Hypertension Objective Treatment Based on Measurement by

Transcription

Hypertension Objective Treatment Based on Measurement by
Copyright 2001, HOMED-BP Secretariat All Right Reserved.
Hand-o
ut infor
mation
Hypertension Objective Treatment Based on Measurement
by Electrical Devices of Blood Pressure Study
General background and design
The HOMED-BP explored to what extent long-term antihypertensive treatment guided by the home BP impacted on cardiovascular outcomes in patients.
aged ≥40 years were recruited from 457 general practices throughout Japan.
HOMED-BP is a clinical trial with prospective randomized
open-blinded endpoint evaluation (PROBE) design.
Patients with home BP ≥135/85 mm Hg (home BP
<180/120 mm Hg and clinic BP <220/125 mm Hg)
Treatment naïve patients as well as previously treated
patients, whose antihypertensive drug treatment
could be discontinued for ≥2 weeks, qualified for enrolment.
Measurement and treatment after randomization
Based on the 2 × 3 factorial design, 3518 eligible patients were randomized to usual (125–134/80–84 mm Hg
[UC]) vs. tight (<125/<80 mm Hg [TC]) control of home BP and to initiation of drug treatment with CCB, ACEI
or ARB. These randomizations, performed by the host computer, are transmitted to terminal microcomputer at
outpatient clinical via the Internet.
Home BP is measured using OMRON HEM 747IC-N (Omron Healthcare Co.,Ltd, Kyoto, Japan) with IC memory,
which can store up to 350 readings in its memory. Practitioners obtained 2 consecutive clinic BP using the fully
automated oscillometric OMRON HEM-907IT (Omron Healthcare).
At each outpatient visit, the home BP values stored in memory were uploaded to the server. These values were
automatically calculated by the server and immediately displayed on the screen of the local computer in
the practices along with an advice for treatment adStep 1: CCB, ACEI or ARB
justment based on a computerized algorithm running
Step 2: Dose increment
on the central server.
Treatment
Step
The algorithm consisted of 5 steps (right panel).
When the home BP was less than 110 mm Hg systolic or
65 mm Hg diastolic, treatment was tailored down.
Step 3: Addition of diuretics
Step 4: Addition of α or β blockers
Step 5: Use of any drugs
Main results and interpretation
At last follow-up (median 5.3 years), 1759 TC compared with 1759 UC patients
used more antihypertensive drugs (1.82 vs. 1.74 defined daily doses,
p=0.045), had more home BP reduction (21.3/13.1 mm Hg vs. 22.7/13.9
mm Hg, p=0.018/0.020), but less frequently achieved the lower home BP
targets (37.4% vs. 63.5%, p<0.0001).
The primary endpoint, cardiovascular death plus stroke and myocardial infarction, occurred in 25 UC and 26 TC patients (p=0.94).
Rates were also similar (p≥0.13) in the 3 drug groups.
In all patients combined, the risk of the primary endpoint independently increased by 41% (p=0.019) and 47% (p=0.0020) for a 1-SD increase in baseline (12.5 mm Hg) and follow-up (13.2 mm Hg) systolic home BP. The 5 year
risk was minimal (≤1%) if
on-treatment systolic home BP
was 131.6 mm Hg or less.
Acknowledgements
HOMED-BP study, endorsed by the Japanese
Society of Hypertension, is supported by
grants from the Japan Cardiovascular
Research Foundation and the Japan
Arteriosclerosis Prevention Fund.
HOMED-BP proved the
feasibility of adjusting
antihypertensive drug
treatment based on
home BP.
The study suggests that
a systolic home BP
level of 130 mm Hg
should be an achievable and safe target.
Fujitsu Systems East Limited (Sendai, Japan)
and Omron Healthcare Co. (Kyoto, Japan)
have developed and maintained the
Internet and home BP based systems.
The HOMED-BP study is designed, conducted,
and interpreted by the investigators
independently of all sponsors and
companies.
Contact: Kei Asayama MD, PhD
Studies Coodinating Centre, KU Leuven
e-mail: [email protected]
Recent publications
1. Y Noguchi et al. Predictive power of home blood pressure and clinic blood pressure in hypertensive patients with impaired glucose metabolism and diabetes. J Hypertens. 2013: 1593.
2. K Kamide et al. Genome-wide response to antihypertensive medication using home blood pressure
measurements —a pilot study nested within the HOMED-BP study. Pharmacogenomics 2013 (in press)
3. K Asayama et al. Cardiovascular outcomes in the first trial of antihypertensive therapy guided by
self-measured home blood pressure. Hypertens Res. 2012: 1102.