TY - JOUR
T1 - Two-year follow-up of 4 months metformin treatment vs. placebo in ST-elevation myocardial infarction
T2 - data from the GIPS-III RCT
AU - Hartman, Minke H T
AU - Prins, Jake K B
AU - Schurer, Remco A J
AU - Lipsic, Erik
AU - Lexis, Chris P H
AU - van der Horst-Schrivers, Anouk N A
AU - van Veldhuisen, Dirk J
AU - van der Horst, Iwan C C
AU - van der Harst, Pim
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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.
KW - Acute myocardial infarction
KW - Diabetes
KW - Heart failure
KW - Percutaneous coronary intervention
KW - Metformin
KW - PERCUTANEOUS CORONARY INTERVENTION
KW - LEFT-VENTRICULAR FUNCTION
KW - PERMEABILITY TRANSITION PORE
KW - RANDOMIZED CONTROLLED-TRIAL
KW - NONDIABETIC PATIENTS
KW - REPERFUSION INJURY
KW - METABOLIC SYNDROME
KW - HEART
KW - CARDIOPROTECTION
KW - ISCHEMIA
U2 - 10.1007/s00392-017-1140-z
DO - 10.1007/s00392-017-1140-z
M3 - Article
C2 - 28755285
SN - 1861-0684
VL - 106
SP - 939
EP - 946
JO - Clinical Research in Cardiology
JF - Clinical Research in Cardiology
IS - 12
ER -