A, Mantovani, L, and Corrao, G

Subjects
Drug, Value (ethics), Pharmacovigilance, Drug Toxicity, spontaneous reporting, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, National Health Programs, media_common.quotation_subject, National Health Program, MEDLINE, spontaneous reporting, Information Storage and Retrieval, Disease, Toxicology, computer.software_genre, 030226 pharmacology & pharmacy, Pharmacovigilance, 03 medical and health sciences, Pharmacology, Pharmacology (medical), 0302 clinical medicine, Drug Utilization Review, Drug Toxicity, Health care, Product Surveillance, Postmarketing, Medicine, Electronic Health Records, 030212 general & internal medicine, media_common, Database, business.industry, Health technology, Italy, Observational study, Electronic Health Record, business, Drug-Related Side Effects and Adverse Reaction, computer
Abstract

Enormous progress has been made globally in the use of evidence derived from patients’ clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas.

Published
2018

25. Vascular and metabolic risk factor differences prior to dementia diagnosis: a multidatabase case-control study using European electronic health records

Author

Perera, G. (Gayan), Rijnbeek, P.R. (Peter), Alexander, M. (Myriam), Ansell, D. (David), Avillach, P. (Paul), Duarte-Salles, T. (Talita), Gordon, M.F. (Mark Forrest), Lapi, F. (Francesco), Mayer, M.A. (M.), Pasqua, A. (Alessandro), Pedersen, L. (Lars), Lei, J. (Johan) van der, Visser, P.J. (Pieter Jelle), Stewart, R.J. (Robert J.), Perera, G. (Gayan), Rijnbeek, P.R. (Peter), Alexander, M. (Myriam), Ansell, D. (David), Avillach, P. (Paul), Duarte-Salles, T. (Talita), Gordon, M.F. (Mark Forrest), Lapi, F. (Francesco), Mayer, M.A. (M.), Pasqua, A. (Alessandro), Pedersen, L. (Lars), Lei, J. (Johan) van der, Visser, P.J. (Pieter Jelle), and Stewart, R.J. (Robert J.)

Abstract

OBJECTIVE: The objective of the study is to compare body mass index (BMI), systolic/diastolic blood pressure (SBP/DBP) and serum total cholesterol levels between dementia cases and controls at multiple time intervals prior to dementia onset, and to test time interval as a modifying factor for these associations. DESIGN: Case-control study. SETTING: Six European electronic health records databases. PARTICIPANTS: 291 780 cases at the date of first-recorded dementia diagnosis, compared with 29 170 549 controls randomly selected from the same databases, age matched and sex matched at this index date. EXPOSURE: The following measures were extracted whenever recorded within each dataset: BMI (kg/m2), SBP and DBP (mm Hg) and serum total cholesterol (mmol/L). Levels for each of these variables were defined within six 2-year time intervals over the 12 years prior to the index date. MAIN OUTCOMES: Case-control differences in exposures of interest were modelled for each time period and adjusted for demographic and clinical factors (ischaemic/unspecified stroke, type 2 diabetes mellitus, acute myocardial infarction, hypertension diagnosis, antihypertensive medication, cholesterol-lowering medication). Coefficients and interactions with time period were meta-analysed across the six databases. RESULTS: Mean BMI (coefficient -1.16 kg/m2; 95% CI -1.38 to 0.93) and SBP (-2.83 mm Hg; 95% CI -4.49 to -1.16) were lower in cases at diagnosis, and case-control differences were greater in more recent time periods, as indicated by significant case-x-time interaction and case-x-time-squared interaction terms. Time variations in coefficients for cholesterol levels were less consistent between databases and those for DBP were largely not significant. CONCLUSION: Routine clinical data show emerging divergence in levels of BMI and SBP prior to the diagnosis of dementia but less evidence for DBP or total cholesterol levels. These divergences should receive at least some consideration in routine

Published
2020
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26. Impact of risk minimisation measures on the use of strontium ranelate in Europe : a multi-national cohort study in 5 EU countries by the EU-ADR Alliance

Author

Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

Published
2020

27. Incidence, risk factors and re-exacerbation rate of severe asthma exacerbations in a multinational, multidatabase pediatric cohort study

