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| |  Raloxifine Not As Effective As HRT In Improving Heart Disease Risk Factors CHICAGO, IL -- May 12, 1998 -- A drug to prevent osteoporosis is also effective in lowering risk factors for cardiovascular disease in postmenopausal women, but is not as effective as hormone replacement therapy (HRT), according to an article in tomorrow’s issue of The Journal of the American Medical Association. Brian Walsh, M.D., of Brigham and Women's Hospital in Boston, MA., and colleagues studied 390 healthy postmenopausal women to identify the effects of the drug raloxifene on the risk of cardiovascular disease in postmenopausal women as compared to HRT. Raloxifene is one member of a new class of drugs called selective estrogen receptor modulators (SERMs) and is approved by the United States Food and Drug Administration for marketing for the prevention of osteoporosis. It is part of ongoing efforts by researchers to find new drugs that have the positive effects on risk of osteoporosis and heart disease like estrogen replacement therapy without the negative effects to the breast and uterine tissues. The study participants were randomized to receive one of four treatments: raloxifene, 60 mg/day; raloxifene, 120 mg/day; hormone replacement therapy (conjugated equine estrogen, 0.625 mg/day and medroxyprogesterone acetate, 2.5 mg/day), or placebo. The researchers found that compared to the placebo group, both dosages of raloxifene lowered markers that are known risk factors for coronary artery disease, but did not lower them to the magnitude of HRT treatment. For example, raloxifene lowered low-density lipoprotein cholesterol by 11 percent, compared to the 13 percent reduction for HRT. Raloxifene also lowered lipoprotein(a) levels by four percent, which was four times less than the 16 percent decrease with HRT. Raloxifene lowered fibrinogen (a clot-forming protein that at high levels increases risk of heart disease in healthy people) by 12 percent to 14 percent, whereas HRT had no effect. Raloxifene also increased high-density lipoprotein-2 cholesterol by 15 percent to 17 percent, which was less than the 33 percent increase with HRT. Unlike HRT, raloxifene did not significantly change overall HDL cholesterol, triglycerides (form of fat) and plasminogen activator inhibitor-1 (a protein that interferes with the body's ability to dissolve blood clots). HRT increased HDL by 11 percent and triglycerides by 20 percent, and decreased plasminogen activator inhibitor-1 by 19 percent. The authors state whether or not to take estrogen replacement is a difficult dilemma for millions of postmenopausal women, given that estrogen may protect against osteoporosis and heart disease but may increase the risks of breast and endometrial cancers. About half of postmenopausal women who begin HRT discontinue it within a year because of their concerns about the long-term hazards and adverse affects such as vaginal bleeding and breast tenderness. The study showed that raloxifene did not cause vaginal bleeding or breast tenderness. However, it also did not relieve hot flashes. "This study demonstrates that raloxifene favorably alters several markers of cardiovascular risk in healthy postmenopausal women," the authors write. "Further clinical trials are necessary to determine whether these favorable biochemical effects are associated with protection against cardiovascular disease."
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