ALEXION DRUG DOESN'T BENEFIT ANGIOPLASTY, STENT PATIENTS

Use of Alexion's pexelizumab immediately before and for 24 hours after stent placement or angioplasty for certain heart attack patients did not have any significant treatment effect compared with placebo, according to a study in the Jan. 3 issue of The Journal of the American Medical Association. The medication had shown promise in preliminary studies, according to study authors.

Reperfusion with percutaneous transluminal coronary intervention (PCI), including balloon angioplasty and stent placement, is highly effective at improving outcomes in patients with acute ST-elevation myocardial infarction (STEMI), according to investigators. However, in patients without prompt reestablishment of adequate coronary blood flow, risk of death remains high, indicating the need for new treatments, including drugs intended to reduce the inflammation associated with a heart attack.

The APEX AMI trial evaluated the effectiveness of the intravenous administration of pexelizumab in conjunction with primary PCI in lowering the risk of death from STEMI. The double-blind, placebo-controlled, Phase III study include 5,745 patients, of whom 2,885 were randomly assigned to receive placebo and 2,860 pexelizumab, prior to PCI followed by infusion over 24 hours. The patients were treated at 296 hospitals in 17 countries from July 2004 to May 2006.

The researchers found that there was no difference in the rate of death at 30 days between placebo and pexelizumab treated patients, with each experiencing a low death rate of 3.92 percent and 4.06 percent, respectively. The secondary endpoints of death, cardiac shock or heart failure was also similar between treatment groups (9.19 percent for placebo and 8.99 percent with pexelizumab). Also, at 90 days death remained low and similar in both treatment groups.