Author

Engelkes, M. (Marjolein), Baan, E.J. (Esme J.), Ridder, M.A.J. (Maria) de, Svensson, E. (Elisabeth), Prieto-Alhambra, D. (Daniel), Lapi, F. (Francesco), Giaquinto, C. (Carlo), Picelli, G. (Gino), Boudiaf, N. (Nada), Albers, F. (Frank), Evitt, L.A. (Lee A.), Cockle, S. (Sarah), Bradford, E. (Eric), Van Dyke, M.K. (Melissa K.), Suruki, R. (Robert), Rijnbeek, P.R. (Peter), Sturkenboom, M.C.J.M. (Miriam), Janssens, H.M. (Hettie), Verhamme, K.M.C. (Katia), Engelkes, M. (Marjolein), Baan, E.J. (Esme J.), Ridder, M.A.J. (Maria) de, Svensson, E. (Elisabeth), Prieto-Alhambra, D. (Daniel), Lapi, F. (Francesco), Giaquinto, C. (Carlo), Picelli, G. (Gino), Boudiaf, N. (Nada), Albers, F. (Frank), Evitt, L.A. (Lee A.), Cockle, S. (Sarah), Bradford, E. (Eric), Van Dyke, M.K. (Melissa K.), Suruki, R. (Robert), Rijnbeek, P.R. (Peter), Sturkenboom, M.C.J.M. (Miriam), Janssens, H.M. (Hettie), and Verhamme, K.M.C. (Katia)

Abstract

Background: There are sparse real-world data on severe asthma exacerbations (SAE) in children. This multinational cohort study assessed the incidence of and risk factors for SAE and the incidence of asthma-related rehospitalization in children with asthma. Methods: Asthma patients 5-17 years old with ≥1 year of follow-up were identified in six European electronic databases from the Netherlands, Italy, the UK, Denmark and Spain in 2008-2013. Asthma was defined as ≥1 asthma-specific disease code within 3 months of prescriptions/dispensing of asthma medication. Severe asthma was defined as high-dosed inhaled corticosteroids plus a second controller. SAE was defined by systemic corticosteroids, emergency department visit and/or hospitalization all for reason of asthma. Risk factors for SAE were estimated by Poisson regression analyses. Results: The cohort consisted of 212 060 paediatric asthma patients contributing to 678 625 patient-years (PY). SAE rates ranged between 17 and 198/1000 PY and were higher in severe asthma and highest in severe asthma patients with a history of exacerbations. Prior SAE (incidence rate ratio 3-45) and younger age increased the SAE risk in all countries, whereas obesity, atopy and GERD were a risk factor in some but not all countries. Rehospitalization rates were up to 79% within 1 year. Conclusions: In a real-world setting, SAE rates were highest in children with severe asthma with a history of exacerbations. Many severe asthma patients were rehospitalized within 1 year. Asthma management focusing on prevention of SAE is important to reduce the burden of asthma.

Published
2020
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28. PREVALENCE OF ADVANCED LIVER FIBROSIS AMONG PRIMARY CARE PATIENTS WITH NAFLD. RESULTS FROM GENERAL PRACTITIONER DATABASE NAFLD (GPS-NAFLD) STUDY

Author

Miele, L, Lapi, F, Grattagliano, I, Liguori, A, Dajko, M, Marrone, G, Biolato, M, Napodano, C, De Magistris, A, Rapaccini, G, Rossi, A, Gasbarrini, A, Cricelli, C, Grieco, A, Miele, L (ORCID:0000-0003-3464-0068), Napodano, C (ORCID:0000-0002-8720-6284), Rapaccini, G (ORCID:0000-0002-6467-857X), Gasbarrini, A (ORCID:0000-0002-7278-4823), Miele, L, Lapi, F, Grattagliano, I, Liguori, A, Dajko, M, Marrone, G, Biolato, M, Napodano, C, De Magistris, A, Rapaccini, G, Rossi, A, Gasbarrini, A, Cricelli, C, Grieco, A, Miele, L (ORCID:0000-0003-3464-0068), Napodano, C (ORCID:0000-0002-8720-6284), Rapaccini, G (ORCID:0000-0002-6467-857X), and Gasbarrini, A (ORCID:0000-0002-7278-4823)

Abstract

N/A

Published
2020

29. Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance

Author

Global Health, JC onderzoeksprogramma Infectieziekten, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Global Health, JC onderzoeksprogramma Infectieziekten, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

Published
2020

30. Incidence, risk factors and re-exacerbation rate of severe asthma exacerbations in a multinational, multidatabase pediatric cohort study

