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7. Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures: Evidence from the AIFA-BEST observational study

Author

Ghirardi, Arianna, Di Bari, Mauro, Zambon, Antonella, Scotti, Lorenza, Della Vedova, Gianluca, Lapi, Francesco, Cipriani, Francesco, Caputi, Achille P., Vaccheri, Alberto, Gregori, Dario, Gesuita, Rosaria, Vestri, Annarita, Staniscia, Tommaso, Mazzaglia, Giampiero, Corrao, Giovanni, and This study is on behalf of the BEST investigators

Published
2014
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13. Safety Profile of the Fluoroquinolones: Analysis of Adverse Drug Reactions in Relation to Prescription Data Using Four Regional Pharmacovigilance Databases in Italy

Author

Lapi, Francesco, Tuccori, Marco, Motola, Domenico, Pugi, Alessandra, Vietri, Michele, Montanaro, Nicola, Vaccheri, Alberto, Leoni, Olivia, Cocci, Alfredo, Leone, Roberto, Conforti, Anita, Moretti, Ugo, Sessa, Emiliano, Mazzaglia, Giampiero, Mugelli, Alessandro, Mazzei, Teresita, and Vannacci, Alfredo

Published
2010
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33. Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions

Author

Monaco, Luca, Biagi, Chiara, Conti, Valentino, Melis, Mauro, Donati, Monia, Venegoni, Mauro, Vaccheri, Alberto, Motola, Domenico, Monaco, Luca, Biagi, Chiara, Conti, Valentino, Melis, Mauro, Donati, Monia, Venegoni, Mauro, Vaccheri, Alberto, and Motola, Domenico

Subjects
Adult, Male, Adolescent, Databases, Factual, Pyridones, adverse drug reaction, apixaban, Administration, Oral, World Health Organization, Young Adult, Drug Safety, Rivaroxaban, Risk Factors, Atrial Fibrillation, Adverse Drug Reaction Reporting Systems, Humans, Pharmacology (medical), Child, Aged, Cerebral Hemorrhage, Pharmacology, Infant, Newborn, Anticoagulants, Infant, Middle Aged, Dabigatran, Stroke, pharmacovigilance, Child, Preschool, Pyrazoles, Female, Warfarin, Gastrointestinal Hemorrhage
Abstract

Aim: Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to be addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase. Methods: Study based on reports of suspected ADRs held in VigiBase as at December 2014, in which a DOAC or warfarin were administered in patients with nonvalvular AF and listed as suspected/interacting drugs. Medical Dictionary for Regulatory Activities was used to classify ADRs. Reporting odds ratio (ROR) with 95% confidence interval were calculated. Results with P ≤ 0.05 were statistically significant. Results: We retrieved 32 972 reports. We identified 204 ADRs with a ROR >1 (P ≤ 0.05) and we focused on 105 reactions. Positive ROR emerged for DOACs and gastrointestinal haemorrhage compared with warfarin [(1.6 (1.47–1.75)], but no disproportionality with cerebral haemorrhage was found [0.31 (0.28–0.34)]. We identified other potential signals that have not been associated with DOACs previously. Conclusions: As well as premarketing authorization clinical trial studies, we found a reduced risk of intracranial haemorrhage, but an increased risk of gastrointestinal haemorrhage in patients treated with DOACs compared to warfarin. We provide new data and we highlight several differences between the three novel oral anticoagulants, in the rate and type of ADRs occurred.

Published
2017

38. Modalita di utilizzo di farmaci antibiotici in pediatria: confronto fra la regione Emilia Romagna e la Norvegia

Author

Vaccheri, Alberto, Donati, Monia <1979>, Vaccheri, Alberto, and Donati, Monia <1979>

