June 6, 2005 representatives of the company “Pfizer” reported on the FDA approval of Revatio drug (sildenafil citrate), used to treat primary pulmonary hypertension. It is a rare disease, characterized by aggressive course and rapid onset of death. As it is known sildenafil citrate is an active substance of Viagra best-seller, intended to treat erectile dysfunction, to date more than 26, 000 000 men use Viagra all over the world.

Primary pulmonary hypertension is characterized by pronounced increase of pressure in the arteries of  lungs, leading to the development of symptoms such as shortness of breath, dizziness, fast fatigue. This rare disease is observed in about 100 thousand of people in the world. In the absence of adequate treatment, the average life expectancy of such patients from diagnosis is less than 3 years.

Employees of Pfizer company during 6 years has been carrying out clinical program to improve the treatment of patients with primary pulmonary hypertension, who great need in the increase of pharmacotherapy possibilities. and obtained convincing evidence that the use of sildenafil is an effective treatment. Pfizer employees obtained convincing evidences that the use of sildenafil citrate is effective treatment method.

The FDA approval of Revatio drug is based on results of large-scale randomized double-blind, placebo-controlled study, which was participated by 277 patients with primary pulmonary hypertension. During clinical trials patients’ tolerance to physical loads was studied after 12 weeks of pharmacotherapy. Patients were randomized into 4 comparable groups and respectively, were appointed Revatio 20mg, 40mg, 80mg 3 times a day or placebo in similar scheme. In contrast with placebo, a significant improvement of indicator in 6-minute walk test (the standard method of studying tolerance to physical loads in patients with primary pulmonary hypertension) was revealed in all patients who have been appointed sildenafil citrate. Patients well tolerated Revatio in the appointment in all 3 researched dosages. Most common side effects were headache, dyspepsia, hot flashes, nosebleeds and sleep disorders. Given that reliable dose-dependent increase of Revatio clinical effectiveness was not revealed, the FDA approved the drug use in the minimum dose – 20 mg 3 times a day.

In addition, in patients taking Revatio a pressure reduction in the pulmonary trunk and improvement of other functional parameters of cardiac activity were observed. After the end of the study, results of prolonged observations of patients who continued to take sildenafil citrate were also obtained. By the end of 1 year therapy indicators of 6-minute walk test and functional class remained stable in most of them and 94 % of patients are still alive.

Thus, Revatio has become the first oral drug, approved to use in patients at initial stages of primary pulmonary hypertension. Use of Revatio drug will allow doctors to start the treatment as soon as possible. Safety profile of Revatio is similar to that of Viagra, herewith its simultaneous appointment with organic nitrates is also contraindicated. In order for a new drug looks different from Viagra, Revatio is supplied in the form of round white tablets, each tablet contains 20mg of sildenafil.

Revatio contraindications

• hypersensitivity to any Revatio components;
• pulmonary veno-occlusive disease;
• simultaneous use of Revatio with nitric oxide donators or nitrates in any form;
• simultaneous use of Revatio with potent inhibitors of isoenzyme CYP3A4 (including ketoconazole, itraconazole and ritonavir);
• loss of vision in one eye due to the anterior ischemic optic neuropathy;
• hereditary degenerative diseases of the retina (retinitis pigmentosa);
• severe liver dysfunction (class C by Child-Pugh);
• stroke or myocardial infarction in a history;
• severe hypotension (systolic blood pressure (SBP) less than 90 mmHg., diastolic blood pressure (DBP) less than 50 mmHg.);
• lactase deficiency, galactosemia or glucose-galactose malabsorption;
• age under 18 years (studies of the effectiveness and safety were not conducted).

If you have any of these or other conditions tell your doctor to be sure you can safely take Revatio.

Revatio side effects

Serious Revatio side effects are: sudden hearing loss; sudden vision loss; shortness of breath; chest pain; general ill feeling; sweating; nausea; vision changes; swelling in your hands, ankles or feet; irregular heartbeat.

Less serious Revatio side effects are: headache; stuffy nose; upset stomach; redness in your face, neck or chest; memory problems; back pain.

These are not all Revatio side effects and others can occur. Consult your doctor for medical advice about side effects.

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