Seminal HRT study touches off flurry of questions for R.Ph.s


The results of a landmark study have forced physicians to revise their standardized approach to treating menopausal complaints and treat women based on their specific symptoms. The study investigators concluded that the overall health risks from the use of combination HRT exceeded the benefits.



Seminal HRT study touches off flurry of questions for R.Ph.s

The results of a landmark study have forced physicians to take a closer look at their standardized approach to treating menopausal complaints.

In the July 17 issue of the Journal of the American Medical Association, the investigators of the Women's Health Initiative (WHI) reported that after a mean of 5.2 years of follow-up, the trial of conjugated equine estrogens/ medroxyprogesterone acetate (Prempro, Wyeth) versus placebo would be stopped because of an increased risk of breast cancer, stroke, pulmonary embolism (PE), and coronary heart disease (CHD) in healthy postmenopausal women taking the combination hormone replacement therapy (HRT). The investigators concluded that the overall health risks from the use of combination HRT exceeded the benefits. Wyeth notified pharmacists of the study results in a letter that also clarified the risks and benefits of HRT.

The WHI's findings have received extensive media coverage, including numerous articles in the New York Times and cover stories in Time and Newsweek magazines. This firestorm of publicity has sent women scrambling to consult with their doctors and pharmacists.

Louise Parent-Stevens, Pharm.D., clinical assistant professor, College of Pharmacy, University of Illinois, said, "The questions we're getting from women are, Should I continue taking hormone therapy? If I choose to discontinue taking it, do I still need to be concerned about risks down the line? If I choose to continue taking it, what should I be concerned about? Should I change the product that I'm using?"

"Women should be handled on an individual basis," said Jennifer Hardman, Pharm.D., pharmacotherapist, University of Illinois and assistant professor, departments of pharmacy practice and obstetrics/gynecology. "Some women are very uncomfortable with their menopausal symptoms and need relief. Sometimes it's HRT that provides relief for them." It is important to consider the reasons that a woman wants to take or is taking HRT prior to making any decisions about starting or continuing therapy, explained Hardman.

"I'm using the approach of asking why a woman is taking HRT in the first place," concurred Parent-Stevens. "If she is taking it for the relief of menopausal symptoms such as hot flashes, I would try to gauge how much the symptoms are bothering her. If they are not bothering her, I'd advise her to try stopping the hormone therapy. If the symptoms recur, I would probably counsel her to at least try the therapy again, the reason being that for most women, symptoms such as hot flashes last only a few years. Menopausal symptoms usually require only short-term use of HRT."

Parent-Stevens pointed out that the big concern with WHI was the risk of breast cancer, but that an increase in cancer risk was not seen until women had been taking HRT for four years.

Other options women have for treating hot flashes include clonidine, and some newer studies have found that selective serotonin reuptake inhibitors, specifically venlafaxine (Effexor, Wyeth), can help with hot flashes, said Parent-Stevens. "In Europe and Canada, clonidine has an indication for the treatment of hot flashes, but we've used it in women who cannot or do not want to take estrogen."

In general, taking HRT for osteoporosis prevention implies long-term use, said Parent-Stevens. "This study has changed that. We have other drugs that are effective at preventing and treating osteoporosis. If the only reason a woman is taking HRT is to prevent osteoporosis, I think that considering other drugs would be prudent."

"Women who are taking HRT for the prevention of heart disease should be given the opportunity to switch to an appropriate intervention, such as lipid-lowering agents, based on what their heart disease risks are," said Hardman.

Some herbal remedies for menopausal complaints are also available, said Erika Schwartz, M.D., founder of The Natural Hormone Pharmacy, Hawthorne, N.Y. Black cohosh may provide relief for hot flashes, but it takes about eight weeks to alleviate symptoms, she said.

In a recent study, said Mary Hardy, M.D., medical director, Cedars-Sinai Integrative Medicine Program, Los Angeles, black cohosh had some positive effect on mood swings, night sweats, and vasomotor symptoms, but did not appear to have an estrogenic effect.

Vitex (chasteberry) is sometimes used to relieve hot flashes, Schwartz said. Hardy added that it is used to treat irregular menses and premenstrual syndrome (PMS). Perimenopausal women who are experiencing irregular menstrual bleeding and PMS-like symptoms may find it effective.

Oil of evening primrose can be very soothing, according to Schwartz, who is also the author of The Hormone Solution (Warner, 2002). The oil is also good for relieving anxiety and mood swings. According to Hardy, oil of evening primrose has not been found to have a strong positive effect in clinical studies, but physicians and their patients often report that they find it effective. It alone is of no value in the treatment of hot flashes, however, Schwartz said.

St. John's wort can relieve depression but needs four to six weeks to show whether it is effective, said Schwartz. Valerian may be better than conventional sleep medications for the relief of insomnia and the improvement of sleep quality; it has no side effects and is better tolerated, Schwartz explained. It also presents a lower risk of dependency.

Unfortunately, Hardman said, it is not known how the WHI results apply to women using other products such as Ortho PreFest, Fem HRT, Activella, and HRT patches. "Women who are using these products are in an awkward position, because we do not know whether they increase risks and cause the same outcomes as Prempro."

Charlotte LoBuono


Charlotte LoBuono. Seminal HRT study touches off flurry of questions for R.Ph.s. Drug Topics 2002;15:21.

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