Blue Pills for the Treatment of Pulmonary Arterial Hypertension in Children

Sildenafil is a vasodilator developed for the treatment of erectile dysfunction. Recently it has been used to dilating the blood vessels of the lungs in cases of pulmonary hypertension

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Pfizer Inc., who owns the patent on Viagra, is currently selling this form of the drug under the brand name Revatio. Pulmonary arterial hypertension is a condition that makes the right side of the heart work harder than normal and is characterized by abnormally high pressure in the arteries of the lungs. It is a progressive, frequently fatal, debilitating disease.

First sign of pulmonary hypertension is often light-headedness and dizziness during physical activity. These symptoms may be accompanied by fast heart rate and over time will appear during mild activity or even while at rest.

Other symptoms include swelling of the legs and ankles, cyanosis (bluish color of the lips or skin), chest pain or pressure, fainting spells and dizziness, weakness and fatigue. Although there are several treatments available for pulmonary arterial hypertension, there is presently no known cure.

Compared to other vasodilators, Sildenafil has the advantage of fewer side effects, being orally administered and costing significantly less than other medications. Additionally, some studies show that Sildenafil may increase the overall survival rate of patients diagnosed with pulmonary arterial hypertension and may be better tolerated by patients refractory to other forms of treatment.

In 2001, the FDA asked Pfizer to study the medicine in children affected by the rare lung disorder. Pfizer, the world’s largest drug company, states that pulmonary hypertension affects around 600 children a year. Patents for Viagra and Revatio, which earned the drug maker $1.89 billion and $450 million respectively in 2009, were previously expected to expire in 2012.

If the New York based company meets the FDA study requirements, this would grant Pfizer another six months of no generic competition for their drug. Some pediatricians are already using Sildenafil as a treatment in kids affected by the lung disease. ­

A randomized, double-blinded study conducted by Dr. Robyn Barst, MD, FCCP, Columbia University, New York, NY, involved 32 medical centers in 16 countries and aimed to assessed the outcome of Sildenafil therapy in 237 children with pulmonary arterial hypertension between the ages of 1 and 17 years.

The children were administered low, medium or high doses of Sildenafil, or placebo for 16 weeks. Medium and high doses of Sildenafil showed an increase in oxygen delivery and blood flow through the lungs. Sildenafil treatment also increased the exercise ability of the children as well as the ease with which they could sustain effort. The gas exchange efficiency of the lungs during physical effort was also improved in patients treated with Sildenafil.

Overall, studies reflect that a medium dose of Sildenafil may be more effective than higher dosage at improving symptoms of pulmonary arterial hypertension. Although many pediatricians currently prescribe Sildenafil to children affected by PAH, the medical community tends to agree that more studies are necessary in establishing the overall efficacy of the drug as long as the long term side effects. The drug is not currently approved by the FDA for the treatment of pulmonary hypertension.

Please always consult your doctor before taking any medicine.