Oral low-dose estradiol plus norethisterone acetate with or without simvastatin in dyslipidemic and symptomatic menopausal women: A randomized clinical trial

摘要

Context and Objective: Cardiovascular diseases are the leading causes of death in postmenopausal women and dyslipidemia has important contributing factor. The objective of the study was to evaluate low-dose estrogen plus progestogen therapy (EPT) + simvastatin for vasomotor symptoms and lipid and lipoprotein profiles. Design and Setting: Clinical trial was conducted in a private clinical research center. Methods: Two hundred forty symptommatic postmenopausal women with dyslipidemia were randomized to one of three treatment groups: A) 1 mg estradiol/ 0.5 mg norethisterone acetate (E2/NETA) + 20 mg simvastatin;B) E2/NETA + placebo;or C) 20 mg simvastatin + placebo. Lipid and lipoprotein profiles and menopausal symptoms were evaluated after 16 weeks. Results: Total cholesterol, LDL cholesterol, non-HDL cholesterol decreased (P < 0.05) in all three groups, Apo-B/Apo-A1 and ApoB (P < 0.01) in groups A and C and TG and ApoA1 only in group A comparing baseline versus final. Comparing the groups, group B showed differences in relation to others in total cholesterol, non-HDL cholesterol, LDL cholesterol, Apo B and ApoB/Apoa1 (P Conclusions: Thus in postmenopausal women with dyslipidemia, the association of E2/ NETA low-dose with simvastatin relieved climacteric symptoms similar to that observed with isolated E2/NETA and improved lipid and lipoprotein profile similar to the isolated use of simvastatin. The use of E2/NETA alone decreased menopausal symptoms, but did not improve dyslipidemia.