Efficacy and safety of raloxifene 60 milligrams/day in postmenopausal Asian women.
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.
Kung
Annie W C
AW
Department of Medicine, The University of Hong Kong, Division of Endocrinology, Queen Mary Hospital, Hong Kong, People's Republic of China.
Chao
Hsiang-Tai
HT
Huang
Ko-En
KE
Need
Allan G
AG
Taechakraichana
Nimit
N
Loh
Foo-Hoe
FH
Gonzaga
Florante
F
Sriram
Usha
U
Ismail
Nik Mohd Nasri
NM
Farooqi
Abid
A
Rachman
Ichramsjah Azim
IA
Crans
Gerald G
GG
Wong
Mayme
M
Thiebaud
Daniel
D
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
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004965:Estrogen Antagonists; D014280:Triglycerides; D020849:Raloxifene Hydrochloride