Editorials - September 15, 1999 - American Academy of Family Physicians

Editorials

Is Raloxifene the Answer to the HRT Story?

BARBARA APGAR, M.D., M.S.
University of Michigan Medical School,
Ann Arbor, Michigan

The search for the most optimal postmenopausal hormone replacement therapy (HRT) is rapidly becoming one of the most widely pursued ventures in modern medicine. A few basic goals should be considered. The optimal agent should prevent cardiovascular disease; it should prevent osteoporosis and encourage osteoblastic proliferation; it should not have an adverse effect on target tissue; and last, but not least, it should be effective in relieving the patient's symptoms.

See article in this issue.

A typical scenario is a woman who makes an office visit because she is experiencing perimenopausal symptoms such as vasomotor events or sleep dysfunction. She may already be knowledgeable about HRT and have formed strong opinions about whether she would be interested in receiving this therapy. Added to the dilemma is the fact that many women perceive HRT as "unnatural."¹ Women may pursue health food supplements as an alternative to traditionally prescribed therapies, because these supplements are perceived as natural and thereby free of adverse effects. These women may already have purchased some of these products before visiting the family physician's office.

How do family physicians address this issue? First of all, how convinced are we that traditional HRT does what it is purported to do without adverse effects? Second, how convinced are we that nontraditional therapies are of unproved benefit or harmful to the patient? Third, have we done a careful review of the woman's risk of breast cancer, cardiovascular disease and osteoporosis?

The bottom line is that what really matters more than risk is the patient's perception of benefit or harm. Even if the woman has numerous risk factors that may affect her long-term health and longevity, she is not going to take HRT unless she believes it will do her no harm. Therein lies the dilemma. The fear of breast cancer, whether overestimated or not, is causing many women to decline HRT. Discussions that center on the fact that more women die of cardiovascular disease than breast cancer may not convince the patient that she only has a low risk of developing breast cancer while receiving HRT. Therefore, before a discussion of the pros and cons of HRT is initiated, the woman's fears and concerns have to be addressed rationally and compassionately. Because the patient may desire only relief of undesired symptoms, she may not view the entire portfolio of preventive health options that HRT affords.

The article by Scott and associates² reviews the unique properties of the selective estrogen receptor modulators (SERMs) that mimic the beneficial effects of estrogen on the cardiovascular and skeletal system while minimizing adverse effects on other tissue such as breast. SERMs are synthetic compounds that bind with high affinity to estrogen receptors and act as either estrogen agonists or antagonists. They are called "designer" drugs, because they are designed to target certain tissue receptors and avoid others.

The epithelium of the breast is stimulated by estrogen. Whether this stimulation induces abnormal epithelial growth is a subject of debate. A direct cause-and-effect relationship between estrogen and development of breast cancer has not been established. Tamoxifen (Nolvadex), classified as an estrogen antagonist on breast tissue, has been approved for the treatment of early and advanced breast cancer and for the prevention of breast cancer. Studies have demonstrated significant reductions in breast cancer recurrence and mortality in survivors who used adjuvant tamoxifen therapy.³ The downside of tamoxifen therapy is that it acts as a partial estrogen agonist in endometrial tissue, thus only partially blocking the stimulatory effect of estrogen on the endometrium.

Another SERM, raloxifene (Evista), is designed to mimic the effect of estrogen on the skeletal structure and serum lipids but, unlike tamoxifen, acts as a complete estrogen antagonist in the breast and endometrium. To date, there is no convincing evidence that raloxifene stimulates endometrial tissue or increases the risk of endometrial cancer.⁴ The Multiples Outcomes of Raloxifene Evaluation study⁵ compared the use of raloxifene with placebo in postmenopausal patients with documented osteoporosis. Compared with placebo, risk of vertebral fracture was reduced in two groups of women receiving different dosages of raloxifene. The reduction was seen both in women with prevalent fracture and in women without prevalent fracture. Risk of nonvertebral fractures did not differ significantly when raloxifene was compared with placebo. Raloxifene increased bone mineral density in the femoral neck and spine. The beneficial effects of raloxifene in reducing fracture incidence were in addition to the beneficial effects of supplemental calcium and cholecalciferol. However, clinical recommendations from these data must consider that, until more definitive comparisons are completed, estrogen or bisphosphonates remain the preferred therapy for postmenopausal women at high risk for nonspinal fractures.⁶

