Raloxifene reduced vertebral fractures and breast cancer regardless of prior hormone therapy use in women

doi:10.1136/ebm.10.3.84

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Evidence-Based Medicine 2005; 10:84
© 2005 BMJ Publishing Group Ltd.

Therapeutics

Raloxifene reduced vertebral fractures and breast cancer regardless of prior hormone therapy use in women

Johnell O, Cauley JA, Kulkarni PM, et al. Raloxifene reduces risk of vertebral fractures and breast cancer in postmenopausal women regardless of prior hormone therapy. J Fam Pract 2004;53:789–96.[Medline]

Q In postmenopausal women with osteoporosis, does previous hormone therapy (HT) influence the effect of raloxifene on the risk of vertebral fractures and breast cancer?

Clinical impact ratings GP/FP/Primary care $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ IM/Ambulatory care $*$ $*$ $*$ $*$ $*$ ${star}$ ${star}$ Gynaecology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Oncology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Endocrine $*$ $*$ $*$ $*$ $*$ $*$ ${star}$

Key Words: breast neoplasms • oestrogen replacement therapy • osteoporosis (postmenopausal) • raloxifene • spinal fractures

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

METHODS
Design: randomised placebo controlled trial (the Multiple Outcomes ofRaloxifene Evaluation [MORE] trial).

Allocation: {concealed^*}.

Blinding: blinded {patients, healthcare providers, and outcome assessors}.^*

Follow up period: 4 years.

Setting: {180 clinical centres in 25 countries} ${dagger}$ .

Patients: 7705 postmenopausal women $<=$ 80 years of age (mean age 67 y) withosteoporosis. 7682 women (99.7%) reported HT status; 2235 women(29.1%) had used HT previously. Exclusion criteria includedother bone diseases and history of breast or endometrial cancer

Intervention: among women with prior HT use, raloxifene, 60 mg/day or 120mg/day (n = 1497), or placebo (n = 738). Among women withoutprior HT use, raloxifene, 60 mg/day or 120 mg/day (n = 3614)or placebo (n = 1833). All women received daily supplementationwith calcium, 500 mg, and vitamin D, 400–600 IU.

Outcomes: new vertebral fractures, breast cancer, and cardiovascular events.

Patient follow up: 88%.

MAIN RESULTS
Regardless of prior . . . [Full text of this article]

Carolyn Crandall, MD, MS, FACP

Los Angeles, California, USA