No Mortality Reduction with Glucose-Insulin-Potassium Therapy in Patients with STEMI
November 8, 2004 (eshonline.org) - The CREATE-ECLA trial reported today at the American Heart Association Scientific Sessions showed that intravenous glucose-insulin-potassium (GIK) therapy administered within 12 hours of symptom onset had no impact on all-cause mortality, cardiac death, cardiac arrhythmia, or cardiogenic shock . This low-cost therapy was safe with no apparent adverse effects.
Patients were randomly assigned to GIK plus usual care (10,088) or usual care alone (10,107) for 24 hours in a 2x2 factorial design. Mortality at 30 days occurred in 10.0% of the GIK patients and 9.7% of the control patients (hazard ratio 1.03; p=0.45). Cardiac arrest occurred in 1.4% of GIK patients and 1.5% of control patients, cardiogenic shock in 6.6% and 6.3% of GIK and control patients respectively, and reinfarction occurred in 2.3% and 2.4% respectively. The results were the same across all pre-specified subgroups, including diabetics who comprised 17% of the study population.
Surprisingly, at 7 days recurrent ischemia was reduced from 6.5% in the control patients to 4.6% in the GIK patients (p=0.004) and this was maintained at 30 days (p=0.036). However, Shamir Mehta, the study presenter, stated this finding requires cautious interpretation. Although the reduction was significant and consistent with the mechanism of action of GIK, it more likely opens new avenues of future research, for example, the use of GIK in angina pectoris. A trend toward benefit in the patients who underwent PCI and received thrombolytic therapy was an interesting observation and perhaps justifies further study in this regard. The findings in this large-scale, international collaborative study "put to rest the question of the use of GIK in the setting of AMI," Mehta stated.
The Clinical Trial of Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation (CREATE)-ECLA study was conducted in 518 centers in 21 regions including India, China, South America, Pakistan, North America, Europe, and the Middle East.
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