Important Safety Information for Vardenafil 20 mg

Two patients (one in each treatment group) had an AE that led to discontinuation. The patient who discontinued from the placebo group reported headache, fatigue, pain and pyrexia but had not taken the study drug before these AEs occurred.

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All patients provided signed written, informed consent. The study was conducted in accordance with regulatory standards of Good Clinical Practice and the Declaration of Helsinki (1996). Of the 483 patients screened, 383 were randomized to treatment with vardenafil (n=194) or placebo (n=189). 1 shows the disposition of patients at study entry. A higher proportion of patients in the placebo group discontinued from the study, compared with the vardenafil group (16% vs 9%), primarily because of insufficient efficacy and withdrawal of consent.

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Baseline patient characteristics were similar between treatment groups (Table 1). Most patients (75%) were Caucasian and diagnosed with moderate or severe ED (66%). Total exposure to study drug was greater in the vardenafil group, compared vardenafil hcl 10mg with the placebo group. The mean (SD) number of doses in the placebo group was 22.5 (14.91) taken over 59.5 (16.2) days; 28.3 (14.81) doses in the vardenafil group were taken over 63.6 (13.2) days. At week 2, 94% of patients receiving placebo and 75% receiving vardenafil had their initial dose of study medication increased from 10 to 20mg. The patient who discontinued from vardenafil 10mg experienced hypotension, which was considered severe and treatment related, and resolved on discontinuation of treatment.

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There were no clinically relevant findings in laboratory evaluations, vital signs or ECG assessments in either treatment group.

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Information from previous patient diary studies indicated that patients often deviated from specific instructions, and the ±2-hour window thus represents a realistic expectation of patients’ behaviour. The main focus of the SEP data was during weeks 2–10, which represented the period of treatment once patients had the opportunity to titrate their dose if necessary. Success (defined as a positive answer to SEP) rates were calculated first at the per-patient level and then averaged across each treatment group. A ≥18% difference in SEP3 was defined as clinically meaningful, in line with accepted practice and values used in previous studies [23,24]. This magnitude of contrast represented a difference in treatment response that provided patients with an appreciable relative improvement in ED symptoms.

3.4 Safety

Last observation carried forward (LOCF) was used to account for missing SEP data and was compared with the use of analysis of covariance (ANCOVA) with adjustment for centre and baseline response. IIEF-EF domain score, GAQ, GCQ and EQS were assessed at weeks 6 and 10 or on premature discontinuation (as observed and LOCF for week 10 only). IIEF-EF was compared with the use of ANCOVA with adjustment for centre and baseline IIEF-EF domain score. A 5-point increase on the EF domain was considered a clinically meaningful response [25]. GAQ was analyzed with the use of logistic regression on the basis of responses from week 10 using LOCF data. This study provides the first prospectively generated evidence for the extended duration of action of flexibly dosed vardenafil in men with ED when taken 8hours before intercourse and supports previous findings from retrospective studies.

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Adverse-event (AE) and safety monitoring including clinical laboratory tests, vital signs, sexual tablets for women 12-lead electrocardiograms (ECGs) and physical examinations were undertaken throughout the study. AEs that had been identified in the study protocol as being of particular clinical interest in patients with ED were defined a priori to include angina pectoris, myocardial infarction, stroke, atrial tachycardia, ventricular arrhythmia, syncope, hypotension and visual AEs. The safety population included all patients receiving one or more doses of study drug and who had any postrandomization safety data. The intent-to-treat population included patients within the safety population who had baseline and any postbaseline efficacy data. With a projected screening failure rate of 20% and a postrandomization dropout rate of 25%, 478 patients needed to be screened and 382 randomized to obtain 286 completers.

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In total, 143 patients per study arm were required to detect a statistically meaningful treatment difference in SEP3 of 18.0 (standard deviation [SD]=40.0) in a mean proportion of successes at 10 weeks with an alpha level of 0.0125 and 90% power. A Bonferroni approach was used to control the overall type I error rate associated with testing multiple hypotheses: SEP3 (primary), SEP2, IIEF-EF domain and GAQ. Demonstration of superiority depended on achieving both a clinically meaningful difference and statistical significance between treatments. Each of the primary comparisons of interest was assessed on its own clinical and statistical merits. Ethics committees or institutional review boards approved the study protocol and subsequent protocol amendment. Vardenafil-treated patients achieved statistically significant improvements in all primary (SEP3) and secondary efficacy end points (SEP2, GAQ, IIEF-EF domain score, GCQ and EQS), compared with placebo.

• Effectiveness can vary based on individual physiology and ED severity.
• Available in some markets as orally disintegrating tablets (ODT).
• The 20 mg tablet is often scored, allowing for splitting if prescribed.
• A patient assistance program may exist for the brand-name medication.
• Regular follow-ups with a doctor are recommended to assess ongoing use.
• It is one of several effective second-line oral treatments for ED.

In this study, patients were instructed to initiate sexual intercourse 8hours after taking vardenafil or placebo.

