Womenʼs Health Initiative estrogen plus progestin clinical trial

作者: Sócrates Aedo , Gabriel Cavada , Juan E. Blümel , Peter Chedraui , Juan Fica

DOI: 10.1097/GME.0000000000000472

关键词: Internal medicineWomen's Health InitiativeMedroxyprogesterone acetateSurgeryMedicineHip fractureBreast cancerHazard ratioClinical trialPlaceboProportional hazards modelObstetrics and gynaecology

摘要: Objective: This study aims to determine time differences (differences in restricted mean survival times [RMSTs]) the onset of invasive breast cancer, coronary heart disease, stroke, pulmonary embolism, colorectal and hip fracture between placebo group conjugated equine estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 Women_s Health Initiative (WHI) trial based on curves original report provide adequate interpretation clinical effects a given intervention. Methods: Distribution function was obtained from cumulative hazard plots WHI report; Monte Carlo simulation performed obtain censored observations for each outcome, which assumptions Cox model were evaluated once corresponding ratios had been estimated. Using estimation methods such as numerical integration, pseudovalues, flexible parametric modeling, we determined RMSTs outcome. Results: Obtained plots, ratios, outcome rates simulated did not show relation report. The RMST (in modeling) 1.17 days (95% CI, j2.25 4.59) 7.50 2.90 12.11) 2.75 j0.84 6.34) 4.23 1.82 6.64) j2.73 j5.32 j0.13) j2.77 j5.44 j0.1) fracture. Conclusions: outcomes are too small establish risks related hormone therapy use.

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