Abstract | OBJECTIVE: To assess the efficacy of unopposed estrogen, and three estrogen/progestin regimens on selected heart disease risk factors among adherent women and to contrast those results with efficacy among all women in the PEPI study. DESIGN: A 3-year, multicenter, randomized, double-blinded, placebo-controlled clinical trial. PARTICIPANTS: A total of 847 healthy postmenopausal women aged 45 to 64 years of age with no known contraindication to hormone therapy, who attended their 36 month clinical visit. INTERVENTION: Participants were randomized in equal numbers to one of the following treatments: (1) placebo; (2) conjugated equine estrogen (CEE) 0.625 mg daily; (3) CEE 0.625 daily plus medroxyprogesterone acetate (MPA) 10 mg, days 1-12; (4) CEE 0.625 daily plus MPA 2.5 mg daily; or (5) CEE 0.625 daily plus micronized progesterone (MP) 200 mg, days 1-12. ANALYSIS: Analyses are based on adherent women, where adherence is defined as taking at least 80% of pills at each 6-month visit. RESULTS: Adherence rates were high in all groups except women with a uterus assigned to unopposed CEE. The difference in HDL-C levels resulting from the CEE vs. CEE+MP was approximately three times larger than in the intent-to-treat analyses, reaching statistical significance (P < 0.05). In each active treatment, LDL-C decreased 10-15%. Triglycerides increased 15-20% in each opposed CEE arm and over 25% in the CEE only arm; this difference was not statistically significant. Fibrinogen increased by 7% among placebo adherers, but decreased or remained fairly stable among the active arm adherers. Systolic blood pressure increased 3-5% in all treatment arms. Women adherent to the CEE+MPA arms had twice the increase of 2 h glucose levels as women adherent to CEE only, or CEE+MP (8-9% vs. 3-4%). Two-hour insulin levels decreased 3-12% for all arms. The patterns of change for fibrinogen, SBP, 2 h glucose and insulin were similar to those from the intent-to-treat analyses. CONCLUSIONS: In analyses limited to adherent women, all active treatments, compared to placebo, continued to have similar and favorable effects on LDL-cholesterol and fibrinogen and no significant effects on blood pressure or insulin levels. Given the overall high adherence rates in PEPI, the results are similar to the intent-to-treat analyses, as expected. Only the trend of HDL-C to have a larger increase in the CEE only arm (in the intent-to-treat analyses) gained statistical significance in analyses restricted to adherers.
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Authors | E Barrett-Connor, S Slone, G Greendale, D Kritz-Silverstein, M Espeland, S R Johnson, M Waclawiw, S E Fineberg |
Journal | Maturitas
(Maturitas)
Vol. 27
Issue 3
Pg. 261-74
(Jul 1997)
ISSN: 0378-5122 [Print] Ireland |
PMID | 9288699
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Blood Glucose
- Cholesterol, HDL
- Cholesterol, LDL
- Estrogens, Conjugated (USP)
- Insulin
- Progestins
- Triglycerides
- Progesterone
- Fibrinogen
- Medroxyprogesterone Acetate
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Topics |
- Blood Glucose
(metabolism)
- Blood Pressure
(drug effects)
- Cholesterol, HDL
(blood)
- Cholesterol, LDL
(blood)
- Climacteric
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Estrogen Replacement Therapy
(adverse effects)
- Estrogens, Conjugated (USP)
(administration & dosage, adverse effects)
- Fibrinogen
(metabolism)
- Glucose Tolerance Test
- Humans
- Insulin
(blood)
- Medroxyprogesterone Acetate
(administration & dosage, adverse effects)
- Middle Aged
- Progesterone
(administration & dosage, adverse effects)
- Progestins
(administration & dosage, adverse effects)
- Treatment Outcome
- Triglycerides
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