Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33

Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33

CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. D...

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Autores principales: Vera P-G,Claudio, Rada G,Gabriel
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2003
Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000800019
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spelling oai:scielo:S0034-988720030008000192004-12-13Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33Vera P-G,ClaudioRada G,GabrielCONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. INTERVENTIONS: Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10.000 person years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10.000 person years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10.000 person years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2 years follow up among healthy postmenopausal US women. All cause mortality was not affected during the trial. The risk benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHDinfo:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.131 n.8 20032003-08-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000800019es10.4067/S0034-98872003000800019
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
description CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. INTERVENTIONS: Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10.000 person years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10.000 person years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10.000 person years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2 years follow up among healthy postmenopausal US women. All cause mortality was not affected during the trial. The risk benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD
author Vera P-G,Claudio
Rada G,Gabriel
spellingShingle Vera P-G,Claudio
Rada G,Gabriel
Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
author_facet Vera P-G,Claudio
Rada G,Gabriel
author_sort Vera P-G,Claudio
title Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
title_short Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
title_full Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
title_fullStr Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
title_full_unstemmed Terapia hormonal de reemplazo... primum non nocere: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 2002; 288: 321-33
title_sort terapia hormonal de reemplazo... primum non nocere: principal results from the women's health initiative randomized controlled trial. jama 2002; 288: 321-33
publisher Sociedad Médica de Santiago
publishDate 2003
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872003000800019
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AT radaggabriel terapiahormonaldereemplazoprimumnonnocereprincipalresultsfromthewomenshealthinitiativerandomizedcontrolledtrialjama200228832133
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