FDA Advises on How to Consider Blood Pressure Effects in Drug Development
The FDA recommended systemic characterization of a drug’s effect on blood pressure during drug development in newly issued guidance, which addresses precision of blood pressure measurements in assessing the effects of short-term and chronic use drugs in development.
Drugs intended for short-term use that have small effects on blood pressure should warrant little concern, so assessing blood pressure through cuff blood pressure measurement during routine study visits should be adequate, the agency said. But drugs intended for chronic use raise more concern because even small, sustained chronic increases in blood pressure could increase the risk of cardiovascular adverse events, and detecting those changes is important for chronic use drugs.
The FDA recommends sponsors of chronic use drugs conduct Ambulatory Blood Pressure Monitoring (ABPM) for blood pressure assessment because this can detect small but potentially significant blood pressure effects and assess them over a 24-hour period.