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Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada.;McMaster Univ, Dept Med, Hamilton, ON, Canada..
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada.;McMaster Univ, Sch Rehabil Sci, Hamilton, ON, Canada..
Univ Santander, Fdn Oftalmol Santander, Bucaramanga, Colombia.;Univ Santander, Sch Med, Inst Masira, Bucaramanga, Colombia..
Chinese Acad Med Sci, Fu Wai Hosp, Beijing 100730, Peoples R China.;Peking Union Med Coll, Beijing 100021, Peoples R China..
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2016 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 374, no 21, 2009-2020 p.Article in journal (Refereed) Published
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Abstract [en]

BACKGROUND Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear.

METHODS In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years.

RESULTS The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P = 0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P = 0.02 and P = 0.009, respectively, for trend in the two outcomes).

CONCLUSIONS Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. ( ClinicalTrials. gov number, NCT00468923.)

Place, publisher, year, edition, pages
2016. Vol. 374, no 21, 2009-2020 p.
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Medical and Health Sciences
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URN: urn:nbn:se:uu:diva-298082DOI: 10.1056/NEJMoa1600175ISI: 000376443500004PubMedID: 27041480OAI: oai:DiVA.org:uu-298082DiVA: diva2:944613
Funder
AstraZeneca
Available from: 2016-06-29 Created: 2016-06-29 Last updated: 2016-06-29Bibliographically approved

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