The DIGAMI 2 Trial is reviewed and summarized including methods, results and conclusions. The primary and secondary endpoints and inclusion and exclusion . The DIGAMI Trial is reviewed and summarized including methods, results and conclusions. The primary and secondary endpoints are included as well as. Methods and results DIGAMI 2 recruited patients (mean age 68 years; 67% males) with type 2 diabetes and suspected acute myocardial.

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Sign In or Create an Account. Patients with diabetes have a two-fold increase in hospital mortality when compared with those without diabetes. These assumptions would require a sample size of patients in groups 1 and 2 and patients in group 3 for a two-tailed test with an alpha-value of 0.

The corresponding values for fasting blood glucose were 8. The outcome of DIGAMI 2 contrasts with the findings in the first DIGAMI trial, which concluded that an insulin—glucose infusion followed by insulin-based therapeutic regime reduced mortality in diabetic patients with acute myocardial infarction.

DIGAMI 2 trial post hoc analysis: Lessons in overinterpretation

The DIGAMI 2 study, originally planned to recruit patients, was stopped prematurely owing to the slow patient recruitment rate. Outpatient visits to the responsible physician were scheduled after 3, 6, 9, and 12 months and thereafter 22 sixth month. Intensive insulin digaml in critically ill patients. This experience raises the question of whether time has come to discuss for which trials community-owned hospitals should be open, as well as dgami possibilities and principles in future clinical research, as has been acknowledged by the European Society of Cardiology.

Moreover, the study could not answer the question of whether the beneficial effects related to the acute insulin—glucose infusion or to the continuous insulin-based metabolic control or both. The prevalence of abnormal glucose regulation in patients with coronary artery disease across Europe.

In their paper, the ISIS-2 investigators state: DIGAMI 2 could not provide a firm answer to the important question of whether a glucose-lowering treatment towards normoglycaemia has a potential to further improve prognosis. However, although statistically significant, this difference was smaller than expected. The overall long-term glucose control was better in the second than in the first DIGAMI trial, which may have had a favourable influence on the outcome in the latter.


There were no significant differences in morbidity expressed as non-fatal reinfarctions and strokes among the three groups. Outcome benefit of insulin therapy in the crtitical ill: Our findings have important implications for the analysis and interpretation of clinical studies. I agree to the terms and conditions. This is particularly evident in the diabetic patient, who already has a diminished capability to secrete insulin and to use glucose for production of energy rich phosphates.

Needless to say, a selection bias hampers such comparisons, but the inclusion criteria in the DIGAMI 2 were wide and without age limits, whereas the registry does not include people above the age of 80 years. The 12 Most Read Stories of Evaluation of risk factors for development of complications in type 2 diabetes in Europe. Moreover, the question concerning a possible relation between insulin and malignant diseases cannot be based on the few events in this trial but should, if of any further interest, be studied in large databases.

Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction DIGAMI study: Norhammar; study nurses, secretaries, and BMI, R. This assumption is supported by short-term data from the Munich registry report that intensification of multiple therapeutic strategies, including insulin infusions, resulted in a substantial reduction of in-hospital mortality comparable to the rates in non-diabetic patients.

Telecommunicated information about baseline variables were transferred into the computer and the subsequent randomization was based on an algorithm including important prognostic markers in the first DIGAMI trial 910 as follows: The National Diabetes Register in Sweden: 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.

Creating certainty out of uncertainty.

DIGAMI 2 trial post hoc analysis: Lessons in overinterpretation | MD Magazine

The DIGAMI 2 trial was planned and conducted to further explore the possible benefits of an insulin-based management of diabetic patients with myocardial infarction. Factors of possible importance for the poor prognosis among diabetic patients with acute myocardial infarction may act before, during, or after an event.


No patient was lost to follow-up. Thank you for submitting a comment on this article. European Guidelines on cardiovascular disease prevention in clinical practice.

The nature of the study, a truly investigator-initiated trial, rendered it a low-budget trial despite generous research grants. It had been postulated that insulin-based treatment should be superior to glucose-lowering therapy by means of oral glucose-lowering agents.

Long-term prognosis of digai patients with myocardial infarction: An important message from the DIGAMI 2 trial is that updated Digsmi and blood glucose were significant and independent mortality predictors together with the traditional risk factors age, heart failure, and elevated serum creatinin. Almost all remaining patients had coronary artery disease mostly presenting as unstable angina pectoris.

Mortality remains high among patients with diabetes and myocardial infarction as digai by recent registry studies, also reporting on a suboptimal use of established treatment modalities in these patients. The secondary objective was to compare total mortality between groups 2 and 3, whereas morbidity differences served as tertiary objectives.

Fasting blood glucose represents updated values during the time of follow-up. The hypothesis behind the study was that early and continued insulin-based metabolic control is a key to mortality reduction. The corresponding values for fasting blood glucose were 8. Cardiovascular causes were most common without any significant differences among the groups, whereas a lower incidence of non-cardiovascular deaths in group 3 explained the trend towards a somewhat lower overall mortality in this group compared with groups 2 and 3.

The study used 3 treatment strategies: Please check for further notifications by email.

There was a trend towards fewer secondary events in groups 2 and 3 compared with group 1. Still, dihami remained one of the most important prognostic predictors.

Comparisons among groups were accordingly done both for crude and for adjusted HRs. The Diabetic Coronary Patient.