Key result
Ambulatory blood pressure monitoring studies submitted to the FDA provide precise estimates of blood pressure changes and lack a pronounced placebo response.
Why the study?
Mean increases in systolic blood pressure of 2-3 mmHg can increase cardiovascular risk, prompting new regulatory recommendations for safety ambulatory blood pressure monitoring studies to assess chronically used drugs.
Ambulatory blood pressure monitoring studies are valuable for precisely estimating drug-induced blood pressure changes and predicting cardiovascular risk in drug development programs.
Supports ABPM endpoints in antihypertensive development; leaves open translation to clinical practice.
According to models developed from large epidemiological studies, mean increases in systolic blood pressure of 2-3 mmHg can increase the risk of cardiovascular (CV) adverse events, especially in patients with a high risk for CV disease. There are new regulatory recommendations for the use of a safety ambulatory blood pressure monitoring (ABPM) study to assess the blood pressure (BP) effects of drugs used chronically. The ABPM study collects BP measurements over 24 hours at baseline and during treatment in patients with underlying CV risk. Our evaluation of ABPM studies submitted to the US Food and Drug Administration (FDA) shows these studies can provide precise estimates of BP changes and lack a pronounced placebo response. With the assessment of BP effects in development programs, opportunities exist for developing quantitative safety models to predict CV risk, support dose selection, identify patients with increased BP response, and provide insight into underlying mechanisms.
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Garnett et al. (2019) conducted a review in Cardiovascular risk. Ambulatory blood pressure monitoring (ABPM) was evaluated on Blood pressure changes. Ambulatory blood pressure monitoring studies submitted to the FDA provide precise estimates of blood pressure changes and lack a pronounced placebo response.
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