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Serious concern is being given by researchers to see if Viagra could be used to treat pulmonary hypertension in those suffering with sickle cell disease. It is already approved under the brand name of Revatio, (Pfizer) for use in patients with pulmonary hypertension without sickle cell disease. That condition causes high blood pressure inside the arteries carrying blood to the lungs and can lead to heart failure and death.
Relaxing blood vessels allows the blood to flow more easily. About one-third of those who have sickle cell disease also go on to develop pulmonary hypertension. But now the National Institutes of Health (NIH) has stopped a drug trial after it was found that the drug caused serious medical problems in sickle cell patients. In all, 74 patients were enrolled. All had sickle cell disease and mild to severe pulmonary hypertension, according to the NIH.
Thankfully no deaths were reported.
Negative Findings are Specific to Sickle-cell Patients
The NHLBI, a part of the National Institutes of Health that conducted the study, emphasized that the findings were specific to sickle-cell patients and therefore “should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective.” It said that sickle-cell patients taking Revatio should consult their doctors.
Researchers are now looking at the efficacy of the drug: Did it actually have any effect, positive or negative, on pulmonary hypertension? If there were positive effects, the researchers said, there may be other ways it could be used.“It may be that we could use the drug in patients whose pain is controlled with either transfusions or hydroxyurea, although it’s possible that the risk-benefit ratio would only play out in patients with higher pulmonary hypertension,” Gladwin said. “The patients in this trial had mild-to-moderate pulmonary hypertension.
Viagra maker Pfizer said the safety of Viagra and Revatio is “well-established.” The company also said it would be a mistake to compare the safety of sildenafil, the active ingredient in Viagra and Revatio, in patients coping with erection issues to its safety in those suffering from pulmonary hypertension because of differences in the two conditions.
In 2004 a clinical trial in India, published in The Journal of the American College of Cardiology, showed that Viagra increased the ability of patients to exercise by about 40 percent. The authors said that was greater than the effect seen with other drugs in different trials. It was the first randomized test to compare Viagra against a placebo for pulmonary hypertension.
Pfizer, the manufacturer of Viagra, said it expected results of its own much larger and more definitive trial around the middle of that year. Investigators expected to present results at the American Heart Association’s annual meeting in November of 2004. But because doctors are allowed to prescribe a drug for any use, once it wins regulatory approval, some were already using Viagra for pulmonary hypertension. The drug was even being given to babies.
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