E. David Crawford sits down with Robert A. Kloner, MD, PhD, and Raymond Rosen, MD, to discuss retrospective evidence of PDE5 inhibitors in preventing major adverse cardiac events (MACE) in men. Crawford, Kloner, and Rosen discuss a retrospective study examining occurrences of MACE in men which demonstrated a significant reduction in MACE in men using PDE5 inhibitors versus those who were not.
They discuss the possibility of over-the-counter (OTC) approval for PDE5 inhibitors, but acknowledge that FDA approval for OTC use of PDE5 inhibitors is not assured. Dr. Rosen discusses the barriers faced by regulatory authorities in approving over-the-counter PDE5 inhibitors. Dr. Kloner discusses pharmacist-mediated prescriptions of PDE5 inhibitors and the patient screening involved. They conclude by touching on the use of PDE5 inhibitors for female patients, and the European OTC PDE5 inhibitor trials which are presently ongoing.Read More