The PEARL trial: lasofoxifene and incidence of fractures, breast cancer and cardiovascular events in postmenopausal osteoporotic women

Abstract

Lasofoxifene is a selective estrogen-receptor modulator with high affinity and selectivity for estrogen receptors, leading to estrogen-agonist effects in some tissues and estrogen-antagonist effects in others. Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) was a global, multicenter, double-blind, placebo-controlled randomized trial which recruited 8556 women between 59–80 years of age with osteoporosis under therapy with lasofoxifene 0.25 mg/d, lasofoxifene 0.5 mg/d, or placebo for 5 years. In postmenopausal women with osteoporosis, lasofoxifene 0.5 mg/day for 5 years reduced the risk of nonvertebral and vertebral fractures, major coronary heart disease, stroke and both total and estrogen receptor-positive invasive breast cancer risk. However, both doses of lasofoxifene increased the risk of venous thromboembolic events.