Efficacy and safety of raloxifene 60 milligrams/day in postmenopausal Asian women

Annie W.C. Kung, Hsiang Tai Chao, Ko En Huang, Allan G. Need, Nimit Taechakraichana, Foo Hoe Loh, Florante Gonzaga, Usha Sriram, Nik Mohd Nasri Ismail, Abid Farooqi, Ichramsjah Azim Rachman, Gerald G. Crans, Mayme Wong, Daniel Thiebaud

Research output: Contribution to journalArticlepeer-review

35 Citations (Scopus)

Abstract

In healthy Caucasian postmenopausal women, raloxifene increases bone mineral density (BMD), decreases biochemical markers of bone turnover, and lowers low-density lipoprotein (LDL) cholesterol, without effects on high-density lipoprotein (HDL) cholesterol and triglycerides. This randomized, double-blind study examines the effects of raloxifene 60 mg/d (n = 483) or placebo (n = 485) in healthy postmenopausal Asian women (mean age 57 yr) from Australia, Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Singapore, Taiwan, and Thailand. Serum osteocalcin, serum N-telopeptide, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were assessed at baseline and 6 months. Lumbar spine BMD was measured at baseline and 1 yr in 309 women from 4 countries. Clinical adverse events were recorded at each interim visit. At 6 months, raloxifene 60 mg/d significantly decreased osteocalcin, N-telopeptide, total cholesterol, and LDL cholesterol by medians of 15.9%, 14.6%, 5.3%, and 7.7%, respectively, from placebo. Changes in HDL cholesterol and triglycerides were similar between raloxifene and placebo. Raloxifene 60 mg/d increased mean lumbar spine BMD (1.9%) from placebo at 1 yr (P = 0.0003). The incidences of hot flashes (placebo 3.5%, raloxifene 5.6%, P = 0.12), and leg cramps (placebo 2.7%, raloxifene 4.3%, P = 0.16) were not different between groups. No case of venous thromboembolism was reported. The effects of raloxifene 60 mg/d on bone turnover, BMD, and serum lipids in healthy postmenopausal Asian women were similar to that previously reported in Caucasian women.

Original languageEnglish
Pages (from-to)3130-3136
Number of pages7
JournalJournal of Clinical Endocrinology and Metabolism
Volume88
Issue number7
DOIs
Publication statusPublished - 1 Jul 2003

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