Randomized control study of the effects of raloxifene on serum lipids and homocysteine in older women

OBJECTIVE(S): Raloxifene, a selective estrogen receptor modulator, has bene ficial estrogen agonist effects on bone and cardiovascular risk factors and estrogen antagonist effects on the breast and uterus. Limited clinical dat a have shown a sustained decrease in total cholesterol, low-density lipopro tein cholesterol, and homocysteine levels; an elevated homocysteine level i s an independent risk factor for atherosclerosis. All of these studies were conducted in relatively young populations of women (mean age, 52-54 years) . Raloxifene does not affect hot flushes, a major immediate symptom of meno pause. This drug may therefore be useful in older women to prevent osteopor osis and cardiovascular disease. The aim of this clinical study was to eval uate the effects of raloxifene on plasma lipids and homocysteine in older w omen. STUDY DESIGN: The subjects were 45 healthy postmenopausal women, aged 60 to 70 years. The women were randomly assigned to therapy with raloxifene or p lacebo, 60 mg/d for 1 year. Twenty-six women received raloxifene and 19 rec eived placebo. Checkups were performed every 3 months. At baseline and afte r 3, 6, 9, and 12 months of treatment we measured homocysteine, total serum cholesterol, triglycerides, and both high-density lipoprotein and low-dens ity lipoprotein cholesterol. RESULTS: An effect on lipids was evident by 3 months with no significant ad ditional modification at 12 months. Mean low-density lipoprotein cholestero l levels were lowered by 15% and total cholesterol was lowered by 8.5%. No reduction in high-density lipoprotein cholesterol or triglycerides was obse rved. After 3 months of therapy, homocysteine was significantly lower than at baseline (9.9 +/- 1.6 vs 11 +/- 2.1 mu mol/L; P < .05). The greatest red uction with respect to baseline was reached after 6 months of therapy (-19. 5% +/- 3%; P < .05). CONCLUSION(S): The results of our study show that raloxifene at a dose of 6 0 mg/d reduces serum concentrations of low-density lipoprotein cholesterol and total cholesterol in healthy older women. Our study shows that in older women raloxifene leads to a 19.5% +/- 3% reduction in fasting homocysteine levels. Raloxifene may have a favorable effect on the incidence of cardiov ascular disease in older women.