Tibolone tied to increased BMD, less bleeding: not available in the United States.(Gynecology)

MIAMI BEACH -- The synthetic steroid tibolone appears to increase bone mineral density as well as hormone therapy, but without the side effects of breast pain and breakthrough bleeding, Dr. Robert D. Langer reported in a poster session at the annual meeting of the North American Menopause Society.

Tibolone (Livial), marketed by Organon International and prescribed in 70 countries worldwide for relief of postmenopausal symptoms since the 1980s, is not yet available in the United States. It appears to confer effective protection against osteoporosis, with a tolerability profile that could keep compliance much higher than exists with current hormone therapy (HT), Dr. Robert Langer said in an interview.

"The majority of women who receive a hormone prescription aren't taking it after 2 years, and most drop out within the fast 6 months," said Dr. Langer of the University of California, San Diego. "The number one reason they quit is they don't like the bleeding pattern and the number two reason is breast pain. This is superior in both respects."

Dr. Langer presented the first results of the Osteoporosis Prevention and Arterial Effects of Tibolone study (OPAL), a 3-year randomized, placebo-controlled study that investigated the effects of tibolone on bone mineral density (BMD) and carotid intima media thickness, compared with the effects of estrogen-progestogen therapy and placebo. The study was sponsored by Organon International.

Only the bone data have been analyzed so far. OPAL randomized 866 healthy postmenopausal women aged 45-76 years to therapy with tibolone (2.5 rag/day), estrogen/progestogen therapy (0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate/day) or placebo. All women also received a daily calcium supplement of 500 mg.

Dual x-ray absorptiometry measurements of the lumbar spine, total hip, ...