Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women

Journal of the American Medical Association

Volumn 280, Issue 7, 1998, Pages 605-613

  Hulley, Stephen ^a   Grady, Deborah ^a   Bush, Trudy ^b   Furberg, Curt ^c   Herrington, David ^c   Riggs, Betty ^d   Vittinghoff, Eric ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c WAKE FOREST SCHOOL OF MEDICINE   (United States)

^d WYETH AYERST RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN; GESTAGEN; MEDROXYPROGESTERONE ACETATE; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; CORONARY RISK; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; ESTROGEN THERAPY; FEMALE; HIGH RISK POPULATION; HUMAN; ISCHEMIC HEART DISEASE; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; ORAL DRUG ADMINISTRATION; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SECONDARY PREVENTION;

AGED; CORONARY DISEASE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; ESTROGEN REPLACEMENT THERAPY; ESTROGENS, CONJUGATED (USP); FEMALE; FOLLOW-UP STUDIES; HUMANS; LIPOPROTEINS; MEDROXYPROGESTERONE 17-ACETATE; MIDDLE AGED; POSTMENOPAUSE; PROGESTERONE CONGENERS; PROPORTIONAL HAZARDS MODELS; RISK; SURVIVAL ANALYSIS;

EID: 0032547326     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.280.7.605     Document Type: Article

References (55)

