Safety and efficacy of liraglutide treatment in Japanese type 2 diabetes patients after acute myocardial infarction: A non-randomized interventional pilot trial.

BACKGROUND: Glucagon-like peptide 1 analogs are expected to exert a cardio-protective action due to their effective glucose-lowering action and favorable potency on multifactorial metabolic pathways. However, the safety and tolerability of liraglutide treatment after a recent acute coronary syndrome (ACS) in Japanese patients with type 2 diabetes mellitus (T2DM) have yet to be fully established. METHODS: A total of eight T2DM patients were recruited within 2 weeks after the onset of a ST-elevation myocardial infarction (STEMI) followed by successful percutaneous coronary intervention (PCI). The patients continued to receive liraglutide (up to 0.9mg once daily) for 24 weeks after the ACS combined with standard treatment such as a statin or beta-blocker. Changes in various metabolic parameters from pre-liraglutide treatment values were evaluated 24 weeks after liraglutide treatment, and included glycemic and lipid profiles, and cardiac systolic and diastolic function assessed by cardiac ultrasonography. RESULTS: Twenty-four weeks of treatment with liraglutide reduced body weight (67.0±5.8kg to 62.0±7.8kg, p=0.003) and HbA1c level (6.6±0.5% to 5.9±0.5%, p=0.006) and increased the level of 1,5-anhydroglucitol (12.8±6.9μg/mL to 18.7±8.2μg/mL, p=0.008) without development of hypoglycemia. There were no significant changes over 24 weeks in left ventricular systolic or diastolic function assessed by cardiac ultrasonography. No participant developed a major adverse cardiac event during the 24 weeks of liraglutide treatment, defined as cardiac death, new onset or recurrence of myocardial infarction, or needing target lesion revascularization. CONCLUSIONS: The present trial demonstrated that liraglutide treatment after onset of STEMI was well-tolerated in Japanese patients with T2DM over 24 weeks, and provided the first evidence to support clinical application of liraglutide treatment even just after ACS in Japanese high-risk T2DM patients.