Raloxifene produced both harms and benefits in postmenopausal women, with no reduction in cardiovascular disease risk

doi:10.1136/ebm.11.6.178

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Evidence-Based Medicine 2006;11:178; doi:10.1136/ebm.11.6.178
Copyright © 2006 by the BMJ Publishing Group Ltd.

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Therapeutics

Raloxifene produced both harms and benefits in postmenopausal women, with no reduction in cardiovascular disease risk

Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006;355:125–37.[Abstract/Free Full Text]

Q In postmenopausal women, does raloxifene reduce the risks of coronary events and invasive breast cancer?

Clinical impact ratings GP/FP/Primary care $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Internal medicine $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Cardiology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Geriatrics $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Haematology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Oncology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Rheumatology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Gynaecology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Endocrine $*$ $*$ $*$ $*$ $*$ ${star}$ ${star}$

Key Words: breast neoplasms • coronary disease • raloxifene • selective oestrogen receptor modulators

The first 150 words of the full text of this article appear below.

METHODS
Design: randomised placebo controlled trial (Raloxifene Use for TheHeart [RUTH] trial).

Allocation: concealed.^*

Blinding: blinded (clinicians, participants, outcome assessors, laboratorystaff, and sponsor).^*

Follow up period: median 5.6 years.

Setting: 177 centres in 26 countries worldwide.

Participants: 10 101 postmenopausal women $>=$ 55 years of age (mean 68 y) withor at increased risk of coronary heart disease. Exclusion criteriaincluded recent myocardial infarction (MI) or revascularisationprocedure; history of cancer, venous thromboembolism (VTE),heart failure, or chronic liver or renal disease; life expectancy<5 years; and recent use of oestrogen.

Intervention: oral raloxifene, 60 mg/day (n = 5044), or placebo (n = 5057).

Outcomes: coronary events (death from coronary causes, MI, or hospitaladmission for an acute coronary syndrome), breast cancer, deathfrom cardiovascular causes, death from any cause, stroke, VTE,clinical fractures, and adverse events.

Participant follow up: 80% completed the trial (100% included in intention to treat. . . [Full text of this article]

Holly L Thacker, MD

Cleveland Clinic Women’s Health Center, Cleveland, Ohio, USA

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