4.5 Article

Cardiovascular outcomes in the first trial of antihypertensive therapy guided by self-measured home blood pressure

Journal

HYPERTENSION RESEARCH
Volume 35, Issue 11, Pages 1102-1110

Publisher

SPRINGERNATURE
DOI: 10.1038/hr.2012.125

Keywords

antihypertensive drug treatment; blood pressure control; home blood pressure; randomized clinical trial

Funding

  1. Japan Research Foundation for Clinical Pharmacology
  2. Daiichi Sankyo
  3. Kyowa Hakko Kirin
  4. Merck Sharpe and Dohme
  5. Tanabe-Mitsubishi
  6. Novartis
  7. Novo Nordisk
  8. Asteras
  9. AstraZeneca
  10. Dainippon-Sumitomo
  11. Pfizer
  12. Takeda
  13. Sigma-Tau
  14. Omron Healthcare
  15. Japan Cardiovascular Research Foundation
  16. Japan Arteriosclerosis Prevention Fund
  17. Tohoku University

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Hypertension guidelines recommend blood pressure self-measurement at home (HBP), but no previous trial has assessed cardiovascular outcomes in hypertensive patients treated according to HBP. The multicenter Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP; 2001-2010) trial involved 3518 patients (50% women; mean age 59.6 years) with an untreated systolic/diastolic HBP of 135-179/85-119 mm Hg. In a 2 x 3 design, patients were randomized to usual control (125-134/80-84 mm Hg (UC)) vs. tight control (<125/<80 mm Hg (TC)) of HBP and to initiation of drug treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers or calcium channel blockers. During follow-up, a computer algorithm automatically generated treatment recommendations based on HBP. At the last follow-up (median 5.3 years), TC patients used more antihypertensive drugs than UC patients (1.82 vs. 1.74 defined daily doses, P = 0.045) and had a greater HBP reduction (21.3/13.1 mm Hg vs. 22.7/13.9 mm Hg, P = 0.018/0.020), but they less frequently achieved the lower HBP targets (37.4 vs. 63.5%, P<0.0001). The primary end point, cardiovascular death plus stroke and myocardial infarction, occurred in 25 UC and 26 TC patients (hazard ratio, 1.02; 95% confidence interval, 0.59-1.77; P = 0.94). Rates were similar (P >= 0.13) in the three drug groups. In all patients combined, the risk of the primary end point independently increased by 41% (6-89%; P = 0.019) and 47% (15-87%; P = 0.0020) for a 1-s.d. increase in baseline (12.5 mm Hg) and follow-up (13.2 mm Hg) systolic HBP. The 5-year risk was minimal (<= 1%) if on-treatment systolic HBP was 131.6 mm Hg or less. HOMED-BP proved the feasibility of adjusting antihypertensive drug treatment based on HBP and suggests that a systolic HBP level of 130 mm Hg should be an achievable and safe target. Hypertension Research (2012) 35, 1102-1110; doi:10.1038/hr.2012.125; published online 16 August 2012

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