Sometimes, creating a drug that can save heart patients' lives is not enough; researchers also have to make it affordable. A newly tested drug trade-named Integrilin promises to do both.
Dr. James Tcheng, a cardiologist at the Duke Clinical Research Institute, led nationwide clinical trials of the drug-also known as eptifibatide-and presented the findings March 14 at the annual scientific meeting of the American College of Cardiology.
Integrilin, similar to a currently available but expensive drug, was shown to cut by 40 percent the number of heart attacks, post-procedure complications and emergency surgeries within 48 hours of a coronary intervention.
To prevent clotting after doctors open partially clogged arteries, doctors now intravenously give patients abciximab, also called Reopro. The drug blocks a specific platelet-to-platelet interaction receptor and thus prevents blood from clotting.
Integrilin, the new medicine, performs the same function as Reopro at nearly a quarter of the cost-Integrilin costs about $400 compared to $1,500 for Reopro.
Blocked arteries are a very common ailment among heart patients. In such cases, the blockage interferes with the blood flow and causes heart pain, also called an angina. In a procedure call coronary angioplasty, doctors remove such blockage by inserting a tube into the body and passing it to the heart.
Such coronary interventions are alternatives to surgery and are used only when the number of blocked arteries is fairly low. A catheter and a balloon are used to press the blockage flat and a stent of medical-grade stainless steel is implanted to prop the artery open, restoring bloodflow. Around 600,000 coronary angioplasty procedures are performed in the United States each year-of these, more than 95 percent use stents.
But plenty can go wrong in the process, and in about 10 percent of the cases, it does. "The stent is a foreign object in the body, and can often cause blood clotting to occur," said Tcheng. Blood clotting inside the arteries again restricts blood flow, renewing the earlier condition.
Reopro reduces the likelihood of such clots, but doctors say it is too expensive to be widely administered.
In this complicated time for medical reimbursements, hospitals receive a fixed fee for the procedure because the majority of patients are covered by Medicare or the hospitals are members of a diagnostic related group, Tcheng explained. As a result, if a hospital provided every one of its heart patients with Reopro, it would either lose money per procedure or the patients would simply not be able to afford it, Tcheng said.
Therefore, patients with a high risk of a blood clot forming became the only candidates for Reopro.
"Previously, a hospital could only afford to treat about 20 percent of the patients," said Tcheng, adding that with Integrilin, the hospital could treat almost everyone.
The lower price of Integrilin is mostly a factor of the drug's manufacturing process. Reopro is expensive to make because it requires monoclonal antibodies, genetic engineering and growth in a delicate bacterial culture. Integrilin is made by way of peptides, which are much easier to synthesize, explained project leader Diane Joseph, who works with Tcheng.
The multi-million dollar trial was funded by COR Therapeutics Inc. and Schering-Plough Corp., developers of eptifibatide.
It began in June 1999 and finished earlier than planned, in February 2000, after it results proved exceedingly favorable. The trial was conducted in 32 hospitals in the United States and Canada and ultimately involved 2,064 patients.
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