Vivus Inc has achieved positive results in a clinical pharmacology study evaluating the hemodynamic responses to glyceryl trinitrate in subjects pretreated with placebo, avanafil, and Pfizer's Viagra.
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Avanafil is Vivus’ investigational oral phosphodiesterase type 5 (PDE5) inhibitor being developed for the treatment of erectile dysfunction. Nitrates, such as glyceryl trinitrate (GTN), are commonly used to treat angina pectoris, or chest pain, and are known to lower blood pressure. When nitrates and PDE5 inhibitors are administered together, profound and sometimes life-threatening decreases in blood pressure have occurred.
In a patient group receiving GTN 30 minutes after PDE5 inhibitors were administered, avanafil plus GTN produced a numerically but not statistically greater decrease in blood pressure than sildenafil plus GTN.
“Results of this study demonstrate that avanafil, which has a shorter plasma half-life and a greater selectivity for the phosphodiesterase type 5 enzyme, had less effect versus sildenafil on heart rate and blood pressure when taken prior to nitrates,” said Professor Christian Stief, a recognized expert on PDE5 inhibitors and director of the Urology Clinical Division, Ludwigs-Maximilians-Universitat Munchen, Klinikum der Universitat, Munich, Germany.
“These results offer encouragement that avanafil may provide an improved cardiovascular profile in the treatment of men with erectile dysfunction.”