The postmenopausal estrogen/progestin interventions study: Primary outcomes in adherent women

Maturitas

Volumn 27, Issue 3, 1997, Pages 261-274

  Barrett Connor, Elizabeth ^a   Slone, Stacey ^d   Greendale, Gail ^b   Kritz Silverstein, Donna ^a   Espeland, Mark ^d   Johnson, Susan R ^c   Waclawiw, Myron ^d   Fineberg, S Edwin ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF IOWA   (United States)

^d NONE

Author keywords

Conjugated equine estrogen; Estrogen progestin; Medroxyprogesterone acetate; Micronized progestrone

Indexed keywords

ESTROGEN; GESTAGEN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO;

ADULT; ARTICLE; BLOOD PRESSURE MEASUREMENT; CELL ADHESION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FIBRINOGEN BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MENOPAUSAL SYNDROME; MENSTRUAL CYCLE; MULTICENTER STUDY; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; SYSTOLIC BLOOD PRESSURE;

BLOOD GLUCOSE; BLOOD PRESSURE; CHOLESTEROL, HDL; CHOLESTEROL, LDL; CLIMACTERIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; ESTROGEN REPLACEMENT THERAPY; ESTROGENS, CONJUGATED (USP); FIBRINOGEN; GLUCOSE TOLERANCE TEST; HUMANS; INSULIN; MEDROXYPROGESTERONE 17-ACETATE; MIDDLE AGED; PROGESTERONE; PROGESTINS; TREATMENT OUTCOME; TRIGLYCERIDES;

EQUIDAE;

EID: 0030786416     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5122(97)00041-8     Document Type: Article

References (35)

1. The Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 1995;273:199-208.
2. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 2nd ed. Littleton, Mass: PSG Publishing, 1985.
3. Espeland MA, Bush TL, Mebane-Sims I, Stefanick ML, Johnson S, Sherwin R, Waclawiw M. Rationale, design, and conduct of the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials 1995;16(Suppl 4):S3-19.
4. Miller VT, Byington RL, Espeland MA, Langer R, Marcus R, Shumaker S, Stern MP. Baseline characteristics of the PEPI participants. Postmenopausal Estrogen/ Progestin Interventions. Control Clin Trials 1995;16(Supl. 4):54s-65s.
5. Johnson S, Mebane-Sims I, Hogan PE, Stoy DB. Recruitment of postmenopausal women in the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials 1995;16(Suppl 4):20S-35S.
6. Wood PD, Kessler G, Lippel K, Stefanick ML, Wasilauskas CH, Wells HB. Physical and laboratory measurements in the PEPI Trial Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials 1995;16(Suppl 4):36S-53S.
7. Warnick GR. Enzymatic methods for quantification of lipoprotein lipids. Methods Enzymol 1986;129:101-23.
8. Bachorik PS, Albers JJ. Precipitation methods for quantification of lipoproteins. Methods Enzymol 1986;129:78-100.
9. Hainline, A, Karon, J, Lippel, K, editors. Manual of laboratory operations. Lipid research clinics program, lipid and lipoprotein analysis. 2nd ed. NIH-Department of Health and Human Services, 1982.
10. Trinder P. Determination of glucose in blood using glucose oxidase with an alternative oxygen acceptor. Ann Clin Biochem 1969;6:24.
11. Morgan CR, Laarow A. Immunoassay of insulin: two antibody system. Plasma levels of normal, subdiabetic and diabetic rats. Diabetes 1963;12:115-26.
12. Clauss A. Gerinnungs physiologische schnellmethode zur bestimmung des fibrinogens. Acta Haemat 1957;17:237-46.
13. SAS Institute, SAS/STAT User's Guide, Version 6, 4th ed. vol 2, Cary, NC: SAS Institute, 1989.
14. Goldbourt U, Medalie JH. High density lipoprotein cholesterol and incidence of coronary heart disease-the Israeli Ischemic Heart Disease Study. Amer J Epidemiol 1979;109:296-308.
15. Castelli WP. Cardiovascular disease in women. Am J Obstet Gynecol 1988;158:1553-60.
16. Bass KM, Newschaffer CJ, Klag MJ, Bush TL. Plasma lipoprotein levels as predictors of cardiovascular death in women. Arch Intern Med 1993;153:2209-16.
17. Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs Jr DR, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease, four prospective American studies.. Circulation 1989;79:8-15.
18. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-89.
19. Bradford RH, Downton M, Chremos AN, Langendorfer A, Stinnett S, Nash DT, Mantell G, Shear CL. Efficacy and tolerability of lovastatin in 3390 women with moderate hypercholesterolemia. Ann Int Med 1993;118:850-5.
20. Barrett-Connor E, Bush TL. Estrogen and coronary heart disease in women. JAMA 1991;265:1861-7.
21. Tikkanen MJ. Mechanisms of cardiovascular protection by postmenopausal hormone replacement therapy. Cardiovasc Risk Factors 1993;3:138-43.
22. Riedel M, Rafflenbeul W, Lichtlen P. Ovarian sex steroids and atherosclerosis. Clin Invest 1993;71:406-12.
23. Gangar KF, Reid BA, Crook D, Hillard TC, Whitehead MI. Oestrogens and atherosclerotic vascular disease: local vascular factors. Bailliere's Clin Endocrinol Metab 1993;7:47-59.
24. Miller VT. Dyslipoproteinemia in women. Special Considerations. Endocrinol Metab Clinics N Am 1990;19:381-98.
25. Gordis. L. Conceptual and methodologic problems in measuring patient compliance. In: Haynes, RB, Taylor, DW, Sackett DL, editors. Compliance in Health Care. Baltimore: John Hopkins Press, 1979:23-45.
26. Black DM, Brand RJ, Greenlick M, Hughes G, Smith J. for the SHEP Pilot Research Group. Compliance to treatment for hypertension in elderly patients: The SHEP Pilot Study. J Gerontol 1987;42:552-7.
27. Pullar T, Kumar S, Tindall H, Feely M. Time to stop counting the tablets?. Clin Pharmacol Ther 1989;46:163-8.
28. Brittain E, Wittes J. The run-in period in clinical trials: The effect of misclassification on efficiency. Control Clin Trials 1990;11:327-38.
29. The Writing Group for the PEPI Trial. Effects of hormone therapy on bone mineral density. Results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 1996;276:1389-96.
30. Sackett DL, Gent M. Controversy in counting and attributing events in clinical trials. N Engl J Med 1979;301:1410-2.
31. Armitage P. Controversies and achievements in clinical trials. Control Clin Trials 1984;5:67-72.
32. Efron B, Feldman D. Compliance as an explanatory variable in clinical trials (with discussion). J Am Statistic Assoc 1991;86:9-26.
33. Rochon J. Supplementing the intent-to-treat analysis: accounting for covariates observed postrandomization in clinical trials. J Am Statistic Assoc 1995;90:292-300.
34. Black LJ, Sato M, Rowley ER, Magee DE, Bekele A, Williams DC, Cullinan GJ, Bendele R, Kauffman RF, Bensch WR, et al. Raloxifene (LY139481 HCI) prevents bone loss and reduces serum cholesterol without causing uterine hypertrophy in ovariectomized rats. J Clin Invest 1994;93(1):63-9.
35. Gradym D, Rubin SM, Petitti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 1992;117:1016-37.