In a randomized, double-blind five-year trial, we tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein (HDL) cholesterol and lowering levels of non-HDL cholesterol with gemfibrozil in reducing the risk of coronary heart disease in 4081 asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter [5.2 mmol per liter] in two consecutive pretreatment measurements). One group (2051 men) received 600 mg of gemfibrozil twice daily, and the other (2030 men) received placebo. Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total, low-density lipoprotein (LDL), and non-HDL cholesterol and triglycerides. There were minimal changes in serum lipid levels in the placebo group. The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group--a reduction of 34.0 percent in the incidence of coronary heart disease (95 percent confidence interval, 8.2 to 52.6; P less than 0.02; two-tailed test). The decline in incidence in the gemfibrozil group became evident in the second year and continued throughout the study. There was no difference between the groups in the total death rate, nor did the treatment influence the cancer rates. The results are in accord with two previous trials with different pharmacologic agents and indicate that modification of lipoprotein levels with gemfibrozil reduces the incidence of coronary heart disease in men with dyslipidemia.
To study the effects of different types of progestogens on lipoprotein metabolism, we treated three groups of postmenopausal women (six subjects each) for three weeks with estradiol valerate, 2 mg per day, and continued the treatment with different sequential estradiol-progestogen regimens as follows: Group A received norethindrone acetate, 10 mg per day, from Day 15 to Day 24 of the cycle; Group B, medroxyprogesterone acetate, 10 mg per day; and Group C, norgestrel, 0.5 mg per day. These regimens were followed by two consecutive cycles. Total cholesterol decreased in all groups by 10 to 18 per cent from the base-line values (P < 0.05). High-density-lipoprotein (HDL) cholesterol decreased by 20 per cent from the base-line level during treatment with both the estradiol-norethindrone acetate (P < 0.05) and estradiol-norgestrel (P < 0.01) regimens, whereas estradiol with medroxyprogesterone acetate was not associated with a significant change in HDL cholesterol. Our results suggest that the androgenic progestogens of the 19-nortestosterone series reverse the beneficial effect of postmenopausal estrogen treatment on HDL cholesterol, whereas the hydroxyprogesterone derivative medroxyprogesterone acetate has no such effect.
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