New Data Support Long-term Safety Profile of Osteoporosis Drug

DECEMBER 01, 2005
Susan Farley

Eight years of trial data for Evista (raloxifene HCl), a selective estrogen receptor modulator used in the prevention and treatment of osteoporosis, supported the drug's long-term safety profile. Data were compiled from 2 clinical trials, the Multiple Outcomes of Raloxifen Evaluation (MORE), which measured fracture risk reduction, and the Continuing Outcomes Relevant to Evista (CORE), which measured breast cancer risk reduction. MORE was a 4-year, double-blind, placebo-controlled study, including 7705 postmenopausal women with osteoporosis. CORE, a 4-year, placebo-controlled follow-up trial to MORE, included 4011 postmenopausal women with osteoporosis. Both studies included patients' reports of adverse events. Results showed that, when compared with placebo, Evista did not increase risk for the following side effects: myocardial infarction; stroke; endometrial hyperplasia; postmenopausal bleeding; and uterine and ovarian cancer. In the CORE trial, however, researchers found that Evista increased the risk for developing venous thromboembolism—1.7%, compared with 1% in the placebo group. Therefore, Evista is not recommended for women with a history of deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. Silvano Martino, CORE's lead investigator, stated, "The results of these studies...[provide] physicians and patients with information they need to weigh the risks and benefits of treatment and to decide if Evista is right for [them]."

Ms. Farley is a freelance medical writer based in Wakefield, RI.




SHARE THIS SHARE THIS
0

Become A RESPIMAT T.O.P. Performer 

Get to know RESPIMAT, the slow-moving mist inhaler from Boehringer Ingelheim Pharmaceuticals, Inc.

Watch the RESPIMAT video and test your knowledge with a short multiple-choice quiz. When you get all the answers right, you’ll receive a certificate naming you a RESPIMAT T.O.P. Performer. Why not check it out today?


Pharmacy Times Strategic Alliance
 

Pharmacist Education
Clinical features with downloadable PDFs


Next-Generation Pharmacist® Awards


3rd Annual Convenient Healthcare and Pharmacy Collaborative Conference


SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.