September 12, 2012

Daily Pill Effective for Some Men Who
Don’t Respond to PRN ED Drugs

Chicago—Once-a-day tadalafil (Cialis) may be marketed to improve spontaneity over on-demand erectile dysfunction therapies, but it may have an even more practical advantage: effectiveness in some of the men for whom PRN dosing doesn’t work.

An abstract presented recently at the World Meeting on Sexual Medicine in Chicago said that, with the use of up to 5 mg of tadalafil every day, normal erectile function was achieved for about 40% of study participants for whom on-demand treatment was ineffective.

Lead author Edward Kim, MD, of the University of Tennessee Medical Center in Knoxville, and colleagues said they sought to find out if men who could not achieve normal erectile function with the maximum dose of an as-needed phosphodiesterase type 5 (PRN PDE5) inhibitor would have a significantly greater probability of return to normal erectile function when treated with tadalafil once daily compared to placebo.

Researchers conducted two double-blind, randomized, controlled trials in 623 men, mean age of 58, who had no response to as-needed treatment even with maximum dosage. Over a 12-week period, participants were randomly assigned to receive every day either tadalafil 2.5 mg titrated to 5 mg, 5 mg of tadalafil, or placebo.

Based on the International Index of Erectile Function (IIEF-EF), a significantly higher percentage of men treated with tadalafil 2.5 to 5 mg (39%) and tadalafil 5 mg (40%) achieved improved erectile function compared with placebo (12%).

In fact, both tadalafil groups showed an 8-point improvement from a baseline IIEF-EF domain score of 14, compared to 2 points for the placebo group. Significant improvement was also seen in change from baseline in responses to the Sexual Encounter Profile 3 with tadalafil 2.5 to 5 mg (38%) and tadalafil 5 mg (40%) compared with 12% for placebo.

Daily doses of the drug were well tolerated and the study had no adverse events outside of the norm, according to the abstract.

Once daily use of tadalafil “may be a viable option for men with erectile dysfunction that could help restore normal erectile function,” according to Kim.

U.S. Pharmacist Social Connect