Levitra (Vardenafil Hydrochloride) - Summary

LEVITRA SUMMARY

LEVITRA^® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

LEVITRA is indicated for the treatment of erectile dysfunction.

See all Levitra indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Levitra (Vardenafil)

Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. [2011.10]
INTRODUCTION: The prevalence of erectile dysfunction (ED) is increased in men with metabolic syndrome compared with the general population. AIM: The aim of this study was to evaluate the efficacy and safety of vardenafil vs. placebo in men who had ED and metabolic syndrome... CONCLUSIONS: This is the first study to assess the efficacy and safety of vardenafil, taken alone, for ED therapy in a population of men who all had metabolic syndrome. Although baseline erectile function in these patients was low, vardenafil treatment was associated with significant improvements in erectile function and rates of successful intercourse, and was well tolerated. (c) 2011 International Society for Sexual Medicine.

The use of beat-to-beat electrocardiogram analysis to distinguish QT/QTc interval changes caused by moxifloxacin from those caused by vardenafil. [2011.09]
QT correction factors (QTc) can cause errors in the interpretation of drug effects on cardiac repolarization because they do not adequately differentiate changes when heart rate or autonomic state deviates from the baseline QT/RR interval relationship... This study demonstrated that newer methods of electrocardiogram (ECG) analysis can differentiate changes in the QT interval to improve identification of proarrhythmia risk.

Vardenafil in pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled study. [2011.06.15]
RATIONALE: Although the phosphodiesterase type 5 inhibitors sildenafil and tadalafil have demonstrated efficacy in patients with pulmonary arterial hypertension (PAH), monotherapy with these agents has not been conclusively shown to reduce clinical worsening events. OBJECTIVES: To evaluate the safety and efficacy of the phosphodiesterase type 5 inhibitor vardenafil in Chinese patients with PAH... CONCLUSIONS: Vardenafil is effective and well tolerated in patients with PAH at a dose of 5 mg twice daily.

[Small-dose vardenafil restores erectile function after penile surgery]. [2011.04]
OBJECTIVE: To investigate the impact of penile surgery on the erectile function of the patient and to evaluate the role of small-dose vardenafil in restoring the impaired penile erection... CONCLUSION: Long-term administration of small-dose vardenafil after penile surgery helps to restore and maintain penile erectile function.

Comparison of the first intake of vardenafil and tadalafil in patients with diabetic neuropathy and diabetic erectile dysfunction. [2011.03]
INTRODUCTION: Diabetic neuropathy (DN) is one of the key pathogenetic factors for diabetic erectile dysfunction (DED). AIM: The aim of this study was to compare the effect of the first intake of tadalafil and vardenafil in men with DN and DED... CONCLUSIONS: In this study design, tadalafil and vardenafil are equally effective with the first intake in patients with diabetes and DN. Baseline indicators of erectile dysfunction and the ones verifying the effect of the treatment show significant correlation with the DN indicator-NDS. Tadalafil and vardenafil are well tolerated with no serious side effects. (c) 2010 International Society for Sexual Medicine.

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Clinical Trials Related to Levitra (Vardenafil)

ELATED: Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction [Completed]
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.

The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED medication), the unmedicated period can be only 2 weeks.

Approximately 150 investigational centres may be utilised with approximately 10 subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should try to recruit approximately 50% of subjects who have not previously tried oral PDE5 inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects whose partners are interested in being involved.

Sites will be randomized in a 1: 1:1: 1 ratio to receive either the education intervention at the Primary care Physician (PCP) level, at the subject level, both levels or no intervention (usual care).

The PCP education program is an accredited CME program and included a comprehensive overview on the screening and diagnosis of ED, the available treatment options and appropriate treatment selection, as well as subject and partner counseling. The subject education was a two-pronged approach which included physician-to-subject instruction and a direct-to-subject education method.

After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This will be followed by a flexible dose titration period of 4 weeks during which subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage regimen is either maintained, increased or decreased by one step according to the three applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable dosage regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is required within 24 hours of the last dose of vardenafil to collect data concerning serious adverse events, if needed.

REALISE Levitra® - Real Life Safety and Efficacy of Levitra [Completed]
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction [Completed]
To find out more information on how treating impotence with vardenafil in comparison to placebo affects the quality of life (QoL) of men and their partners. Subjects will receive 10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their 'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected via questionnaires

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving ED [Active, not recruiting]

To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction [Completed]
A total of 173 subjects were randomized in 6 centers (vardenafil: 129 subjects; placebo: 44 subjects). All 173 randomized subjects were analyzed for safety. Of these, 162 subjects (94%) were included in the ITT sample (vardenafil: 123 subjects; placebo: 39 subjects) and 149 subjects (86%) were included in the PP sample (vardenafil: 115 subjects; placebo: 34 subjects). The PP sample was only used to analyze the primary efficacy variable (EF domain score).

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Reports of Suspected Levitra (Vardenafil) Side Effects

Drug Ineffective (123),  Erectile Dysfunction (76),  Headache (42),  Flushing (23),  NO Adverse Event (20),  Nasal Congestion (15),  Tinnitus (10),  Dizziness (10),  Nausea (10),  Vision Blurred (9), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Levitra review by 58 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		ED
Dosage & duration:		20mg taken as needed for the period of 1 year
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The stuff works like a charm--fast and effective.
Side effects:		None
Comments:		One pill 30 mins. before activity

Levitra review by 74 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Erectile dysfunction
Dosage & duration:		1/2 pill one hour prior taken 2x weekly for the period of Currently
Other conditions:		Diabetes 2, hypertension
Other drugs taken:		Gipizide, Cozaar,
		Reported Results
Benefits:		Had to take an extra 1/2 pill in addition to prescribed dose of 1/2 pill per event, usually night before in order to achieve satisfactory benefit of performance. Previously used another brand but was discontinued by HMO. Much depends on regular exercise & regular sleep activities to be effective.
Side effects:		None discerned.
Comments:		Take prescribed dosage about one-half to one hour prior to sexual activity.

Levitra review by 74 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Erectile dysfunction
Dosage & duration:		1/2 pill one hour prior taken 2x weekly for the period of Currently
Other conditions:		Diabetes 2, hypertension
Other drugs taken:		Gipizide, Cozaar,
		Reported Results
Benefits:		Had to take an extra 1/2 pill in addition to prescribed dose of 1/2 pill per event, usually night before in order to achieve satisfactory benefit of performance. Previously used another brand but was discontinued by HMO. Much depends on regular exercise & regular sleep activities to be effective.
Side effects:		None discerned.
Comments:		Take prescribed dosage about one-half to one hour prior to sexual activity.