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The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose. At t max , only the mean

change

in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11).

When using the individual correction formulae, none of the values were out of the limit.

In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect. Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone. The actual clinical impact of these QT changes is unknown.

In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.

Over 2,500 patients have been treated with vardenafil for six months or longer. Of these, 900 patients have been treated for one year or longer. The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidemia (22%), depression (5%), radical prostatectomy (9%). The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3). No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed.

Across the pivotal trials, treatment with vardenafil ( tablets) resulted in an improvement of erectile function compared to placebo. In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for

penetration

and maintenance of erection was consistently greater than placebo.

In fixed dose studies ( tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period. The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on

placebo

. In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%). In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.

The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.

In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.

In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo.

The number of patients who returned to a normal IIEF domain score ( >26) were 53% on vardenafil compared to 9% on placebo. The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p th Floor, 40 Bank Street, Canary Wharf.

1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day. Orally disintegrating tablet (ODT): 10 mg PO placed on tongue.

1 hour before sexual activity; not to exceed 1 dose/day. 10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed. Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day Ritonavir (600 mg q12hr): Vardenafil dosage not to exceed 2.5 mg/72 hr. Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day.

Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO initially. Mild, moderate, severe impairment: Dosage adjustment not necessary Hemodialysis: Not recommended. Child-Pugh class A: Dosage

adjustment

not necessary Child-Pugh class B: Film-coated tablet, 5 mg PO.

1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended Child-Pugh class C: Not recommended.

Pulmonary Arterial Hypertension (Orphan) Orphan designation for treatment of pulmonary arterial hypertension. Respira Therapeutics, Inc; 5901 Indian School Road NE, suite 107; Albuquerque, New Mexico 87110. AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men Enter a drug name and vardenafil. Flulike syndrome (3%) Increased creatine phosphokinase (2%) Formulary Patient Discounts. Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans.

Your list will be saved and can be edited at any time.

Adding plans allows you to: View the formulary and any restrictions for each plan. Manage and view all your plans together – even plans in different states.

Compare formulary status to other drugs in the same class.

Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only.

Individual plans may vary and formulary information changes.

Contact the applicable plan provider for the most current information.

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. Young , MD 2, Jerome Fischer , MD 3, Keith Bangerter , PHD 4, Thomas Segerson , MD 4, Terry Taylor , MD 4 and The Vardenafil Diabetes Study Group 1 Boston University Medical Center, Boston, Massachusetts 2 South Coast Urological Medical Center, Laguna Hills, California 3 Diabetes and Glandular Disorders Clinic, San Antonio, Texas 4 Bayer Corporation, West Haven, Connecticut. 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 50% of diabetic

men

develop ED within 10 years of being diagnosed with diabetes (5). The prevalence of ED increases with age, from 9% in diabetic men ages 20–29 years to 95% in diabetic men >70 years (5), and increases with duration, poor control, and complications of diabetes (such as vascular and microvascular disease and neuropathies) (6). Diabetic men with ED tend to be less responsive to treatment perhaps because the pathogenesis of diabetes-associated ED is likely to be multifactorial (7,8).

Although treatment with phosphodiesterase type 5 (PDE5) inhibitors is less effective in the diabetic patient than in the nondiabetic ED patient, the convenience of an orally formulated PDE5 inhibitor has popularized treatment in a large number of men with diabetes and ED (9,10). Vardenafil, a new PDE5 inhibitor, is more selective for PDE5 and more biochemically potent than sildenafil in in vitro and in vivo studies when tested under the same conditions (11–13). These properties suggest that vardenafil may be a highly efficacious oral treatment in the difficult-to-treat ED patients with diabetes. The objective of this study was to assess the efficacy, tolerability, and safety of vardenafil in the treatment of ED in men with diabetes.

The study was a randomized double-blind fixed-dose parallel-group trial conducted at 47 centers in the U.S.

