Angiomax achieves similar ischemic results to standard therapy

According to US drugmaker The Medicines Company, data from the ACUITY trial show that patients treated with Angiomax (bivalirudin), a thrombin-specific anticoagulant, had similar rates of ischemic clinical outcomes as those who received the standard therapy, unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). The findings were presented at the 56th annual conference of the American College of Cardiology, held in New Orleans.

The results showed that death rates in the three groups (Angiomax alone, Angiomax plus GPI or heparin plus GPI) were 3.8%, 4.2% and 4.4%, respectively. In addition, the firm said that there was an observed numerical reduction in late mortality, defined as being death that occurred between one month and a year after the treatment initiation.

The data also showed that the occurance of composite ischemia events (defined as death, heart attack or unplanned revascularization) was similar across all three groups (16.4%, 16.5% and 16.3%), respectively. The firm said that it intends to submit a supplemental New Drug Application requesting approval for the drug's use in the treatment of emergency ACS to the Food and Drug Administration in the third quarter of the year. Currently, the product is cleared for the treatment of patients undergoing percutaneous transluminal coronary angioplasty and those at risk of heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS).