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RECORD
Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes
Ongoing trial
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Author(s) |
(a) Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP
(b) Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJV |
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Title(s) |
(a) Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol
(b) Rosiglitazone evaluated for cardiovascular outcomes – an interim analysis |
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Reference(s) |
(a) Diabetologia 2005;48:1726–35
(b) N Engl J Med 2007;357:28–38 |
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Disease |
Diabetes mellitus |
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Purpose |
To evaluate the effects of rosiglitazone on cardiovascular outcomes and long-term glycaemic control in patients with type 2 diabetes |
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Study design |
Randomised, open, parallel-group |
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Follow-up |
Aim 6 years |
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Patients |
4447 patients (2220 rosiglitazone, 2227 control), aged 40–75 years, with type 2 diabetes and inadequate glycaemic control (HbA1c 7.1–9.0%) with metformin or sulphonylurea
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Treatment regimen |
Metformin, standard dose, plus rosiglitazone, 4 mg/day, or sulphonylurea, standard dose. Alternatively, sulphonylurea plus rosiglitazone, 4 mg/day, or metformin. If HbA1c ≥ 8.5% after 8 weeks, combination therapy with sulphonylurea and metformin plus rosiglitazone or insulin
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Results |
An unplanned interim analysis at a mean follow-up of 3.75 years showed that there were no significant differences between the rosiglitazone group and the control group in time to first cardiovascular hospitalisation or death (217 vs 202 events, hazard ratio 1.08, 95% CI 0.89–1.31; p = 0.43). There were no statistically significant differences between groups in incidence of AMI, death from cardiovascular causes or any cause, or the composite of cardiovascular death, MI and stroke. Patients in the rosiglitazone group had a significantly higher risk of congestive heart failure than those in the control group (38 vs 17, hazard ratio 2.24, 95% CI 1.27–3.97; p = 0.006) |
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