Dataset Information

Antihypertensive drug effects according to the pretreatment self-measured home blood pressure: the HOMED-BP study.

ABSTRACT:

Objectives

To clarify whether or not the antihypertensive drug effect is proportional to the baseline pretreatment self-measured home blood pressure (HBP) in accordance with the law of initial value (Wilder's law).

Design

A post-hoc analysis of a multicentre clinical trial.

Setting

Outpatients across Japan with mild-to-moderate essential hypertension.

Participants

Among 3518 randomised participants, 2423 who self-measured HBP during the pretreatment drug-free period (10-28 days after starting fixed-dose antihypertensive monotherapy) with a mean 7.0 years follow-up were eligible.

Main outcome measures

We analysed individual HBP readings during pretreatment and monotherapy.

Results

The day-to-day HBP during both the pretreatment period and monotherapy period remains almost the same throughout each period; the results were consistent, regardless of the pretreatment HBP. Following monotherapy, the reduction in the HBP increased by 2.2 mm Hg (95% CI: 1.8 to 2.5 mm Hg) per 10 mm Hg pretreatment HBP increase, up to 11.0 mm Hg (95% CI: 9.9 to 12.0 mm Hg) among patients with an HBP ?165 mm Hg during pretreatment. Among the 1005 patients receiving low-dose monotherapy (defined daily dose: 0.5 units), the reduction peaked at 8.9-9.1 mm Hg in those with pretreatment HBP 155-164 mm Hg and ?165 mm Hg (p=0.88).

Conclusions

According to Wilder's law, the HBP reduction due to fixed-dose monotherapy was proportional to the pretreatment HBP without any regression to the mean phenomenon. With low-dose antihypertensive drugs, however, the HBP reduction peaked in patients with a high pretreatment HBP, indicating the need for such patients to receive a sufficient amount of antihypertensive drug medication at the initial treatment.

Trial registration

UMIN Clinical Trial Registry (http://www.umin.ac.jp/ctr), Unique identifier: C000000137.

SUBMITTER: Sano H

PROVIDER: S-EPMC7735093 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Antihypertensive drug effects according to the pretreatment self-measured home blood pressure: the HOMED-BP study.

Sano Hikari H Hara Azusa A Asayama Kei K Miyazaki Seiko S Kikuya Masahiro M Imai Yutaka Y Ohkubo Takayoshi T

BMJ open 20201212 12

<h4>Objectives</h4>To clarify whether or not the antihypertensive drug effect is proportional to the baseline pretreatment self-measured home blood pressure (HBP) in accordance with the law of initial value (Wilder's law).<h4>Design</h4>A post-hoc analysis of a multicentre clinical trial.<h4>Setting</h4>Outpatients across Japan with mild-to-moderate essential hypertension.<h4>Participants</h4>Among 3518 randomised participants, 2423 who self-measured HBP during the pretreatment drug-free period ...[more]

PMID: 33310801

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Project description:BackgroundRecent literature suggests that blood pressure variability (BPV) predicts outcome beyond blood pressure level (BPL) and that antihypertensive drug classes differentially influence BPV. We compared calcium channel blockers, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockade for effects on changes in self-measured home BPL and BPV and for their prognostic significance in newly treated hypertensive patients.Methods and resultsWe enrolled 2484 patients randomly allocated to first-line treatment with a calcium channel blocker (n=833), an angiotensin-converting enzyme inhibitor (n=821), or angiotensin receptor blockade (n=830). Home blood pressures in the morning and evening were measured for 5 days off treatment before randomization and for 5 days after 2 to 4 weeks of randomized drug treatment. We assessed BPL and BPV changes as estimated by variability independent of the mean and compared cardiovascular outcomes. Home BPL response in each group was significant (P≤0.0001) but small in the angiotensin-converting enzyme inhibitor group (systolic/diastolic: 4.6/2.8 mm Hg) compared with the groups treated with a calcium channel blocker (systolic/diastolic: 8.3/3.9 mm Hg) and angiotensin receptor blockade (systolic/diastolic: 8.2/4.5 mm Hg). In multivariable adjusted analyses, changes in home variability independent of the mean did not differ among the 3 drug classes (P≥0.054). Evening variability independent of the mean before treatment significantly predicted hard cardiovascular events independent of the corresponding home BPL (P≤0.022), whereas BPV did not predict any cardiovascular outcome based on the morning measurement (P≥0.056). Home BPV captured after monotherapy had no predictive power for cardiovascular outcome (P≥0.22).ConclusionsSelf-measured home evening BPV estimated by variability independent of the mean had prognostic significance, whereas antihypertensive drug classes had no significant impact on BPV changes. Home BPL should remain the primary focus for risk stratification and treatment.Clinical trial registrationURL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000137.

