Postmarketing pharmacovigilance of adverse drug reactions: the case of rosiglitazone in Mexico

• Published in: International journal of clinical pharmacology and therapeutics Vol. 50; no. 1; p. 1
• Main Authors: Reyes-Morales, Hortensia, Mino-León, Dolores, Doubova, Svetlana V, Flores-Hernández, Sergio
• Format: Journal Article
• Language: English
• Published: Germany 01.01.2012
• Subjects: Administration, Oral; Adult; Aged; Diabetes Mellitus, Type 2 - drug therapy; Drug Combinations; Edema - chemically induced; Female; Follow-Up Studies; Glyburide - administration & dosage; Glyburide - adverse effects; Glyburide - therapeutic use; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Male; Medication Adherence; Metformin - administration & dosage; Metformin - adverse effects; Metformin - therapeutic use; Mexico; Middle Aged; Pharmacovigilance; Prospective Studies; Rosiglitazone; Thiazoles - administration & dosage; Thiazoles - adverse effects; Thiazoles - therapeutic use; Thiazolidinediones - administration & dosage; Thiazolidinediones - adverse effects; Thiazolidinediones - therapeutic use; Weight Gain - drug effects
• ISSN: 0946-1965
• DOI: 10.5414/CP201615

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. 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. 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. 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.