Current Edition

Off-target Blood Pressure Effects in Biopharmaceutical Therapeutic Treatment Development: Points to Consider

In this Special Feature column, Jeff Heilbraun, MS, Senior
Director of Strategic Development at Bioclinica Cardiac
Safety observes that, over the past five years, there has been
an increasing interest in blood pressure as a cardiovascular
safety endpoint. There is presently no specific regulatory
guidance for the industry that provides a framework for
evaluating a compound which may have an “off-target” blood
pressure response. It is important to note that most of the
recent discussions on blood pressure have been associated
with increases in blood pressure, but we should not overlook
that some compounds (non-anti-hypertensive) may generate
a blood pressure lowering effect which may also be a
consideration based on patient population and therapeutic