15 Apr 2008
Investigative drug MC-1 provides no added benefit for patients undergoing coronary artery bypass graft (CABG) surgery, researchers have claimed.
Findings presented at the American College of Cardiology 57th annual scientific session show no difference in efficacy between the naturally-occurring small metabolite of vitamin B6 and placebo, DGDispatch reports.
More than 3,000 patients undergoing CABG surgery were randomised to receive MC-1 or placebo in a double-blind, placebo-controlled, multi-centre phase III study.
Researchers found that 9.3 per cent of 1,510 patients randomly receiving the MC-1 250 mg/day experienced cardiovascular death of a nonfatal myocardial infarction up to 30 days after the heart surgery was carried out. This same primary endpoint was found in nine per cent of the 1,486 patients receiving placebo.
Lead author John Alexander described the outcome of the study as "a disappointment" but added that MC-1 was still "very safe".
"[MC-1] is very well tolerated. In fact, there were no significant side effects associated with its use. Unfortunately, it doesn't prevent heart attacks, at least in this setting," Mr Alexander said.
The team would be "going back to the drawing board with renewed commitment" to find a way to diminish perioperative heart attack risk in CABG patients, he added.
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Printed on 04/12/2008 7:45 PM
