Livial® (tibolone), an agent used to reduce menopausal symptoms as well as bone loss, significantly reduces the risk of breast cancer and prevents bone loss and fractures; however, it doubles the risk of stroke among postmenopausal women. These results were recently published in the New England Journal of Medicine.
Historically, women have often been treated with hormone-replacement therapy (HRT) in order to reduce menopausal symptoms. However, research has emerged indicating that HRT is associated with an increased risk of breast cancer. Since these studies have been published, the use of HRT has decreased dramatically.
Livial is an agent that is approved in 45 countries to relieve menopausal symptoms and in 90 countries to prevent bone loss. It contains properties that mimic both female and male hormones.
Researchers affiliated with the Long-Term Intervention on Fractures with Tibolone (LIFT) trial recently conducted a clinical trial to evaluate Livial among postmenopausal women with osteoporosis. This trial included 4,538 women between the ages of 60 and 85 years; one group of patients was treated with Livial, and the other group received placebo (inactive substitute).
- Patients treated with Livial had a significantly decreased risk of developing both breast cancer and colon cancers.
- Patients treated with Livial had a significantly decreased risk of both spinal and non-spinal fractures.
- Patients treated with Livial had more than a twofold increased risk of a stroke, an endpoint that prompted the study to be stopped early due to safety risks.
- There were no significant differences of heart disease or blood clots between the two groups of patients.
The researchers concluded: “Tibolone reduced the risk of fracture and breast cancer and possibly colon cancer but increased the risk of stroke in older women with osteoporosis.”
Reference: Cummings S, Ettinger B, Delmas P, et al. The Effects of Tibolone in Older Postmenopausal Women. New England Journal of Medicine. 2008;359:697-708.