Regression to the mean in home blood pressure: Analyses of the BP GUIDE study.
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SUBMITTER: Wang N
PROVIDER: S-EPMC8029697 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo 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).DesignA post-hoc analysis of a multicentre clinical trial.SettingOutpatients across Japan with mild-to-moderate essential hypertension.ParticipantsAmong 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 measuresWe analysed individual HBP readings during pretreatment and monotherapy.ResultsThe 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).ConclusionsAccording 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 registrationUMIN Clinical Trial Registry (http://www.umin.ac.jp/ctr), Unique identifier: C000000137.
| S-EPMC7735093 | biostudies-literature
Project description:BackgroundThe development of automated, smartphone application (app)-assisted home blood pressure monitoring (HBPM) allows for standardized measurement of blood pressure (BP) at home. The aim of this study was to evaluate the (diagnostic) agreement between app-assisted HBPM, automated office BP (OBP), and the reference standard 24-hour ambulatory BP monitoring (ABPM).MethodsIn this open randomized 5-way cross-over study, patients diagnosed with hypertension were randomized to one of 10 clusters, each containing 5 BP measurement methods (ABPM, HBPM, attended OBP, unattended OBP, and unattended 30-minute BP) in different order.ResultsIn total, 113 patients were included. The average 24-hour ABPM was 126±11/73±8 mm Hg compared with 141±14/82±10 mm Hg with app-assisted HBPM, 134±13/80±9 mm Hg with unattended 30-minute BP, 137±16/81±11 mm Hg with attended OBP, and 135±15/81±10 mm Hg with unattended OBP monitoring. Diagnostic agreement between app-assisted HBPM and 24-hour ABPM for diagnosing sustained (OBP >140/90 mm Hg and ABPM ≥130/80 mm Hg or HBPM ≥135/85 mm Hg), white-coat (OBP ≥140/90 mm Hg and ABPM <130/80 mm Hg or HBPM <135/85 mm Hg), and masked hypertension (OBP <140/90 mm Hg and ABPM ≥130/80 mm Hg or HBPM ≥135/85 mm Hg) was fair-to-moderate (κ statistics ranging from 0.34 to 0.40). App-assisted HBPM had high sensitivities (78%-91%) and negative predictive values (90%-97%) for diagnosing sustained and masked hypertension.ConclusionsThis study showed a considerable (diagnostic) disagreement between app-assisted HBPM and ABPM. App-assisted HBPM had high sensitivity in the diagnosis of sustained and masked hypertension and may therefore be used as complementary to, but not a replacement of, ABPM.
| S-EPMC9444260 | biostudies-literature
Project description:A self-measured home blood pressure (BP)-guided strategy is an effective practical approach to hypertension management. The Asia BP@Home study is the first designed to investigate current home BP control status in different Asian countries/regions using standardized home BP measurements taken with the same validated home BP monitoring device with data memory. We enrolled 1443 medicated hypertensive patients from 15 Asian specialist centers in 11 countries/regions between April 2017 and March 2018. BP was relatively well controlled in 68.2% of patients using a morning home systolic BP (SBP) cutoff of <135 mm Hg, and in 55.1% of patients using a clinic SBP cutoff of <140 mm Hg. When cutoff values were changed to the 2017 AHA/ACC threshold (SBP <130 mm Hg), 53.6% of patients were well controlled for morning home SBP. Using clinic 140 mm Hg and morning home 135 mm Hg SBP thresholds, the proportion of patients with well-controlled hypertension (46%) was higher than for uncontrolled sustained (22%), white-coat (23%), and masked uncontrolled (9%) hypertension, with significant country/regional differences. Home BP variability in Asian countries was high, and varied by country/region. In conclusion, the Asia BP@Home study demonstrated that home BP is relatively well controlled at hypertension specialist centers in Asia. However, almost half of patients remain uncontrolled for morning BP according to new guidelines, with significant country/regional differences. Strict home BP control should be beneficial in Asian populations. The findings of this study are important to facilitate development of health policies focused on reducing cardiovascular complications in Asia.
| S-EPMC8031357 | biostudies-literature
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.
| S-EPMC4943272 | biostudies-literature
Project description:BACKGROUND:The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. METHODS:Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these. RESULTS:Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes. CONCLUSION AND PUBLIC HEALTH IMPACT:BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.
| S-EPMC7067555 | biostudies-literature
Project description:Background:Previous studies have suggested that the effects of medical interventions tend to diminish over time. We investigated whether the effects of blood pressure lowering treatment on all-cause mortality and stroke have diminished over time. Methods:We conducted meta-regression analyses. We extracted the target trials from two recently published comprehensive systematic reviews and meta-analyses. Adopted variables were relative risk (RR) of all-cause mortality and stroke, trial start year, mean age, sample size, baseline systolic blood pressure (SBP), difference in attained SBP reduction between intervention groups and control groups (SBP difference), and regional dummies. We implemented single meta-regressions, in which the dependent variable was the log of RR and the explanatory variable was each of other adopted variables. We also conducted multiple meta-regressions, in which the dependent variable was the log of RR and explanatory variables were all of other adopted variables. Our variable of greatest interest was trial start year. Results:The included reviews assessed 85 trials with a total of 343,126 participants. Although trial start year was positively associated with the log of RR in the results of single meta-regressions, it lost significance in multiple meta-regressions for both all-cause mortality and stroke. Conclusions:The effects of blood pressure lowering treatment on all-cause mortality and stroke have not diminished over time.
