Biomedical subjects

Martin Homering

Publications and source records attributed to Martin Homering.

5 recordsLinked to original sources

PubMed2005

Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age.

OBJECTIVES: To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups. PATIENTS AND METHODS: In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) "Has the treatment you have been taking over the past 4 weeks improved your erections?'. The 1385 men were grouped by age (< 45, 45-64 and > or =65 years). RESULTS: At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged > or = 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45-64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in approximately 71%, 76% and 85% of men aged <45, 45-64 and > or = 65 years (P < or = 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age. CONCLUSION: Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.

Adult↗

PubMed2005

Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis.

OBJECTIVE: To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials. METHODS: In two randomized, double-blind studies, men with ED for > 6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment. RESULTS: Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from < or = 15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from < or = 15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%). CONCLUSION: In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).

Coitus↗

PubMed2004

Vardenafil provides reliable efficacy over time in men with erectile dysfunction.

OBJECTIVES: To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED). METHODS: In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group. RESULTS: At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis. CONCLUSIONS: Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.

Clinical Trials, Phase III as Topic↗

PubMed2004

Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification.

BACKGROUND: Vardenafil (Levitra) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. METHODS: Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). RESULTS: Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. CONCLUSIONS: Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMedDate not supplied

Vardenafil in patients with erectile dysfunction: achieving treatment optimization.

This post hoc analysis of data from a multicenter, randomized, double-blind study determined how many attempts were needed to record at least 1 successful penetration and maintenance of erection long enough for successful intercourse in a broad population of men with erectile dysfunction taking vardenafil at 5, 10, or 20 mg or placebo. The cumulative probability of achieving successful penetration and of maintaining an erection increased with the number of attempts for all 3 vardenafil groups. For the first attempt, the probability of achieving successful penetration was higher in all 3 vardenafil groups compared with placebo; 67% in the 5-mg vardenafil group, 77% in the 10-mg vardenafil group, and 74% in the 20-mg vardenafil group compared with 46% for placebo. By the third attempt, the probability of at least 1 success was 82% for 5, 88% for 10, and 85% for 20 mg vardenafil compared with 68% for placebo. The probability of maintaining an erection long enough to complete intercourse at the first attempt was 51% for 5, 69% for 10, and 61% for 20 mg vardenafil compared with 28% for the placebo group. By the third attempt, the probability of maintaining an erection was 66% for 5, 81% for 10, and 77% for 20 mg vardenafil in contrast to 53% for placebo. The results of this analysis indicate that patients without initial treatment success should continue treatment or increase the dose because the cumulative probability of success increases with additional attempts with vardenafil, with a plateau at about the fourth dose.

Adult↗