European Heart Journal Advance Access originally published online on February 23, 2005
European Heart Journal
2005 26(7):650-661; doi:10.1093/eurheartj/ehi199
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Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity
1Department of Cardiology, Karolinska University Hospital Solna, 171 76 Stockholm, Sweden
2Nordic School of Public Health, Göteborg, Sweden
3Department of Endocrinology, Aker University Hospital, Oslo, Norway
4Department of Medicine, Erasmus MC, Rotterdam, The Netherlands
5Department of Medicine, Rogaland Hospital, Stavanger, Norway
6Department of Endocrinology, Karolinska University Hospital, Stockholm, Sweden
7Department of Endocrinology, Glasgow Royal Infirmary, Glasgow, UK
8Department of Medicine, Sahlgrenska University Hospital, Göteborg, Sweden
9Department of Cardiology and Endocrinology, Frederiksberg Hospital, Frederiksberg, Denmark
10Department of Medicine, Royal Devon and Exeter Hospital, Exeter, UK
11Department of Medicine, Kuopio University Hospital, Kuopio, Finland
12Department of Medicine and Cardiology, Bispebjerg Hospital, Copenhagen, Denmark
13Department of Medicine, Umeå University Hospital, Umeå, Sweden
Received 31 December 2004; revised 1 February 2005; accepted 9 February 2005; online publish-ahead-of-print 23 February 2005.
* Corresponding author. Tel: +46 8 517 7121; fax: +46 8 31 10 44. E-mail address: lars.ryden{at}medks.ki.se
See page 639 for the editorial comment on this article (doi:10.1093/eurheartj/ehi232)
Aims Patients with diabetes have an unfavourable prognosis after an acute myocardial infarction. In the first DIGAMI study, an insulin-based glucose management improved survival. In DIGAMI 2, three treatment strategies were compared: group 1, acute insulin–glucose infusion followed by insulin-based long-term glucose control; group 2, insulin–glucose infusion followed by standard glucose control; and group 3, routine metabolic management according to local practice.
Methods and results DIGAMI 2 recruited 1253 patients (mean age 68 years; 67% males) with type 2 diabetes and suspected acute myocardial infarction randomly assigned to groups 1 (n=474), 2 (n=473), and 3 (n=306). The primary endpoint was all-cause mortality between groups 1 and 2, and a difference was hypothesized as the primary objective. The secondary objective was to compare total mortality between groups 2 and 3, whereas morbidity differences served as tertiary objectives. The median study duration was 2.1 (interquartile range 1.03–3.00) years. At randomization, HbA1c was 7.2, 7.3, and 7.3% in groups 1, 2, and 3, respectively, whereas blood glucose was 12.8, 12.5, and 12.9 mmol/L, respectively. Blood glucose was significantly reduced after 24 h in all groups, more in groups 1 and 2 (9.1 and 9.1 mmol/L) receiving insulin–glucose infusion than in group 3 (10.0 mmol/L). Long-term glucose-lowering treatment differed between groups with multidose insulin (
3 doses/day) given to 15 and 13% of patients in groups 2 and 3, respectively compared with 42% in group 1 at hospital discharge. By the end of follow-up, HbA1c did not differ significantly among groups 1–3 (
6.8%). The corresponding values for fasting blood glucose were 8.0, 8.3, and 8.6 mmol/L. Hence, the target fasting blood glucose for patients in group 1 of 5–7 mmol/L was never reached. The study mortality (groups 1–3 combined) was 18.4%. Mortality between groups 1 (23.4%) and 2 (22.6%; primary endpoint) did not differ significantly (HR 1.03; 95% CI 0.79–1.34; P=0.831), nor did mortality between groups 2 (22.6%) and 3 (19.3%; secondary endpoint) (HR 1.23; CI 0.89–1.69; P=0.203). There were no significant differences in morbidity expressed as non-fatal reinfarctions and strokes among the three groups.
Conclusion DIGAMI 2 did not support the fact that an acutely introduced, long-term insulin treatment improves survival in type 2 diabetic patients following myocardial infarction when compared with a conventional management at similar levels of glucose control or that insulin-based treatment lowers the number of non-fatal myocardial reinfarctions and strokes. However, an epidemiological analysis confirms that the glucose level is a strong, independent predictor of long-term mortality in this patient category, underlining that glucose control seems to be an important part of their management.
Key Words: Myocardial infarction • Diabetes mellitus • Mortality • Morbidity • Insulin • Metabolic control
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