Abstract

INTRODUZIONE Il consumo eccessivo e talvolta inappropriato di farmaci antibiotici rappresenta una delle principali cause di sviluppo di resistenza batterica; ciò accade principalmente nella popolazione pediatrica. Numerosi studi riportano differenze tra i Paesi del Nord e Sud Europa in ambito di terapia antibiotica. Scopo del progetto di ricerca è confrontare le modalità prescrittive di farmaci antibiotici nei bambini di età compresa fra 0 e 5 anni, in Emilia Romagna e in Norvegia. METODI I dati sono stati ottenuti dalla bancadati regionale dell’Assistenza Farmaceutica Territoriale (AFT) per l’Emilia Romagna e dal Norwegian Prescription Database (NORPD) per la Norvegia. E’ stata condotta un’analisi descrittiva dei dati italiani in cinque differenti gruppi di età: 0-12 mesi, 13-24 mesi, 25-36 mesi, 37-48 mesi e 49-60 mesi. I risultati sono stati quindi messi a confronto con i dati norvegesi. RISULTATI In Emilia Romagna si osserva un uso maggiore di antibiotici (prevalenza variabile dal 68% al 59% nel periodo in studio), mentre in Norvegia il 29% circa dei bambini ha ricevuto almeno una prescrizione di antibiotici. In tutti i gruppi di età, i bambini italiani hanno ricevuto un numero di prescrizioni per anno maggiore rispetto a quelli norvegesi. Importanti differenze emergono anche in relazione alla tipologia di farmaci prescritti: amoxicillina, da sola e in combinazione ad acido clavulanico sono i principi attivi più prescritti in Emilia Romagna contro la fenossimetilpenicillina in Norvegia. CONCLUSIONI I risultati dello studio mostrano differenze nell’utilizzo di terapie antibiotiche nei bambini in Emilia Romagna e Norvegia. In particolare, è emerso un utilizzo eccessivo di antibiotici nella popolazione pediatrica italiana considerata e un approccio terapeutico spesso non coerente con quanto riportato dalle linee guida e dalle raccomandazioni nazionali e internazionali. Il confronto con una realtà più virtuosa pone le basi per una riflessione sulle strategie di migl, INTRODUCTION Population level exposure to antibiotics is associated with antibiotic resistance, and frequent antibiotic prescribing to children is accepted as an indicator for sub-optimal prescribing to outpatients. There are a number of European studies investigating antibiotic prescribing to children and adolescents that report large variations between countries in choice of therapy and periodic prevalence of prescribing. Aim of this study is to analyse and compare the pattern of antibiotic prescription and use in children 0-5 years in Norway and in Italy (Emilia-Romagna Region). METHODS A retrospective observational study was conducted; data on antibiotic prescribing were obtained from the Norwegian Prescription Database (NorPD) and from Emilia-Romagna Health Authority Database (AFT). All outpatients between 0 and 5 years, with a dispensed prescription on antibiotics (Anatomical Therapeutic Chemical, ATC code J01) were included and a descriptive analysis was made to compare patients, prescriptions of antibiotics and prescribers characteristics among the following 5 age groups: 0-12 months, 13-24 months, 25-36 months, 37-48 months, 49-60 months. RESULTS In Emilia Romagna a greater use of antibiotics was registered (prevalence ranging from 68% to 59% in the study period), while in Norway about 29% of children received at least one prescription of antibiotics. Important differences also emerged in relation to the type of drugs prescribed: amoxicillin, alone and in combination with clavulanic acid, was the most used in Emilia Romagna against phenoxymethylpenicillin in Norway. CONCLUSION The results of the study showed differences in the use of antibiotic therapies in children in Emilia Romagna and Norway. In particular, excessive use of antibiotics has emerged in the Italian pediatric population; this therapeutic approach was often not consistent with national and international guidelines and recommendations. The comparison with a more virtuous reality leads to a ref

Published
2019

40. Human papilloma virus vaccination in males: A pharmacovigilance study on the Vaccine Adverse Event Reporting System.

Author

Bonaldo, Giulia, Montanaro, Nicola, Vaccheri, Alberto, and Motola, Domenico

Subjects
PAPILLOMAVIRUSES, HUMAN papillomavirus vaccines, CLINICAL trial registries, SEXUALLY transmitted diseases, VACCINATION, VACCINES
Abstract

Aims: Human papilloma virus (HPV) is 1 of the most common sexually transmitted infection responsible for different types of cancer: cervical, penile, vulvar, anal and oropharyngeal. It can affect both males and females. Our aim was to enrich the knowledge on the safety profiles of HPV vaccines in the male population. Methods: We reviewed all the reports of adverse events following immunization (AEFI) present in the US Vaccine Adverse Event Reporting System from 1 January 2006 to 30 September 2018. Statistical data mining was performed using the reporting odds ratio with 95% confidence interval in order to detect disproportionality in reporting. Results: A total of 5493 reports of AEFI were retrieved. The events most reported and that proportionally occurred more frequently with HPV vaccines than with others in males were: syncope (n = 701, reporting odds ratio = 2.85, 95% confidence interval [1.41–5.76p), loss of consciousness (n = 425, 2.79 [1.36–5.72]) and fall (n = 272, 3.54 [2.00–6.26]). Conclusion: Most of the AEFIs were already reported in premarketing clinical trials and acknowledged for the corresponding vaccines. A disproportionate reporting was found for some of these events including syncope. The HPV vaccines are generally well tolerated in males, although limitations own of spontaneous reporting should be considered. [ABSTRACT FROM AUTHOR]