Author

Engelkes, Marjolein, Baan, Esmé, de Ridder, Maria, Svensson, E, Prieto-Alhambra, D, Lapi, F, Giaquinto, C, Picelli, G, Boudiaf, N, Albers, F, Evitt, LA, Cockle, S, Bradford, E, Van Dyke, MK, Suruki, R, Rijnbeek, Peter, Sturkenboom, M, Janssens, Hettie, Verhamme, Katia, Engelkes, Marjolein, Baan, Esmé, de Ridder, Maria, Svensson, E, Prieto-Alhambra, D, Lapi, F, Giaquinto, C, Picelli, G, Boudiaf, N, Albers, F, Evitt, LA, Cockle, S, Bradford, E, Van Dyke, MK, Suruki, R, Rijnbeek, Peter, Sturkenboom, M, Janssens, Hettie, and Verhamme, Katia

Published
2020

31. Vascular and metabolic risk factor differences prior to dementia diagnosis: A multidatabase case-control study using European electronic health records

Author

Perera, G, Rijnbeek, Peter, Alexander, M, Ansell, D, Avillach, P, Duarte-Salles, T, Gordon, MF, Lapi, F, Mayer, MA, Pasqua, A, Pedersen, L, Lei, Johan, Visser, PJW (Pieter-Jan), Stewart, R, Perera, G, Rijnbeek, Peter, Alexander, M, Ansell, D, Avillach, P, Duarte-Salles, T, Gordon, MF, Lapi, F, Mayer, MA, Pasqua, A, Pedersen, L, Lei, Johan, Visser, PJW (Pieter-Jan), and Stewart, R

Published
2020

32. Correction to:: Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance (Osteoporosis International, (2019), 10.1007/s00198-019-05181-6)

Author

Epi Methoden Team 2, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Gutthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Epi Methoden Team 2, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Gutthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

Published
2020

33. Multimorbidity and polypharmacotherapy in Italian primary care patients with NAFLD: General Practitioner databaSe NAFLD (GPS-NAFLD) Study

Author

Miele, L., primary, Cricelli, C., additional, Lapi, F., additional, Grattagliano, I., additional, Dajko, M., additional, Liguori, A., additional, De Magistris, A., additional, Napodano, C., additional, Marrone, G., additional, Biolato, M., additional, Rossi, A., additional, Rapaccini, G., additional, Grieco, A., additional, and Gasbarrini, A., additional

Published
2021
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35. General Practitioner databaSe NAFLD (GPS-NAFLD) Study: prevalence of advanced liver fibrosis among Italian primary care patients with NAFLD

Author

Miele, L., primary, Cricelli, C., additional, Lapi, F., additional, Grattagliano, I., additional, Dajko, M., additional, Liguori, A., additional, De Magistris, A., additional, Napodano, C., additional, Rossi, A., additional, Rapaccini, G., additional, Gasbarrini, A., additional, and Grieco, A., additional

Published
2021
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39. Adherence of Elderly Patients with Cardiovascular Disease to Statins and the Risk of Exacerbation of Chronic Obstructive Pulmonary Disease: Evidence from an Italian Real-World Investigation

Author

Rea, F, Calusi, G, Franchi, M, Vetrano, Dl, Roberto, G, Bonassi, S, Kirchmayer, U, Chinellato, A, Bettiol, A, Sultana, J, Mugelli, A, Corrao, G, Agabiti, N, Bartolini, C, Bernabei, Rita, Caputi, Ap, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Giorgianni, F, Lapi, F, Lombardi, N, Lucenteforte, E, Onder, G, Sorge, C, Tari, M, Trifirò, G, Vannacci, A, Vitale, C., Rea, F, Calusi, G, Franchi, M, Vetrano, D, Borloni, R, Bonassi, S, Kirchmayer, U, Chinellato, A, Bettiol, A, Sultana, J, Mugelli, A, Corrao, G, Agabiti, N, Bartolini, C, Bernabei, R, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Giorgianni, F, Lapi, F, Lombardi, N, Lucenteforte, E, Onder, G, Sorge, C, Tari, M, Trifirò, G, Vannacci, A, and Vitale, C

Subjects
Male, medicine.medical_specialty, Exacerbation, Disease, Lower risk, Medication Adherence, Geriatrics and Gerontology, Pharmacology (medical), Cohort Studies, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Internal medicine, Medicine, Humans, 030212 general & internal medicine, Aged, Aged, 80 and over, Cardiovascular Diseases, Female, Hospitalization, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Italy, Proportional Hazards Models, business.industry, Proportional hazards model, Hazard ratio, Confidence interval, 030228 respiratory system, Cohort, business, Cohort study
Abstract

