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Study Confirms Need for Metabolic Control in Diabetes After Heart Attack

Irl Hirsch, MD and Bruce Goldfarb

A highly anticipated follow-up study assessing the metabolic management of patients with diabetes who are suspected of having acute myocardial infarction (AMI) has confirmed the value of aggressive metabolic control. Patients in all of the study groups— including the control group— showed an overall mortality of 18.4%, substantially lower than the expected rate of 22.3%.

The Diabetes Mellitus Insulin-Glucose Infusion in Acute Myocardial Infarction 2 (DIGAMI 2) trials "[present] lower mortality than anything I've ever seen reported in the diabetic population," says Karolinska Institute cardiologist Lars Rydén, MD, who presented the controversial findings at the annual meeting of the European Association for the Study of Diabetes (EASD) in Munich (see page 4 for editorial).

Despite the overall message about the efficacy of high control, however, DIGAMI 2 raised questions about how best to achieve that control. The study found no advantage with a glucose-insulin-potassium (GIK) infusion over insulin glucose infusion followed by standard metabolic control—or even routine metabolic management according to local practice.

Patients with diabetes tend to have a high rate of mortality following AMI. The first DIGAMI study, reported in 1995, revealed that patients who received GIK infusion and subsequent subcutaneous insulin therapy had about 30% lower mortality than those who received the usual care for AMI and diabetes based on the treating physician's judgment.

DIGAMI raised as many questions as it answered, mainly whether the emergent GIK infusion or the ongoing insulin management was responsible for improved mortality.

DIGAMI 2 included a total of 1,253 patients with suspected acute myocardial infarction from 48 hospitals in Europe. Patients were randomized to one of three groups: (1) acute insulin-glucose infusion followed by insulin-based long-term glucose control (474 patients); (2) insulin-glucose infusion followed by standard glucose control (i.e., no insulin) (473 patients); or (3) routine metabolic management according to local practice (306 patients).

The primary endpoint was all-cause mortality between groups 1 and 2 according to intention-to-treat analysis, while mortality differences between groups 2 and 3 and morbidity differences served as secondary and tertiary endpoints, respectively. The mean time of follow-up was about 2 years.

Researchers found no statistical differences between the groups in terms of mortality, stroke, or second AMI. Despite the unexpected results, investigators say the data show important benefits from aggressive metabolic management following AMI in patients with diabetes.

Several reasons account for the results, says DIGAMI 2 principal investigator Klas Malmberg, MD, also of Karolinska Institute. Overall, patients in DIGAMI 2 were younger and healthier than those in the earlier DIGAMI study. More importantly, patients in all three groups were treated aggressively, resulting in an overall mortality rate of 18.4%, which is substantially lower than the expected rate of 22.3%.

The majority of subjects in all three groups received state-of-the-art cardiac treatments: acute reperfusion, beta-blockers (80%), aspirin (almost 90%), ACE inhibitors (65%), and statin therapy (65%).

Initial blood glucose and glycated hemoglobin (A1C) levels were not different between the three groups: approximately 229 mg/dl and 7.3%, respectively. Both of these values are substantially lower than the initial glycemic values in the first DIGAMI study.

Groups 1 and 2, receiving the GIK infusions, had statistically significant improvements in glycemia: 164 mg/dl for both groups compared to 180 mg/dl for group 3. Forty-one percent in group 3 received extra insulin during the hospital period and 14% received an insulin infusion.

Researchers found that fasting blood glucose (FBG) and the patient's age were predictors of outcomes. An elevated FBG increased the risk of death by 20%, according to investigators, while increasing the patient's age by 10 years raised the risk of mortality within 2 years of AMI by 210%.

"We have confirmed that glucose level is a strong independent predictor of mortality following acute myocardial infarction," says Malmberg. "We think that the study shows that it's important to treat patients with diabetes as intensively as possible with all means."

Footnotes

FYI

DIGAMI Study Group, Malmberg K, Rydén L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L: A randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction: Effects on mortality at 1 year. J Am Coll Cardiol 26: 57–65, 1995[Abstract].

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Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hirsch, I. Articles by Goldfarb, B. Search for Related Content PubMed Articles by Hirsch, I. Articles by Goldfarb, B. Social Bookmarking                What's this?