-
Article
Open AccessLessons to be Learnt from Real-World Studies on Immune-Related Adverse Events with Checkpoint Inhibitors: A Clinical Perspective from Pharmacovigilance
The advent of immune checkpoint inhibitors (ICIs) caused a paradigm shift both in drug development and clinical practice; however, by virtue of their mechanism of action, the excessively activated immune syste...
-
Article
Signal of potentially protective drug–drug interactions from spontaneous reporting systems: proceed with caution
-
Article
Myopathy with DPP-4 inhibitors and statins in the real world: investigating the likelihood of drug–drug interactions through the FDA adverse event reporting system
To investigate the occurrence of myopathy with oral glucose-lowering drugs (OGLDs) and statins, with a focus on dipeptidyl peptidase-4 inhibitors (DPP4-is).
-
Article
Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System
Immune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte associated protein 4 (CTLA4) and programmed cell death 1 or its ligand (PD1/PDL1), elicit different immune-related adv...
-
Article
The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?
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 n...
-
Article
Open AccessPatterns and trends of utilization of incretin-based medicines between 2008 and 2014 in three Italian geographic areas
The incretin-based medicines GLP1 analogues (GLP1a) and dipeptidyl peptidase-4 inhibitors (DPP4i) are hypoglycaemic agents licensed for the treatment of type 2 diabetes mellitus (T2DM). Although these drugs po...
-
Article
Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems
Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still in...
-
Article
Open AccessRecurrence of pericarditis after influenza vaccination: a case report and review of the literature
This case report describes a patient with pericarditis likely attributed to influenza vaccination (positive rechallenge), with a literature review.
-
Article
Use of antihistamines and risk of ventricular tachyarrhythmia: a nested case-control study in five European countries from the ARITMO project
After regulatory restrictions for terfenadine and astemizole in ‘90s, only scarce evidence on proarrhythmic potential of antihistamines has been published. We evaluate the risk of ventricular tachyarrhythmia (...
-
Article
Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Map**
The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated.
-
Article
Drug-Induced Arrhythmia: Bridging the Gap Between Pathophysiological Knowledge and Clinical Practice
-
Article
Authors’ Reply to Alain Braillon’s Comment on “The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project”
-
Article
Response to comment on: “antibiotic use varies substantially among adults—a cross‑national study from five European Countries in the ARITMO project”
-
Article
Erratum to: Antibiotic use varies substantially among adults: a cross-national study from five European Countries in the ARITMO project
-
Article
Open AccessThe Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project
Spontaneous reporting systems (SRSs) are pivotal for signal detection, especially for rare events with a high drug-attributable component, such as torsade de pointes (TdP). Use of different national SRSs is ra...
-
Article
Trends in paediatric macrolide use in five European countries—a population-based study
The study aims to analyse overall as well as subgroup-specific outpatient paediatric macrolide use in five European countries, including time trends of macrolide prescription rates, and to provide potential ta...
-
Article
Antibiotic use varies substantially among adults: a cross-national study from five European Countries in the ARITMO project
To examine patterns of outpatient and community antibiotic use among adults in five European countries.
-
Article
Open AccessDrug-Induced Renal Damage in Preterm Neonates: State of the Art and Methods for Early Detection
Only a small fraction of drugs widely used in neonatal intensive care units (NICU) are specifically authorized for this population. Even if unlicensed or off-label use is necessary, it is associated with incre...
-
Article
Comment on: “Pharmacokinetics in Patients with Chronic Liver Disease and Hepatic Safety of Incretin-Based Therapies for the Management of Type 2 Diabetes Mellitus”
-
Article
Open AccessUse of phytoestrogens and effects perceived by postmenopausal women: result of a questionnaire-based survey
Use of food supplements-containing phytoestrogens among postmenopausal women is rapidly increasing. Although phytoestrogens are often perceived as safe, evidence for overall positive risk-benefit profile is st...
