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Tibolone

Tibolone

Tibolone is a synthetic analog of the gonadal steroids with combined estrogenic, progestogenic and androgenic properties, which has been approved in the treatment of menopausal symptoms. Its effects on BMD are comparable to those of hormone replacement therapy. Although The Long term Intervention on Fractures with Tibolone (LIFT) study indicates beneficial effects of tibolone on vertebral fracture risk in postmenopausal women (HR=0.59), this study has been stopped owing to an increased risk of strokes(HR=2.3, after 2.75 years) (ischemic plus haemorrhagic).
Another randomized, double-blind, placebo-controlled clinical trial, recently published in the New England Journal of Medicine, investigated the effects of 1.25mg tibolone daily in older postmenopausal women (60-85 years old). After 3 years treatment, a statistically significant decrease of the risk of vertebral fracture (HR= 0.55) and non vertebral fracture (HR=0.74) was observed in the tibolone group. These effects were particularly marked among osteoporotic women with prevalent fractures. In addition to these favourable effects on bone, the tibolone group had a decreased risk of invasive breast cancer (HR=0.32) and colon cancer (HR=0.31). However, an increased risk of strokes was observed in the treated group (HR=2.19). The authors recommended not using tibolone in elderly women with risk factors for stroke.

References

  1. Cummings SR. LIFT study is discontinued. BMJ 2006;332:667
  2. Cummings SR, Ettinger B, Delmas PD, Kenemans P, Stathopoulos V, Verweij P, Mol-Arts M, Kloosterboer L, Mosca L, Christiansen C, Bilezikian J, Kerzberg EM, Johnson S, Zanchetta J, Grobbee DE, Seifert W, Eastell R, for the LIFT Trial Investigators. The effects of Tibolone in older postmenopausal women. N Engl J Med 2008, 359:697-708
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