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

Marcelo Luis Steiner, Luciano Melo Pompei, Rodolfo Strufaldi, Everaldo Porto Cunha, César Eduardo Fernandes

Assistant Physician, Gynecological Endocrinologyand Menopause Division, Department of Gynecology and Obstetrics, Faculdade de Medicina do ABC (FMABC), S?o Bernardo do Campo, S?o Paulo, Brazil.
Assistant Professor, Department of Gynecologyand Obstetrics, Faculdade de Medicina do ABC (FMABC), S?o Bernardo do Campo, S?o Paulo, Brazil.
Head of the Gynecological Endocrinology and Menopause Division, Department of Gynecology and Obstetrics, Faculdade de Medi- cina do ABC (FMABC), S?o Bernardo do Campo, S?o Paulo, Brazil.
Postgraduate Student in Gynecology, Obstetricsand Mastology, Universidade Estadual de S?o Paulo (Unesp), Botucatu, S?o Paulo, Brazil.

DOI: 10.4236/health.2013.57A4016                

Abstract

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.

Keywords

Dyslipidemia; Hormone Replacement Therapy; Lipoproteins; Simvastatin; Cardiovascular Diseases

Conflicts of Interest

The authors declare no conflicts of interest.

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