Raloxifene shown safe for 8 years

January 1, 2005

A study extending experience with raloxifene to 8 years shows no adverse impact on gynecologic health with longer-term use. Results of the Continuing Outcomes Relevant to EVISTA (CORE) trial build on and support previous findings from the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

A study extending experience with raloxifene to 8 years shows no adverse impact on gynecologic health with longer-term use. Results of the Continuing Outcomes Relevant to EVISTA (CORE) trial build on and support previous findings from the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

Presented at the 15th Annual Meeting of the North American Menopause Society, the CORE trial involved a subset of approximately 4,000 women who participated in MORE. MORE assessed raloxifene's efficacy in reducing breast cancer incidence over a 4-year period. CORE, in contrast, looked at the drug's impact on rates of endometrial cancer and hyperplasia and vaginal bleeding during the same period and for 4 years beyond.

Over the 8-year period, the placebo and raloxifene groups did not differ in incidence of uterine cancer, endometrial hyperplasia, ovarian cancer, or vaginal bleeding. There were also similar rates of self-reported pelvic organ prolapse in the two groups. Overall, there were 11 uterine cancers, 11 cases of endometrial hyperplasia, five ovarian cancers, and 41 cases of vaginal bleeding reported.