Cor Therapeutics' Integrilin Drug Is Found to Benefit Heart Patients
By RON WINSLOW
Staff Reporter of THE WALL STREET JOURNAL
Cor Therapeutics Inc.'s anticlotting drug Integrilin significantly reduced the incidence of heart attacks and other complications for at least six months in a study of heart patients undergoing procedures to reopen clogged coronary arteries.
The study showed that the drug lowered the combined occurrence of death, heart attack or need for a repeat heart procedure by 22%, compared with patients given a placebo. When the combination of heart attack and death was considered, the drug reduced the risk by 35%.
James E. Tcheng, a cardiologist at Duke University Medical Center and lead investigator for the study, said the findings show the drug "provides a sustainable, long-term benefit" for patients undergoing the heart procedures and should address any "remaining concerns" doctors may have over using such an agent for those patients.
The results, which Cor expects to announce Monday, may also provide a boost for Cor in its marketing battle with Johnson & Johnson's Centocor unit, which makes a competing anticlotting medicine called ReoPro. "Nobody is disappointed in these data," said Vaughn Kailian, chief executive of Cor, of South San Francisco, Calif.
Integrilin costs about $450 a patient, and it has eclipsed ReoPro, which runs about $1,350 a patient, in market share since last spring when the initial, 48-hour results of the study involving Integrilin showed significant benefits.
One effect of the study was to expand use of the anticlotting agents to more patients. Only about 25% to 30% of patients undergoing angioplasty procedures were getting ReoPro, largely because of the cost.
But other long-term studies have shown that ReoPro, the first drug in the class to reach the market, has a life-saving benefit. In the Integrilin study, there was a trend toward such a benefit, but it didn't reach statistical significance. Even with the cost difference, cardiologists are sharply divided over which is the preferred drug for what patients. The drugs, which prevent clots by blocking
the aggregation of blood cells called platelets, are in a class called IIb/IIIa inhibitors, and are used in patients who receive a metal scaffold called a stent to prop open a diseased coronary artery after it is opened with an angioplasty balloon.
The new findings are likely to give cardiologists who already favor Integrilin assurance that it provides a durable result. But other doctors may want to see one-year data before embracing the cheaper drug. Vaughn Kailian, Cor's chief executive, said researchers will continue to follow patients and prepare a study based on one-year follow-up.
The new six-month findings showed that 7.5% of patients given Integrilin, known by its generic name as eptifibatide, either died or suffered a heart attack within six months after an angioplasty and stent procedure compared with 11.5% of patients who got a placebo, or a 35% relative reduction.
When the need for a repeat procedure is added to the picture, the drug reduced the patients suffering adverse events by 14.2% compared with 18.3% for placebo patients, a 22% difference.
The study found that 0.8% of patients given Integrilin died within six months compared with 1.4% given placebo, a favorable trend for the drug, but one that wasn't considered statistically meaningful.
Schering-Plough Corp. co-markets Integrilin with Cor. Eli Lilly & Co. co-markets ReoPro with Centocor. |
