Impact of the Women's Health Initiative Trial Results on Hormone Replacement Therapy

Authors

  • Megan B. Bestul Pharm.D.,

    Corresponding author
    1. Department of Clinical Pharmacy, School of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado.
    Search for more papers by this author
  • Marianne McCollum Ph.D.,

    Corresponding author
    1. Department of Clinical Pharmacy, School of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado.
    Search for more papers by this author
  • Laura B. Hansen Pharm.D.,

    1. Department of Clinical Pharmacy, School of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado.
    2. Department of Family Medicine, School of Medicine, University of Colorado Health Sciences Center, Denver, Colorado.
    Search for more papers by this author
  • Joseph J. Saseen Pharm.D., FCCP

    1. Department of Clinical Pharmacy, School of Pharmacy, University of Colorado Health Sciences Center, Denver, Colorado.
    2. Department of Family Medicine, School of Medicine, University of Colorado Health Sciences Center, Denver, Colorado.
    Search for more papers by this author

4200 East 9th Avenue, Box C238, Denver, CO 80246–0238; e-mail: Joseph.Saseen@uchsc.edu.

Abstract

Study Objective. To describe the impact of the results of the Women's Health Initiative (WHI) on hormone replacement therapy (HRT) discontinuation rates.

Design. Retrospective chart review.

Setting. University-based family medicine clinic.

Subjects. Ninety-eight postmenopausal women (aged 50–79 yrs) with an intact uterus who were receiving HRT.

Measurements and Main Results. Two study periods were defined: pre-WHI (July 9, 2001–January 9, 2002) and post-WHI (July 9, 2002–January 9, 2003). Patient demographics and HRT discontinuation or persistence data were collected. Seven women were eligible for only for pre-WHI, 13 only for post-WHI, and 78 were eligible for both groups based on HRT use during both time periods. Forty-two of the 78 women were randomized to the pre-WHI group and 36 to the post-WHI group to yield equal groups of 49 each. No significant demographic differences existed between the groups. Time-to-event analysis revealed an increased probability of HRT discontinuation after WHI versus before WHI (log-rank test, p<0.01). A subset of 85 women taking HRT 1 year before WHI were followed for 18 months. Discontinuation rates were 8% (7 of 85 patients) during the 12 months before WHI and 38% (30 of 78) during the 6 months after WHI, with 80% (24 of 30) of these patients discontinuing within 3 months.

Conclusion. Increased HRT discontinuation was temporally associated with release of WHI data, which implies that highly publicized, negative outcomes data can quickly influence pharmacotherapy decisions.

Ancillary