CARDIOVASCULAR OUTCOMES IN TYPE-2 DIABETES - A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF BEZAFIBRATE - THE ST. MARYS, EALING, NORTHWICK PARKDIABETES CARDIOVASCULAR-DISEASE PREVENTION (SENDCAP) STUDY

OBJECTIVE- To determine whether serum lipid intervention, in addition to conventional diabetes treatment, could alter cardiovascular outcome s in type 2 diabetes. RESEARCH DESIGN AND METHODS- There were 164 type 2 diabetic subjects (117 men, 47 women) without a history of clinical cardiovascular disease randomized to receive either bezafibrate or pl acebo daily on a double-blind basis in addition to routine diabetes tr eatment and followed prospectively for a minimum of 3 years. Serial bi ochemical and noninvasive vascular assessments, carotid and femoral ar tery B-mode ultrasound measurements, and those pertaining to coronary heart disease (CHD)-clinical history, the World Health Organization (W HO) cardiovascular questionnaire, and resting and exercise electrocard iogram (ECG)-were recorded. RESULTS- Bezafibrate treatment was associa ted with significantly greater reductions over 3 years in median serum triglyceride (-32 vs. 4%, P = 0.001), total cholesterol (-7 vs. -0.3% , P = 0.004), and total-to-HDL cholesterol ratio (-12 vs. -0.0%, P = 0 .001), and an increase in HDL cholesterol (6 vs. -2%, P = 0.02) as com pared with placebo. There was a trend toward a greater reduction of fi brinogen (-18 vs. -6%, P = 0.08) at 3 years. No significant difference s between the two groups were found in the progress of ultrasonically measured arterial disease. In those treated with bezafibrate, there wa s a significant reduction (P = 0.01, log-rank test) in the combined in cidence of Minnesota-coded probable ischemic change on the resting ECG and of documented myocardial infarction. CONCLUSIONS- Improving dysli pidemia in type 2 diabetic subjects had no effect on the progress of u ltrasonically measured arterial disease, although. the lower rate of ' 'definite CHD events'' in the treated group suggests that this might r esult in a reduction in the incidence of coronary heart disease.