Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction - DIGAMI 1

May 18, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Swedish Heart-Lung Foundation
Date Updated:
05/18/2014
Original Posted Date:
05/18/2014
References

Description:

The current trial studied insulin-glucose infusion versus standard care in acute myocardial infarction (AMI) patients with elevated blood glucose levels.

Hypothesis:

To evaluate whether rapid improvement of metabolic control in diabetic patients with an insulin-glucose infusion decreases mortality and morbidity.

Study Design

  • Randomized

Patients Enrolled: 620
Mean Follow Up: 1 year (3.4 years for second report; 7.3 years for third report)
Mean Patient Age: 67.5 years
Female: 37%

Patient Populations:

  • Patients with suspected MI in preceding 24 hours and blood glucose >11 mM on admission (with or without prior diagnosis of diabetes)

Exclusions:

  • Severe comorbidity

Primary Endpoints:

  • All-cause mortality

Drug/Procedures Used:

Diabetic patients with AMI were randomized to continuous intravenous insulin infusion for 24 hours (started at 5 U/h) or until normoglycemia was achieved (goal of 7–10 mM), followed by subcutaneous insulin for 3 months (n = 306) versus conventional therapy (n = 314).

 

Principal Findings:

At 24 hours, the insulin-glucose treated patients had lower glucose levels (9.6 vs. 11.7 mM). The insulin glucose group had 29% lower 1-year mortality (18.6% vs. 26.1%; p = 0.027). The mortality reduction was most significant (52%) in patients with a low cardiovascular risk profile or no previous insulin therapy. Only 10% of patients had insulin discontinued due to hypoglycemia and there was no associated morbidity.

At a mean follow-up of 3.4 years, the mortality reduction associated with insulin was maintained (33% vs. 44%, relative risk [RR] 0.72, p = 0.011); again, the largest benefit was seen in patients with no prior insulin therapy (RR 0.49).

At a mean follow-up of 7.3 years, 89% of patients died in the intensive glycemic control group vs. 91% of patients in the control group. The median survival was 7.0 years in the intensive glycemic control group vs. 4.7 years in the control group (p = 0.027).

Interpretation:

Insulin-glucose infusion followed by a multidose insulin therapy improved long-term survival in diabetic patients after AMI. Possible mechanisms for this benefit are that intense insulin may restore impaired platelet function, decrease PAI-1 activity, and possibly improve metabolism of noninfarcted areas. The period of enrollment was 1990 to 1993; therefore, the findings might be less robust in the current era with potent antiplatelet therapy, lipid-lowing therapy, antihypertensive therapy, and improved glycemic control.

References:

Ritsigner V, Malmberg K, Mårtensson A, Rydén L, Wedel H, Norhammar A. Intensified insulin-based glycaemic control after myocardial infarction: mortality during 20 year follow-up of the randomised Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction (DIGAMI 1) trial. Lancet Diabetes Endocrinol 2014;May 13:[Epub ahead of print].

Malmberg K, Rydén L, Efendic S, et al. Randomised trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on one year mortality. J Am Coll Cardiol 1995;26:57-65. 

Malmberg K, for the DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. BMJ 1997;314:1512-15.

Keywords: Myocardial Infarction, Insulin, Follow-Up Studies, Lipids, Coronary Disease, Plasminogen Activator Inhibitor 1, Blood Platelets, Risk Factors, Hypoglycemia, Blood Glucose, Cardiovascular Diseases, Hypoglycemic Agents, Diabetes Mellitus


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