The OGA Preliminary Response to the Women's Health Initiative (WHI) Study
July 15, 2002

The OGA Gynecologists do have great concerns about the results of the WHI Study soon to be published in The Journal of the American Medical Association.

The study was discontinued after a mean of 5.2 years follow-up because overall health risks exceeded benefits. The conclusion of the study was that this particular hormone replacement regimen "should not be initiated or continued for primary prevention of coronary artery disease". The particular regimen was Premarin in combination with Provera.

The study DID NOT address:

1. other estrogens with or without other progestins
2. Premarin alone (without Provera), or Premarin with other progestins
3. Smaller doses of Premarin in combination with Provera

Frankly, the labels on these products have disclosed these risks for years and it is something we discuss with our patients. It is our opinion that this study only adds more statistical information-not necessarily new information. For instance, in the study, the risk of Breast Cancer was 38/10,000 women per year in the hormone group and 30/10,000 women per year in the placebo group. This represents less than a fraction of one- percent risk for an individual patient. It has long been suspected that estrogen/progestin therapy might slightly increase the risk of breast cancer. This study simply quantifies the risk. As stated above, this combination of hormones does not prevent heart disease.

Additionally, hormone replacement therapy has substantial benefits in decreasing the risk of osteoporosis, reducing the risk of vaginal atrophy, delaying the onset of cognitive dysfunction (Alzheimer's), and alleviation of the often-severe symptoms of menopause. As with any medication or therapy, the risks and benefits should always be taken into consideration. Remember, when we prescribe any medication, we take into account these risks and benefits as they apply to you, the patient and not as a participant in a study.

For the vast majority of patients, you should continue your current therapy but be sure to discuss the issue with your physician at your next visit. The risks of breast cancer and heart disease in the individual patient are exceedingly small.

Regardless, OGA feels that patients on Premarin/Provera or PremPro that are concerned and worried should discontinue these medications until they have a frank discussion with their physician regarding their particular risk factors and the benefits of estrogen replacement in their particular case. Alternative medications can be suggested and tried if desired.

Clearly, in light of this data, if you have risk factors for stroke, coronary artery disease, or blood clots, you should discontinue Premarin/Provera or PremPro and come in for a consultation.

We feel this is a complex issue and not a suitable topic for a phone call. You should make an appointment with your gynecologist and discuss this matter in person.

Obstetrical and Gynecological Associates