TY - JOUR
T1 - Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes
T2 - The Diabetes Atherosclerosis Intervention Study, a randomised study
AU - Diabetes Atherosclerosis Intervention Study Investigators
AU - Steiner, G.
AU - Hamsten, A.
AU - Hosking, J.
AU - Stewart, D.
AU - McLaughlin, P.
AU - Gladstone, P.
AU - Sole, M.
AU - Syvanne, M.
AU - Camelon, K.
AU - Schloegl, G.
AU - Genest, J.
AU - Reeves, F.
AU - Savard, R.
AU - Letarte, A.
AU - Bellavance, N.
AU - Touchette, J.
AU - Latour, Y.
AU - Marchand, P.
AU - Rondeau, C.
AU - Rivard-Gervais, N.
AU - Belanger, A.
AU - Hamel, D.
AU - Dumas, R.
AU - Sandri, M.
AU - Morin, N.
AU - Caponi, E.
AU - Barbeau, C.
AU - Gauthier, S.
AU - Ooi, T. C.
AU - Davies, R. F.
AU - Braaten, J. T.
AU - Baker, A.
AU - Favreau, C.
AU - Collar, C.
AU - Zinman, B.
AU - Aldridge, H.
AU - Donat, D. J.
AU - Tsui, E.
AU - Barnie, A.
AU - DiMonte, L.
AU - MacLean, S.
AU - Bond, M.
AU - Martin, C.
AU - Zawacki, R.
AU - Dziuran, K.
AU - M-R Gouveia, Gouveia
AU - Taskinen, M. R.
AU - Nieminen, M.
AU - Nikkila, K.
AU - Brown, M.
N1 - Funding Information:
We thank the patients who volunteered for this study. DAIS was supported by Laboratoires Fournier SA, Daix, France.
PY - 2001/3/24
Y1 - 2001/3/24
N2 - Background: Atherosclerosis is the most common complication of diabetes. Correction of hyperglycaemia helps to prevent microvascular complications but has little effect on macrovascular disease. Post-hoc analyses of diabetic subpopulations in lipid intervention trials suggest that correction of lipoprotein abnormalities will lead to a decrease in coronary-artery disease. The Diabetes Atherosclerosis Intervention Study (DAIS) was specifically designed to assess the effects of correcting lipoprotein abnormalities on coronary atherosclerosis in type 2 diabetes. Methods: 731 men and women with type 2 diabetes were screened by metabolic and angiographic criteria. 418 were randomly assigned micronised fenofibrate (200 mg/day) or placebo for at least 3 years. They were in good glycaemic control (mean haemoglobin A1c 7.5%), had mild lipoprotein abnormalities, typical of type 2 diabetes, and at least one visible coronary lesion. Half had no previous clinical coronary disease. Initial and final angiograms followed a standard protocol and were analysed by a computer-assisted quantitative approach. Missing data for the primary endpoints (minimum lumen diameter, mean segment diameter, and mean percentage stenosis) were imputed. Analyses were by intention to treat. Findings: Total plasma cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride concentrations all changed significantly more from baseline in the fenofibrate group (n=207) than in the placebo group (n=211). The fenofibrate group showed a significantly smaller increase in percentage diameter stenosis than the placebo group (mean 2.11 [SE 0.594] vs 3.65 [0.608]%, p=0.02), a significantly smaller decrease in minimum lumen diameter (-0.06 [0.016] vs -0.10 [0.016] mm, p=0.029), and a non-significantly smaller decrease in mean segment diameter (-0.06 [0.017] vs -0.08 [0.018] mm, p=0.171). The trial was not powered to examine clinical endpoints, but there were fewer in the fenofibrate group than the placebo group (38 vs 50). Interpretation: DAIS suggests that treatment with fenofibrate reduces the angiographic progression of coronary-artery disease in type 2 diabetes. This effect is related, at least partly, to the correction of lipoprotein abnormalities, even those previously judged not to need treatment.
AB - Background: Atherosclerosis is the most common complication of diabetes. Correction of hyperglycaemia helps to prevent microvascular complications but has little effect on macrovascular disease. Post-hoc analyses of diabetic subpopulations in lipid intervention trials suggest that correction of lipoprotein abnormalities will lead to a decrease in coronary-artery disease. The Diabetes Atherosclerosis Intervention Study (DAIS) was specifically designed to assess the effects of correcting lipoprotein abnormalities on coronary atherosclerosis in type 2 diabetes. Methods: 731 men and women with type 2 diabetes were screened by metabolic and angiographic criteria. 418 were randomly assigned micronised fenofibrate (200 mg/day) or placebo for at least 3 years. They were in good glycaemic control (mean haemoglobin A1c 7.5%), had mild lipoprotein abnormalities, typical of type 2 diabetes, and at least one visible coronary lesion. Half had no previous clinical coronary disease. Initial and final angiograms followed a standard protocol and were analysed by a computer-assisted quantitative approach. Missing data for the primary endpoints (minimum lumen diameter, mean segment diameter, and mean percentage stenosis) were imputed. Analyses were by intention to treat. Findings: Total plasma cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride concentrations all changed significantly more from baseline in the fenofibrate group (n=207) than in the placebo group (n=211). The fenofibrate group showed a significantly smaller increase in percentage diameter stenosis than the placebo group (mean 2.11 [SE 0.594] vs 3.65 [0.608]%, p=0.02), a significantly smaller decrease in minimum lumen diameter (-0.06 [0.016] vs -0.10 [0.016] mm, p=0.029), and a non-significantly smaller decrease in mean segment diameter (-0.06 [0.017] vs -0.08 [0.018] mm, p=0.171). The trial was not powered to examine clinical endpoints, but there were fewer in the fenofibrate group than the placebo group (38 vs 50). Interpretation: DAIS suggests that treatment with fenofibrate reduces the angiographic progression of coronary-artery disease in type 2 diabetes. This effect is related, at least partly, to the correction of lipoprotein abnormalities, even those previously judged not to need treatment.
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U2 - 10.1016/S0140-6736(00)04209-4
DO - 10.1016/S0140-6736(00)04209-4
M3 - Article
C2 - 11289345
AN - SCOPUS:0035941990
SN - 0140-6736
VL - 357
SP - 905
EP - 910
JO - Lancet
JF - Lancet
IS - 9260
ER -