Tibolone for Postmenopausal Women: Systematic Review of Randomized Trials

Modelska, Katharina; Cummings, Steven R.

doi:10.1210/jcem.87.1.8141

Cited by 142 publications

(89 citation statements)

References 34 publications

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“…Tibolone is an attractive alternative to HT as it is associated with minimal endometrial and breast epithelial stimulation, as well as minimal increase in breast density (25). Similar to Agrawal (21), we have found that tibolone significantly increases serum VEGF levels among healthy postmenopausal women.…”

Section: Discussionsupporting

confidence: 87%

Effect of hormone therapy, tibolone and raloxifene on circulating vascular endothelial growth factor in Greek postmenopausal women

Christodoulakos

Lambrinoudaki²,

Panoulis³

et al. 2004

European Journal of Endocrinology

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Objective: To evaluate the effect of continuous combined hormone therapy (HT), tibolone and raloxifene on circulating vascular endothelial growth factor (VEGF) in postmenopausal women. Design: One-year prospective intervention study. Methods: One hundred and forty-six postmenopausal women with a mean age of 51.8^4.1 (S.D.) years received 0.625 mg conjugated equine estrogen (CEE) plus 5 mg medroxyprogesterone acetate (MPA) (CEE/MPA, n ¼ 34), 2.5 mg tibolone (n ¼ 37), 60 mg raloxifene (n ¼ 40) or no active treatment (control group, n ¼ 35). Plasma VEGF was estimated at baseline and at 6 and 12 months. Results: In both the CEE/MPA-treated and the tibolone-treated groups plasma VEGF increased significantly at month 6 and remained elevated at month 12 (CEE/MPA baseline: 268.1^187.8 pg/ml, month 6: 320.0^175.3 pg/ml, month 12: 321.1^181.8 pg/ml, P ¼ 0.01; tibolone baseline: 240.6^165.8 pg/ml, month 6: 271.4^172.7 pg/ml, month 12: 274.8^183.1 pg/ml, P ¼ 0.03). These changes were significantly different from the respective changes in the control group after adjusting for T-score in bone densitometry (CEE/MPA: P ¼ 0.02, tibolone: P ¼ 0.04). The effect of HT or tibolone on plasma VEGF was mainly evident in women with low baseline VEGF levels (,243.2 pg/ml, median for whole sample). On the contrary, VEGF levels in the raloxifene-treated or the control group did not change throughout the study. Conclusion: Both continuous combined HT and tibolone increased circulating VEGF in postmenopausal women, while raloxifene had no effect. Further research is needed to clarify the clinical relevance of these findings with respect to cardiovascular risk in postmenopausal women.

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Section: Discussionsupporting

confidence: 87%

Effect of hormone therapy, tibolone and raloxifene on circulating vascular endothelial growth factor in Greek postmenopausal women

Christodoulakos

Lambrinoudaki²,

Panoulis³

et al. 2004

European Journal of Endocrinology

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“…A maioria dos estudos avaliando o efeito da tibolona sobre o perfil lipídico de mulheres saudáveis na pós-menopausa demonstrou diminuições nos níveis do HDL-colesterol e triglicerídeos, todavia os níveis de colesterol total, LDL-colesterol e lipoproteína (a) não apresentaram alterações significativas (8,9,29,30). No tocante às mulheres na pós-menopausa portadoras de DMNID, Prelevic e cols.…”

Section: Discussionunclassified

“…(11) observaram diminuição significativa nos níveis dos triglicerídeos e da lipoproteína (a), sem variações nos níveis do colesterol total, HDL-colesterol e LDL-colesterol. Em nossa pesquisa, encontramos mudanças no perfil lipídico semelhantes aos observados em pacientes não-diabéticas (8,9,29,30). A redução do HDL-colesterol pela tibolona se deve ao efeito androgênico do metabólito ∆ 4 -isômero na lipase hepática (30).…”

