At the European Association of Urology (EAU) congress in Stockholm, Sweden, Bayer Schering Pharma presented new data that might change the image of therapy for erectile difficulties. Two independent placebo-controlled clinical studies demonstrated that Levitra® (vardenafil HCI) results in a significantly prolonged erection(1,2) which is a prerequisite for an increase in the duration of intercourse. Placebo-treated men with ED had an average duration of erection of only 4 minutes.
Levitra was able to prolong this to a 2 - 3-fold extent, even in men with underlying medical conditions.(2) With a prolonged duration of erection Levitra may have a substantial beneficial impact on a couples chance to reach satisfactory successful intercourse.
"Duration of erection can be considered an innovative and meaningful efficacy parameter indicating patient's satisfaction with treatment of ED," said Dr. Matt Rosenberg, Medical Director at Mid-Michigan Health Centers, USA and principal investigator of the ENDURANCE study. "Sharing sexual
satisfaction with his partner is an important element of a man's sexual experience."
To date, Levitra is the only PDE5 inhibitor showing in two independent placebo-controlled studies to significantly prolong the duration of erection in men with ED.
The ENDURANCE study was a randomized, double-blind, placebo-controlled, crossover study to evaluate the duration of erection in 201 men with ED and underlying medical conditions (dyslipidemia 24 percent, hypertension 32 percent, diabetes 7 percent). Patients received fixed-dose Levitra 10 mg or
placebo over two 4-week treatment periods, separated by a one-week wash-out phase. This is the first study evaluating the stopwatch-assessed duration of erection as the primary efficacy endpoint. Duration of erection, timed with a stopwatch, is clinically defined as the time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina leading to successful intercourse as measured by sexual encounter profile question (SEP3) (stop stopwatch).(2) Studies have revealed that the average duration of intercourse in healthy men is between 9.2 and 10.0 minutes and decreases significantly with age.(3,4)
"Contrary to public presumption about the need for hours of sexual activity, a recent survey of U.S. and Canadian sex therapists revealed that satisfactory sexual intercourse for couples lasts from 7 to 13 minutes,"(5) said Dr. Rosenberg.
The second study confirming the findings on duration of erection in men with ED and underlying medical conditions was lead by Dr. Martin Miner, clinical associate professor of family medicine at Brown University, Swansea, Massachusetts, USA. The Dyslipidemia study investigated the efficacy and safety of Levitra in 395 ED patients with dyslipidemia and other underlying medical conditions (hypertension 61 percent, obesity 51 percent, diabetes 40 percent). Men were randomized in a double-blind, placebo-controlled study and received either on-demand, flexible-dose Levitra 10 mg (5-20 mg based on efficacy and safety) or placebo for 12 weeks. The stopwatch-assessed duration of erection leading to completion of successful intercourse was evaluated as a secondary efficacy endpoint.(1)
In both studies, Levitra was well tolerated and demonstrated significant improvement in sexual function in the majority of patients as reported by increased SEP2 and SEP3 success rates. Levitra provided a 2 - 3-fold increase in the overall duration of erection compared to placebo
(Dyslipidemia study 10 vs. 3.38 minutes; ENDURANCE study 12.81 vs. 5.45 minutes; pd0.001 for both studies).(1,2)
As the world's population continues to age and live longer, the prevalence of erectile dysfunction (ED) in men over the age of 40 will increase.(6)
Treatment outcomes for ED are enhanced if the objectives of treatment are oriented towards the restoration of a satisfying sexual relationship rather than enhancing rigidity per se.(7) Notably, when considering a treatment for ED, 93 percent of men deem the length of time being able to maintain an erection as an essential feature.(8) Enhancing the duration of erection is an important prerequisite for prolonging the duration of sexual intercourse to a satisfactory level.
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1. Miner M et al. Vardenafil in men with stable statin therapy and dyslipidemia. J Sex Med. 2008; 5(6):1455-67
2. Rosenberg MT et al. Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study. Int J Clin Pract 2009; 63: 1
3. Patrick D et al. Premature ejaculation: an observational study of men and their partners. J Sex Med. 2005; 2(3):358-67
4. Giuliano F et al. Premature ejaculation: results from a five-country European observational study. Eur Urol. 2008; 53(5):1048-57
5. Corty EW and Guardiani JM. Canadian and American sex therapists' perceptions of normal and abnormal ejaculatory latencies: how long should intercourse last? J Sex Med. 2008; 5:1251-1256
6. Johannes CB et al. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000; 163:460.
7. Hackett GI. What do patients expect from erectile dysfunction therapy? Eur Urol suppl. 2002; 1:4-11
8. Taylor H and Leitman R. Men with erectile dysfunction (ED) want improved relations with their partners Harris Interactive online survey 2001; 1;14