The value of the polypill in cardiovascular disease: an Italian multidisciplinary Delphi panel consensus.

The purpose of this work was to reach the consensus of a multidisciplinary and multistakeholder Italian panel on the value of polypill in cardiovascular disease, with respect to the clinical, technological, economic and organizational dimension. A three-step modified Delphi method was used to establish consensus. Eleven experts in the area of cardiology, pharmaceutical technology, general practice, hospital pharmacy, pharmacology, and health economics participated in the expert panel.

Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis.

Introduction: Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving.

Objective: The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings related to avoidable ADEs.

Methods: A systematic review was performed, according to the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) statements, on observational studies published from 2006 to 2016 in MEDLINE and EMBASE, focusing on direct costs of ADEs in the inpatient setting from high-income countries.

Adherence with regulatory resolutions on prevention of NSAIDS-related gastrointestinal injury in Italy.

Background The rate of gastrointestinal (GI) complications with non-steroidal antiinflammatory drugs (NSAIDs) or low-dose aspirin (LD-ASA) varies according to risk factors. For at risk patients, the Italian regulatory resolution enforce prophylaxis with proton pump inhibitors (PPIs) or misoprostol. Objective This study evaluated the consistency with such resolution in patients receiving NSAIDs or LD-ASA and assessed whether patients continued to receive GI protection with PPIs for an adequate time following NSAID discontinuation.

Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis.

Introduction: Certolizumab pegol (CZP), an anti-tumor necrosis factor PEGylated Fab' fragment of a humanized monoclonal antibody, is currently approved for treatment of some immune-mediated inflammatory diseases (IMIDs). To our knowledge, no systematic review and meta-analysis evaluating the overall safety profile of CZP has been performed.

Objective: The objective of this systematic review was to assess the adverse event (AE) patterns of CZP versus a control in patients with IMIDs.

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

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.

Use of selective serotonin reuptake inhibitors during pregnancy and risk of major and cardiovascular malformations: an update.

General consensus exists about the need to avoid drug intake as much as possible during pregnancy due to the lack of thorough evidence about the safety of pharmacologic treatments during gestation for both mothers and fetuses. In this respect, the overall safety profile of selective serotonin reuptake inhibitors (SSRIs) in pregnancy remains unclear. This article reviews current evidence about the safety of each SSRI during pregnancy in order to describe their specific teratogenic potential, with a particular focus on major and cardiovascular malformations, and to verify whether such toxicity can be considered as a class effect.

Safety concerns associated with the use of serotonin reuptake inhibitors and other serotonergic/noradrenergic antidepressants during pregnancy: a review.

Background: There is ongoing debate about the safety of selective serotonin reuptake inhibitors (SSRIs) and other serotonergic/noradrenergic antidepressants when used during pregnancy.

Objective: This article reviews the available literature on the main safety concerns associated with the use of SSRIs and other serotonergic/noradrenergic antidepressants (serotonin-norepinephrine reuptake inhibitors, norepinephrine reuptake inhibitors, noradrenergic and specific serotonergic antidepressants) during pregnancy.

Methods: English-language reports of analytical and descriptive studies, including case reports, case series, and meta-analyses, were identified through searches of MEDLINE, EMBASE, and PsycINFO (1966-April 2009).