Metformin in non-Diabetic Patients Presenting with ST Elevation Myocardial Infarction: Rationale and Design of the Glycometabolic Intervention as Adjunct to Primary Percutaneous Intervention in ST Elevation Myocardial Infarction (GIPS)-III Trial

• Published in: Cardiovascular drugs and therapy Vol. 26; no. 5; pp. 417 - 426
• Main Authors: Lexis, Chris P. H., van der Horst, Iwan C. C., Lipsic, Erik, van der Harst, Pim, van der Horst-Schrivers, Anouk N. A., Wolffenbuttel, Bruce H. R., de Boer, Rudolf A., van Rossum, Albert C., van Veldhuisen, Dirk J., de Smet, Bart J. G. L.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.10.2012; Springer; Springer Nature B.V
• Subjects: Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular system; Coronary heart disease; Diabetes. Impaired glucose tolerance; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Glucose Tolerance Test; Heart; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Humans; Hypoglycemic Agents - therapeutic use; Medical sciences; Medicine; Medicine & Public Health; Metformin - therapeutic use; Myocardial Infarction - drug therapy; Myocardial Infarction - surgery; Percutaneous Coronary Intervention; Pharmacology. Drug treatments; Ventricular Dysfunction, Left - drug therapy; Ventricular Dysfunction, Left - surgery; Ventricular Function, Left - drug effects; Ventricular Function, Left - physiology; Heart failure; ST-elevation myocardial infarction; Metformin; Cardiac remodeling; Left ventricular ejection fraction; Endocrinopathy; Heart; Human; Myocardial infarction; Diabetes mellitus; Cardiovascular disease; Patient; Coronary heart disease; Myocardial disease; Left ventricle; Percutaneous route; ST elevation; Hypoglycemic agent; Biguanides; Gastrointestinal hormone; Circulatory system; Gastric inhibitory peptide; Ejection fraction
• ISSN: 0920-3206; 1573-7241; 1573-7241
• DOI: 10.1007/s10557-012-6413-1

Background Left ventricular dysfunction and the development of heart failure is a frequent and serious complication of myocardial infarction. Recent animal experimental studies suggested that metformin treatment reduces myocardial injury and preserves cardiac function in non-diabetic rats after experimental myocardial infarction. We will study the efficacy of metformin with the aim to preserve left ventricular ejection fraction in non-diabetic patients presenting with ST elevation myocardial infarction (STEMI). Methods The Glycometabolic Intervention as adjunct to Primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial is a prospective, single center, double blind, randomized, placebo-controlled trial. Three-hundred-and-fifty patients, without diabetes, requiring primary percutaneous coronary intervention (PCI) for STEMI will be randomized to metformin 500 mg twice daily or placebo treatment and will undergo magnetic resonance imaging (MRI) after 4 months. Major exclusion criteria were prior myocardial infarction and severe renal dysfunction. The primary efficacy parameter is left ventricular ejection fraction 4 months after randomization. Secondary and tertiary efficacy parameters include major adverse cardiac events, new onset diabetes and glycometabolic parameters, and echocardiographic diastolic function. Safety parameters include renal function deterioration and lactic acidosis. Conclusions The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.