title: Sitagliptin plus granulocyte colony-stimulating factor in patients suffering from acute myocardial infarction: A double-blind, randomized placebo-controlled trial of efficacy and safety (SITAGRAMI trial).
abstract: OBJECTIVE
  In animal models, G-CSF based progenitor cell mobilization combined with a DPP4 inhibitor leads to increased homing of bone marrow derived progenitor cells to the injured myocardium via the SDF1/CXCR4 axis resulting in improved ejection fraction and survival after acute myocardial infarction (AMI).
  
  
  METHODS
  After successful revascularization in AMI, 174 patients were randomized 1:1 in a multi-centre, prospective, placebo-controlled, parallel group, double blind, phase III efficacy and safety trial to treatment with G-CSF and Sitagliptin (GS) or placebo. Diabetic and non-diabetic patients were included in our trial. The primary efficacy endpoint hierarchically combined global left and right ventricular ejection fraction changes from baseline to 6 months of follow-up (ΔLVEF, ΔRVEF), as determined by cardiac MRI.
  
  
  RESULTS
  At follow-up ΔLVEF as well as ΔRVEF did not differ between the GS and placebo group. Patients in the placebo group had a similar risk for a major adverse cardiac event within 12 months of follow-up as compared to patients under GS.
  
  
  CONCLUSIONS
  Progenitor cell therapy comprising the use of G-CSF and Sitagliptin after successfully revascularized acute myocardial infarction fails to show a beneficial effect on cardiac function and clinical events after 12 months. (EudraCT: 2007-003,941-34; ClinicalTrials.gov: NCT00650143, funding: Heinz-Nixdorf foundation).
authors.affiliation: Department of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria; Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Brenner
authors.affiliation: Institute for Medical Informatics, Biometry und Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Adrion
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Grabmaier
authors.affiliation: Institute of Clinical Radiology, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Theisen
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Franz
authors.initials: F
authors.lastname: von Ziegler
authors.affiliation: Department of Cardiology, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Leber
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Becker
authors.affiliation: Department of Cardiology, Klinikum Innenstadt, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Sohn
authors.affiliation: Department of Cardiology, Klinikum Bogenhausen, Munich, Germany.
authors.forename: Ellen
authors.initials: E
authors.lastname: Hoffmann
authors.affiliation: Institute for Medical Informatics, Biometry und Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mansmann
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Steinbeck
authors.affiliation: Department of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria; Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany. Electronic address: wolfgang-michael.franz@i-med.ac.at.
authors.forename: Wolfgang-Michael
authors.initials: WM
authors.lastname: Franz
authors.affiliation: Department of Internal Medicine I, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Hans Diogenes
authors.initials: HD
authors.lastname: Theiss
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D011446:Prospective Studies; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage* / Q000009:adverse effects; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D013318:Stroke Volume / Q000187:drug effects / Q000502:physiology; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D000068900:Sitagliptin Phosphate
keywords: Acute myocardial infarction; Granulocyte colony stimulating factor; Progenitor cell therapy; Sitagliptin