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
N1 - Funding Information:
Funding The GIPS-III randomized controlled clinical trial was supported by Grant no. 95103007, from ZonMw, the Netherlands Organization for Health Research and Development, The Hague, the Netherlands.
Publisher Copyright:
© 2017, The Author(s).
PY - 2017/12/1
Y1 - 2017/12/1
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 - Administration, Ophthalmic
KW - Aged
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Electrocardiography
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Hypoglycemic Agents/administration & dosage
KW - Magnetic Resonance Imaging, Cine
KW - Male
KW - Metformin/administration & dosage
KW - Middle Aged
KW - Percutaneous Coronary Intervention
KW - Prospective Studies
KW - ST Elevation Myocardial Infarction/diagnosis
KW - Time Factors
KW - Treatment Outcome
KW - Heart failure
KW - Percutaneous coronary intervention
KW - Diabetes
KW - Metformin
KW - Acute myocardial infarction
UR - http://www.scopus.com/inward/record.url?scp=85026440223&partnerID=8YFLogxK
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 -