PDE-5 inhibitor safe, effective in hypertensive men

German researchers from Clinic Osnabruck in Osnabruck and GlaxoSmithKline in Munich conducted the randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of flexible-dose vardenafil in hypertensive males being treated with a range of medications. The subjects were taking one or multiple antihypertensive drugs, including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. The study population consisted of 354 subjects, age 18 years and older, who had experienced erectile dysfunction for more than 6 months. Patients in the vardenafil group were on an average of 1.5 antihypertensives, similar to the number (1.4) in the placebo group.

Patients in the vardenafil group were prescribed 5 to 20 mg of the drug for 12 weeks and were asked to record their responses to the Sexual Encounter Profile questions regarding vaginal insertion and maintenance of erection. The study also included gathering data from the Global Assessment Question, which asks about improved erections.

The study authors reported that 83% of men in the vardenafil group versus 58% of those in the placebo arm achieved vaginal insertion, and 67% in the vardenafil group versus 35% in the placebo group reported erection maintenance. Eighty percent of men in the vardenafil group reported experiencing improved erections, compared with 40% in the placebo arm.

There were no significant changes in either group regarding systolic and diastolic blood pressure or heart rate, and the most commonly reported treatment-related side effects were headache and flushing. There were, however, six serious adverse events in the vardenafil arm (including unstable angina, prostatitis, osteitis, bloody stools, and diverticulitis, missing data) and two in the placebo group. While there were more adverse events in the treatment group, the study's institutional review board deemed the events were unrelated to the drug and the study.

The study offers definitive information about the safety and efficacy of vardenafil in this population of men, according to Matt Toren Rosenberg, MD, medical director of the Mid-Michigan Health Centers, a family practice in Jackson, MI.

Dr. Rosenberg, a family physician with training as a urologist who is on the advisory board of GlaxoSmithKline and Schering-Plough, says it helps to quell drug-drug interaction concerns, especially among primary care physicians, about vardenafil use in combination with hypertensive medications.

"We know, for instance, that beta-blockers are notorious for causing ED in patients, and the question is: Can you use a PDE-5 inhibitor in combination and have a good result and safety? This study answered yes. And the other hypertensives had essentially equivalent results in terms of their response to the PDE-5 inhibitor," Dr. Rosenberg said.

While this study may set the bar for PDE-5 inhibitor use in patients being treated for hypertension, it does not prove a class effect, he said.

Still, in his practice, Dr. Rosenberg said he feels comfortable treating most patients with the spectrum of PDE-5 inhibitors, except those patients on nitroglycerin. It is important to first get hypertensive patients' blood pressures under control before prescribing vardenafil or any other PDE-5 inhibitor, he pointed out.