Biomedical subjects

Jay M Young

Publications and source records attributed to Jay M Young.

4 recordsLinked to original sources

PubMed2003

Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups.

OBJECTIVES: To assess whether vardenafil would improve erectile function irrespective of etiology, baseline severity, or patient age. The consistency of the response over time was also evaluated. METHODS: A multicenter, randomized, double-blind, placebo-controlled at-home study of vardenafil treatment (5, 10, and 20 mg) was performed. This secondary analysis compared the mean International Index of Erectile Function (IIEF) erectile function domain scores of various subgroups at 12 weeks of treatment. These populations included organic, psychogenic, or mixed etiologies; mild, moderate, or severe baseline severity; and four age groups (younger than 45, 45 to 55, 56 to 65, and older than 65 years). In addition, all IIEF domains were compared at sequential 4-week periods, before and during treatment. RESULTS: In the 580 men of the intent-to-treat population, the mean erectile function domain scores were statistically greater than placebo, irrespective of etiology, baseline severity, or age. This was seen at all dosages. Compared with placebo, vardenafil statistically improved the IIEF domain scores of erectile function, orgasmic function, intercourse satisfaction, and overall satisfaction after 4 weeks of treatment, and these improvements were maintained for 12 weeks. The rates of the most common adverse events (headache, flushing, and dyspepsia) were either constant or declined over time; they were generally mild to moderate and transient in nature. CONCLUSIONS: Vardenafil improved erectile function regardless of the general etiology, baseline severity of erectile dysfunction, or patient age. Improvements in erectile function and other key IIEF domains were consistently seen throughout the study.

Aged↗

PubMed2003

Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study.

OBJECTIVE: This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes. RESEARCH DESIGN AND METHODS: In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks. Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ) about erection improvement during the previous 4 weeks. RESULTS: After 12 weeks of treatment, a dose-dependent (P = 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo (P < 0.0001). For the erectile function domain, dose-dependent (P = 0.03) final scores for the 10- and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo (P < 0.0001). Both vardenafil doses significantly enhanced the rates of successful penetration (P < 0.0001) and successful intercourse (P < 0.0001) compared with placebo. Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity, at each level of plasma HbA(1c), and for type 1 and 2 diabetes. Treatment-emergent adverse events were primarily mild to moderate headache (<or=13%), flushing (<or=10%), and rhinitis (<or=10%). CONCLUSIONS: Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED.

Administration, Oral↗

PubMed2002

Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men.

The objective of this study was to assess the efficacy and safety of sildenafil citrate (Viagra) in black American and Hispanic American men with erectile dysfunction (ED) of broad-spectrum etiology. A total of 246 black American and 197 Hispanic American men were randomized to sildenafil (50 mg, adjustable to 25 mg or 100 mg, depending on efficacy and tolerability; n = 124 and n = 99, respectively) or matching placebo (n = 122 and n = 98, respectively). After 6 weeks, patients were given the option of switching to the other blinded treatment for the following 6 weeks. The 12 weeks of double-blind treatment were followed by 12 weeks of open-label extension. Despite differences in prevalence of hypertension, diabetes mellitus, hyperlipidemia, and use of concomitant antihypertensive agents between the 2 study groups, sildenafil was efficacious and well tolerated. After 6 weeks, scores for questions 3 and 4 from the International Index of Erectile Function (IIEF) were significantly higher among sildenafil-treated black and Hispanic patients than in placebo-treated patients. In addition, compared with placebo, a significantly larger proportion of sildenafil patients reported improved erections and improved ability to have sexual intercourse. When efficacy results were stratified by ED severity or number of risk factors, scores for IIEF questions 3 and 4 were lower in men with severe ED versus mild-to-moderate ED. Similarly, the percentage of patients reporting improved erections decreased with ED severity and number of risk factors. The proportion of patients switching to the other treatment after 6 weeks was significantly higher in the placebo group (71% to 85%) than in the sildenafil group (27% to 28%). The most common adverse events included headache and vasodilation, which were mild to moderate in nature and were comparable between groups. These data demonstrate that despite differences in prevalence rates of comorbidities, efficacy and safety of sildenafil is maintained across different ethnic groups.

Adult↗

PubMed2002

Vardenafil.

Vardenafil hydrochloride is a potent and highly selective inhibitor of phosphodiesterase Type 5 that increases blood flow to the penis during sexual stimulation and helps restore the ability to achieve and sustain an erection in men with erectile dysfunction. Vardenafil was developed specifically to be an effective and safe oral medication for the treatment of erectile dysfunction, with potential advances over existing therapies. This review summarises key findings during the rapid and aggressive development of this compound, from in vitro assays to Phase III trials with both broad and special populations. Emphasis is placed on the presentation of data that demonstrates the clinical effectiveness and safety of this agent which is anticipated to be available in 2003.

3',5'-Cyclic-GMP Phosphodiesterases↗