Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction—The REC-DUT-002 Trial
Authorvon Lewinski, Dirk
Smits, Pieter C.
Gabor Kiss, Robert
Nagy, Gergely Gyorgy
Coats, Andrew J. S.
GroupCardiovascular Research Center (Temple University)
Permanent link to this recordhttp://hdl.handle.net/20.500.12613/8247
MetadataShow full item record
AbstractPatients 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.
Citationvon Lewinski D, Benedikt M, Alber H, Debrauwere J, Smits PC, Édes I, Kiss RG, Merkely B, Nagy GG, Ptaszynski P, Zarebinski M, Kubica J, Kleinrok A, Coats AJS, Wallner M. Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction—The REC-DUT-002 Trial. Journal of Clinical Medicine. 2022; 11(19):5728. https://doi.org/10.3390/jcm11195728
Citation to related workMDPI
Has partJournal of Clinical Medicine, Vo. 11, No. 19
ADA complianceFor Americans with Disabilities Act (ADA) accommodation, including help with reading this content, please contact email@example.com