Section: Discussionunclassified

“…Em nossa pesquisa, encontramos mudanças no perfil lipídico semelhantes aos observados em pacientes não-diabéticas (8,9,29,30). A redução do HDL-colesterol pela tibolona se deve ao efeito androgênico do metabólito ∆ 4 -isômero na lipase hepática (30). A elevação dos triglicerídeos plasmáticos nas pacientes com DM representa mais um fator de risco para a doença cardiovascular (19,20), e esse declínio induzido pela tibolona observado no nosso estudo parece ser benéfico.…”

Section: Discussionunclassified

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Terapêutica com tibolona em mulheres diabéticas na pós-menopausa: parâmetros clínicos e laboratoriais de segurança

Freitas

Prado

et al. 2005

Arq Bras Endocrinol Metab

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RESUMOObjetivo: determinar o perfil de segurança clínico-laboratorial da terapia com tibolona em mulheres portadoras de diabetes mellitus não-insulinodependente (DMNID). Método: estudo prospectivo, longitudinal, aberto e controlado envolvendo 24 mulheres na pós-menopausa portadoras de DMNID, tratadas seqüencialmente com placebo (6 meses) e tibolona 2,5mg/dia (6 meses). Parâmetros clínicos, antropométricos, bioquímicos, hormonais e ultra-sonográficos foram avaliados no período basal, após 6 (tempo 1) e 12 meses de acompanhamento (tempo 2). Análise estatística foi realizada utilizando-se ANOVA para medidas repetidas, com nível de significância 5%. Resultados: efeitos colaterais surgiram apenas durante uso da tibolona (cefaléia e mastalgia em 8,3% e sangramento genital em 16,6%). Houve diminuição significativa dos sintomas climatéricos avaliados através do índice de Blatt-Kuperman [22,2 ± 7,1 (basal) vs. 13,6 ± 6,7 (tempo 1) vs. 3,1 ± 3,3 (tempo 2); p< 0,0001]. Após uso da tibolona, evidenciamos reduções significativas no percentual de gordura corporal, pressão arterial diastólica, níveis de transaminases, triglicerídeos e HDL-colesterol. Não houve variações significativas na pressão arterial sistólica, freqüência cardíaca, índice de massa corporal, relação cintura/quadril, glicemia de jejum, hemoglobina glicosilada, uréia, colesterol total e LDL-colesterol. A avaliação ultra-sonográfica não revelou variações significativas do volume uterino e espessura endometrial. Conclusão: o tratamento com tibolona em curto prazo mostrou bom perfil de segurança clínico-laboratorial em pacientes na pós-menopausa portadoras de DMNID. (6 months) and 2.5mg/day tibolone (6 months). Clinical evaluation, anthropometric parameters, biochemical and hormonal measurements, and transvaginal ultrasonography were performed at baseline and after 6 (time 1) and 12 months of follow-up (time 2). Statistical analysis was performed by repeated measures analysis of variance, with the level of significance set at 5%. Results: Side effects were present only during tibolone use (headache and mastalgia in 8.3% and genital bleeding in 16.6%). There was a significant reduction in the climacteric symptoms evaluated by Blatt-Kupperman index [22.2 ± 7.1 (baseline) vs. 13.6 ± 6.7 (time1) vs. 3.1 ± 3.3 (time 2); p< 0.0001]. After the tibolone use, we observed significant reductions in % body fat, diastolic arterial pressure, aminotransferases, triglycerides and HDL-cholesterol. There were no significant variations in artigo original

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“…Clinical trials have shown that tibolone prevents bone loss and maintains skeletal integrity in postmenopausal women (6,7). One study examined the three-year effect of tibolone at a dose of 2.5 mg daily on bone mineral density.…”