Published
2021
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43. Antibacterial prescription in Italian preschool children: analysis of 7 years of data from the Emilia-Romagna region reimbursement database.

Author

D'Annibali, Ottavio, Bonaldo, Giulia, Donati, Monia, Småbrekke, Lars, Motola, Domenico, and Vaccheri, Alberto

Subjects
PRESCHOOL children, MEDICAL prescriptions, REIMBURSEMENT, JUVENILE diseases, ANTIBACTERIAL agents
Abstract

Objectives: To describe antibacterial prescribing patterns in outpatients aged 0-5 years from 2007 to 2013 in the Emilia-Romagna region, assessing sex- and age-specific consumption over time.Methods: All children aged 0-5 years resident in the Emilia-Romagna region who received at least one prescription of a systemic antibacterial in the period 2007-13 were enrolled. The prescriptions of systemic antibacterials to children were collected from the regional prescription database. Data were stratified by year, sex and age, and analysed in terms of periodic prevalence and of annual prescription rate per 1000 person-years.Results: The prevalence of children receiving at least one prescription per year varied from 68.0% in 2007 to 59.0% in 2013, while the average prevalence of children receiving five or more prescriptions per year was 6.96%. The annual prescription rate varied from 1621.26 in 2007 to 1372.27 in 2013. Penicillins + β-lactamase inhibitors accounted for 35.3% of total prescriptions, followed by extended-spectrum penicillins (28.6%), macrolides (17.0%) and third-generation cephalosporins (13.9%).Conclusions: Despite recommendations, a significant overprescription of antibacterials to children still exists, showing no satisfactory improvements over the years. In contrast to Northern European countries, adherence to evidence-based guidelines was poor, with frequent prescribing of broad-spectrum agents for the treatment of mostly viral childhood infectious disease. [ABSTRACT FROM AUTHOR]

Published
2019
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45. Liver Injury due to Amoxicillin vs. Amoxicillin/Clavulanate: A Subgroup Analysis of a Drug-Induced Liver Injury Case-Control Study in Italy

Author

Donati, Monia, primary, Motola, Domenico, additional, Leone, Roberto, additional, Moretti, Ugo, additional, Stoppa, Giovanna, additional, Arzenton, Elena, additional, Carmela Lenti, Maria, additional, Bonaiuti, Roberto, additional, Mugelli, Alessandro, additional, Vannacci, Alfredo, additional, Rafaniello, Concetta, additional, Sportiello, Liberata, additional, Capuano, Annalisa, additional, Bortolami, Oscar, additional, and Vaccheri, Alberto, additional

Published
2017
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46. Oral bisphosphonates do not increase the risk of severe upper gastrointestinal complications: a nested case–control study

Author

Ghirardi, Arianna, Scotti, Lorenza, Vedova, Gianluca D., D'Oro, Luca C., Lapi, Francesco, Cipriani, Francesco, Caputi, Achille P., Vaccheri, Alberto, Gregori, Dario, Gesuita, Rosaria, Vestri, Annarita, Staniscia, Tommaso, Mazzaglia, Giampiero, Corrao, Giovanni, Sessa, E., Arcoraci, V., Parodi, A., Zambon, A., Montanaro, N., Piccinni, C., Suzzi, C., Puccini, A., Sturkenboom, M., Geppetti, P., Sati, L., Di Bari, M., Forlan, F., Carle, F., Menna, A., Valenti, M., Ghirardi A, Scotti L, Vedova GD, D'Oro LC, Lapi F, Cipriani F, Caputi AP, Vaccheri A, Gregori D, Gesuita R, Vestri A, Staniscia T, Mazzaglia G, Corrao G, AIFA-BEST Investigators, Ghirardi, A, Scotti, L, DELLA VEDOVA, G, D'Oro, L, Lapi, F, Cipriani, F, Caputi, A, Vaccheri, A, Gregori, D, Gesuita, R, Vestri, A, Staniscia, T, Mazzaglia, G, Corrao, G, AIFA BEST, I, and Medical Informatics