Objective: The objective of this study was to investigate the relationship between adherence to statin therapy and the risk of exacerbation among elderly individuals affected by chronic obstructive pulmonary disease and cardiovascular disease. Methods: Using the healthcare utilisation databases of five Italian territorial units accounting for nearly 35% of the Italian population, we recruited a cohort of 6263 elderly persons (i.e. aged 65 years or older) with co-existing chronic obstructive pulmonary disease and cardiovascular disease who initiated statin therapy. Exposure was adherence to statins measured by the proportion of days of follow-up covered. Outcome was the first hospital admission for chronic obstructive pulmonary disease occurring in the period of observation. A proportional hazards model was used to estimate the hazard ratio and 95% confidence intervals for the exposure–outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty. Results: During an average follow-up of about 4 years, 1307 cohort members experienced the outcome. Compared with patients with low adherence (proportion of days of follow-up covered ≤ 40%), those with intermediate (proportion of days of follow-up covered 41–80%) and high (proportion of days of follow-up covered > 80%) adherence exhibited a lower risk of exacerbation of 16% (95% confidence interval 3–27) and 23% (95% confidence interval 10–34). Conclusions: In a real-world setting, we observed evidence that adherence to statin therapy markedly reduced the risk of chronic obstructive pulmonary disease exacerbations in elderly patients with co-existing chronic obstructive pulmonary disease and cardiovascular disease. Given the limited and controversial evidence from trials, more randomised controlled trials are urgently needed to better examine the potential benefits of statins as adjunct therapy in chronic obstructive pulmonary disease.

Published
2018

40. NSAIDs utilization for musculoskeletal indications in elderly patients with cerebro/cardiovascular disease

Author

Roberto, G., Bartolini, C., Rea, Federico, Onder, G., Vitale, C., Trifirò, G., Kirchmayer, U., Chinellato, A., Lucenteforte, E., Corrao, G., Mugelli, A., Lapi, F., Gini, R., Agabiti, N., Bernabei, R., Bettiol, A., Bonassi, S., Caputi, A. P., Cascini, S., Davoli, M., Fini Storchi, Marco, Giorgianni, F., Lombardi, N., Rea, F., Sorge, C., Tari, M., Vannacci, A., Vetrano, D. L., Vitale, Claudia, Roberto, G, Bartolini, C, Rea, F, Onder, G, Vitale, C, Trifirò, G, Kirchmayer, U, Chinellato, A, Lucenteforte, E, Corrao, G, Mugelli, A, Lapi, F, Gini, R, On Behalf Of The Italian Group For Appropriate Drug Prescription In The Elderly (I-Grade): Agabiti, N, Bernabei, R, Bettiol, A, Bonassi, S, Caputi, A, Cascini, S, Davoli, M, Fini, M, Giorgianni, F, Lombardi, N, Sorge, C, Tari, M, Vannacci, A, and Vetrano, D

Subjects
Drug Utilization, medicine.medical_specialty, Diclofenac, Pharmacoepidemiology and Prescription, NSAIDs, Population, Psychological intervention, Cardiovascular risk Coxibs Diclofenac Drug utilization Elderly NSAIDs, Disease, 030204 cardiovascular system & hematology, Coxib, 03 medical and health sciences, 0302 clinical medicine, Elderly, Internal medicine, medicine, Coxibs, Drug utilization, Humans, Pharmacology (medical), Musculoskeletal Diseases, 030212 general & internal medicine, Medical prescription, education, Aged, Aged, 80 and over, Pharmacology, education.field_of_study, business.industry, Anti-Inflammatory Agents, Non-Steroidal, General Medicine, Cardiovascular risk, NSAID, Cardiovascular Diseases, Cohort, Female, business, Nimesulide, medicine.drug
Abstract

