What is the use of vardenafil (Levitra)?

From the Guidelines

Vardenafil is a recommended treatment option for erectile dysfunction (ED) in men, with a strong recommendation for its use based on high-quality evidence 1.

Key Points to Consider

• Vardenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which also includes sildenafil and tadalafil.
• The medication is typically taken orally 30-60 minutes before sexual activity, with doses ranging from 5-20mg depending on individual response and tolerability.
• The dose of vardenafil should be titrated to provide optimal efficacy, with a strong recommendation for dose titration based on Grade B evidence 1.
• Vardenafil should not be used by individuals taking nitrate medications for chest pain or alpha-blockers for prostate problems, as this combination can cause a dangerous drop in blood pressure.
• Common side effects include headache, flushing, nasal congestion, and indigestion, with most adverse events following a dose-response pattern 1.

Important Considerations

• Patients should seek immediate medical attention if experiencing an erection lasting longer than 4 hours, sudden vision or hearing loss, or chest pain.
• The medication is most effective when taken on an empty stomach, as high-fat meals may delay its absorption and effectiveness.
• The choice of a specific PDE5 inhibitor, including vardenafil, should be based on individual preferences, ease of use, cost of medication, and adverse effects profile, with a weak recommendation based on low-quality evidence 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Vardenafil Overview

• Vardenafil is a phosphodiesterase type-5 (PDE-5) inhibitor developed as an oral therapy for erectile dysfunction (ED) 2, 3.
• It has been shown to improve erectile function in men with mild to severe ED of varying aetiology 3.
• Vardenafil is effective in men with ED associated with diabetes mellitus or ED following unilateral or bilateral nerve-sparing radical retropubic prostatectomy 3, 4.

Efficacy and Safety

• Vardenafil has a rapid onset of action, with completion of successful sexual intercourse possible for some patients 16 minutes after its administration 2.
• It has sustained long-term efficacy, providing up to 92% of patients with improved erections during more than 2 years of treatment 2.
• Vardenafil is well tolerated, with an adverse event profile typical of the class of PDE-5 inhibitors 2, 3.
• The most common adverse events include headache, flushing, rhinitis, and dyspepsia, which are mild or moderate and generally decrease with continued treatment 2, 3.

Clinical Evidence

• Vardenafil has demonstrated a favorable efficacy and safety profile in men with ED, including those with associated underlying conditions such as diabetes, hypertension, and dyslipidemia 4.
• The concomitant use of medication for these conditions is not associated with any noteworthy changes in the efficacy and safety of vardenafil 4.
• Vardenafil is considered a first-line treatment option in men with ED who are suitable candidates for oral PDE-5 inhibitor therapy 3, 4.

Pharmacology and Pharmacokinetics

• Vardenafil is a potent and selective inhibitor of the phosphodiesterase 5 (PDE5) enzyme 5.
• It has a rapid onset of action, is hepatically metabolized, and has a half-life of 4-6 hours 5.
• Vardenafil has a higher potency and PDE5 selectivity compared with sildenafil, which may confer a lower risk of vision-related adverse effects 5.