Raloxifene Safe, Effective in Postmenopausal Women

Laurie Barclay, MD

July 23, 2003

July 23, 2003 — Raloxifene (Evista) can prevent the development of osteoporosis and osteopenia and improve lipid profiles in postmenopausal women without adversely affecting breast or uterus, according to a report published in the July/August issue of Menopause. This was a five-year analysis of patients enrolled into an extension of two randomized trials that lasted 36 months.

"Raloxifene hydrochloride (60 mg/day) is a selective estrogen receptor modulator indicated for the prevention and treatment of postmenopausal osteoporosis," write Elaine E. Jolly, MD, from Ottawa General Hospital in Ontario, Canada, and colleagues. "Raloxifene treatment for three years increases bone mineral density (BMD) and, unlike tamoxifen (a triphenylethylene selective estrogen receptor modulator), does not stimulate the endometrium in healthy postmenopausal women. The effect of longer duration of treatment with raloxifene is not known."

The investigators analyzed data from two identically designed, prospective, double-blinded trials that randomized postmenopausal women (mean age, 55 years) to raloxifene, 60 mg/day (n = 185) or placebo (n = 143). All subjects received a daily supplement of 400 to 600 IU elemental calcium. Osteoporosis and osteopenia were diagnosed according to World Health Organization criteria, using the manufacturer's database for the lumbar spine and the National Health and Nutrition Examination Survey's 1998 reference base for the hip.

Compared with placebo, raloxifene treatment for five years was associated with reduced bone turnover markers (osteocalcin, -10.9%; P < .001; bone-specific alkaline phosphatase, -7.2%; P = .042; urinary C-telopeptide, -11.1%; P = .034) and with increased BMD in the lumbar spine (2.8%; P < .001) and total hip (2.6%; P < .001).

Compared with women in the placebo group, women in the raloxifene group were less likely to develop osteoporosis (relative risk [RR], 0.13; 95% confidence interval [CI], 0.00 - 0.37; P = .001) or osteopenia (RR, 0.23; 95% CI, 0.00 - 0.81; P = .038) at the lumbar spine, and were more likely at five years to achieve normal BMD status at the lumbar spine (RR, 4.01; 95% CI, 1.34 - 11.23; P = .043) and total hip (RR, 3.92; 95% CI, 1.12 - 14.27; P = .011).

The raloxifene group also had greater reduction in total cholesterol (-5.5%; P < .001) and in low-density lipoprotein cholesterol (-8.7%; P < .001) than did the placebo group, but there were no significant changes in high-density lipoprotein cholesterol ( P = .257) or triglycerides ( P = .620).

Hot flashes occurred in 47 women (28.8%) taking raloxifene and in 21 women (16.8%) taking placebo ( P = .017). During the five-year follow-up, incidence of vaginal bleeding and mean endometrial thickness of more than 5 mm visualized with transvaginal ultrasonography was similar in both groups, and there were no diagnoses of endometrial hyperplasia or endometrial cancer.

"Five years of raloxifene treatment in healthy postmenopausal women preserves BMD, significantly reduces the likelihood of development of osteoporosis, and was not associated with an increased rate of vaginal bleeding, endometrial hyperplasia, or endometrial carcinoma, compared with the case of placebo," the authors write.

Eli Lilly supported this study and employs one of its authors.

Menopause. 2003;10:337-344

Reviewed by Gary D. Vogin, MD

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