Home (Self) Monitoring of Blood Pressure in Clinical Trials

Stergiou, George S.; Ntineri, Angeliki

doi:10.1007/978-3-319-22771-9_19

Cited by 6 publications

(3 citation statements)

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“…During the last two decades, HBPM has been used increasingly in clinical hypertension research [17,155,[267][268][269][270][271][272][273]. Its multiple advantages lead to superior diagnostic reliability and measurement reproducibility, ensuring improved accuracy of clinical trials as compared with the use of OBP measurements, and thereby leading to smaller study sample size and lower research costs, together with better patients' acceptance, particularly for longer term trials [17].…”

Section: Hbpm In Clinical Research (Box 30)mentioning

confidence: 99%

Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension

Parati

Stergiou

Bilo

et al. 2021

Journal of Hypertension

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The present paper provides an update of previous recommendations on Home Blood Pressure Monitoring from the European Society of Hypertension (ESH) Working Group on Blood Pressure Monitoring and Cardiovascular Variability sequentially published in years 2000, 2008 and 2010. This update has taken into account new evidence in this field, including a recent statement by the American Heart association, as well as technological developments, which have occurred over the past 20 years. The present document has been developed by the same ESH Working Group with inputs from an international team of experts, and has been endorsed by the ESH.

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Section: Hbpm In Clinical Research (Box 30)mentioning

confidence: 99%

Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension

Parati

Stergiou

Bilo

et al. 2021

Journal of Hypertension

Self Cite

102

100

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show abstract

“…Additionally, while techniques like 24-hr ambulatory blood pressure monitoring have been shown to increase reproducibility [ 13 – 15 ] and yield lower estimations of placebo response [ 16 – 19 ], their adoption as primary efficacy endpoints in FDA clinical trials for hypertension has not been widespread. Only two out of 63 trials (3.2%) used such a technique as a primary outcome measure.…”

Section: Discussionmentioning

confidence: 99%

“…Changing the context and increasing data points by using more frequent out-of-office measurements, such as 24-hour ambulatory blood pressure cuffs or in-home self-monitoring, may reduce the statistical noise of normal blood pressure variability. Such techniques may therefore increase reproducibility [ 13 – 15 ] and yield lower estimations of placebo response [ 16 – 19 ]. The adoption of such techniques in the measurement of primary efficacy endpoints in FDA clinical trials has not been quantified.…”

Section: Introductionmentioning

confidence: 99%

Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

et al. 2018

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BackgroundRecent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension.MethodFor this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms). Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures.ResultsLike trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018) and effect size (R2 = 0.013, p = 0.187) drug-placebo difference (R2 = 0.013, p = 0.182) and success rate (134/142, 94.4%) have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, p<0.001). Treatment arms are likely overpowered with sample sizes increasing over time (R2 = 0.387, p<0.0001) and stable, large effect sizes (0.78 ±0.37). The exploratory analysis of sample size, trial duration, baseline blood pressure, and number of treatment arms yielded mixed results unlikely to explain the pattern of placebo response and efficacy outcomes over time. The magnitude of placebo response had no relationship to effect size (p = 0.877), antihypertensive-placebo differences (p = 0.752), or p-values (p = 0.963) but was correlated with antihypertensive response (R2 = 0.347, p<0.0001).ConclusionsAs hypothesized, this study shows that placebo response is increasing in clinical trials for hypertension without any evidence of this increase impacting trial outcomes. Attempting to control placebo response in clinical trials for hypertension may not be necessary for successful efficacy outcomes. In exploratory analysis, we noted that despite finding significant relationships, none of the trial or patient characteristics we examined offered a clear explanation of the rise in placebo and stability in outcome measures over time. Collectively, these data suggest that the phenomenon of increasing placebo response and stable efficacy outcomes may be a general trend, occurring across trials for various psychiatric and medical conditions with physiological and non-physiological endpoints.

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Methodology and Applicability of Home Blood Pressure Monitoring in Children and Adolescents

Stergiou

Ntineri

2023

Pediatric Hypertension

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Home (Self) Monitoring of Blood Pressure in Clinical Trials

Cited by 6 publications

References 55 publications

Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension

Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension

Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

Methodology and Applicability of Home Blood Pressure Monitoring in Children and Adolescents

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