ADA: Rosiglitazone Effect on Heart Attack Risk Studied
No significant increase in CV disease or death, although heart failure, fractures more frequent
FRIDAY, June 5 (HealthDay News) -- Adding rosiglitazone to diabetic therapy does not significantly affect the risk of cardiovascular disease or death, although risks of heart failure and fracture are higher, according to a study reported in the June 5 online edition of The Lancet and discussed at the American Diabetes Association's 69th Scientific Sessions, held from June 5 to 9 in New Orleans.
Philip D. Home, of Newcastle University in the United Kingdom, and colleagues randomly assigned 4,447 patients with type 2 diabetes, who were taking either metformin or sulfonylurea alone, to take either rosiglitazone in addition to their monotherapy or both metformin and sulfonylurea in combination.
The researchers found that in the 5.5-year mean follow-up, 321 people in the rosiglitazone group and 323 in the control group were hospitalized for a cardiovascular event (hazard ratio, 0.84) or died from cardiovascular causes (hazard ratios, 1.14 for myocardial infarction and 0.72 for stroke). However, hospitalization or death from heart failure occurred in 61 people in the rosiglitazone group and just 29 in the active control group. Also, arm and leg fractures increased in patients given rosiglitazone, mainly in women.
"Rosiglitazone is not recommended for people with a history of heart failure or with previous problems that might have led to myocardial dysfunction. Rosiglitazone should be used with caution in women at high risk of fractures," the authors conclude. "Although our evidence is insufficient to rule out a small increased risk of myocardial infarction caused by rosiglitazone when compared with other glucose-lowering agents, rosiglitazone does not increase overall cardiovascular morbidity or mortality."
Financial disclosures included funding from GlaxoSmithKline; two study authors are GSK employees.