A new drug for pulmonary arterial hypertension (PAH) Letairis has been released. In PAH small arteries in the lungs narrow and the pressure of blood in the vessels increase and the right side of the heart works harder to pump the blood. The result is enlargement and then weakening of the right sided heart muscle. There is also thickening and loss of efficiency of oxygen exchange in the pulmonary blood vessels. Patients become short of breath, tired, have chest pain, dizziness and often have syncopal episodes. About 100,000 people in the United States have pulmonary arterial hypertension.
Letairis is an ERA, or endothelin receptor antagonists. The drug relaxes the vessels, lowers blood pressure and lightens the load on the heart and lungs.
Gilead the manufacturer notes:
“In two randomized, double-blind, 12-week, placebo-controlled Phase III clinical trials (ARIES-1 and ARIES-2) involving a total of 393 patients, treatment with Letairis resulted in a significant improvement in six-minute walk distance. An increase in walk distance was observed after four weeks of treatment with each dose regimen of Letairis, with a dose-response observed after 12 weeks of treatment. In ARIES-1, placebo-adjusted mean and median changes from baseline of 31 meters and 27 meters (p=0.008), respectively, were observed for the 5 mg dose. Placebo-adjusted mean and median changes from baseline of 51 meters and 39 meters (p less than 0.001), respectively, were observed for the 10 mg dose. In ARIES-2, placebo-adjusted mean and median changes from baseline of 59 meters and 45 meters (p less than 0.001), respectively, were observed for the 5 mg dose.” (Emphasis by medicynic)
“The long-term follow-up of the patients who were treated with Letairis in the two pivotal studies and the open-label extension (n=383) shows that 95 percent were still alive at one year and 94 percent were still receiving Letairis monotherapy. These uncontrolled observations do not allow comparison with a group not given Letairis and cannot be used to determine the long-term effect of Letairis.” (Emphasis by medicynic)
“Gilead is committed first and foremost to patients,” said Dr. Martin. “Our hope is that this program will ensure greater access to care for PAH patients with a variety of circumstances, including the often overlooked group of patients who have some form of prescription insurance but have prohibitively high out-of-pocket expenses.”
In the New York Times it was noted:
“Gilead said Letairis, a once-a-day pill, will cost $3,940 a month, about the same as Tracleer, which is also known as bosentan. The company said it was establishing programs to help uninsured or under-insured patients obtain the drug.”
In summary: the drug doesn’t cure the disease. Exercise improvement, depending on the dose is limited to 100 and 200 feet additional distance in a 6 minute walk. There also may be an improvement in survival but the study for this was not conclusive. The price almost $50,000/year.
It’s wonderful there is progress in this disease but the benefit is quite limited and the price exorbitant–not surprising given the Pharmaceutical Industry’s track record. The only question is when such pricing will break the bank.