Safety profile of chimeric antigen receptor T-cell immunotherapies (CAR-T) in clinical practice.

Purpose: Two chimeric antigen receptor T-cell (CAR-T) therapies have been approved in the United States (USA) in 2017 and Europe (EU) in 2018: axicabtagene ciloleucel and tisagenlecleucel. They contain the patient's own T cells, which are extracted, genetically modified, and reinfused. Alongside the good efficacy results, the assessment of safety profile of these new therapies represents a great challenge.

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

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.

Evaluation of the safety profile of rotavirus vaccines: a pharmacovigilance analysis on American and European data.

Rotaviruses (RVs) are the most common cause of severe diarrheal disease. To date two rotavirus oral vaccines are licensed: Rotarix and Rotateq. Our aim was to contribute to the post-marketing evaluation of these vaccines safety profile.

Drug-induced disseminated intravascular coagulation: a pharmacovigilance study on World Health Organization's database.

Background: Disseminated intravascular coagulation (DIC) occurs in several clinical conditions, including drug therapy. We aim to investigate the association between the administration of several drug classes and the onset of DIC by using the reports of Adverse Drug Reactions (ADR) collected in Vigibase, the World Health Organization (WHO) database of ADR.

Methods: We collected reports of drug-related DIC from 1968 to September 2015, classified in Vigibase according to the MedDRA (Medical Dictionary for Regulatory Activities) term "Disseminated intravascular coagulation".

Direct-acting oral anticoagulants and alopecia: The valuable support of postmarketing data.

Little is known about the administration of direct-acting oral anticoagulants (DOACs) and the occurrence of alopecia. Our aim was to analyse the reports of alopecia following DOAC administration received until 2 May 2018 from VigiBase, the World Health Organization database. A descriptive analysis of age, sex, seriousness and dechallenge/rechallenge outcome was carried out.

The prescription of antimicrobials by general practitioners: the differences between north and south Italian provinces.

: Antimicrobials resistance (AMR) is an increasingly serious global health problem, both in terms of clinical implications and economic expenditure. In Italy, there are differences in prescribing rates between regions. We aimed to compare these differences in two Italian provinces: one of Emilia Romagna (north region) and one of Puglia (south region).

Cardiovascular safety of macrolide and fluoroquinolone antibiotics: An analysis of the WHO database of adverse drug reactions.

Introduction: The cardiovascular safety profile of macrolides and fluoroquinolones has been widely discussed. The aim of the present study is to provide the contribution of real-world data onto the ongoing discussion about cardiovascular toxicity of both macrolides and fluoroquinolones.

Methods: Reports of adverse drug reactions (ADRs) were retrieved from VigiBase.

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

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.

Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017.

Aims: Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk-benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the safety profile of the HPV vaccine basing on real-life data derived from reports of suspected AEFIs collected in the US Vaccine Adverse Events Reporting System (VAERS) and assess if the searches on Google overlap with spontaneous reporting.

Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology.

Purpose: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD).

Methods: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis.

Safety profile of H1-antihistamines in pediatrics: an analysis based on data from VigiBase.

Purpose: H1-antihistamines are commonly used in infants and children for the relief of histamine-mediated symptoms in a variety of conditions. Little is known about their safety profile in these patients. We performed a comparative analysis of the safety profiles of H1-antihistamines using data from the WHO database (VigiBase).

Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance.

Background: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV).

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

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.

Ibuprofen-associated hypothermia in children: analysis of the Italian spontaneous reporting database.

Purpose: An analysis of Italian spontaneous adverse drug reactions (ADR) reporting database highlighted a potential association between hypothermia and ibuprofen in children. Hypothermia is defined as a core body temperature of 35 °C (95 °F). Ibuprofen is the most prescribed NSAID for the treatment of fever and moderate pain in children.

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

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%.

No Direct Survival Effect of Light to Moderate Alcohol Drinking in Community-Dwelling Older Adults.

Objectives: To assess the relationship between light to moderate alcohol consumption and mortality, particularly accounting for baseline health status and physical activity.

Design: Prospective, longitudinal, population-based study.

Setting: The Pianoro Study, which consisted of community-dwelling older adults in three towns in northern Italy.

Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO Adverse Drug Reaction Database.

Objective: To identify safety signals concerning the association between the use of various drug classes and the onset of progressive multifocal leukoencephalopathy (PML).

Methods: All reports containing suspected or interacting PML-related or leukoencephalopathy-related drugs, held in the World Health Organization spontaneous individual case safety reports database as at 1 September 2014, were retrieved. We identified safety signals by analysing the drug-reaction pairs, using the reporting odds ratio as a measure of disproportionality.

Use of Antibiotics in Pediatrics: 8-Years Survey in Italian Hospitals.

Objectives: To evaluate antibiotic consumption in the pediatric wards of Emilia-Romagna Region, from 2004 to 2011, with a focus on the antibiotics reserved to the most serious infections, and to analyse the ADRs reported for antibiotics by the pediatric wards of Emilia-Romagna hospitals.

Methods: Reference population was represented by all the patients (0-14 years old) admitted to the pediatric wards of all the hospitals of Emilia-Romagna Region. Drug consumption was expressed as number of DDDs per 100 Bed-Days (BD) and data were analysed by active substance, by therapeutic subgroups or by ward type.

Acute renal failure in patients treated with dronedarone or amiodarone: a large population-based cohort study in Italy.

Purpose: Causes of ARF are numerous including drugs. In 2012, spontaneous reporting showed a possible association between dronedarone and ARF. To further investigate such association, a retrospective cohort study on health-service claim databases was performed taking amiodarone as comparison.

Off-label use of nicardipine as tocolytic and acute pulmonary oedema: a post-marketing analysis of adverse drug reaction reports in EudraVigilance.

Purpose: To evaluate a signal of acute pulmonary oedema (APO) due to nicardipine used off-label as tocolytic in pregnant women.

Methods: All the suspected cases of APO recorded in EudraVigilance database up to 31/01/2013 and associated with nicardipine containing medicinal products were retrieved. The Proportional Reporting Ratio was considered as measure of disproportionality.

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

Purpose: Osteoporosis is a chronic disease of the bone, whose incidence increases progressively with aging. The main consequences of osteoporosis are fragility fractures, which have considerable medical, social, and economic implications. Adequate treatment of osteoporosis must be considered as a compelling public health intervention.

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

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 55 years or more who were hospitalized for fracture during 2003-2005 entered into the cohort.

Ten years of pharmacovigilance in Italy: the experience of Emilia-Romagna region in the monitoring of drug's safety profile.

Objective: To describe the evolution of adverse drug reactions (ADRs) spontaneously reporting in the Emilia-Romagna region (ERR) in the period 2001 - 2010 through qualitative and quantitative indicators following local educational and editorial initiatives.

Methods: Data of regional spontaneous reporting from 1 January 2001 to 31 December 2010 were obtained from the Pharmacovigilance National Network of the Italian Medicines Agency. Drugs were classified according to the Anatomical Therapeutic Chemical classification.

Use of antibacterial agents in Italian hospitals: a 2004 to 2011 drug utilization survey in the Emilia-Romagna region.

To assess 8-year antibiotic consumption and expenditure in all of the hospitals of Emilia Romagna. The analysis was based on the pharmacy records of each hospital. Antibiotic drug consumption was expressed as DDDs per 100 bed-days used (BDU) and data were analyzed according to ATC classification and to single wards.

Oral bisphosphonates do not increase the risk of severe upper gastrointestinal complications: a nested case-control study.

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.