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The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial

The Writing Group for the PEPI Trial; Valery T. Miller, MD; John LaRosa, MD; Vanessa Barnabei, MD, PhD; Craig Kessler, MD; Ginny Levin; Ann Smith-Roth; Margaret Griffin, RN, PA; Diane B. Stoy, RN, BS, PhD; Trudy Bush, PhD; Howard Zacur, MD, PhD; David Foster, MD; Jean Anderson, MD; Alice McKenzie, MS; Susan Miller, ScD; Peter D. Wood, DSc; Marcia L. Stefanick, PhD; Robert Marcus, MD; Allison Akana, PA; W. LeRoy Heinrichs, MD; Charlene Kirchner, RD; Katherine O'Hanlan, MD; Melissa Ruyle; Mary Sheehan, MS; Howard L. Judd, MD; Gail Greendale, MD; Richard Bayalos, MD; Kathy Lozano, RNP; Kathy Kawakami, RN; Elizabeth Barrett-Connor, MD; Robert Langer, MD; Donna Kritz-Silverstein, PhD; Mary Lou Carrion-Petersen, RN; Carmela Cavero, MS, CNM; Helmut G. Schrott, MD; Susan R. Johnson, MD; Deborah A. Feddersen, RN; Denise L. Krutzfeldt; Jo Ann Benda, MD; Carl Pauerstein, MD; Jose Trabal, MD; Robert Schenken, MD; Michael P. Stern, MD; Mercedes Rodriguez-Sifuentes, RN; Carann Easton, RN; H. Wells, PhD; Mark Espeland, PhD; George Howard, DrPh; Robert Byington, PhD; Claudine Legault, PhD; Sally Shumaker, PhD; Patricia Hogan, MS; Don Hire, BS; Carol Wasilauskas, MS; Margaret James, MS; Kathy Lane, BS; Tim Terrell, MS; Stephanie Reece, BS; June Pierce, AB; Mary Snow; Susan Anthony, BS; Irma L. Mebane-Sims, PhD; Paula Einhorn, MD; Sally Hunsberger, PhD; Myron Waclawiw, PhD; Ken Lippel, PhD; Diane Lucas, PhD; Joel Verter, PhD; Sherry Jackson, MD; Joseph Kelaghan, MD; Jeffrey Perlman, MD; Pam Wolf, PhD; Joan McGowan, PhD; Stephen Gordon, PhD; Stephen Heyse, MD; Judith Fradkin, MD; Sherry Sherman, PhD; Lot Page, MD; Ann Sorenson, PhD; Barbara Hulka, MD; Baruch Brody, PhD; Ronald Burkman, MD; Robert Heaney, MD; Ronald Krauss, MD; Harold Roberts, MD; Janet Wittes, PhD; Lawrence Riggs, MD; Cpt Richard Moss; John Albers, PhD; Santica Marcovina, PhD; S. Edwin Fineberg, PhD; Russell P. Tracy, PhD; Maria Merino, MD; Robert Scully, MD; Virginia Livolsi, MD; Gerald Kessler, PhD

JAMA. 1995;273(3):199-208.

Abstract
Objective.
—To assess pairwise differences between placebo, unopposed estrogen, and each of three estrogen/progestin regimens on selected heart disease risk factors in healthy postmenopausal women.

Design.
—A 3-year, multicenter, randomized, double-blind, placebo-controlled trial.

Participants.
—A total of 875 healthy postmenopausal women aged 45 to 64 years who had no known contraindication to hormone therapy.

Intervention.
—Participants were randomly assigned in equal numbers to the following groups: (1) placebo; (2) conjugated equine estrogen (CEE), 0.625 mg/d; (3) CEE, 0.625 mg/d plus cyclic medroxyprogesterone acetate (MPA), 10 mg/d for 12 d/mo; (4) CEE, 0.625 mg/d plus consecutive MPA, 2.5 mg/d; or (5) CEE, 0.625 mg/d plus cyclic micronized progesterone (MP), 200 mg/d for 12 d/mo.

Primary Endpoints.
—Four endpoints were chosen to represent four biological systems related to the risk of cardiovascular disease: (1) high-density lipoprotein cholesterol (HDL-C), (2) systolic blood pressure, (3) serum insulin, and (4) fibrinogen.

Analysis.
—Analyses presented are by intention to treat. P values for primary endpoints are adjusted for multiple comparisons; 95% confidence intervals around estimated effects were calculated without this adjustment.

Results.
—Mean changes in HDL-C segregated treatment regimens into three statistically distinct groups: (1) placebo (decrease of 0.03 mmol/L [1.2 mg/dL]); (2) MPA regimens (increases of 0.03 to 0.04 mmol/L [1.2 to 1.6 mg/dL]); and (3) CEE with cyclic MP (increase of 0.11 mmol/L [4.1 mg/dL]) and CEE alone (increase of 0.14 mmol/L [5.6 mg/dL]). Active treatments decreased mean low-density lipoprotein cholesterol (0.37 to 0.46 mmol/L [14.5 to 17.7 mg/dL]) and increased mean triglyceride (0.13 to 0.15 mmol/L [11.4 to 13.7 mg/dL]) compared with placebo. Placebo was associated with a significantly greater increase in mean fibrinogen than any active treatment (0.10 g/L compared with -0.02 to 0.06 g/L); differences among active treatments were not significant. Systolic blood pressure increased and postchallenge insulin levels decreased during the trial, but neither varied significantly by treatment assignment. Compared with other active treatments, unopposed estrogen was associated with a significantly increased risk of adenomatous or atypical hyperplasia (34% vs 1%) and of hysterectomy (6% vs 1%). No other adverse effect differed by treatment assignment or hysterectomy status.

Conclusions.
—Estrogen alone or in combination with a progestin improves lipoproteins and lowers fibrinogen levels without detectable effects on postchallenge insulin or blood pressure. Unopposed estrogen is the optimal regimen for elevation of HDL-C, but the high rate of endometrial hyperplasia restricts use to women without a uterus. In women with a uterus, CEE with cyclic MP has the most favorable effect on HDL-C and no excess risk of endometrial hyperplasia.

(JAMA. 1995;273:199-208)

Author Affiliations
George Washington University, Washington, DC; The Johns Hopkins University, Baltimore, Md; Stanford (Calif) University; The University of California, Los Angeles; The University of California, San Diego; The University of Iowa, Ames; The University of Texas Health Science Center, San Antonio; Coordinating Center: The Bowman Gray School of Medicine; Participating Institutes of the National Institutes of Health: National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Aging; Data and Safety Monitoring Board; Central Facilities: Drug Distribution Center, Public Health Services, Health Resources and Services Administration, Supply Service Center, Perry Point, Md; Lipid Laboratory, Seattle, Wash; Northwest Lipid Research Center; Glucose/Insulin Laboratory, Indianapolis, Ind; Wishard Memorial Hospital; Hemostasis Laboratory, Burlington, Vt; University of Vermont; Pathology Laboratory, Bethesda, Md; National Cancer Institute; Pathology Arbiter, Boston, Mass; Massachusetts General Hospital; Laboratory Consultant; The Jewish Hospital of St Louis

Footnotes
A complete list of the PEPI Trial Group appears at the end of the article.

Reprint requests to NHLBI, National Institutes of Health, Federal Bldg, Room 401, 7550 Wisconsin Ave, MSC 9070, Bethesda, MD 20892-9070 (Dr Mebane-Sims).

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