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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 - Early Online Publication, 06/09/09

Home PD et al. – Addition of rosiglitazone to glucose-lowering therapy in pts with type 2 diabetes is confirmed to increase risk of heart failure and of some fractures, mainly in women. Despite inconclusive data are about any possible effect on myocardial infarction, rosiglitazone does not increase risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs.

Methods

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

Results

• 321 pts in rosiglitazone group and 323 in active control group experienced primary outcome during mean 5.5-yr follow-up, meeting criterion of non-inferiority
• HR was 0.84 for cardiovascular death, 1.14 for myocardial infarction, and 0.72 for stroke
• 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 women assigned to rosiglitazone
• Mean HbA1c lower in rosiglitazone vs control group at 5 yrs