Project description:BackgroundThe Global Burden of Diseases Study 2010 reported that hypertension is worldwide the leading risk factor for cardiovascular disease, causing 9.4 million deaths annually. We examined to what extent self-measurement of home blood pressure (HBP) refines risk stratification across increasing categories of conventional blood pressure (CBP).Methods and findingsThis meta-analysis included 5,008 individuals randomly recruited from five populations (56.6% women; mean age, 57.1 y). All were not treated with antihypertensive drugs. In multivariable analyses, hazard ratios (HRs) associated with 10-mm Hg increases in systolic HBP were computed across CBP categories, using the following systolic/diastolic CBP thresholds (in mm Hg): optimal, <120/<80; normal, 120-129/80-84; high-normal, 130-139/85-89; mild hypertension, 140-159/90-99; and severe hypertension, ≥160/≥100. Over 8.3 y, 522 participants died, and 414, 225, and 194 had cardiovascular, cardiac, and cerebrovascular events, respectively. In participants with optimal or normal CBP, HRs for a composite cardiovascular end point associated with a 10-mm Hg higher systolic HBP were 1.28 (1.01-1.62) and 1.22 (1.00-1.49), respectively. At high-normal CBP and in mild hypertension, the HRs were 1.24 (1.03-1.49) and 1.20 (1.06-1.37), respectively, for all cardiovascular events and 1.33 (1.07-1.65) and 1.30 (1.09-1.56), respectively, for stroke. In severe hypertension, the HRs were not significant (p≥0.20). Among people with optimal, normal, and high-normal CBP, 67 (5.0%), 187 (18.4%), and 315 (30.3%), respectively, had masked hypertension (HBP≥130 mm Hg systolic or ≥85 mm Hg diastolic). Compared to true optimal CBP, masked hypertension was associated with a 2.3-fold (1.5-3.5) higher cardiovascular risk. A limitation was few data from low- and middle-income countries.ConclusionsHBP substantially refines risk stratification at CBP levels assumed to carry no or only mildly increased risk, in particular in the presence of masked hypertension. Randomized trials could help determine the best use of CBP vs. HBP in guiding BP management. Our study identified a novel indication for HBP, which, in view of its low cost and the increased availability of electronic communication, might be globally applicable, even in remote areas or in low-resource settings.

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Project description:Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure. This study aimed to assess self-monitoring plus self-titration of antihypertensive medication versus usual care for reducing systolic blood pressure (SBP) at 12 months in poorly controlled hypertensive patients. The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain. Hypertensive patients older than 40 years, with SBP over 145 mmHg and/or diastolic blood pressure (DBP) over 90 mmHg, were recruited from July 2017 to June 2018. Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration. The primary outcome was the adjusted mean difference (AMD) in SBP between groups at 12 months. Primary outcome data were available for 312 patients (intervention n=156, control n=156) of the 366 who were initially recruited. The AMD in SBP at 12 months (main analysis) was -2.9 mmHg (95% CI, -5.9 to 0.1, p=0.061), while the AMD in DBP was -1.9 mmHg (95% CI, -3.7 to 0.0, p=0.052). The results of the subgroup analysis were consistent with these for the main outcome measures. More patients in the intervention group achieved good blood pressure control (<140/90 mmHg) at 12 months than in the control group (55.8% vs 42.3%, difference 13.5%, 95% CI, 2.5 to 24.5%, p=0.017). At 12 months, no differences were observed in behavior, quality of life, use of health services, or adverse events. Self-monitoring plus self-titration of antihypertensive medication based on an individualized pre-arranged plan used in primary care may be a promising strategy for reducing blood pressure at 12 months compared to usual care, without increasing healthcare utilization or adverse events. EudraCT, number 2016-003986-25 (registered 17 March 2017) and clinicaltrials.gov , NCT03242785.

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Dataset Information

Antihypertensive drug effects according to the pretreatment self-measured home blood pressure: the HOMED-BP study.

Objectives

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Trial registration

Publications

Antihypertensive drug effects according to the pretreatment self-measured home blood pressure: the HOMED-BP study.

Similar Datasets

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