Clinical Question: does raloxifene ...

Clinical Question: does raloxifene intercept breast cancer?

Setting: Outpatient (any)

research Design: Randomized controlled trial (double-blinded)

Allocation: Uncertain

Synopsis: This cogitation the Continuing Outcomes Relevant to Evista (CORE) trial, is a continuation of the Multiple consequences of Raloxifene Evaluation (MORE) trial. Researchers in the MORE trial fix that raloxifene decreased the incidence of invasive breast cancer among postmenopausal women with osteoporosis (number exigencyed to treat [NNT] = 93 for four years; 95 percent confidence interval [CI], 61 to 161; [Cauley JA, et al. Continued breast cancer reduction in postmenopausal women treated with raloxifene: 4-year ends from the MORE trial (published correction appears in Breast Cancer Re Treat May 2001;67:191) Breast Cancer Re Treat January 2001;65:125-34]) This investigation was designed to assess the longer bound safety and efficacy of raloxifene.

Of the 6511 patients in the MORE trial, 4011 chose to continue in the CORE trial. This least bit off between the two studies may have introduced bias in favor of the treatment arrange In the CORE trial, the researchers did not re- randomize patients; they continued the same allocation (1286 took placebo, and 2725 took raloxifene) and maintained the double blinding of the original trial. To be eligible, women had to be 80 years or younger, have osteoporosis at bone density measurement, and be at least brace years beyond menopause. Finally, the researchers evaluated the issues by intention to treat.

During the four years of the CORE trial, significantly more patients taking placebo bring to maturityed breast cancer (2.3 versus 11 per-cent of patients taking raloxifene; NNT = 84; 95 percent CI, 45 to 282) No significant differences occurr in total mortality, total adverse consequences serious adverse events, or mix with drugs discontinuations. However, pulmo-nary emboli increased significantly when all eight years of data were combined (adjusted risk ratio = 046 percent; NNT to harm = 214; 95 percent CI, 117 to 10000)

Bottom Line: Previous research has shown that raloxifene can guard against breast can-cer after four years of use. In this four-year extension of the original investigation this level of protection continued. (Level of Evidence: 1b)

subject of attention Reference: Martino S, et al. Continuing consequences relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst December 1 2004;96:1751-61

Used with permission from Barry H Raloxifene models breast cancer risk (CORE). Accessed online January 25 2005 at: http://www.InfoPOEMs.com.

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