A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability

A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability

Autor Baracat, E. C. Google Scholar
Barbosa, I. C. Google Scholar
Giordano, M. G. Google Scholar
Haidar, Mauro Abi Autor UNIFESP Google Scholar
Marinho, R. M. Google Scholar
Menegocci, J. C. Google Scholar
Morais, K. M. Google Scholar
Tomaz, G. Google Scholar
Wehba, S. Google Scholar
Instituição Universidade Federal de São Paulo (UNIFESP)
Universidade Federal da Bahia (UFBA)
Universidade Federal do Rio de Janeiro (UFRJ)
Fac Med Sci Minas Gerais
Pontifical Catholic Univ
Univ Fed Rio Grande Norte
Univ Fed Paraiba
Santa Casa Misericordia
Resumo Objective To compare the effects of continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) with those of tibolone on symptom control, bleeding pattern, lipid profile and tolerability in postmenopausal women.Methods This was a randomized, open-label, parallel-group, multicenter study. Generally healthy postmenopausal women with an intact uterus and no contraindications to hormone replacement therapy (HRT) or tibolone were enrolled. Each subject was randomly assigned to receive CEE/MPA 0.625 mg-5.0 mg or tibolone 2.5 mg daily for 13 treatment cycles, each of 28 days.Results A total of 85 subjects were enrolled and received at least one dose of study medication, of which 76 (89.4%) subjects completed the study (n = 40, CEE/MPA; n = 363 tibolone). the incidence of postmenopausal symptoms decreased significantly over time in both treatment groups, compared with baseline, including significant decreases in the incidence of urogenital and sexual health symptoms. Significant differences in symptom control (other than hot flushes) were observed between treatment groups in a few different cycles for different symptoms, but no consistent or clinically significant trends were observed. No statistically significant differences in the incidence of bleeding were observed between treatment groups after cycle 4. Significant decreases in total cholesterol (5.6%) and low-density lipoprotein (LDL) cholesterol (7.5%) were observed at cycle 13, compared with baseline, in the CEE/MPA group, and significant decreases in high-density lipoprotein (HDL) cholesterol (8.5%) and triglycerides (13.7%) were observed at cycle 13, compared with baseline, in the tibolone group. Significant weight gain was observed at cycle 13 in the. tibolone group (3.05 kg), compared with the CEE/MPA group (0.96 kg). the incidences of adverse events were similar in both treatment groups.Conclusions Women treated with CEE/MPA or tibolone showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms, and had similar bleeding patterns after four cycles of therapy. CEE/MPA and tibolone each induced a different mix of changes in the lipid profile.
Palavra-chave menopause
hormone replacement therapy
conjugated equine estrogens
tibolone
Idioma Inglês
Data de publicação 2002-03-01
Publicado em Climacteric. Lancaster: Parthenon Publishing Group, v. 5, n. 1, p. 60-69, 2002.
ISSN 1369-7137 (Sherpa/Romeo, fator de impacto)
Publicador Parthenon Publishing Group
Extensão 60-69
Fonte http://dx.doi.org/10.1080/cmt.5.1.60.69
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000178728600009
Endereço permanente http://repositorio.unifesp.br/handle/11600/26793

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