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Lasofoxifene in postmenopausal women with osteoporosis

  • 0San Francisco Coordinating Center, California Pacific Medical Center Research Institute, and University of California, San Francisco, San Francisco, USA. scummings@sfcc-cpmc.net
The New England Journal of Medicine +

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February 26, 2010

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February 26, 2010

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View abstract on PubMed

Summary

This summary is machine-generated.

Lasofoxifene at 0.5 mg daily reduced fracture, breast cancer, heart disease, and stroke risks in postmenopausal women. However, it increased venous thromboembolic events, highlighting a critical risk-benefit consideration for osteoporosis treatment.

Area Of Science

  • Osteoporosis and hormone therapy research
  • Cardiovascular disease and cancer prevention
  • Pharmacological interventions for postmenopausal women

Background

  • The therapeutic effects of lasofoxifene on fracture risk, breast cancer incidence, and cardiovascular events remain unclear.
  • Osteoporosis affects millions of postmenopausal women, increasing fracture risk and impacting quality of life.

Purpose Of The Study

  • To evaluate the efficacy and safety of lasofoxifene in reducing fractures and cancer risk.
  • To assess the impact of lasofoxifene on cardiovascular events and stroke in postmenopausal women.

Main Methods

  • A 5-year randomized trial involving 8556 postmenopausal women aged 59-80 with osteoporosis.
  • Participants received daily lasofoxifene (0.25 mg or 0.5 mg) or placebo, with primary endpoints including vertebral and nonvertebral fractures, and estrogen receptor-positive breast cancer.

Main Results

  • The 0.5 mg dose of lasofoxifene significantly reduced risks of vertebral fractures (HR 0.58), nonvertebral fractures (HR 0.76), ER-positive breast cancer (HR 0.19), coronary heart disease (HR 0.68), and stroke (HR 0.64) compared to placebo.
  • Both doses of lasofoxifene increased the risk of venous thromboembolic events (HRs 2.67 and 2.06).
  • Endometrial cancer incidence was low and similar across groups; overall mortality rates showed no significant difference.

Conclusions

  • Lasofoxifene (0.5 mg/day) effectively reduces fracture, ER-positive breast cancer, coronary heart disease, and stroke risks in postmenopausal women with osteoporosis.
  • The observed increase in venous thromboembolic events necessitates careful consideration of the risk-benefit profile for lasofoxifene therapy.

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