Objectives To describe NSAID utilization for musculoskeletal conditions in a large cohort of Italian elderly with cerebro/cardiovascular disease, a population in which NSAIDs should be generally avoided due to the prothrombotic potential. Methods Administrative data from five Italian geographic areas were analyzed. Patients aged ≥ 65 with a cerebro/cardiovascular event recorded between 2008 and 2011 (cohort entry) were selected. Prescription NSAIDs reimbursed for musculoskeletal conditions and dispensed during 1 year follow-up were retrieved to describe (i) prevalence of use, (ii) average amount of defined daily doses of NSAIDs claimed by users per day of follow-up, and (iii) distribution of the received daily dose (RDD) among patients with ≥ 2 dispensings. Among new users, i.e., patients without NSAID dispensings during 2 years before cohort entry, the first dispensed NSAID molecule was observed. Results Overall, 511,989 patients were selected. Across the five geographic areas, prevalence of use ranged from 48 to 21% and average consumption ranged between 30 and 67 DDD/1000 users/day. Around 10% of patients in the overall cohort had a RDD > 1. Nimesulide (9.6%) and diclofenac (7.5%) had the highest prevalence of use. The most consumed NSAIDs were nimesulide and coxibs with 10.6 and 7.5 DDD/1000 users/day, respectively. Among new users recruited in 2011, 30% had diclofenac or a coxibs as the first prescription. Conclusions NSAID use was common in the study cohort, particularly in central-southern areas. In contrast with current recommendations, coxibs and diclofenac were among the most prescribed active principles, even in new users. Interventions to promote appropriateness of use are warranted. Electronic supplementary material The online version of this article (10.1007/s00228-018-2411-y) contains supplementary material, which is available to authorized users.

Published
2018

41. The Burden of Chronic Heart Failure in Primary Care in Italy

Author

Piccinni, C, Antonazzo, I, Simonetti, M, Mennuni, M, Parretti, D, Cricelli, C, Colombo, D, Nica, M, Cricelli, I, Lapi, F, Piccinni C., Antonazzo I. C., Simonetti M., Mennuni M. G., Parretti D., Cricelli C., Colombo D., Nica M., Cricelli I., Lapi F., Piccinni, C, Antonazzo, I, Simonetti, M, Mennuni, M, Parretti, D, Cricelli, C, Colombo, D, Nica, M, Cricelli, I, Lapi, F, Piccinni C., Antonazzo I. C., Simonetti M., Mennuni M. G., Parretti D., Cricelli C., Colombo D., Nica M., Cricelli I., and Lapi F.

Abstract

Introduction: Chronic heart failure (CHF) is a major public health concern. From a public health perspective, the epidemiology of CHF needs to be distinguished from that of its related acute form. Data stemming from primary care are crucial to better know and update the prevalence and incidence rates of CHF. Aim: To update the epidemiology of CHF in an Italian primary care setting and to describe socio-demographic, lifestyle, and clinical characteristics of these patients. Methods: A population-based study was conducted among 800 Italian general practitioners collecting data in a dedicated database. Information was extracted from adult subjects with a diagnosis of CHF from 2002 to 2013, and the prevalence and incidence rate of CHF were calculated. The study population was described in terms of socio-demographic, lifestyle, and clinical characteristics. Results: A total of 13,633 patients with CHF were identified. Overall, the prevalence of CHF was 1.25% (95% CI 1.23–1.27), and the incidence rate was 1.99 per 1000 person-years (95% CI 1.81–2.08). In this population, smoking, alcohol use, and obesity were present in 2.93, 0.45, and 10.80% of cases, respectively. Hypertension (58.40%), chronic kidney disease (51.36%), dyslipidaemia (44.62%), ischaemic heart disease (25.75%), and atrial fibrillation (25.32%) were the most represented comorbidities. Conclusion: This study provides an updated epidemiological scenario of CHF in a primary care setting in Italy. These data may be useful to weight the social and economic impact of CHF and to plan strategies for improving the clinical care of CHF in general practice.

Published
2017

42. Assessing Risk of Osteoporotic Fractures in Primary Care: Development and Validation of the FRA-HS Algorithm

Author

Lapi, F, Bianchini, E, Michieli, R, Pasqua, A, Cricelli, I, Mazzaglia, G, Frediani, B, Prieto-Alhambra, D, Brandi, M, Cricelli, C, Lapi F, Bianchini E, Michieli R, Pasqua A, Cricelli I, Mazzaglia G, Frediani B, Prieto-Alhambra D, Brandi ML, Cricelli C, Lapi, F, Bianchini, E, Michieli, R, Pasqua, A, Cricelli, I, Mazzaglia, G, Frediani, B, Prieto-Alhambra, D, Brandi, M, Cricelli, C, Lapi F, Bianchini E, Michieli R, Pasqua A, Cricelli I, Mazzaglia G, Frediani B, Prieto-Alhambra D, Brandi ML, and Cricelli C