Section: Introductionmentioning

confidence: 99%

Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

Krejovic¹,

Živanović²,

Živanović³

et al. 2012

Journal of Medical Biochemistry

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Summary: Osteoporosis, a systemic disease of the bones, is a serious health and socio-economic problem because of its consequences, i.e. broken bones. It is believed that 10% of the world's population suffers from osteoporosis and it affects mostly postmenopausal women (postmenopausal osteoporosis). Tibolone is a synthetic steroid that has estrogenic, androgenic, and progestagenic properties. It has been used primarily for the prevention of postmenopausal osteoporosis and treatment of climacteric symptoms. The research included a group of 40 postmenopausal women with osteopenia treated with tibolone. The control group included 40 postmeno pausal women who were not taking any medication. Control group patients were older (54.5 ± 9.84) than the patients treated with tibolone (51.6 ± 6.22). Bone meta bolic activity was evaluated using osteocalcin (N-MID osteocalcin) for bone formation and CTX I for bone resorption. Blood samples were taken before therapy was introduced and 3 months after its introduction. The average value of osteocalcin after three months of tibolone therapy was 26.32 ± 3.312 ng/mL compared to the average osteocalcin value prior to the rapy of 29.6 ± 3.343 ng/mL. The average value of CTX I three months after tibolone therapy of 0.2870 ± 0.0783 ng/mL was lower compared to the average CTX I value before the therapy of 0.4539 ± 0.1144 ng/mL. Our results show the efficacy of tibolone in preventing bone loss, which was highly statistically significant. They also reveal its suppressive effects on bone for mation and resorption, but these effects are statistically less significant. Tibolone signifKratak sadr`aj: Osteoporoza, sistemsko oboljenje kostiju, predstavlja ozbiljan zdravstveni i socijalno-ekonomski problem zbog svojih posledica, preloma kostiju. Smatra se da 10% svetske populacije boluje od osteoporoze, a posebno su ugro `ene `ene u postmenopauzi. Tibolon je tkivno specifi~an steroid sa estrogenim, progestagenim i androgenim svojstvima. Prvenstveno se koristi za prevenciju postmenopauzalne osteoporoze i ubla`avanje klimakteri~nih tegoba. Istra`ivanje je sprovedeno u grupi od 40 `ena sa osteopenijom u postmenopauzi tretiranih tibolonom. Kontrolnu grupu ~inilo je 40 `ena u postmenopauzi koje nisu uzimale nikakvu terapiju. Pacijentkinje kontrolne grupe bile su starije (54,5 ± 9,84) od pacijentkinja tretiranih tibolonom (51,6 ± 6,22). Od para metara metaboli~ke aktivnosti kosti kori{}eni su osteo kalcin kao parametar formiranja kosti i CTX I kao parametar resorpcije kosti. Krv je va|ena pre uvo|enja terapije i 3 meseca nakon uvo|enja terapije. Prose~na vrednost osteokalcina tri meseca nakon terapije tibolonom je bila ni`a (26,32 ± 3,312 ng/mL) u odnosu na prose~nu vrednost osteokalcina pre terapije (29,6 ± 3,343 ng/mL). Prose~na vrednost CTX I tri meseca nakon terapije tibolonom je bila ni`a (0,2870 ± 0,0783 ng/mL) u odnosu na prose~na vrednost CTX I pre te rapije (0,4539 ± 0,1144 ng/mL). Na{i rezultati pokazali su izrazito koristan uticaj tibolona na ko{tanu resorpciju i supresivni efekat na ko{tan...

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Tibolone for Postmenopausal Women: Systematic Review of Randomized Trials

Cited by 142 publications

References 34 publications

Effect of hormone therapy, tibolone and raloxifene on circulating vascular endothelial growth factor in Greek postmenopausal women

Effect of hormone therapy, tibolone and raloxifene on circulating vascular endothelial growth factor in Greek postmenopausal women

Terapêutica com tibolona em mulheres diabéticas na pós-menopausa: parâmetros clínicos e laboratoriais de segurança

Effects of Tibolone on Markers of Bone Metabolic Activity in Postmenopausal Women

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