By Chris Berrie
BRUSSELS, Belgium -- December 12, 2008 -- The phosphodiesterase 5 (PDE5) inhibitor vardenafil is well tolerated and significantly improves erectile function and duration of erection over placebo in men with erectile dysfunction (ED) and dyslipidaemia who are on stable statin therapy, according to a 12-week, randomised, double-blind, placebo-controlled study.
Principal investigator Martin Miner, MD, Men's Health Clinic, Miriam Hospital, Brown University School of Medicine, Providence, Rhode Island, presented the findings here on December 10 at the Joint Congress of the European and International Societies for Sexual Medicine (ESSM-ISSM).
ED is associated with the cardiovascular and metabolic conditions of hypertension, dyslipidaemia, and diabetes. Indeed, as Dr. Miner said, with dyslipidaemia representing an independent risk factor for ED, "there are several studies in the literature that reveal that the treatment of dyslipidaemia with statins has a variable effect on male sexual dysfunction."
However, there have been no studies of men with ED and dyslipidaemia in the context of PDE5 inhibition, so the aim was to evaluate the efficacy and safety of vardenafil in this patient population under stable statin treatment.
The study enrolled men aged 18 to 64 years with ED for more than 6 months and with dyslipidaemia controlled with stable statin treatment for 3 months or more. They also had an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score of 25 or greater.
In the intention-to-treat population of eligible patients, 194 men were randomised to placebo and 192 to on-demand, flexible-dose vardenafil starting at 10 mg, titrated to 5 or 20 mg if necessary. Mean ages in the 2 groups were 54.1 and 54.6 years, respectively.
Patients in the placebo and active treatment groups had hypertension (63% and 58%), diabetes (39% and 42%), and body mass index >30 kg/m2 (52% and 51%).
At baseline, there were no significant differences across placebo and vardenafil treatment groups for the primary endpoints of mean baseline IIEF-EF scores (12.4 vs 12.0), and rates of sexual intercourse success rates as determined by Sexual Encounters Profile (SEP) 2 (47.2% vs 45.8%) and SEP3 (15.9% vs 17.9%).
Baseline stopwatch-assessed durations of erection -- as measured from the time erection was perceived to allow for penetration until withdrawal from the partner's vagina after successful intercourse -- were 0.5 and 0.6 minutes in the 2 groups, respectively.
After 12 weeks of treatment, mean IIEF-EF scores were significantly higher for vardenafil over placebo (22.0 vs 14.8; P < .001), and Dr. Miner noted similar improvements for patients with dyslipidaemia plus concomitant hypertension (21.0 vs 14.6) or diabetes (19.0 vs 14.9).
Significant improvements (P < .001) were also seen for SEP2 (79.1% vs 51.9%) and SEP3 (66.7% vs 33.8%), and for duration of erections (10.0 vs 3.4 min; P < .001). These benefits were maintained across the subgroup analyses for concomitant hypertension and diabetes.
Dr. Miner stressed that although their new erection duration measure is relatively subjective in nature, there was a significant 10-fold increase from baseline with vardenafil, representing a significant 3-fold increase over placebo.
Funding for this study was provided by GlaxoSmithKline and Schering-Plough.
[Presentation title: Improvement of Erectile Function and Duration of Erection With Vardenafil in Men With Erectile Dysfunction and Dyslipidaemia on Stable Statin Therapy. Abstract MP-092]
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