Abstract

We aimed to develop and validate the FRActure Health Search (FRA-HS) score for prediction of risk of osteoporotic fractures in primary care in Italy. We selected a cohort of patients aged 40 years between 1999 and 2002. They were followed until the occurrence of osteoporotic fracture, death, end of data registration, or end of data availability (December 31, 2012). Age, sex, history of osteoporotic fractures, secondary osteoporosis, long-term use of corticosteroids, rheumatoid arthritis, body mass index, smoking, and alcohol abuse/alcohol-related diseases, and the interaction terms sex*use of corticosteroids and age*secondary osteoporosis were entered in a competing-risk regression (Fine and Gray method) to predict the risk of hip/femur or overall major osteoporotic fractures. The coefficients were combined to obtain the FRA-HS for individual patients. Explained variance, discrimination, and calibration measures were computed to evaluate the models accuracy. The final model was tested using an independent data source. The FRA-HS explained 47.36 and 20.6% of the variation for occurrence of hip/femur and overall major osteoporotic fractures, respectively. Area Under Curve was 0.77 and 0.73, respectively. Predicted/observed ratios revealed a margin of error lower than 30% in the 80% of the population. After stratifying by sex, prediction models for hip/femur fractures confirmed acceptable accuracy in both sexes, while poor explained variance (<20%) was observed for overall major fractures. These findings indicate that FRA-HS might be implemented in primary care for risk prediction of hip/femur fractures. General practitioners could be therefore supported by this tool in clinical decision making.

Published
2017

43. Erratum to: Assessing risk of osteoporotic fractures in primary care: development and validation of the FRA-HS algorithm (Calcif Tissue Int, 10.1007/s00223-016-0230-7)

Author

Lapi F., Lapi, F, Bianchini, E, Michieli, R, Pasqua, A, Cricelli, I, Mazzaglia, G, Frediani, B, Prieto-Alhambra, D, Brandi, M, Cricelli, C, Lapi F., Bianchini E., Michieli R., Pasqua A., Cricelli I., Mazzaglia G., Frediani B., Prieto-Alhambra D., Brandi M. L., Cricelli C., Lapi F., Lapi, F, Bianchini, E, Michieli, R, Pasqua, A, Cricelli, I, Mazzaglia, G, Frediani, B, Prieto-Alhambra, D, Brandi, M, Cricelli, C, Lapi F., Bianchini E., Michieli R., Pasqua A., Cricelli I., Mazzaglia G., Frediani B., Prieto-Alhambra D., Brandi M. L., and Cricelli C.

Abstract

The original version of this article contained a mistake whereby the authors’ surnames preceded their first names.The correct order of the authors names is given in this erratum.

Published
2017

50. Non-alcoholic fatty liver disease and risk of incident acute myocardial infarction and stroke: findings from matched cohort study of 18 million European adults

Author

Alexander, M. (Myriam), Loomis, A.K. (A Katrina), Lei, J. (Johan) van der, Duarte-Salles, T. (Talita), Prieto-Alhambra, D. (Daniel), Ansell, D. (David), Pasqua, A. (Alessandro), Lapi, F. (Francesco), Rijnbeek, P.R. (Peter), Mosseveld, M. (Mees), Avillach, P. (Paul), Egger, P. (Peter), Dhalwani, N.N. (Nafeesa N.), Kendrick, S. (Stuart), Celis-Morales, C. (Carlos), Waterworth, D.M. (Dawn M.), Alazawi, W. (William), Sattar, N. (Naveed), Alexander, M. (Myriam), Loomis, A.K. (A Katrina), Lei, J. (Johan) van der, Duarte-Salles, T. (Talita), Prieto-Alhambra, D. (Daniel), Ansell, D. (David), Pasqua, A. (Alessandro), Lapi, F. (Francesco), Rijnbeek, P.R. (Peter), Mosseveld, M. (Mees), Avillach, P. (Paul), Egger, P. (Peter), Dhalwani, N.N. (Nafeesa N.), Kendrick, S. (Stuart), Celis-Morales, C. (Carlos), Waterworth, D.M. (Dawn M.), Alazawi, W. (William), and Sattar, N. (Naveed)

Abstract

OBJECTIVE: To estimate the risk of acute myocardial infarction (AMI) or stroke in adults with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). DESIGN: Matched cohort study. SETTING: Population based, electronic primary healthcare databases before 31 December 2015 from four European countries: Italy (n=1 542 672), Netherlands (n=2 225 925), Spain (n=5 488 397), and UK (n=12 695 046). PARTICIPANTS: 120 795 adults with a recorded diagnosis of NAFLD or NASH and no other liver diseases, matched at time of NAFLD diagnosis (index date) by

Published
2019
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