title: No substantial gender differences in suspected adverse reactions to ACE inhibitors and ARBs: results from spontaneous reporting system in Campania Region.
abstract: BACKGROUND
  Today, there is a poor knowledge about gender differences in adverse drug reactions (ADRs) to cardiovascular drugs such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). Therefore, the aim of this study was to analyze spontaneous reports of suspected ADRs induced by ACE-inhibitors and ARBs, between January 2001 and June 2015, recorded in a Region of Southern Italy (Campania Region).
  
  
  METHODS
  We performed a descriptive gender-related analysis of regional safety data, obtained from the spontaneous reporting system.
  
  
  RESULTS
  In the considered period, 772 suspected ADRs to ACE inhibitors and ARBs (in monotherapy or in combination) were reported with a slightly higher frequency in men compared with women. In both genders, the most involved category was ARBs in combination, whereas the most prescribed active substance was ramipril. General and administration site conditions, vascular disorders and modification of laboratory parameters were more common in men, while respiratory disorders were most common in women. In 88.2% of cases, not serious ADRs were described more by men than women.
  
  
  CONCLUSIONS
  This analysis suggested no substantial gender differences. Further studies such as randomized population studies or meta-analysis of ACE inhibitors and ARBs randomized studies are needed to clarify whether gender differences exist in the safety profile of these drugs.
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Maria Giuseppa
authors.initials: MG
authors.lastname: Sullo
authors.affiliation: b Novartis Farma Italia , Value & Access Department , Varese , Italy.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Nica
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Scavone
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Francesca Futura
authors.initials: FF
authors.lastname: Bernardi
authors.affiliation: b Novartis Farma Italia , Value & Access Department , Varese , Italy.
authors.forename: Delia Maria
authors.initials: DM
authors.lastname: Colombo
authors.affiliation: a Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine , Second University of Naples , Naples , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012737:Sex Factors
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors
keywords: ACE inhibitors; ARBs; Campania Region; adverse drug reactions; gender differences; spontaneous reporting system