Extended-release niacin vs gemfibrozil for the treatment of low levels of high-density lipoprotein cholesterol

Objective: To provide a direct comparison of agents that raise plasma level s of high-density lipoprotein cholesterol (HDL-C) to help devise strategies for coronary risk reduction. Methods: In a multicenter, randomized, double-blind trial, we compared the effects of extended-release niacin (Niaspan), at doses increased sequential ly from 1000 to 2000 mg at bedtime, with those of gemfibrozil, 600 mg given twice daily, in raising low levels of HDL-C. Enrollment criteria included an HDL-C level of 1.03 mmol/L or less (less than or equal to 40 mg/dL), a l ow-density lipoprotein cholesterol level of 4.14 mmol/L or less (less than or equal to 160 mg/dL) or less than 3.36 mmol/L (130 mg/dL) with atheroscle rotic disease, and a triglyceride level of 4.52 mmol/L or less (less than o r equal to 400 mg/dL). Results: Among 173 patients, 72 (82%) of the 88 assigned to Niaspan treatme nt and 68 (80%) of the 85 assigned to gemfibrozil treatment completed the s tudy. Niaspan, at 1500 and 2000 mg, vs gemfibrozil raised the HDL-C level m ore (21% and 26%, respectively, vs 13%), raised the apolipoprotein A-I leve l more (9% and 11% vs 4%), reduced the total cholesterol-HDL-C ratio more ( -17% and -22% vs -12%), reduced the lipoprotein(a) level (-7% and -20% vs n o change), and had no adverse effect on the low-density lipoprotein cholest erol level (2% and 0% change vs a 9% increase). Significance levels for com parisons between medications ranged from P<.001 to P<.02. Gemfibrozil reduc ed the triglyceride level more than Niaspan (P<.001 to P = .06, -40% for ge mfibrozil vs -16% to -29% for Niaspan, 1000 to 2000 Mg). Effects on plasma fibrinogen levels were significantly favorable for Niaspan compared with ge mfibrozil (P<.02), as gemfibrozil increased the fibrinogen level (from 5% t o 9%) and Niaspan tended to decrease the fibrinogen level (from -1% to -6%) . Conclusions: In patients with a low baseline HDL-C level, Niaspan at its hi gher doses provided up to 2-fold greater HDL-C increases, decreases in lipo protein(a), improvements in lipoprotein cholesterol ratios, and lower fibri nogen levels compared with gemfibrozil. Gemfibrozil gave a greater triglyce ride reduction but also increased the low-density lipoprotein cholesterol l evel, which did not occur with Niaspan.