Single-dose nPA shows promise
Lanoteplase compares favorably with alteplase
A new single-dose clotbuster, the plasminogen activator (nPA) lanoteplase (Princeton, NJ-based Bristol-Myers Squibb), shows promise for acute myocardial infarction (AMI) treatment.
A quick, single shot of the drug reopens blocked blood vessels during a heart attack and keeps them open longer than current treatments that require slower-dosing infusion pumps. Researchers tested 602 people in 13 countries enrolled in the InTIME (Intravenous nPA for Treatment of Infarcting Myocardium Early) study, a trial that compared lanoteplase with alteplase.1
When injected into a vein, lanoteplase lasts about 10 times longer than alteplase, and this longer availability in the bloodstream allows for a single injection of less than two minutes compared with the multistep, 90-minute administration required for alteplase.
"In the treatment of heart attacks, time is muscle," said the researchers in a statement. That is, early treatment saves heart muscle and lives. The development of single-shot thrombolytic agents that can be administered in two minutes or less shortens the time it takes to dissolve the clot and restore blood flow. In addition, with faster delivery of treatment, patients may be transferred to coronary care units more quickly, and other drug infusions will not be hampered by the administration of thrombolytics.
Faster, longer-lasting thrombolytics could also lead to their use outside of hospitals during the first hour after a heart attack, when early treatment can make a big difference in the amount of heart damage or survival. At the highest dose, lanoteplase was more effective than alteplase in restoring blood flow at 90 minutes after treatment.
Bleeding complications are sometimes a side effect when using thrombolytics. In this trial:
• Less than 10% of all patients experienced bleeding incidents, and most was at the puncture site.
• Moderate bleeding occurred in 5% to 8% of the lanoteplase patients and in 10.5% of the group that received alteplase.
• Major bleeding occurred in about 2% of the lanoteplase patients and 5% of the alteplase group.
• There were 15 cardiac-related deaths among the 474 patients receiving lanoteplase — 3.1% — compared to eight deaths — 6.5% — in the 124 alteplase patients.
Lanoteplase has just finished phase-three trials and is not yet approved by the Food and Drug Administration, so its potential cost is unknown.
Reference
1. den Heijer P, Vermeer F, Ambrosioni E, et al. Evaluation of a weight-adjusted single-bolus plasminogen activator in patients with myocardial infarction: A double-blind, randomized angiographic trial of lanoteplase vs. alteplase. Circulation 1998; 98:2,117-2,125.
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