Daichi Shimbo1, Lu Wang, Michael J Lamonte, Matthew Allison, Gregory A Wellenius, Anthony A Bavry, Lisa W Martin, Aaron Aragaki, Jonathan D Newman, Yael Swica, Jacques E Rossouw, JoAnn E Manson, Sylvia Wassertheil-Smoller. 1. aDepartment of Medicine, Columbia University Medical Center, New York, New York bDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts cDepartment of Social and Preventive Medicine, School of Public Health and Health Professions, University at Buffalo - SUNY, Buffalo, New York dDepartment of Family and Preventive Medicine, University of California San Diego, San Diego, California eDepartment of Epidemiology, Brown University, Providence, Rhode Island fDepartment of Medicine, North Florida/South Georgia Veterans Health System, University of Florida, Gainesville, Florida gDivision of Cardiology, George Washington University, Washington, District of Columbia hFred Hutchinson Cancer Research Center, Seattle, Washington iCenter for Family and Community Medicine, Columbia University Medical Center, New York, New York jNational Heart, Lung, and Blood Institute, Bethesda, Maryland kDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA.
Abstract
OBJECTIVES:Mean and visit-to-visit variability (VVV) of blood pressure (BP) are associated with an increased cardiovascular disease risk. We examined the effect of hormone therapy on mean and VVV of BP in postmenopausal women from the Women's Health Initiative (WHI) randomized controlled trials. METHODS:BP was measured at baseline and annually in the two WHI hormone therapy trials, in which 10 739 and 16 608 postmenopausal women were randomized to conjugated equine estrogens (CEEs, 0.625 mg/day) or placebo, and CEEs and medroxyprogesterone acetate (MPA, 2.5 mg/day) or placebo, respectively. RESULTS: At the first annual visit (year 1), mean SBP was 1.04 mmHg [95% confidence interval (CI) 0.58, 1.50] and 1.35 mmHg (95% CI 0.99, 1.72) higher in the CEEs and CEEs and MPA arms, respectively, compared with the corresponding placebos. These effects remained stable after year 1. CEEs also increased the VVV of SBP (ratio of VVV in CEEs vs. placebo, 1.03; P < 0.001), whereas CEEs and MPA did not (ratio of VVV in CEEs and MPA vs. placebo, 1.01; P = 0.20). After accounting for study drug adherence, the effects of CEEs and CEEs and MPA on mean SBP increased at year 1, and the differences in the CEEs and CEEs and MPA arms vs. placebos also continued to increase after year 1. Further, both CEEs and CEEs and MPA significantly increased the VVV of SBP (ratio of VVV in CEEs vs. placebo, 1.04; P < 0.001; ratio of VVV in CEEs and MPA vs. placebo, 1.05; P < 0.001). CONCLUSION: Among postmenopausal women, CEEs and CEEs and MPA at conventional doses increased mean and VVV of SBP.
RCT Entities:
OBJECTIVES: Mean and visit-to-visit variability (VVV) of blood pressure (BP) are associated with an increased cardiovascular disease risk. We examined the effect of hormone therapy on mean and VVV of BP in postmenopausal women from the Women's Health Initiative (WHI) randomized controlled trials. METHODS: BP was measured at baseline and annually in the two WHI hormone therapy trials, in which 10 739 and 16 608 postmenopausal women were randomized to conjugated equine estrogens (CEEs, 0.625 mg/day) or placebo, and CEEs and medroxyprogesterone acetate (MPA, 2.5 mg/day) or placebo, respectively. RESULTS: At the first annual visit (year 1), mean SBP was 1.04 mmHg [95% confidence interval (CI) 0.58, 1.50] and 1.35 mmHg (95% CI 0.99, 1.72) higher in the CEEs and CEEs and MPA arms, respectively, compared with the corresponding placebos. These effects remained stable after year 1. CEEs also increased the VVV of SBP (ratio of VVV in CEEs vs. placebo, 1.03; P < 0.001), whereas CEEs and MPA did not (ratio of VVV in CEEs and MPA vs. placebo, 1.01; P = 0.20). After accounting for study drug adherence, the effects of CEEs and CEEs and MPA on mean SBP increased at year 1, and the differences in the CEEs and CEEs and MPA arms vs. placebos also continued to increase after year 1. Further, both CEEs and CEEs and MPA significantly increased the VVV of SBP (ratio of VVV in CEEs vs. placebo, 1.04; P < 0.001; ratio of VVV in CEEs and MPA vs. placebo, 1.05; P < 0.001). CONCLUSION: Among postmenopausal women, CEEs and CEEs and MPA at conventional doses increased mean and VVV of SBP.
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