Objective: Patients with NIDDM have a two- to fourfold increased risk of macrovascular disease. The constellation of elevated TGs and decreased HDL cholesterol are recognized as risk factors and constitute the major dyslipidemia in NIDDM. We therefore sought to determine if gemfibrozil (600 mg b.i.d.) was effective in correcting the dyslipidemia of NIDDM.
Research design and methods: After 8 wk of placebo stabilization, 442 patients from 46 study centers were randomized to double-blind treatment, in a designated 2:1 ratio, 295 received gemfibrozil and 147 received placebo for 20 wk. The primary end point was plasma TG; secondary end points were TC, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and HbA1c. No baseline differences were noted between groups in sex, age, weight, type of diabetic therapy, fasting plasma levels of TGs, HbA1c, or C-peptide. About two-thirds received oral hypoglycemic drugs, one-third insulin.
Results: TG fell 26.4% in the gemfibrozil group and rose 7.4% in the placebo group (P < 0.023), by an intent-to-treat analysis. When patients who were noncompliant or with inadequate data were excluded, similar results were found--a 30.4% fall with gemfibrozil and a 4.8% increase with placebo (P < 0.0001). TG levels fell within 4 wk and remained low for 20 wk (P < 0.001). Mean HDL cholesterol rose by 4 wk and increased further at 12 wk (8-12%), P < 0.0001. TC fell. We observed a significant rise in LDL cholesterol in both gemfibrozil- and placebo-treated groups, with no significant differences between these groups. Changes in HbA1c were similar in gemfibrozil and placebo groups. No differences were observed in responses in groups treated with insulin and or oral hypoglycemic drugs. Overall AEs that were clinically important occurred in 6.1% in the gemfibrozil group vs. 2.0% in the placebo group (NS).
Conclusions: We conclude that gemfibrozil is an effective and safe agent in combating the dyslipidemia of NIDDM, irrespective of type of diabetic therapy.