Danegaptide does not reduce reperfusion injury in patients with STEMI
Treatment with danegaptide does not improve myocardial salvage in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), according to the results of a phase II study.
A total of 585 patients were randomized to receive danegaptide at high dose (intravenous 7.5 mg bolus injection followed by 22.5 mg infused over 6 hours; n=184) or at low dose (intravenous 2.5 mg bolus injection followed by 7.5 mg infused over 6 hours; n=206) or placebo (n=195). The per-protocol analysis set included 57, 60 and 52 patients, respectively. The primary endpoint was myocardial salvage, evaluated by cardiac MRI, after 3 months.
Danegaptide had no effect on myocardial salvage index (mean: 63.9 in the high-dose group vs 65.6 in the low-dose group vs 66.7 in the placebo group; p=0.40).
Likewise, the three treatment groups did not significantly differ in terms of final infarct size (mean: 19.6 g in the high-dose group vs 18.6 g in the low-dose group vs 21.4 g in the placebo group; p=0.88) and left ventricular ejection fraction (mean: 53.9 percent in the high-dose group vs 52.7 percent in the low-dose group vs 52.1 percent in the control group; p=0.64).
Clinical outcomes including all-cause mortality (p=0.90), cardiac death (p=0.90), reinfarction after 90 days (p=0.66) and development of heart failure (p=0.44) were similar across the three treatment groups.
In terms of safety, danegaptide was well tolerated. Few side effects occurred, with the number of adverse events, serious adverse events or deaths comparable across the three groups.
Given that reperfusion injury is a complex pathophysiological incidence in STEMI, with a poor prognosis, addressing other targets pharmaceutically may be beneficial, researchers said. However, the present data could not confirm that the gap junction modulating peptide danegaptide reduces reperfusion injury in STEMI patients.