title: Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.
abstract: OBJECTIVE
  Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW).
  
  
  METHODS
  Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5.
  
  
  RESULTS
  In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW.
  
  
  CONCLUSIONS
  'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.'
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands; Department of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Tigray, Ethiopia.
authors.forename: Derbew Fikadu
authors.initials: DF
authors.lastname: Berhe
authors.forename: Kristina
authors.initials: K
authors.lastname: Juhlin
authors.forename: Kristina
authors.initials: K
authors.lastname: Star
authors.forename: Kidanemariam G M
authors.initials: KG
authors.lastname: Beyene
authors.forename: Mukesh
authors.initials: M
authors.lastname: Dheda
authors.forename: Flora M
authors.initials: FM
authors.lastname: Haaijer-Ruskamp
authors.forename: Katja
authors.initials: K
authors.lastname: Taxis
authors.forename: Peter G M
authors.initials: PG
authors.lastname: Mol
mesh_terms: D000293:Adolescent; D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D000368:Aged; D002317:Cardiovascular Agents / Q000009:adverse effects*; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged
chemical_list: D002317:Cardiovascular Agents; D005343:Fibrinolytic Agents; D007004:Hypoglycemic Agents
keywords: Adverse drug reactions; Afrique subsaharienne; Individual Case Safety Report; Informe de Seguridad de Casos Individuales; cardiometabolic drugs; effets indésirables des médicaments; farmacovigilancia; medicamentos cardiometabólicos; médicaments cardiométaboliques; observations individuelles de pharmacovigilance; pharmacovigilance; reacciones adversas a medicamentos; sub-Saharan Africa; África subsahariana