In: Disease13 May 2010
Speaker: William G. Moseley, MD, Medical Director, San Diego Uro-Research, San Diego, California.
Vardenafil (Levitra drug, Bayer/GlaxoSmithKline), a new anti-impotence agent, provided clinically significant, sustained improvement in erectile function over a two-year period in men with erectile dysfunction (ED), whether or not they had previously used the original anti-impotence drug sildenafil (Viagra®, Pfizer).
In a double-blind, multicenter, randomized trial, 1,020 men with ED were randomly assigned to take oral canadian vardenafil 10 or 20 mg, as needed, over 52 weeks. A total of 755 men (74%) completed the full 52-week treatment period; 566 men from 57 centers in 10 countries continued to receive double-blind vardenafil for an additional 52 weeks. In this group of patients, 272 men were receiving vardenafil 10 mg and 292 men were receiving a 20-mg dose. At the baseline evaluation, patients in both groups had moderate ED (2.2 and 2.3, respectively). In addition, 56% of the patients in the 10-mg group and 65% of those in the 20-mg group had taken sildenafil before.
Efficacy was defined as the mean per-patient success rate of vaginal penetration, based on the Sexual Encounter Profile Diary Question 2 (SEPQ2), a completion of intercourse (SEPQ3), and satisfaction with the hardness of erections over the past four treatment weeks. These parameters were examined retrospectively in the intent-to-treat population, which was stratified according to prior sildenafil use.
In general, vardenafil elicited similar mean results for each patient’s SEPQ2 and SEPQ3 success rates, erection improvement, and satisfaction with the hardness of erections, irrespective of their earlier use of sildenafil. For example, at baseline, the SEPQ2 success rates were 48.2% in the vardenafil 10-mg patients and 47.1% in the patients. At the end of the study, the SEPQ2 success rates were 87.2% and 90.1%, respectively, in sildenafil-naive patients and 85% and 83%, respectively, in patients with prior exposure to sildenafil. Global assessments of overall erectile function were 91% and 88.9%, respectively, in sildenafil-naive patients and 90% and 94%, respectively, in patients with prior sildenafil use.
Tadalafil, a Long-Acting Anti-impotence Drug, for Erectile Dysfunction
Speaker: Ridwan Shabsigh, MD, Associate Professor of Urology, Urologic Surgery, and Director, New York Center for
Human Sexuality, Columbia University College of Physicians and Surgeons, New York City, New York.
Results from a randomized, double-blind, placebo-controlled study showed that tadalafil (Eli Lilly) 10 and 20 mg administered to men with erectile dysfunction (ED) significantly improved their erectile ability compared with placebo. Assessments were based on mean per-patient percentages of sexual attempts that resulted in successful completion of intercourse when sexual activity occurred 24 or 36 hours after they took the study drug.
A phase 3 clinical trial involving 483 men, who were at least 18 years of age with a minimum of three months’ history of ED, was conducted in the U.S. The patients were randomly divided into groups according to the combination of study treatment, consisting of placebo, and tadalafil 20 mg.
The study consisted of (1) a four-week run-in phase without medication; (2) a two- to four-week equilibration phase with dosing, as needed, before sexual activity, but not more frequently than once a day; (3) a four- to six-week assessment phase with four doses of medication, each followed by a sexual intercourse attempt at 24 or 36 hours; and (4) a six-month, open-label extension phase of active medication. Efficacy was measured as the mean per-patient percentage of successful intercourse attempts, based on the Sexual Encounter Profile Diary Question 3 (SEPQ3).
Of the 483 men enrolled, 435 men completed the equilibration and assessment phases of the study; 144 received placebo, 145 received tadalafil 10 mg, and 146 received tadalafil 20 mg. Tadalafil in 10- and 20-mg doses was superior to placebo in the mean per-patient percentage of successful intercourse attempts at 24 hours (55.8 and 67.3%, respectively, compared with 41.8% receiving placebo) and at 36 hours (56.2% and 61.9%, respectively, compared with 32.8% receiving placebo).
The significant improvement in erectile function, which resulted in a greater percentage of successful sexual intercourse attempts, was further corroborated by patients’ increased post-dose satisfaction with the hardness of erections and their overall satisfaction with tadalafil compared with placebo at each of the pre-assigned time periods 24 or 36 hours after they took the dose.
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