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Sildenafil Well-Tolerated in Men on Multiple Antihypertensives

MedpageToday

The study, which was sponsored by Pfizer and published in the American Journal of Hypertension, included 568 men with erectile dysfunction (ED) who were taking two or more antihypertensive medications, including diuretics, beta-blockers, ACE-inhibitors, and calcium channel blockers.

The men were randomized to sildenafil (n=281) or placebo (n=287) for a 6-week double-blind trial, followed by a 6-week open label trial. Primary endpoints were frequency of erection and successful sexual intercourse assessed by standard questionnaire.

Action Points

  • Counsel men talking multiple drug pressure medications about the need for compliance with medical therapy.
  • Men with hypertension-associated erectile dysfunction (ED) may request sildenafil therapy as a result of this news. Caution them about the potential hazards described in the AHA/ACC statement as part of informed consent.
  • Carefully monitor men taking sildenafil on top of polypharmacy for hypertension.

Key results are as follows:

  • Seventy-one percent of the sildenafil-treated patients reported improved erections, versus 18% of placebo-treated men.

  • Sixty-nine percent of the treatment group reported improved intercourse, compared to 20% of the placebo group.

  • During double-blind treatment, 40% of the treatment group and 25% of the placebo group experienced adverse events. The researchers suggested this result "can be attributed to sildenafil's modest vasodilatory properties."

  • Compared with placebo, sildenafil was associated with a higher frequency of headache and facial flushing.

  • Overall, adverse events were transient and mild to moderate in severity.

"This is the first large prospective study to evaluate the efficacy and tolerability of sildenafil in men with ED and hypertension who were taking multiple classes of antihypertensives," the study authors wrote. "The study was important because: 1) it directly assessed the effectiveness of sildenafil in a large representative population of men with hypertension; and 2) it directly addressed the concerns raised by the American College of Cardiology and American Heart Association regarding the cardiovascular safety of sildenafil among men taking multiple antihypertensives."


"Our results showed that sildenafil was both effective and well tolerated in men with ED and hypertension who were taking two or more antihypertensives," they concluded.

Primary Source

The American Journal of Hypertension

Source Reference: Pickering T, Shepherd A, Puddey I et al. "Sildenafil Citrate for Erectile Dysfunction in Men Receiving Multiple Antihypertensive Agents" Am J Hypertension 2004;17:1135-1142