Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal Women
Stephen B. Hulley,Deborah Grady,Trudy L. Bush,Curt D Furberg,David M. Herrington,Betty Riggs,Eric Vittinghoff +6 more
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TLDR
Treatment with oral conjugated equine estrogen plus medroxyprogesterone acetate did not reduce the overall rate of CHD events in postmenopausal women with established coronary disease and the treatment did increase the rate of thromboembolic events and gallbladder disease.Abstract:
Context.—Observational studies have found lower rates of coronary heart disease
(CHD) in postmenopausal women who take estrogen than in women who do not,
but this potential benefit has not been confirmed in clinical trials.Objective.—To determine if estrogen plus progestin therapy alters the risk for
CHD events in postmenopausal women with established coronary disease.Design.—Randomized, blinded, placebo-controlled secondary prevention trial.Setting.—Outpatient and community settings at 20 US clinical centers.Participants.—A total of 2763 women with coronary disease, younger than 80 years,
and postmenopausal with an intact uterus. Mean age was 66.7 years.Intervention.—Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone
acetate in 1 tablet daily (n=1380) or a placebo of identical appearance (n=1383).
Follow-up averaged 4.1 years; 82% of those assigned to hormone treatment were
taking it at the end of 1 year, and 75% at the end of 3 years.Main Outcome Measures.—The primary outcome was the occurrence of nonfatal myocardial infarction
(MI) or CHD death. Secondary cardiovascular outcomes included coronary revascularization,
unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke
or transient ischemic attack, and peripheral arterial disease. All-cause mortality
was also considered.Results.—Overall, there were no significant differences between groups in the
primary outcome or in any of the secondary cardiovascular outcomes: 172 women
in the hormone group and 176 women in the placebo group had MI or CHD death
(relative hazard [RH], 0.99; 95% confidence interval [CI], 0.80-1.22). The
lack of an overall effect occurred despite a net 11% lower low-density lipoprotein
cholesterol level and 10% higher high-density lipoprotein cholesterol level
in the hormone group compared with the placebo group (each P<.001). Within the overall null effect, there was a statistically
significant time trend, with more CHD events in the hormone group than in
the placebo group in year 1 and fewer in years 4 and 5. More women in the
hormone group than in the placebo group experienced venous thromboembolic
events (34 vs 12; RH, 2.89; 95% CI, 1.50-5.58) and gallbladder disease (84
vs 62; RH, 1.38; 95% CI, 1.00-1.92). There were no significant differences
in several other end points for which power was limited, including fracture,
cancer, and total mortality (131 vs 123 deaths; RH, 1.08; 95% CI, 0.84-1.38).Conclusions.—During an average follow-up of 4.1 years, treatment with oral conjugated
equine estrogen plus medroxyprogesterone acetate did not reduce the overall
rate of CHD events in postmenopausal women with established coronary disease.
The treatment did increase the rate of thromboembolic events and gallbladder
disease. Based on the finding of no overall cardiovascular benefit and a pattern
of early increase in risk of CHD events, we do not recommend starting this
treatment for the purpose of secondary prevention of CHD. However, given the
favorable pattern of CHD events after several years of therapy, it could be
appropriate for women already receiving this treatment to continue.read more
Citations
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Journal ArticleDOI
Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial
Jacques E. Rossouw,Garnet L. Anderson,Ross L. Prentice,Andrea Z. LaCroix,Charles Kooperberg,Marcia L. Stefanick,Rebecca D. Jackson,Shirley A.A. Beresford,Barbara V. Howard,Karen C. Johnson,Jane Morley Kotchen,Judith K. Ockene +11 more
TL;DR: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
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2013 ESH/ESC Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC).
