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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