@article {VALIQUETTE:November 2006:1368-5031:1378,
	author = "VALIQUETTE, L.",
	author = "MONTORSI, F.",
	author = "AUERBACH, S.",
	title = "First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities: RELY-I",
	journal = "International Journal of Clinical Practice",
	volume = "60",
	year = "November 2006",
	abstract = "Summary <P></P>First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10&#8201;mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability - Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10&#8201;mg or placebo for 12&#8201;weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10&#8201;mg dose of vardenafil, 32&#37; had hypertension, 16&#37; had diabetes and 19&#37; had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87&#37; and 74&#37; respectively. First-dose SEP-2 and SEP-3 success rates were 84&#37; and 66&#37; in men with hypertension (<I>n</I>&#8201;=&#8201;191); 84&#37; and 72&#37; in men with dyslipidaemia (<I>n</I>&#8201;=&#8201;116); and 75&#37; and 58&#37; in men with diabetes (<I>n</I>&#8201;=&#8201;95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5&#37;), were mild to moderate in intensity. Vardenafil 10&#8201;mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.",
	pages = "1378-1385(8)",
	url = "http://www.ingentaconnect.com/content/bsc/ijcp/2006/00000060/00000011/art00010"
	doi = "doi:10.1111/j.1742-1241.2006.01170.x"
}