OCWMG Response to Recent Hormone Replacement Therapy (HRT) Developments

Dear Patients,

Many concerns have been raised with the recent news regarding the WHI (Women's Health Initiative) trial and HRT (hormone replacement therapy). How does this information affect you and should you continue HRT are the questions you may be asking. There are no concrete answers at this time, but we will share with you what we know.

The WHI trial included healthy postmenopausal women ages 50 to 79 who were randomized to Prempro® (specifically 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate) vs. placebo. The study was stopped after 5 years due to an increased risk of breast cancer, heart attacks, stroke and blood clots in the group of women taking Prempro®. While the trial found benefits to Prempro®, including reduced rates of hip fracture and colon cancer, overall the harm was greater than the benefit. The WHI study of estrogen-only use in women who had previously undergone hysterectomies is continuing with no reported increased risk of breast cancer.

The data indicate that each year 10,000 women take Prempro® as compared to 10,000 women not taking Prempro®:

8 more will develop invasive breast cancer

7 more will have a heart attack or other coronary event

8 more will have a stroke, and

8 more will have blood clots in the lungs.

The reason this particular study is so important is that it is the best scientific design, being a randomized, placebo-controlled study. However, there are many unanswered questions. This study looked only at Prempro® and there are many different preparations of HRT. The majority of the women in the study, approximately 65%, were between the ages of 60 and 79 (a higher risk group to begin with). Why does the group on estrogen alone not show the same increased risks? As you can see this information is difficult for the experts to discern.

The increased risk of breast cancer did not appear in the first four years of use. Women who have been on HRT for many years should not panic - the relative risks are small. Each woman on HRT should examine the purposes for which she takes HRT.

The most common reasons to take HRT include:

1. To keep my bones strong and prevent osteoporosis

The current alternatives to HRT are:

A. Weight bearing exercise, such as walking 2 miles briskly, 3 times per week

B. Medications, i.e., Evista, Fosamax or Actonel

C. Calcium Supplements: 1,200 to 1,500 mg/day

DEXA Bone Density scanning can show your current bone status. Check with your physician to see if you are a candidate for this study.

2. To Prevent Heart Disease

There is currently no evidence to support this, and if this is your only reason for taking HRT, you should consider discontinuing HRT.

3. To Prevent Menopause Symptoms (i.e., hot flashes, night sweats, insomnia, etc.)

It is possible that those original symptoms may have resolved or decreased to tolerable states. Also alternative medical treatments may now exist. If you take HRT only for previous symptoms, and especially if you have taken it for greater than 5 years, you should consider stopping HRT and observing for any remaining symptoms.

Recommended method for stopping: Go to every other day for one month, then stop

If you have no significant symptoms, or ones you are willing to live with, stay off HRT. If your symptoms are too great, you should check with your physician regarding treatment alternatives, including possibly returning to low dose HRT of the same type or alternative HRT medications.

Whether to start, continue or discontinue HRT is a personal, individualized decision best made after consultation with your physician. If you want to discuss changing your medications, we encourage you to discuss it at your next annual exam or you are welcome to make an appointment. We are committed to your health and are carefully watching for any new information that will help you make the best decision.

Best wishes from the OCWMG physicians