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In response to the GAQ, a higher proportion of patients on vardenafil compared with placebo stated at week 10 (LOCF) that treatment over the previous 4 weeks had improved their erections (77% vs 27%; p<0.001) (Fig. Superiority of vardenafil over placebo was evident by week 6 (weeks 2–6, 75% vs 28%; p<0.001) and was maintained over the 10-week treatment phase. Vardenafil-treated patients achieved a greater improvement in self-confidence (based on GCQ scores) by week 6 (weeks 2–6, 3.50 vs 2.54; p<0.001) that was sustained until week 10 (Table 3). Moreover, EQS total scores demonstrated superior erection quality with vardenafil, compared with placebo by week 6 (weeks 2–6, 35.40 vs 19.57; p<0.001), which was sustained until week 10 (Table 3). Fewer than half of the patients in each treatment group had any treatment-emergent AEs during the study (placebo, 22%; vardenafil, 39%). This time frame was selected to better quantify the effectiveness of vardenafil at extended time intervals postadministration.

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At week 6, most patients in each treatment group remained on the same dose as the previous 4 weeks (placebo, 96%; vardenafil, 89%). Patients treated with vardenafil achieved a clinically meaningful (≥18%) and statistically significant greater least-squares (LS) mean per-patient SEP3 success rate over weeks 2–10 compared with patients receiving placebo: 69% vs 34%; p<0.001 (Fig. SEP3 success rate was maintained across the 6–10-hour postdose time interval over weeks 2–10 (Fig. Further data analysis (including the initial 2-week titration phase) showed that the superiority of vardenafil over placebo was evident from the week 2 assessment (weeks 0–2: 52% vs 27%; p<0.001) and was maintained over the entire treatment phase (Table 2). Patients treated with vardenafil achieved a clinically meaningful (≥18%) and statistically significant greater LS mean per-patient SEP2 success rate over weeks 2–10 compared with patients receiving placebo: 81% vs 51%; p<0.001 (Fig.

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SEP2 success rate was maintained across the 6–10-hour postdose time interval (Fig. Further data analysis (including the initial 2-week titration phase) showed that the superiority of vardenafil over placebo was evident from week 2 (weeks 0–2, 74% vs 48%; p<0.001) and was maintained over the 10-week treatment phase (Table 2). At week 10 (LOCF), vardenafil-treated patients achieved clinically meaningful (≥5 points) and statistically significant greater LS mean IIEF-EF domain scores compared with placebo-treated patients (22.8 vs 14.9; p<0.001) (Fig. Superiority of vardenafil over placebo was evident at the weeks 2–6 assessment (p<0.001) and was maintained over the 10-week treatment phase. A significantly higher proportion of patients in the vardenafil group returned to normal erectile function (defined as IIEF-EF ≥26), compared with placebo (50% vs 11%; p<0.001; LOCF). Previous studies have examined the efficacy rates of vardenafil at extended time intervals in which to achieve successful sexual intercourse. For example, a retrospective analysis of two randomized, double-blind, fixed-dose studies of vardenafil (5, 10 or 20mg/d) in men with ED demonstrated that vardenafil was statistically superior to placebo irrespective of when couples choose to initiate sexual activity after dosing, from ≤15minutes up to 8–12hours postdose [20].

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Most treatment-emergent AEs were of mild or moderate intensity: Only eight patients in the vardenafil group (4%) and none in the placebo group experienced serious AEs. These AEs included flushing, headache, hypoaesthesia, hypotension, muscle cramp (all were considered related to study medication and resolved); and arthralgia, back pain, diarrhoea, intervertebral disc protrusion and lethargy (none was related to study medication). The incidence of drug-related, treatment-emergent AEs was 26% in the vardenafil group best ed treatments and 5% in the placebo group (Table 4). This finding was primarily due to the higher incidence among vardenafil-treated patients of drug-related headache, flushing and nasal congestion, commonly reported AEs with PDE5 inhibitors. No deaths or nonfatal serious AEs occurred during the study. Furthermore, a 12-week, open-label study of fixed-dose vardenafil (10mg) in men with ED for >6 months found that SEP3 success rates improved from within 30minutes of taking vardenafil up to 12hours postmedication [26]. In a recent open-label study, vardenafil was effective (SEP3 success rate, 77%) when taken 15minutes to 4hours before intercourse [27].

• Vardenafil is sometimes used off-label for pulmonary arterial hypertension.
• Use caution when combining with other vasodilators or certain antidepressants.
• The drug is often prescribed after diagnosis of erectile dysfunction by a clinician.
• It’s essential to follow the prescribed course and not self-medicate.

The findings of the current study add to our knowledge of the extended time frame in which vardenafil would prove to be efficacious. Previously shown to have a rapid onset of action as early as 10minutes postdose [21], our prospective, controlled trial showed that the efficacy of vardenafil extends up to at least 8hours postdose, which allows couples the freedom to engage in sexual activities within this extended time frame.

Property	Description	Value
Molecular Formula	-	C23H32N6O4
Molecular Weight	-	488.54 g/mol
Solubility	In water	Slightly soluble
pKa	-	4.8