In May 2018, the FDA issued new draft guidance advising sponsors on assessing a drug’s effect on blood pressure during a clinical trial.
Clarified further in a meeting in February 2019, this guidance is the result of regulators looking for a connection between high blood pressure levels and cardiovascular events during drug therapy.
What You Need to Know: FDA Guidance Takeaways
As regulators increasingly ask for precise assessments of a new drug’s effect on blood pressure, it’s important for sponsors to understand the relevant FDA guidance.
According to the guidance:
- Elevated systolic and diastolic blood pressure increase cardiovascular risk
- Whether and how much a drug increases blood pressure should be factored into the drug’s overall benefit-risk assessment
- Even small sustained blood pressure increases (1-2 mm Hg) are of concern
- All drugs intended for chronic use will be required to undergo blood pressure evaluation in the targeted population
- Ambulatory blood pressure monitoring (ABPM) assessment is the best way to measure blood pressure effects over 24 hours
The Connection Between BP And Cardiovascular Events
High blood pressure is one of the leading risk factors of cardiovascular disease. It can result in increased incidence of:
- Cardiovascular mortality
- Sudden death
- Coronary heart disease
- Heart failure
- Atrial fibrillation
- Peripheral artery disease
- Renal insufficiency
The Benefits of ABPM
With ABPM, a wearable blood pressure cuff periodically takes a patient’s blood pressure one to several times an hour and automatically transmits the data to a recording device.
According to hypertensive experts and regulators ABPM assessment is the best way to measure a drug’s effect on blood pressure. Over an extended period of time, typically 24 hours, the device takes a patient’s blood pressure while they continue with their daily routines.
This provides a more accurate blood pressure assessment when compared to single readings taken periodically. Additionally, ABPM prevents elevations in blood pressure influenced by a patient’s anxiety about being in a doctor’s office (also known as “white coat hypertension”.)
Implementing ABPM in Your Trial
An effective ABPM solution doesn’t just collect data. It includes sophisticated analysis of ABPM quality to provide immediate meaningful feedback to site personnel to enable patient coaching for improved compliance. Flexible technology ensures you receive accurate high-quality data that meets your specific study objectives, and adheres to regulatory guidelines.
Patricia Castellano is a Senior Director of Product Management at ERT.