| S-EPMC6237040 | biostudies-literature
Project description:BACKGROUND:The clinical significance of long-term seasonal variations in self-measured home blood pressure (BP) has not been elucidated for the cardiovascular disease prevention. METHODS AND RESULTS:Eligible 2787 patients were classified into 4 groups according to the magnitude of their seasonal variation in home BP, defined as an average of all increases in home BP from summer (July-August) to winter (January-February) combined with all decreases from winter to summer throughout the follow-up period, namely inverse- (systolic/diastolic, <0/<0 mm Hg), small- (0-4.8/0-2.4 mm Hg), middle- (4.8-9.1/2.4-4.5 mm Hg), or large- (?9.1/?4.5 mm Hg) variation groups. The overall cardiovascular risks illustrated U-shaped relationships across the groups, and hazard ratios for all cardiovascular outcomes compared with the small-variation group were 3.07 (P=0.004) and 2.02 (P=0.041) in the inverse-variation group and large-variation group, respectively, based on systolic BP, and results were confirmatory for major adverse cardiovascular events. Furthermore, when the summer-winter home BP difference was evaluated among patients who experienced titration and tapering of antihypertensive drugs depending on the season, the difference was significantly smaller in the early (September-November) than in the late (December-February) titration group (3.9/1.2 mm Hg versus 7.3/3.1 mm Hg, P<0.001) as well as in the early (March-May) than in the late (June-August) tapering group (4.4/2.1 mm Hg versus 7.1/3.4 mm Hg, P<0.001). CONCLUSIONS:The small-to-middle seasonal variation in home BP (0-9.1/0-4.5 mm Hg), which may be partially attributed to earlier adjustment of antihypertensive medication, were associated with better cardiovascular outcomes.
| S-EPMC6015300 | biostudies-literature
Project description:ObjectiveThe HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management.DesignUnmasked randomised controlled trial with automated ascertainment of primary endpoint.Setting76 general practices in the United Kingdom.Participants622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet.InterventionsParticipants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines.Main outcome measuresThe primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values.ResultsAfter one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction.ConclusionsThe HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded.Trial registrationISRCTN13790648.
| S-EPMC7814507 | biostudies-literature
Project description:IntroductionPeople of South Asian, African-Caribbean and Irish ethnicity are known to have worse cardiovascular outcomes than those from the white British group. While the reasons underpinning this are complex, the effect of hypertension is both significant and modifiable. In recent years, there has been increasing interest in and uptake of 'out-of-office' methods for blood pressure (BP) monitoring. However, guidance in this area has been largely based on research among the white population. This study aims to answer the following questions: (1) How often and in what ways does blood pressure (BP) monitoring occur and how does this differ between white and the above minority ethnic populations. (2) Are the thresholds for diagnosis of hypertension, and treatment targets in hypertension comparable for white British and minority ethnic populations using different measurement modalities: office blood pressure, ambulatory BP monitoring and home monitoring? (3) What preferences for BP measurement do people from white and minority ethnic populations have?Methods and analysisA mixed methods approach will be used including the following: (1) A postal survey sent to 8000 hypertensive and not-known-to-be-hypertensive people from all four ethnic groups will determine current patterns of BP monitoring. (2) A validation study will compare BP measurement by ambulatory monitoring with office standard measurement, office research measurement and home monitoring in 200 people from each of the ethnic groups concerned. (3) Focus groups organised by ethnicity and gender will gather qualitative data regarding patient preferences for and experiences of BP measurement in each of the given modalities. The data collected from these phases will be analysed appropriately in order to answer the above research questions.Ethics and disseminationEthical approval has been gained from the Black Country Research Ethics Committee: Ref 09/H1202/114. The results of this work will be disseminated via journal publication and conference presentation.
| S-EPMC3532997 | biostudies-literature
Project description:Home blood pressure monitoring is the self-measurement of blood pressure by patients. In the diagnosis and management of high blood pressure it is complementary to 24-hour ambulatory blood pressure monitoring and clinic blood pressure measurements. Home monitoring can also help to identify white-coat and masked hypertension. Home monitoring has good reproducibility, is well tolerated and relatively inexpensive. It is superior to blood pressure taken in the clinic in predicting cardiovascular events and mortality. Twice-daily measurements are recommended, usually in the morning and evening for a minimum of five days. The threshold for defining hypertension is an average home blood pressure of 135/85 mmHg or above. Patients are engaged with their management when they monitor their own blood pressure. This results in increased adherence to therapy and lower blood pressure.
| S-EPMC4654038 | biostudies-literature