Study Shows Tracleer Doesn't Avert Hospital Stays for Heart Failure Patients
By: Johanna Bennett
Dow Jones Newswires
ATLANTA -- A drug that the Swiss company Actelion AG had hoped to market as a treatment for heart failure appears to make patients feel worse before they feel better.
Data from a major clinical trial presented at theof Cardiology's annual conference here showed that the drug Tracleer, now used to treat a rare condition known as pulmonary hypertension, failed to significantly decrease hospital stays and deaths among patients with chronic heart failure.
For reasons that researchers and company officials don't understand, heart failure patients treated with Tracleer suffered fluid retention during the two or three weeks after first taking the drug. This caused their symptoms to worsen initially and lead to more hospital stays during the trial's early weeks than patients who weren't given the drug, according to lead investigator Milton Packer of Columbia Presbyterian Hospital in New York .
Patients' conditions eventually improved. By the end of the 18-month study, known as ENABLE, patients treated with Tracleer reported 312 incidents resulting in hospitalizations or deaths -- nine fewer than the control group.
"These are puzzling results," said Roland Haeseli, spokesman for Actelion.
Tracleer, also known as bosentan, was approved in November as a therapy for a rare condition called pulmonary hypertension. The drug, which belongs to a family known as endothelin receptor antagonists, prevents the pulmonary artery from constricting, which allows blood to flow freely.
As a therapy for pulmonary hypertension, Tracleer's sales could hit $200 million, according to one analyst. So Actelion and its U.S marketing partner Genentech Inc. (DNA), hope to find other uses for the drug.
Some artery-dilating medications improve symptoms of heart failure by expanding blood vessels and easing the heart's blood-pumping workload. If Tracleer joins this list, the drug could reach blockbuster status, with sales of $1 billion, analysts said.
"In experimental models, heart failure looked very promising, Packer said.
Early studies of patients taking 1,000 milligrams of Tracleer a day proved disappointing due to signs of short-term negative effects and worries about liver problems. So in the latest study, researchers lowered the dose by 75% to 250 milligrams a day.
It didn't work.
"There was no favorable effect, though there was a slight trend in the right direction," Mr. Packer said during a press conference. "The same problems from earlier trials were seen again."
Mr. Packer theorized that a lower dose of Tracleer -- a 75% reduction -- may work. But that would require another round of clinical trials, and it's uncertain if Actelion is willing to spend the resources.
The company is still evaluating the ENABLE results, Haeseli said. Meanwhile, Actelion is initiating clinical trials on the drug's usefulness as a treatment for other maladies, he added.
"We are not ruling [heart failure] out. But the priority now is other indications," he said.
Wall Street analysts aren't enthusiastic.
"Given that there are still some concerns, no one thinks this drug is going anywhere," said SG Cowen Securities analyst Eric Schmidt.
-By Johanna Bennett, Dow Jones Newswires; 201-938-5240; johanna.bennett@ dowjones.com |