Subjects
Male, Gastrointestinal Diseases, Administration, Oral, Comorbidity, Risk Factors, 80 and over, Secondary Prevention, Drug safety, Aged, 80 and over, Bone Density Conservation Agents, Diphosphonates, Incidence, Incidence (epidemiology), Gastroenterology, Bisphosphonates, General Medicine, Middle Aged, Calcium Channel Blockers, Italy, Administration, Cohort, Upper gastrointestinal complications, Nested case-control, Female, Research Article, Oral, Healthcare utilization database, medicine.medical_specialty, Database, Fracture prevention, Internal medicine, medicine, Humans, Bisphosphonate, MED/01 - STATISTICA MEDICA, Aged, business.industry, Case-control study, Case-Control Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Osteoporotic Fractures, Odds ratio, medicine.disease, Confidence interval, Surgery, Regimen, Nested case-control study, Bisphosphonates, Drug safety, Healthcare utilization database, Upper gastrointestinal complications, Osteoporosis, healthcare utilization database, upper gastrointestinal complications, drug safety, bisphosphonates, business
Abstract

Background Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures. Methods A nested case–control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates. Results Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities. Conclusions Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.

Published
2014
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47. User-only design to assess drug effectiveness in clinical practice: application to bisphosphonates and secondary prevention of fractures

Author

Corrao G, Ghirardi A, Segafredo G, Zambon A, Della Vedova G, Lapi F, Cipriani F, Caputi A, Gregori D, Gesuita R, Vestri A, Staniscia T, Mazzaglia G, Di Bari M, on behalf of the BEST investigators, VACCHERI, ALBERTO, Corrao, G, Ghirardi, A, Segafredo, G, Zambon, A, DELLA VEDOVA, G, Lapi, F, Cipriani, F, Caputi, A, Vaccheri, A, Gregori, D, Gesuita, R, Vestri, A, Staniscia, T, Mazzaglia, G, Di Bari, M, Best, I, Corrao G, Ghirardi A, Segafredo G, Zambon A, Della Vedova G, Lapi F, Cipriani F, Caputi A, Vaccheri A, Gregori D, Gesuita R, Vestri A, Staniscia T, Mazzaglia G, Di Bari M, and on behalf of the BEST investigators

Subjects
Male, Time Factors, pharmacoepidemiology, Databases, Factual, Fractures, Bone, Secondary Prevention, Humans, Bisphosphonate, propensity score, MED/01 - STATISTICA MEDICA, Aged, Retrospective Studies, Aged, 80 and over, user-only design, Bone Density Conservation Agents, Diphosphonates, Confounding Factors, Epidemiologic, Middle Aged, confounding, Hospitalization, Observational Studies as Topic, Italy, Research Design, fracture, Case-Control Studies, Female
Abstract

Purpose: Different strategies applicable to control for confounding by indication in observational studies were compared in a large population-based study regarding the effect of bisphosphonates (BPs) for secondary prevention of fractures. Methods: The cohort was drawn from healthcare utilization databases of 13 Italian territorial units. Patients aged 55years or more who were hospitalized for fracture during 2003-2005 entered into the cohort. A nested case-control design was used to compare BPs use in cohort members who did (cases) and who did not experience (controls) a new fracture until 2007 (outcome). Three designs were employed: conventional-matching (D1), propensity score-matching (D2), and user-only (D3) designs. They differed for (i) cohort composition, restricted to patients who received BPs straight after cohort entry (D3); (ii) using propensity score for case-control matching (D2); and (iii) compared groups of BPs users versus no users (D1 and D2) and long-term versus short-term users (D3). Results: Bisphosphonate users had odds ratios (95% confidence interval) of 1.20 (1.01 to 1.44) and 0.95 (0.74 to 1.24) by applying D1 and D2 designs, respectively. Statistical evidence that long-term BPs use protects the outcome onset with respect to short-term use was observed for user-only design (D3) being the corresponding odds ratio (95% confidence interval) 0.64 (0.44 to 0.93). Conclusions: User-only design yielded closer results to those seen in RCTs. This approach is one possible strategy to account for confounding by indication. © 2014 John Wiley & Sons, Ltd.

Published
2014

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