December 10, 2001
Vardenafil Study Reports Positive
Results in Improved Sexual Function For Diabetic Men With Erectile Dysfunction
2001 Annual Fall Meeting, Sexual Medicine Society of North America
- New phase III data for vardenafil, an investigational phosphodiesterase-5
(PDE-5) inhibitor, reported statistically significant results in not only
achieving improvements in erectile function for patients with diabetes, but
also improved key aspects of sexual function during the study period. The
data were presented today at the 2001 Annual Meeting of the Sexual Medicine
Society of North America (SMSNA), held in Charleston, S.C.
"In the study population, vardenafil patients reported significant
improvement in many aspects of sexual function. Erection quality, frequency
of successful intercourse, as well as significant improvement in intercourse
satisfaction and orgasmic function were reported in many diabetic patients.
Diabetic patients are a characteristically difficult-to-treat population for
erectile dysfunction (ED)," said Irwin Goldstein, M.D., professor of urology
at Boston University School of Medicine, and lead author of the analysis.
"Perhaps the most exciting aspect of our findings is that diabetic patients
who had the most severe ED responded better than those with mild ED. These
results may have significant implications especially in the US, where the
incidence of adult diabetes is at an all-time high."
In this double-blind, placebo-controlled, randomized study of 452 men,
patients taking 20 mg and 10 mg doses of vardenafil reported statistically
significant improvements in erectile function, intercourse satisfaction,
orgasmic function, and overall sexual satisfaction over patients taking
placebo (P<0.0001). In addition, these positive results were noted early and
sustained throughout the 12-week study.
Approximately 7.5 million American males -- more than eight percent of all
men in the United States -- have diabetes. Men with diabetes are three times
more likely to have ED(1) than other men because of complications related to
their condition. Prevalence of ED in men with diabetes over the age of 50 is
reported to be as high as 50 to 60 percent.(2)
Study Design and Findings
The study participants were ages 18 and older with type 1 or type 2 diabetes
mellitus and had experienced mild-to-severe ED for six months or longer. The
patients were randomized into three groups and received a 20 mg or 10 mg
oral tablet of vardenafil, or placebo to be taken on demand.
Participants were asked to track their attempts at intercourse in a patient
diary. After a four-week baseline period and again at the end of 12 weeks,
the patients were asked if treatment had improved their erections over the
previous four weeks.
In addition to the diary, study participants were evaluated using the
erectile function domain of the International Index of Erectile Function (IIEF)(3).
The IIEF is a 15-question sexual function questionnaire used by urologists.
Questions measure domains of sexual function including erectile function,
intercourse satisfaction, orgasm function, sexual desire, and overall
satisfaction. Scoring is based on a five-point scale, with one being the
most severe. In the erectile function domain, scores 18-25 are classified as
mild ED, 11-17 as moderate ED, and less than 11 are classified as severe ED.
Positive Results in Improving Erectile Function
Baseline International Index of Erectile Function (IIEF) scores were similar
across all treatment groups and included scores 12.4 for the 20 mg group,
11.6 for the 10 mg group, and 11.2 for the placebo group, indicating a study
patient population categorized as having moderate to severe ED.
Dr. Goldstein initially presented data which was reported at last summer's
ADA meeting, demonstrating that vardenafil 20 and 10 mg significantly
improved International Index of Erectile Function (IIEF) scores relative to
placebo. Here, Dr. Goldstein showed novel data in which patients were asked
to respond to a diary question relating their ability to achieve successful
partner penetration and completion of intercourse.
In the patient population studied, which exhibited a wide spectrum of
severity of disease, patients having severe ED had a greater improvement in
the percentage of patients achieving successful intercourse (approximately
10- 18 fold) than patients with mild disease (approximately 2-fold).
Positive Result in Improving Intercourse Satisfaction and Orgasmic Function
Positive findings also were found in other IIEF domains in this study.
Patients in both vardenafil treatment groups reported statistically
significant improvements compared to the placebo group in the intercourse
satisfaction, orgasmic function and overall satisfaction domains.
Side effects associated with this phase III trial were mild to moderate,
transient in nature, and decreased in severity over time. The most common
side effects were headache, upset stomach, vasodilation, and sinusitis.
ED is a largely untreated medical condition
Erectile dysfunction -- the inability to sustain an erection sufficient for
sexual intercourse -- is a major medical condition among men that is largely
untreated. Although ED affects an estimated 30 million men in the United
States(4), research shows only 11 percent of men are being treated for the
There are a number of causes for ED, including medical conditions, such as
diabetes and cardiovascular disease, as well as psychological factors.