title: Postmarketing pharmacovigilance of adverse drug reactions: the case of rosiglitazone in Mexico.
abstract: OBJECTIVE
  Commercialization of rosiglitazone, an oral blood glucose-lowering drug of the thiazolidinedione class, was recently suspended in Europe and significantly restricted in the United States due to a possibly increased risk of ischemic heart disease; the drug is still being marketed in Mexico. This study was aimed to analyze the post-marketing occurrence of adverse drug reactions (ADRs) with rosiglitazone when used in combination therapy in Mexican Type 2 Diabetes patients.
  
  
  METHODS
  A prospective observational study was conducted at a primary health-care clinic in Mexico City. Eligible subjects were adult patients with Type 2 diabetes inadequately controlled with maximal doses of oral monotherapy, in which one of two combined therapeutic schemes was prescribed: rosiglitazone/glibenclamide (R/G), or rosiglitazone/metformin (R/M). Patients' blood pressure, weight, treatment adherence and occurrence of ADRs were monitored during a 6-month follow-up period.
  
  
  RESULTS
  174 patients received treatment with R/M or R/G (112 and 62 patients, respectively). At least one ADR was observed in about 75%, of patients. Prior to the end of the follow-up period, moderate ADRs leading to discontinuation of the treatment occurred in 29.5% and 14.5% of patients treated with R/M and R/G, respectively. The ADRs most frequently observed were peripheral edema and moderate weight gain.
  
  
  CONCLUSIONS
  The use of rosiglitazone in combination with other oral anti-diabetic drugs was associated with a high frequency of ADRs in Mexican patients with Type 2 diabetes. Post-marketing studies are relevant to identify drug-associated risks to patients in clinical practice.
authors.affiliation: Centro de Investigación en Sistemas de Salud, Instituto Nacional de Salud Pública, Morelos, Mexico. hortensia.reyes@insp.mx
authors.forename: Hortensia
authors.initials: H
authors.lastname: Reyes-Morales
authors.forename: Dolores
authors.initials: D
authors.lastname: Mino-León
authors.forename: Svetlana V
authors.initials: SV
authors.lastname: Doubova
authors.forename: Sergio
authors.initials: S
authors.lastname: Flores-Hernández
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004338:Drug Combinations; D004487:Edema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D005905:Glyburide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008800:Mexico; D008875:Middle Aged; D060735:Pharmacovigilance; D011446:Prospective Studies; D000077154:Rosiglitazone; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D015430:Weight Gain / Q000187:drug effects
chemical_list: D004338:Drug Combinations; D007004:Hypoglycemic Agents; D013844:Thiazoles; D045162:Thiazolidinediones; C471074:rosiglitazone-metformin combination; D000077154:Rosiglitazone; D008687:Metformin; D005905:Glyburide