The ideal candidate for raloxifene appears to be a postmenopausal woman with osteopenia or osteoporosis who has no increased risk of thromboembolism and few or no vasomotor symptoms. Raloxifene would be especially suitable for such a candidate if she has experienced any bleeding on ERT or fears an increased risk of breast cancer. This would include women who have been on ERT for 5 years or more, since the use of ERT for more than 5 years significantly increases the risk of breast cancer.4
In my practice, the women who are happiest with raloxifene tend to be older (4 or more years past menopause), concerned about osteoporosis and cardiovascular symptoms, and very glad to be free of vaginal bleeding while on the drug. Since the 2 most common reasons for discontinuing ERT—vaginal bleeding and the fear of breast cancer—are non-issues when raloxifene is given, compliance is likely to be high. The few cases of vaginal dryness that occur usually can be treated with lubricants, small doses of vaginal estrogen tablets, or the vaginal estrogen ring.
TABLE 3
Treatment options for osteoporosis: benefits and side effects
| Agent | Benefits | Side effects |
|---|---|---|
| ERT | Effective, safe, multidimensional.* Eases vasomotor and urogenital symptoms, improves mood, protects cardiovascular health | Bleeding, blood clots, breast cancer |
| Raloxifene | Effective, safe, multidimensional. Improves lipid profile. No bleeding or breast cancer risk | Blood clots. No relief of hot flushes or vaginal dryness |
| Alendronate, risedronate | Effective, safe, multidimensional | Difficult to take. Esophageal and gastric irritation, bleeding |
| Calcitonin | Effective, safe, unidimensional. Analgesic effects in patients with compression fractures | Insignificant |
| *The term “multidimensional” suggests that the agent affects more than 1 organ system. | ||
Conclusion
Thanks to a dramatic increase in life expectancy, American women can expect to live 30 or more years beyond the average age of menopause. With aging, the risk of health problems increases progressively. Several of these problems are specifically related to or augmented by estrogen deficiency. Despite several health benefits of ERT, its use remains very low (less than 30% in postmenopausal women) because of side effects and concerns about safety, bleeding, and breast cancer.7
SERMs—particularly raloxifene—provide many of estrogen’s positive effects on bone metabolism and lipids and other markers of cardiovascular disease without increasing the risk of bleeding or breast cancer. In fact, recent data suggest that raloxifene not only fails to increase the risk of breast cancer but actually may be protective against the disease.
SERMs do not necessarily replace older therapies such as ERT, but they do enhance our ability to modify and improve therapies, individualize regimens, and boost compliance. This is especially important with long-term preventive therapy, which requires a high level of acceptance and commitment by both patient and physician. Because of their multiple beneficial effects and favorable long-term risk-benefit profile, SERMs represent an important therapeutic advance in the field of women’s health.
Dr. Luciano reports that he serves on the speakers’ bureaus for Eli Lilly and Co., Wyeth Labs, and Pharmacia, and that he receives research grants from Pharmacia.