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Efficacy and Safety of Raloxifene 60 Milligrams/Day in Postmenopausal Asian Women

Department of Medicine (A.W.C.K.), The University of Hong Kong, Division of Endocrinology, Queen Mary Hospital, Hong Kong, People’s Republic of China; Department of Obstetrics & Gynecology (H.-T.C.), Veterans General Hospital, Taipei 112, Taiwan; Department of Obstetrics & Gynecology (K.-E.H.), Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan; Institute of Medical and Veterinary Science (A.G.N.), Adelaide, Southern Australia 5000, Australia; Department of Obstetrics & Gynecology (Menopause Research Unit) (N.T.), Chulalongkorn University Hospital, Pathumwan, Bangkok 10330, Thailand; Department of Obstetrics & Gynecology (F.-H.L.), National University Hospital, Singapore 119074; Department of Obstetrics & Gynecology (F.G.), University of the Philippines, Philippine General Hospital, Manila 1000, Philippines; EV Kalyani Medical Center (U.S.), Mylapore, Chennai 600004, India; Hospital University Kebangsaan Malaysia (N.M.N.I.), Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Kuala Lumpur 56000, Malaysia; Department of Rheumatology & Physical Medicine (A.F.), Pakistan Institute of Medical Sciences, G-8/3 Islamabad, Pakistan; Department of Obstetrics & Gynecology (I.A.R.), Dr. Cipto Mangunkusumo Hospital School of Medicine, University of Indonesia-Jakarta, Jakarta 10430, Indonesia; Lilly Research Laboratories (G.G.C., M.W.), Eli Lilly and Company, Indianapolis, Indiana 46285; and Eli Lilly Australia Pty. Ltd. (D.T.), West Ryde, New South Wales 2114, Australia

Address all correspondence and requests for reprints to: Daniel Thiebaud, M.D., Eli Lilly Australia Pty. Ltd., 112 Wharf Road, West Ryde, New South Wales 2114, Australia. E-mail: Thiebaud.Daniel{at}Lilly.com.

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.

Eli Lilly and Company provided funding for this study. Portions of this work were presented at the following meetings: Asian-Oceanic Congress of Obstetrics and Gynecology, 2002, Bangkok, Thailand; National Osteoporosis Foundation (March 2002), Honolulu, Hawaii; International Osteoporosis Foundation (May 2002), Lisbon, Portugal; and International Menopause Society (June 2002), Berlin, Germany.

The following investigators participated in the Raloxifene Asia Pacific study—Australia: Susan Davis, Allan G. Need, Philip Sambrook, John Wark; Hong Kong: Annie W.C. Kung; India: Ambrish Mithal, K.M. Prasannakumar, Nadeem Rais, M.S. Sheshadri, Usha Sriram; Indonesia: Ichramsjah Azim Rachman, Andon Hestiantoro, Ali Baziad, Sjarief Darmasetiawan, Suhartono D. Soeharto; Malaysia: Premitha Damodaran, Nik Mohd Nasri Ismail; Pakistan: Aftab Ahmed, Javed Akram, Abid Z. Farooqi, Mushtaq Haroon, Sadiqua N. Jafarey, Jaweed Akhter; Philippines: Ditas Decena, Florante P. Gonzaga, Genara Limson, Virginia M. Santos-Abalos, Joan Tan-Garcia; Singapore: Soon-Tai Lee, Foo-Hoe Loh, Tze-Tein Yong; Taiwan: Ko-En Huang, Hsiang-Tai Chao; Thailand: Kobchitt Limpaphayom, Manee Rattanachaiyanont, Thaviponk Suvonnakote, Nimit Taechakraichana, Kittisak Wilawan.

Abbreviations: BCE, Bone collagen equivalents; BMD, bone mineral density; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MORE, Multiple Outcomes of Raloxifene Evaluation.

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