Efficacy and safety of bazedoxifene, a novel selective estrogen receptor modulator for the prevention and treatment of postmenopausal osteoporosis

Abstract

Objective:

Osteoporosis affects millions of individuals, particularly postmenopausal women, and imposes a severe burden on patients and the healthcare system. Several therapeutic options are commercially available for the prevention and treatment of osteoporosis, including bisphosphonates, hormone therapy, and the selective estrogen receptor modulator (SERM), raloxifene. Because each of these agents has its own individual risk-benefit profile, their use should be tailored to specific patient populations. While many agents are approved for osteoporosis, new therapies are needed that maximize efficacy outcomes and minimize safety concerns. Several new SERMs are being evaluated in an effort to achieve an ideal tissue selectivity profile, with beneficial effects on bone without negative effects on the endometrium and breast. Bazedoxifene is a novel SERM that was recently approved in the European Union and is undergoing regulatory review in the United States for the prevention and treatment of postmenopausal osteoporosis. This article reviews the clinical efficacy and safety data for bazedoxifene in postmenopausal women with or at risk for osteoporosis.

Methods:

The PubMed database and relevant congress abstract databases were searched to identify all pertinent literature on bazedoxifene for the prevention and/or treatment of postmenopausal osteoporosis.

Results:

In phase 3 clinical studies, bazedoxifene has demonstrated significant reduction in the risk of new vertebral fracture versus placebo and positive effects on bone mineral density and bone turnover. Moreover, in a subgroup analysis of women at high risk for fracture, bazedoxifene significantly reduced the risk of nonvertebral fracture versus both placebo and raloxifene. Bazedoxifene was generally safe and well-tolerated in women with and at risk for osteoporosis, with no evidence of endometrial or breast stimulation. Data inclusion for this review article was limited by what was available in the public domain.

Conclusion:

The available clinical data suggest that bazedoxifene may offer a favorable risk-benefit profile for the prevention and treatment of postmenopausal osteoporosis.

Key words::

• Bazedoxifene
• Bone mineral density
• Fracture
• Osteoporosis
• Postmenopausal
• Selective estrogen receptor modulator

Transparency

Declaration of funding

Medial writing support for this manuscript was funded by Wyeth Pharmaceuticals, Collegeville, PA, which was acquired by Pfizer Inc in October 2009.

Declaration of financial/other relationships

S.P. has been a symposium speaker or advisory board member for Bayer-Schering, Novo Nordisk, Servier, Lilly, Daiichi-Sankyo, sanofi-aventis, MSD, and Procter & Gamble. He has also received research grants and/or consulting fees from Wyeth, Servier, Lilly, Daiichi-Sankyo, Amgen, Arkochim, and Bayer-Schering. Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has received research funding from Bristol Myers Squibb, Merck Sharp & Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, and Servier and that he/she has acted as an advisor to Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB.

Acknowledgments

Medical writing support for this manuscript was provided by Bo Choi, PhD, of MedErgy and was funded by Wyeth Pharmaceuticals, Collegeville, PA, which was acquired by Pfizer Inc in October 2009. The author was not compensated and retained full editorial control over the content of the manuscript.