Pulmonary Arterial Hypertension Treatments: PDE 5 Inhibitors: Vardenafil (Levitra®)

Author: Shelley Ensz. Scleroderma is highly variable. See Types of Scleroderma. Read Disclaimer


Vardenafil is currently not approved for PAH patients. "Off-label" uses include Raynaud's and pulmonary hypertension.

Vardenafil (Levitra) is FDA-approved for erectile dysfunction. Its "off label" use includes treatment of pulmonary arterial hypertension (PAH). (Also see: What is PAH?, What is Scleroderma? and PAH Treatments)

Understanding Investigational Drugs and Off Label Use of Approved Drugs. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an "off-label" use. This can mean that the drug is used for a different disease or medical condition, given in a different way (such as by a different route), or given in a different dose. U.S. Food and Drug Administration.

Vardenafil (Levitra®) relaxes blood vessels, thereby improving circulation and reducing blood pressure in the lungs. It is also used to treat erectile dysfunction, but is used in higher doses for PAH.

Vardenafil (Levitra®) is a pill which is usually taken twice daily for PAH. It is in a class of drugs called phosphodiesterase-5 Inhibitors (PDE 5 Inhibitors). It is manufactured by Bayer HealthCare Pharmaceuticals, Inc. and distributed by GlaxoSmithKline.

New PAH Blood Biomarkers May Lead to Better Treatment for Patients. Since the levels of these markers in the blood are reflecting the clinical efficacy of PAH-specific medical treatment, there is good hope that they soon can be used routinely to measure treatment response. Pulmonary Hypertension News, 01/25/2016.

Updated Treatment Algorithm of Pulmonary Arterial Hypertension.Vardenafil 5 mg twice daily has shown favorable results on exercise capacity, hemodynamics, and time to clinical worsening. The side effect profile was similar to that of sildenafil. Vardenafil is currently not approved for PAH patients. Journal of the American College of Cardiology, Volume 62, Issue 25, Supplement, 24 December 2013, Pages D60-D72.

Vardenafil in pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled study. Vardenafil is effective and well tolerated in patients with PAH at a dose of 5 mg twice daily. PubMed, Am J Respir Crit Care Med, 2011 Jun 15:183(12):1723-9.

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