1. Bush TL. Noncontraceptive estrogen use and risk of cardiovascular disease: an overview and critique of the literature. In: Korenman SG, ed. The Menopause: Biological and Clinical Consequences of Ovarian Failure: Evolution and Management. Norwell, Mass: Serono Symposia; 1990:211-223.
2. Stampfer MJ, Colditz GA. Estrogen replacement therapy and coronary heart disease: a quantitative assessment of the epidemiologic evidence. Prev Med. 1991;20:47-63.
3. Grady D, Rubin SM, Petitti DB, et al. Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992;117: 1016-1037.
4. Psaty BM, Heckbert SR, Atkins D, et al. The risk of myocardial infarction associated with the combined use of estrogens and progestins in postmenopausal women. Arch Intern Med. 1994;154:1333-1339.
5. Sidney S, Petitti DB, Quesenberry CP Jr. Myocardial infarction and the use of estrogen and estrogen-progestogen in postmenopausal women. Ann Intern Med. 1997;127:501-508.
6. Bush TL, Barrett-Connor E, Cowan LD, et al. Cardiovascular mortality and noncontraceptive use of estrogen in women: results from the Lipid Research Clinics Program Follow-up Study. Circulation. 1987;75:1102-1109.
7. Sullivan JM, Vander Zwaag R, Hughes JP, et al. Estrogen replacement and coronary artery disease. Arch Intern Med. 1990;150:2557-2562.
8. Henderson BE, Paganini-Hill A, Ross RK. Decreased mortality in users of estrogen replacement therapy. Arch Intern Med. 1991;151:75-78.
9. O'Brien JE, Peterson ED, Keeler GP, et al. Relation between estrogen replacement therapy and restenosis after percutaneous coronary interventions. J Am Coll Cardiol. 1996;28:1111-1118.
10. Newton KM, LaCroix AZ, McKnight B, et al. Estrogen replacement therapy and prognosis after first myocardial infarction. Am J Epidemiol. 1997; 145:269-277.
11. Sullivan JM, El-Zeky F, Vander Zwaag R, Ramanathan KB. Effect on survival of estrogen replacement therapy after coronary artery bypass grafting. Am J Cardiol. 1997;79:847-850.
12. O'Keefe JH, Kim SC, Hall RR, Cochran VC, Lawhorn SL, McCallister BD. Estrogen replacement therapy after coronary angioplasty in women. J Am Coll Cardiol. 1997;29:1-5.
13. Cauley JA, Cummings SR, Black DM, Mascioli SR, Seeley DG. Prevalence and determinants of estrogen replacement therapy in elderly women. Am J Obstet Gynecol. 1990;163:1438-1444.
14. Barrett-Connor E. Postmenopausal estrogen and prevention bias. Ann Intern Med. 1991;115: 455-456.
15. Petitti DB. Coronary heart disease and estrogen replacement therapy: can compliance bias explain the results of observational studies? Ann Epidemiol. 1994;4:115-118.
16. Grady D, Applegate W, Bush T, et al. Heart and Estrogen/progestin Replacement Study (HERS): design, methods and baseline characteristics. Control Clin Trials. 1998;19:314-335.
17. Rautaharju PM, Calhoun HP, Chaitman BR. Novacode serial ECG classification system for clinical trials and epidemiological studies. J Electrocardiol. 1992;34(suppl):179-187.
18. Schrott HG, Bittner V, Vittinghoff E, Herrington DM, Hulley SB. Adherence to National Cholesterol Education Program treatment goals in postmenopausal women with heart disease. JAMA. 1997;277:1281-1286.
19. Lan KKG, DeMets DL, Halperin M. More flexible sequential and non-sequential designs in long-term clinical trials. Commun Stat Theory Method. 1984;13:2339-2353.
20. Grady D, Hulley SB, Furberg C. Venous thromboembolic events associated with hormone replacement therapy. JAMA. 1997;278:477.
21. Matthews KA, Kuller LH, Wing RR, Meilahn EN, Plantinga P. Prior to use of estrogen replacement therapy, are users healthier than nonusers? Am J Epidemiol. 1996;143:971-978.
22. Grodstein F, Stampfer MJ, Manson JE, et al. Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med. 1996; 335:453-461.
23. Barrett-Connor E, Grady D. Hormone replacement therapy, heart disease, and other considerations. Annu Rev Public Health. 1998;19:55-72.
24. Falkeborn M, Persson I, Adami H, et al. The risk of acute myocardial infarction after oestrogen and oestrogen-progestogen replacement. Br J Obstet Gynaecol. 1992;99:821-828.
25. Thompson SG, Meade TW, Greenberg G. The use of hormonal replacement therapy and the risk of stroke and myocardial infarction in women. J Epidemiol Community Health. 1989;43:173-178.
26. Rosenberg L, Palmer JR, Shapiro S. A case-control study of myocardial infarction in relation to use of estrogen supplements. Am J Epidemiol. 1993; 137:54-63.
27. Mann RD, Lis Y, Chukwujindu J, Chanter DO. A study of the association between hormone replacement therapy, smoking and the occurrence of myocardial infarction in women. J Clin Epidemiol. 1994; 47:307-312.
28. Samaan SA, Crawford MH. Estrogen and cardiovascular function after menopause. J Am Coll Cardiol. 1995;6:1403-1410.
29. Guetta V, Cannon RO. Cardiovascular effects of estrogen and lipid-lowering therapies in postmenopausal women. Circulation. 1996;93:1928-1937.
30. Sarrel PM. How progestins compromise the cardioprotective effects of estrogens. Menopause. 1995; 2:187-190.
31. Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women [published correction appears in JAMA. 1995;274:1676]. JAMA. 1995;273:199-208.
32. Adams MR, Register TC, Golden DL, Wagner JD, Williams JK. Medroxyprogesterone acetate antagonizes inhibitory effects of conjugated equine estrogens on coronary artery atherosclerosis. Arterioscler Thromb Vasc Biol. 1997;17:217-221.
33. Adams MR, Kaplan JR, Manuck SB, et al. Inhibition of coronary artery atherosclerosis by 17-beta estradiol in ovariectomized monkeys: lack of an effect of added progesterone. Arteriosclerosis. 1990; 10:1051-1057.
34. Williams JK, Honoré EK, Washburn SA, Clarkson TB. Effects of hormone replacement therapy on reactivity of atherosclerotic coronary arteries in cynomolgus monkeys. J Am Coll Cardiol. 1994;24: 1757-1761.
35. McCrohon JA, Adams MR, McCredie RJ, et al. Hormone replacement therapy is associated with improved arterial physiology in healthy post-menopausal women. Clin Endocrinol. 1996;45:435-441.
36. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA. 1984;251:365-374.
37. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl JMed. 1995;333: 1301-1307.
38. Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335:1001-1009.
39. Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA. 1998;279: 1615-1622.
40. Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med. 1987;317:1237-1245.
41. Buchwald H, Varco RL, Matts JP, et al. Effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia. N Engl J Med. 1990;323: 946-955.
42. Rosenson RS, Tangney CC. Antiatherothrombotic properties of statins. JAMA. 1998;279:1643-1650.
43. Hemminki E, McPherson K. Impact of postmenopausal hormone therapy on cardiovascular events and cancer: pooled data from clinical trials. BMJ. 1997;315:149-153.
44. Coronary Drug Project Research Group. The Coronary Drug Project: initial findings leading to modifications of its research protocol. JAMA. 1970; 214:1303-1313.
45. Coronary Drug Project Research Group. Findings leading to discontinuation of the 2.5-mg/day estrogen group. JAMA. 1973;226:652-657.
46. Jick H, Derby LE, Myers MW, Vasilakis C, Newton KM. Risk of hospital admission for idiopathic venous thromboembolism among users of postmenopausal oestrogens. Lancet. 1996;348:981-983.
47. Daly E, Vessey MP, Hawkins MM, Carson JL, Gough P, Marsh S. Risk of venous thromboembolism in users of hormone replacement therapy. Lancet. 1996;348:977-980.
48. Grodstein F, Stampfer MJ, Goldhaber SZ, et al. Prospective study of exogenous hormones and risk of pulmonary embolism in women. Lancet. 1996;348: 983-987.
49. Gutthann SP, Rodriguez LAG, Castellsague J, Oliart AD. Hormone replacement therapy and risk of venous thromboembolism: population based case-control study. BMJ. 1997;314:796-800.
50. Everson GT, McKinley C, Kern F Jr. Mechanisms of gallstone formation in women. J Clin Invest. 1991;87:237-246.
51. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Lancet. 1997;350:1047-1059.
52. Herrington D, Fong J, Sempos CT, et al. Comparison of the HERS cohort with women with coronary disease from the NHANES III. Am Heart J. 1998;136:115-124.
53. Rossouw JE. Estrogens for prevention of coronary heart disease: putting the brakes on the bandwagon. Circulation. 1996;94:2982-2985.
54. Women's Health Initiative Study Group. Design of the Women's Health Initiative Clinical Trial and Observational Study. Control Clin Trials. 1998; 19:61-109.
55. Ryan TJ, Anderson JL, Antman EM, et al. ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Managment of Acute Myocardial Infarction). J Am Coll Cardiol. 1996;28:1328-1428.