Giuseppe Mancia,Robert Fagard,Krzysztof Narkiewicz,Josep Redon,Alberto Zanchetti,Michael Böhm,Thierry Christiaens,Renata Cifkova,Guy De Backer,Anna F. Dominiczak,Maurizio Galderisi,Diederick E. Grobbee,Tiny Jaarsma,Paulus Kirchhof,Sverre E. Kjeldsen,Stéphane Laurent,Athanasios J. Manolis,Peter M. Nilsson,Luis M. Ruilope,Roland E. Schmieder,Per Anton Sirnes,Peter Sleight,Margus Viigimaa,Bernard Waeber,Faiez Zannad,Michel Burnier,Ettore Ambrosioni,Mark Caufield,Antonio Coca,Michael H. Olsen,Costas Tsioufis,Philippe van de Borne,José Luis Zamorano,Stephan Achenbach,Helmut Baumgartner,Jeroen J. Bax,Héctor Bueno,Veronica Dean,Christi Deaton,Çetin Erol,Roberto Ferrari,David Hasdai,Arno W. Hoes,Juhani Knuuti,Philippe Kolh,Patrizio Lancellotti,Aleš Linhart,Petros Nihoyannopoulos,Massimo F Piepoli,Piotr Ponikowski,Juan Tamargo,Michal Tendera,Adam Torbicki,William Wijns,Stephan Windecker,Denis Clement,Thierry C. Gillebert,Enrico Agabiti Rosei,Stefan D. Anker,Johann Bauersachs,Jana Brguljan Hitij,Mark J. Caulfield,Marc De Buyzere,Sabina De Geest,Geneviève Derumeaux,Serap Erdine,Csaba Farsang,Christian Funck-Brentano,Vjekoslav Gerc,Giuseppe Germanò,Stephan Gielen,Herman Haller,Jens Jordan,Thomas Kahan,Michel Komajda,Dragan Lovic,Heiko Mahrholdt,Jan Östergren,Gianfranco Parati,Joep Perk,Jorge Polónia,Bogdan A. Popescu,Zeljko Reiner,Lars Rydén,Yuriy Sirenko,Alice Stanton,Harry A.J. Struijker-Boudier,Charalambos Vlachopoulos,Massimo Volpe,David A. Wood +89 more
TL;DR: In this article, a randomized controlled trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly people was presented. But the authors did not discuss the effect of the combination therapy in patients living with systolic hypertension.
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GRADE: an emerging consensus on rating quality of evidence and strength of recommendations
Gordon H. Guyatt,Andrew D Oxman,Gunn Elisabeth Vist,Regina Kunz,Yngve Falck-Ytter,Pablo Alonso-Coello,Holger J. Schünemann +6 more
TL;DR: The advantages of the GRADE system are explored, which is increasingly being adopted by organisations worldwide and which is often praised for its high level of consistency.
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2007 Guidelines for the Management of Arterial Hypertension : The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC).
Giuseppe Mancia,Guy De Backer,Anna F. Dominiczak,Renata Cifkova,Robert Fagard,Giuseppe Germanò,Guido Grassi,Anthony M. Heagerty,Sverre E. Kjeldsen,Stéphane Laurent,Krzysztof Narkiewicz,Luis M. Ruilope,Andrzej Rynkiewicz,Roland E. Schmieder,Harry A.J. Struijker Boudier,Alberto Zanchetti +15 more
TL;DR: 2007 Guidelines for the Management of Arterial Hypertension : The Task Force for the management of Arterspertension of the European Society ofhypertension (ESH) and of theEuropean Society of Cardiology (ESC).
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ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction—Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction)
Elliott M. Antman,Daniel T. Anbe,Paul W. Armstrong,Eric R. Bates,Lee A. Green,Mary M. Hand,Judith S. Hochman,Harlan M. Krumholz,Frederick G. Kushner,Gervasio A. Lamas,Charles J. Mullany,Joseph P. Ornato,David L. Pearle,Michael A. Sloan,Sidney C. Smith,Joseph S. Alpert,Jeffrey L. Anderson,David P. Faxon,Valentin Fuster,Raymond J. Gibbons,Gabriel Gregoratos,Jonathan L. Halperin,Loren F. Hiratzka,Sharon A. Hunt,Alice K. Jacobs +24 more
TL;DR: Although considerable improvement has occurred in the process of care for patients with ST-elevation myocardial infarction (STEMI), room for improvement exists as discussed by the authors, and the purpose of the present guideline is to focus on the numerous advances in the diagnosis and management of patients
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