Iroko Cardio International Sàrl announces data on HDB dosing of tirofiban, abciximab in interventional cardiology

Sep 3 2010

Iroko Cardio International Sàrl announces long-term, three-year, mortality data from the Phase III, open label, multi-national study comparing high-dose bolus (HDB) dosing of AGGRASTAT® (tirofiban) (25mcg/kg bolus followed by a 0.15mcg/kg/min infusion for 18-24 hours) vs. ReoPro® (abciximab) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), presented at the 2010 European Society of Cardiology Meeting in Stockholm, Sweden.

“We look forward to working with the global cardiology community to further discuss the utility of AGGRASTAT® in treating patients with acute coronary syndrome.”

At three years, all but nine patients were available for clinical follow-up

As previously published in JAMA (Apr. 2008; 299:1788-1799) at least 50 percent recovery from ST-elevation occurred in 85.3 percent and 83.6 percent of patients in the HDB tirofiban and abciximab groups, respectively (Relative Risk [RR]: 1.020; 97.5 percent confidence Interval [CI], 0.958 to 1.086; P <0.001 for non-inferiority). At 30 days, ischemic and hemorrhagic outcomes were similar in the HDB tirofiban and abciximab groups, with the incidence of thrombocytopenia being significantly more common with abciximab compared to HDB tirofiban (4.0 versus 0.8 percent,>

A resource utilisation analysis of the MULTISTRATEGY study, presented at the 12^th European Congress of the International Society of Pharmacoeconomics and Health Outcomes Research in Paris, showed that there was no difference in resources used to treat patients in either arm of MULTISTRATEGY, however there was a significant cost-savings of PCI-dosing of HDB tirofiban compared to abciximab therapy (€876.83 vs. €348.20; P<0.000) with an overall cost-savings on therapy of over €195,000 for the study. (ISPOR Outcomes Research Digest; Oct. 2009; Abstract PCV115)

One-year follow-up data was presented at the 59^th Annual Scientific Session of the American College of Cardiology. All but four patients were available for one-year follow-up. At one-year, the incidence of death or myocardial infarction was 7.3% in the HDB tirofiban arm versus 8.1% in the abciximab arm>

"The three-year results of the MULTISTRATEGY study, combined with the previous efficacy, safety and cost-effectiveness data, demonstrate that in STEMI patients undergoing primary PCI, treatment with tirofiban results in similar clinical outcomes with improved safety, in terms of lower thrombocytopenia, and lower-costs relative to abciximab," said Marco Valgimigli, MD, PhD, Director of the Cardiac Catheterisation Lab at the University of Ferrara, Ferrara, Italy and lead study investigator.

"These data underscore the importance of efficacious, safe and cost-effective therapies, like AGGRASTAT®, in interventional cardiology," said Juergen Raths, newly-appointed President and Chief Executive Officer of Iroko Cardio International Sàrl. "We look forward to working with the global cardiology community to further discuss the utility of AGGRASTAT® in treating patients with acute coronary syndrome."