Oral low-dose estradiol plus norethisterone acetate with or without simvastatin in dyslipidemic and symptomatic menopausal women: A randomized clinical trial
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 < 0.01). Relief of menopausal symptoms was better compared in A and B. 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.
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