Baseline characteristics were assessed after a 4-week unmedicated phase during which time patients had to have attempted intercourse lybrido online order on at least 4 separate days and had to have been unsuccessful in at least half of these attempts. Lack of success was defined as failure to penetrate their partner or to maintain an erection to successful intercourse.

Patients

were

then randomized to 10 or 20 mg vardenafil or placebo treatment arms for 12 weeks. Patients were instructed to take the study drug as needed,

but

no more than once a day and ?1 h before intercourse. No specific instructions were given with regard to food or flibanserin online order alcohol use.

Efficacy and safety data were collected at 4-week intervals.

After the active treatment phase, patients had the option of participating in a 12-week extension phase in which all patients received either 10 or 20 mg vardenafil. Safety and efficacy from the extension phase will be reported elsewhere.

Vardenafil hydrochloride (vardenafil) was supplied by Bayer AG.

Men over age 18 years who were in a stable heterosexual relationship, who had a clinical diagnosis of type 1 or type 2 diabetes, and who had experienced ED for longer than 6 months were included. Patients were excluded if their ED was the result of radical prostatectomy, primary hypoactive sexual desire, or spinal cord injury. Patients with previous myocardial infarction, stroke, ischemia by electrocardiography, or life-threatening arrhythmia were allowed to participate if these events had not occurred in the 6 months before the trial. Specific exclusion criteria at screening included uncontrolled atrial tachyarrhythmia, unstable angina pectoris, severe chronic liver disease, clinically significant chronic hematological disease or bleeding disorder, resting hypotension or hypertension, symptomatic postural hypotension within 6 months before screening, retinitis pigmentosa, proliferative diabetic retinopathy that progressed within 6 months before screening, autonomic (but not peripheral sensory) neuropathy associated with clinically significant gastroparesis, hypo- or hyperthyroidism, and recent severe uncontrolled migraine headaches.

According to the protocol, previous exposure to sildenafil was allowable.

However, if patients had discontinued sildenafil because of significant side effects or because of dissatisfaction with its efficacy, they were excluded.

Anti-androgens, anti-coagulant androgens,

and

trazodone hydrochloride were not allowed. The primary measures of efficacy were the erectile function (EF) domain of the validated International Index of Erectile Function (IIEF) questionnaire (14) and two diary questions concerning sexual encounter: “Were you able to insert your penis in your partner’s vagina?” and “Did your erection last long enough for you to have successful intercourse?” The secondary efficacy variable reported here is the global assessment question (GAQ), “Has the treatment you have been taking over the past 4 weeks improved your erections?” Safety. The safety population included all patients who took at least one dose of study medication and who had any

postrandomization

safety data collected.

Blood chemistries, vital signs, and 12-lead electrocardiograms (ECGs) were evaluated at 0, 4, and 12 weeks of treatment. In ?61–75 men in each group, the vital signs and ECGs were obtained within 11 min and 5 h after taking the drug when pharmacologically active plasma concentrations of vardenafil would be expected.

Treatment-emergent adverse events were recorded at 4-week intervals.

Events were determined by each blinded investigator to be probably, possibly, unlikely, or not related to the study drug.

Patients who did not enter the extension study were followed for 7 days after the last dose to record any

serious

adverse events and for 30 days after the last dose to record any deaths.

The intent-to-treat population, defined as individuals who took at least one dose of study medication and who had baseline and any post-baseline efficacy data, was used to calculate all the efficacy variables. For EF domain scores, the last observation carried forward (LOCF) approach was used to account for missing values.

For both diary questions, the mean success rate of each individual patient over the entire treatment period was averaged across all patients and is reported as the mean success rate for each man. For the GAQ, values were obtained from lybrido online order patients who completed 12 weeks of treatment; an LOCF value was also calculated.

The primary efficacy variables were analyzed with ANCOVA, with baseline response as a covariate and with terms for center and treatment. The GAQ was analyzed using logistic regression with terms for center and treatment.



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