Does this all mean that raloxifene is the most optimal postmenopausal replacement drug? Although it is a synthetic compound and is somewhat less effective than estrogen as a preventive agent, will women more readily accept it if the breast cancer issue is resolved? The crucial question is still unanswered and will not be answered until the results of the National Cancer Institute's Study of Tamoxifen and Raloxifene (STAR) are known. It is impossible to make direct comparisons between the two SERMs at this point.

The controversial data on the link between breast cancer and HRT are primarily derived from reexamination of observational studies that suggest that a slightly increased risk of breast cancer has often but not always been seen with increasing duration of HRT use by postmenopausal women.⁷ The uneasiness about the postulated link between HRT and breast cancer is still unresolved, and the current data on raloxifene do not allow clinical recommendations to be made at this time. The search for the "perfect" postmenopausal replacement drug continues.

REFERENCES

Rabin DS, Cipparrone N, Linn ES, Moen M. Why menopausal women do not want to take hormone replacement therapy. Menopause 1999;6:61-7.

Scott JA, da Camera CC, Early JE. Raloxifene: a selective estrogen receptor modulator. Am Fam Physician 1999;60:1131-9.

Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998;90:1371-88.

Delmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 1997;337: 1641-7.

Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. Results from a 3-year randomized clinical trial. JAMA 1999;282: 637-45.

McClung MR. Therapy for fracture prevention [editorial]. JAMA 1999;282:687-9.

Grodstein F, Stampfer MF, Colditz GA, Willett WC, Manson JE, Joffe M, et al. Postmenopausal hormone therapy and mortality. N Engl J Med 1997; 336:1769-75.

Dr. Apgar is clinical associate professor in the Department of Family Medicine at the University of Michigan Medical School, Ann Arbor, Mich. She is an associate editor of American Family Physician.

Address correspondence to Barbara Apgar, M.D., M.S., Chelsea Family Practice Center, University of Michigan, 14700 E. Old U.S. 12, Chelsea, MI 48118.

Home Telemedicine: Merging the Old and New Ways

ANTHONY F. JERANT, M.D
University of California, Davis, School of Medicine,
Davis, California

A recent article in American Family Physician addressed the topic of home health care.¹ Another article on home health care will be published in American Family Physician in the near future.² The first of these articles outlined the physician's role in coordinating and overseeing the wide array of home services available to patients meeting the Medicare "home bound" definition.¹ This "new" system of physician guidance and approval of care provided by nurses, therapists and other ancillary providers has become the predominant home care delivery model in the United States. Under this model, physicians generally do not conduct home visits. Typically, this new system is reactive, with resources deployed temporarily when a family's need for additional support becomes apparent during an acute illness or hospitalization for an exacerbation of a chronic disease.

The second article, which I co-authored, concerns the conduct of home visits by physicians themselves--the "old" system.² While some physicians continue to conduct home visits, the numbers have decreased dramatically because of the economic, geographic and cultural factors that have shaped our health care system since World War II. The fact that such visits strengthen the therapeutic alliance between physicians and families is seldom questioned. However, in the article, we present evidence that physician-conducted home visit programs can also provide clear medical benefits, particularly when they are proactively targeted to at-risk populations, such as the community-dwelling elderly.² Unfortunately, current health care economics suggest this relatively time-consuming, proactive, hands-on physician home care delivery model is unlikely to supplant the current time-efficient, reactive, supervisory model.

Findings of the Home Telemedicine Project of Kaiser Permanente Medical Center, Sacramento, California

Feature
In-person visit
Video visit

Maximal daily caseload 5.2 patients 15 to 20 patients

Length of visit 55 minutes 18 minutes

Required travel time Yes None

Mileage costs Yes None

Response time to patient-initiated calls 24 to 48 hours to arrange visit as needed Immediate televisit as needed

Adapted with permission from Johnson B, Wheeler L, Deuser J. Kaiser Permanente Medical Ceter's pilot tele-home health project. Telemed Today 1997;5:16-8.

