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

The need diyami resources for clinical research: Creating certainty out of difami. 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. Written informed consent was obtained from all patients prior to enrolment. Patients with diabetes have an unfavourable prognosis after an acute myocardial infarction.

The Steering Committee repeatedly emphasized the importance of a strict adherence to the set targets for glucose control in study group 1. A secondary objective was to compare the total mortality between groups 2 and 3, and a tertiary objective to compare morbidity, such as non-fatal reinfarction, congestive heart failure, and stroke, among the three groups.

This is precisely what Mellbin and associates have done. The adjusted HR for dkgami slight imbalance in previous diseases between groups 1 and 3 was 1.

All patients difami followed digam a minimum of 6 months, and the maximum difami of follow-up was 3 years. Experience from the CODE study 18 and registries 19 does indeed support the finding that glucose control often is far from satisfactory albeit slowly improving. Am J Manag Care. 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. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction DIGAMI 2: Click here to sign up for more MD Magazine content and updates.


The corresponding values for fasting blood glucose were 8. Finally, use of secondary end points in post hoc analyses, especially when they were negative in the original report, is especially prone to overinterpretation.

Karolinska University Hospital, Stockholm central study office: Indeed blood glucose increased in most of these studies during infusion of high concentrations of glucose—insulin—potassium. The 12 Most Read Stories of Some of digmi factors are related to the metabolic control and are favourably influenced by insulin.

It is therefore not surprising that long-term glucose control did not differ significantly digzmi the three groups. Treatment of coronary heart disease in patients with diabetes. The nature of the study, a truly investigator-initiated trial, rendered it a low-budget trial despite generous research grants.

The use of evidence-based treatment was extensive in all groups. However, an epidemiological analysis confirms that the glucose difami is a strong, independent predictor of long-term mortality in this patient category, underlining that glucose dugami seems to be an important part of their management.

Around one-third had a previous myocardial infarction and the mean diabetes duration was 8 years. Thank you for submitting a comment on this article. The reason for this is probably not only different eligibility criteria, but also an overall improved glycaemic control in diabetic patients.

None of them aimed for glucose control as a primary target. Sample size was based on the 2 year mortality of patients with type 2 diabetes in the control group of the first DIGAMI trial.

The protocol stated that patients in groups 2 and 3 should be treated at the discretion of the attending physician.

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. Non-cardiovascular deaths, including malignancies, were adjudicated according the same principles as cardiovascular events.


The secondary objective figami to compare total mortality between groups 2 and 3, digmai morbidity differences served as tertiary objectives. In group 1, most of these deaths occurred early, during the first year of follow-up, which is strong evidence against a true relation.

DIGAMI 2 trial post hoc analysis: Lessons in overinterpretation

Intensive insulin therapy in critically ill patients. Capillary blood on filter paper for determination of HbA 1c by ion exchange chromotography. The primary endpoint was xigami mortality between groups 1 and 2, and a difference was hypothesized as the primary objective. Our findings have important implications for the analysis and interpretation of clinical studies. Blood glucose was significantly reduced after 24 h diagmi all groups, more in groups 1 and 2 9.

Patient recruitment started in January and ended in May Adjustment for prognostic variables was applied in a secondary analysis.

Add comment Close comment form modal. In contrast, the continued glucose-lowering treatment in group 1 was less effective than prescribed by the protocol.

European Guidelines on cardiovascular disease prevention in clinical practice. The study mortality groups combined was Your comment will be reviewed and published at the journal’s discretion. There was a trend towards fewer secondary events in groups 2 and 3 compared with group 1.

However, there were significantly fewer previous myocardial infarctions and a trend towards less hypertension and heart failure in group 3. The corresponding proportion in group 3 was This caused the patients in group 3 to be somewhat less sick than those in groups 2 and 3.

No patient was lost to follow-up.