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28.07.2017 | Original Paper | Ausgabe 12/2017 Open Access

Clinical Research in Cardiology 12/2017

Two-year follow-up of 4 months metformin treatment vs. placebo in ST-elevation myocardial infarction: data from the GIPS-III RCT

Zeitschrift:
Clinical Research in Cardiology > Ausgabe 12/2017
Autoren:
Minke H. T. Hartman, Jake K. B. Prins, Remco A. J. Schurer, Erik Lipsic, Chris P. H. Lexis, Anouk N. A. van der Horst-Schrivers, Dirk J. van Veldhuisen, Iwan C. C. van der Horst, Pim van der Harst
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00392-017-1140-z) contains supplementary material, which is available to authorized users.
Minke H. T. Hartman and Jake K. B. Prins contributed equally to the current study.

Abstract

Objectives

Preclinical and clinical studies suggested cardioprotective effects of metformin treatment. In the GIPS-III trial, 4 months of metformin treatment did not improve left ventricular ejection fraction in patients presenting with ST-elevation myocardial infarction (STEMI). Here, we report the 2-year follow-up results.

Methods

Between January 2011 and May 2013, 379 STEMI patients without diabetes undergoing primary percutaneous coronary intervention were randomized to a 4-month treatment with metformin (500 mg twice daily) (N = 191) or placebo (N = 188) in the University Medical Center Groningen. Two-year follow-up data was collected to determine its effect on predefined secondary endpoints: the incidence of major adverse cardiac events (MACE), its individual components, all-cause mortality, and new-onset diabetes.

Results

For all 379 patients all-cause mortality data were available. For seven patients (2%) follow-up data on MACE was limited, ranging from 129 to 577 days. All others completed the 2-year follow-up visit. Incidence of MACE was 11 (5.8%) in metformin and 6 (3.2%) in placebo treated patients [hazard ratio (HR) 1.84, confidence interval (CI) 0.68–4.97, P = 0.22]. Three patients died in the metformin group and one in the placebo treatment group. Individual components of MACE were also comparable between both groups. New-onset diabetes mellitus was 34 (17.8%) in metformin and 32 (17.0%) in placebo treated patients (odds ratio 1.15, CI 0.66–1.98, P = 0.84). After multivariable adjustment the incidence of MACE was comparable between the treatment groups (HR 1.02, CI 0.10–10.78, P = 0.99).

Conclusions

Four months metformin treatment initiated at the time of hospitalization in STEMI patients without diabetes did not exert beneficial long-term effects.

Trial registration

clinicaltrials.gov Identifier: NCT01217307.

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Zusatzmaterial
Supplementary material 1 (DOCX 18 kb)
392_2017_1140_MOESM1_ESM.docx
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