The advent of telemedicine has provided the opportunity to develop a hybrid home care delivery system that incorporates the best aspects of the old and new home health care models. Telemedicine involves the use of distance technologies to provide patient care. No single electronic communication format defines telemedicine, although many assume it is synonymous with two-way interactive videoconferencing with integrated peripheral devices such as electronic stethoscopes. One non-videoconferencing approach was exemplified by a recent project that successfully reduced the rehospitaliztion rates of patients with congestive heart failure by using an automated paging system to send medication reminders and educational information to patients recently discharged from the hospital.³

Other technologies increasingly applied to patient care include use of the Internet and "store-and-forward" graphics transmission systems, such as e-mail. Regular telephone calls to patients at home can also be included in the broader definition of telemedicine, particularly if they are employed in an organized, proactive fashion. Which technologies are used should be determined by the clinical issue at hand as well as cost constraints, logistic feasibility, and acceptance by patient and clinician. However, interactive videoconferencing with integrated peripheral diagnostic tools does offer the closest alternative to the traditional home visit.

Since the 1950s, projects have demonstrated the usefulness of telemedicine for consultation with specialists across geographic barriers, yet home care pilot projects have only recently been conducted. Patients with chronic obstructive pulmonary disease (COPD) or congestive heart failure have most often been studied, because these diagnoses entail frequent emergency department visits and high care costs. The goals have been to reduce the rate of decline in patient function while reducing the cost of care. Nurses working in home telemedicine use predetermined yet flexible care protocols specifying the frequency of contact, parameters to be monitored and therapeutic interventions. Physicians function as health care supervisors and also help conduct a subset of telemedicine visits.

The results of these pilot studies have been promising.^4,5 For example, the Home Health Department at Kaiser Permanente Medical Center, Sacramento, Calif., followed 100 patients who had COPD, cardiac disease, stroke and wounds requiring regular nursing care with home telemedicine visits by nurses while another 100 patients received usual in-person visits and occasional telephone calls. Simple, telemedicine units approved by the U.S. Food and Drug Administration were used. These units work via regular telephone lines and provide interactive videoconferencing as well as monitoring heart and breathing sounds with an integrated electronic stethoscope. Home units cost approximately $5,000, while the central monitoring station costs approximately $7,500. Study findings are summarized in the accompanying table. Care delivery cost savings of 33 to 50 percent were estimated for the telemedicine group, and patient satisfaction with telemedicine visits was reportedly high.⁵

Ideally, telemedicine should augment rather than fully replace traditional home visits. Before implementation on a wider scale, randomized trials must be conducted to determine the incremental benefit of videoconferencing and electronic peripheral devices compared with simpler, less expensive interventions such as frequent telephone follow-up calls. Additionally, solutions to the reimbursement, confidentiality, documentation and legal dilemmas raised by the use of telemedicine must be found. However, consumer-level video telephones will soon become ubiquitous, greatly expanding the feasibility of "virtual" visits. It seems likely that telemedicine will soon allow family physicians to revisit the old values of personalized, proactive physician home care with the cost and time-efficiency of the new model.

REFERENCES

Montauk SL. Home health care. Am Fam Physician 1998;58:1608-14.

Unwin BK, Jerant AF. The home visit. Am Fam Physician 1999;60:in press.

Shah NB, Der E, Ruggerio C, Heidenreich PA, Massie BM. Prevention of hospitalizations for heart failure with an interactive home monitoring program. Am Heart J 1998;135:373-8.

Jerant AF, Schlachta L, Epperly TD, Barnes-Camp J. Back to the future: the telemedicine house call. Fam Pract Management 1998;5:18-22,25-6,28.

Johnson B, Wheeler L, Deuser J. Kaiser Permanente Medical Center's pilot tele-home health project. Telemed Today 1997;5:16-8.

Dr. Jerant is an assistant professor in the Department of Family and Community Medicine at the University of California, Davis, Medical Center.

Address correspondence to Anthony Jerant, M.D., Department of Family and Community Medicine, University of California, Davis, Medical Center, 4860 Y St., Suite 2300, Sacramento, CA 95817.

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