GEMFIBROZIL TREATMENT OF THE HIGH TRIGLYCERIDE-LOW HIGH-DENSITY-LIPOPROTEIN CHOLESTEROL TRAIT IN MEN WITH ESTABLISHED ATHEROSCLEROSIS

Objective. To study the short-term efficacy, tolerability and safety o f the treatment with gemfibrozil 600 mg twice daily or placebo in male patients with established atherosclerosis, with a lipid profile match ing the 'high triglyceride-low high-density lipoprotein (HDL) choleste rol trait'. Design. Double-blind randomized placebo controlled prospec tive trial. Setting. Amsterdam Lipid Research Clinic at the Academic M edical Centre of the University of Amsterdam and the Slotervaart Train ing Hospital affiliated to the University of Amsterdam, Amsterdam, the Netherlands. Subjects. Thirty-five male patients, age 30-70, with est ablished atherosclerosis and the high triglyceride-low HDL cholesterol trait. Main outcome measures. Plasma total cholesterol, triglycerides , lipoproteins, apolipoproteins A(1) and B-100, clinical and laborator y safety parameters. Results. Seventeen patients in the gemfibrozil gr oup and 16 patients in the placebo group completed the study period. C ompliance was considered adequate. Mean (+/-standard deviation) plasma HDL cholesterol levels increased 20.3% (+/-12.22) from 0.82 to 0.99 m mol L(-1) in the gemfibrozil group against 9.9% (+/-18.31) from 0.79 t o 0.87 mmol L(-1) in the placebo group (P = 0.001). Mean plasma trigly ceride level fell 49.5% (+/-14.2 7) from 3.65 to 1.82 mmol L(-1) in th e gemfibrozil group against an increase of 13.6% (+/-40.31) from 3.62 to 4.01 mmol L(-1) in the placebo group (P < 0.001). Although plasma H DL cholesterol and triglyceride levels improved in all patients, norma lization of these lipoproteins was only observed in approximately half of them. Plasma total and low-density lipoprotein (LDL) cholesterol l evels, as well as plasma levels of apolipoprotein (ape) A(1), B-100 an d lipoprotein [Lp(a)], did not show significant alterations compared t o the placebo. All safety parameters were comparable between the two g roups and remained within the reference limits. Gemfibrozil was well t olerated during treatment. Minor inconveniences were equally distribut ed between the two treatment groups. Conclusions. Gemfibrozil is an ef fective and safe drug in patients with coronary heart disease (CHD) an d the high triglyceride-low HDL cholesterol trait.