Patients with acute myocardial infarction are at high risk for developing heart failure
due to scar development. Although regenerative approaches are evolving, consistent
clinical benefits have not yet been reported. Treatment with dutogliptin, a second-generation
DPP-4 inhibitor, in co-administration with filgrastim (G-CSF) has been shown to enhance
endogenous repair mechanisms in experimental models. The REC-DUT-002 trial was a phase
2, multicenter, double-blind placebo-controlled trial which explored the safety, tolerability,
and efficacy of dutogliptin and filgrastim in patients with ST-elevation Myocardial
Infarction (STEMI). Patients (n = 47, 56.1 ± 10.7 years, 29% female) with STEMI, reduced
left ventricular ejection fraction (EF ≤ 45%) and successful revascularization following
primary PCI were randomized to receive either study treatment or matching placebo.
Cardiac magnetic resonance imaging (cMRI) was performed within 72 h post-PCI and repeated
after 3 months. The study was closed out early due to the SARS-CoV-2 pandemic. There
was no statistically significant difference between the groups with respect to serious
adverse events (SAE). Predefined mean changes within cMRI-derived functional and structural
parameters from baseline to 90 days did not differ between placebo and treatment (left
ventricular end-diastolic volume: +13.7 mL vs. +15.7 mL; LV-EF: +5.7% vs. +5.9%).
Improvement in cardiac tissue health over time was noted in both groups: full-width
at half-maximum late gadolinium enhancement (FWHM LGE) mass (placebo: −12.7 g, treatment:
−19.9 g; p = 0.23). Concomitant treatment was well tolerated, and no safety issues
were detected. Based on the results, the FDA and EMA have already approved an adequately
powered large outcome trial.
