June 6, 2005 representatives of the company, Pfizer reported approval by the Office of the U.S. Food and Drug Administration (FDA) the U.S. drugs RevatioTM (sildenafil citrate) for the treatment of patients with primary pulmonary hypertension – a rare disease characterized by an aggressive course and rapid onset of death. It is known that Sildenafil Citrate Foods Containing is the active substance intended for the treatment of patients with erectile dysfunction drug Viagra-selling, which is now used by more than 26 million men worldwide.

For primary pulmonary hypertension is characterized by marked increase in pressure in the arteries of the lungs, leading to the development of symptoms such as shortness of breath, dizziness, fatigue. This is a rare disease found in about 100 thousand people in the world. In the absence of adequate treatment, life expectancy of patients with the time of diagnosis is less than 3 years.

Employees of Pfizer “for 6 years, clinical program to improve the treatment of patients with primary pulmonary hypertension, which are in dire need of empowerment therapy, and obtained convincing evidence that the use of sildenafil is an effective method of treatment. The drug Revatio – a bright example of our commitment to the development of new therapies, most of the contemporary needs of health care, including treatment of patients with rare diseases such as primary pulmonary hypertension, irrespective of their commercial potential “, – said the medical director of Pfizer,” Joy Fechko ( Joe Feczko).

The FDA approval of the drug Revatio based on the results of large-scale randomized double-blind, placebo-controlled study, which was attended by 277 patients with primary pulmonary hypertension. In the course of his patients studied Tolerance to physical exertion after 12 weeks of pharmacotherapy. Patients randomized into 4 comparable groups, respectively, administered Revatio 20 mg, 40 mg, 80 mg 3 times daily or placebo for a similar scheme. Compared with placebo in all patients who had been appointed Sildenafil Citrate Foods Containing, was found a significant improvement in test 6-minute walk (the standard method for studying tolerance to physical loads, used in clinical studies in patients with primary pulmonary hypertension). Patients well tolerated drug for appointment in all 3 dosages studied. The most common adverse reactions were headache, dyspepsia, hot flashes, nosebleeds and sleep disorders. Given that reliable dose-dependent increase clinical efficiency Revatio has been identified, FDA approved the use of the drug in the lowest dose – 20 mg 3 times a day.

In addition, patients taking Revatio, Declines pressure in the pulmonary trunk and improvement in other functional parameters of cardiac activity. After completion of the study were also obtained and the results of long-term observation of patients who continued receiving Sildenafil Citrate Foods Containing. By the end of 1 year of therapy in most of these indicators test 6-minute walking distance and functional class remained stable, and 94% of patients are still alive.

Thus, the drug Revatio is the first oral medicinal products approved for use in patients at the early stages of development of primary pulmonary hypertension. The use of this drug will allow doctors to begin treatment as soon as possible. The safety profile of this drug is similar to that of Viagra, while his joint appointment with organic nitrates is also contraindicated. In order for a new drug look different from Viagra, Revatio comes in the form of round white tablets, each of which contains 20 mg of sildenafil. The company, Pfizer expects that in the U.S. retail novelty will appear in mid-July this year.