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Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre, randomised, open-label trial
The Lancet, 06/23/09

Home PD et al. – Addition of rosiglitazone to glucose-lowering therapy in type 2 diabetes pts is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Data are inconclusive for effects on myocardial infarction; howver, rosiglitazone does not increase risk of overall cardiovascular morbidity or mortality vs standard glucose-lowering drugs.

Methods

Study of cardiovascular outcomes after rosiglitazone addition to either metformin or sulfonylurea vs combination of the 2 over 5-7-yr follow-up
Comparative safety assessment
Multi-center, open-label trial of 4447 type 2 diabetes pts on metformin or sulfonylurea monotherapy with mean hemoglobin A1c (HbA1c) of 7.9%
Randomization to addition of rosiglitazone (2220 pts) or combination of metformin and sulfonylurea (active control group, 2227)
Primary endpoint: cardiovascular hospitalization or cardiovascular death

Results

During mean 5.5-yr follow-up, primary outcome met by 321 rosiglitazone pts and 323 active controls, meeting non-inferiority criterion
Heart failure causing admission to hospital or death in 61 people in rosiglitazone group and 29 in active control group
Upper and distal lower limb fracture rates increased mainly in female rosiglitazone pts
Mean HbA1c lower in rosiglitazone vs control group at 5 yrs