PURPOSE To evaluate the effects of simvastatin alone or together with continuous combined hormone replacement therapy on the serum lipid profile in hypercholesterolemic postmenopausal wowen. Patients and
METHODS One hundred hypercholesterolemic postmenopausal women were stratified to one of the two treatment arms; simvastatin 10 mg daily together with estrogen 0.625 mg and medroxyprogesterone 2.5 mg daily (group A) (n: 50) or simvastatin 10 mg daily (group B) (n:50). Serum total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol and triglyceride levels were measured at baseline, at 3 and 6 months; and laboratory and elinical evidence of adverse events were monitored periodically throughout the study.
RESULTS The initial mean (± SD) cholesterol values were as follows for groups A and B, respectively: total cholesterol 240.0±28.0 and 248.9±28.2 mg/di; LDL-cholesterol 174.7±25.6 and 1 75.1±25.9; HDL cholesterol 37.2±5.0 and 39.9±9.7.3 mg/d!. Compared with the baseline, total and LDL cholesterol levels decreased; and HDL cholesterol levels increased significantly at 3 and 6 months in both groups. However, the mean percent reduction in total cholesterol anad LDL~cholesterol was significantly greater in group A compared with group B both at 3 months (12.3±7.0% vs 8.9±6.2 %; p<0.01; and 19.0±10.6% vs 13.2±10.4 %; p<0.005, respectively) and at 6 months (14.6±7.7 % vs 1 1.3±7.4 %; p<0.05 and 23.3±9.7 % vs 15.8±12.3 %; p<0.005, respectively). The mean percent increase in serum HDL-cholesterol concentrations was also significantly greater in group A compared with group B at both times (14.6±1 1.8 % vs 9.8±1 1.8 %; p<0.005, at 3 months, and 21.3±15.2% vs l 1.1±12.5; p<0.005, at 6 months, respectively). Furthermore, significantly more patients in group A than in group B attained their target treatment goals dictated by the NCEP guidelines. Although the mean percent decrease in triglyceride levels was significantly greater in group in group A at 3 months, the significance disappeared at 6 months.
CONCLUSION The combination of simvastatin and continuous combined hormone replacement therapy seems to be more effective than sirnvastatin alone in the treatment of hypercholesterolemia in postmenopausal women.
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