title: Efficacy and safety of raloxifene 60 milligrams/day in postmenopausal Asian women.
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.
authors.affiliation: Department of Medicine, The University of Hong Kong, Division of Endocrinology, Queen Mary Hospital, Hong Kong, People's Republic of China.
authors.forename: Annie W C
authors.initials: AW
authors.lastname: Kung
authors.forename: Hsiang-Tai
authors.initials: HT
authors.lastname: Chao
authors.forename: Ko-En
authors.initials: KE
authors.lastname: Huang
authors.forename: Allan G
authors.initials: AG
authors.lastname: Need
authors.forename: Nimit
authors.initials: N
authors.lastname: Taechakraichana
authors.forename: Foo-Hoe
authors.initials: FH
authors.lastname: Loh
authors.forename: Florante
authors.initials: F
authors.lastname: Gonzaga
authors.forename: Usha
authors.initials: U
authors.lastname: Sriram
authors.forename: Nik Mohd Nasri
authors.initials: NM
authors.lastname: Ismail
authors.forename: Abid
authors.initials: A
authors.lastname: Farooqi
authors.forename: Ichramsjah Azim
authors.initials: IA
authors.lastname: Rachman
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Crans
authors.forename: Mayme
authors.initials: M
authors.lastname: Wong
authors.forename: Daniel
authors.initials: D
authors.lastname: Thiebaud
mesh_terms: D044466:Asian People; D015519:Bone Density / Q000187:drug effects; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004965:Estrogen Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae; D008875:Middle Aged; D010024:Osteoporosis / Q000208:ethnology / Q000517:prevention & control*; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D014280:Triglycerides / Q000097:blood
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004965:Estrogen Antagonists; D014280:Triglycerides; D020849:Raloxifene Hydrochloride