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001-es BibID:	BIBFORM120032
035-os BibID:	(Scopus)85139803076 (WoS)000866779900001
Első szerző:	von Lewinski, Dirk
Cím:	Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction-The REC-DUT-002 Trial / von Lewinski, Dirk; Benedikt, Martin; Alber, Hannes; Debrauwere, Jan; Smits, Pieter C.; Édes, István; Kiss, Róbert Gábor; Merkely, Béla; Nagy, Gergely Gyorgy; Ptaszynski, Pawel; Zarebinski, Maciej; Kubica, Jacek; Kleinrok, Andrzej; Coats, Andrew J. S.; Wallner, Markus
Dátum:	2022
ISSN:	2077-0383
Megjegyzések:	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.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk myocardial infarction regeneration safety tolerability G-CSF DPP-4 cMR
Megjelenés:	Journal of Clinical Medicine. - 11 : 19 (2022), p. 1-12. -
További szerzők:	Benedikt, Martin Alber, Hannes Debrauwere, Jan Smits, Pieter C. Édes István (1952-) (kardiológus) Kiss Róbert Gábor Merkely Béla (1965-) (orvos) Nagy Gergely György (1976-) (orvos) Ptaszynski, Pawel Zarebinski, Maciej Kubica, Jacek Kleinrok, Andrzej Coats, Andrew Wallner, Markus
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