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.

Author: Voodoosida Nijinn
Country: Czech Republic
Language: English (Spanish)
Genre: Life
Published (Last): 19 January 2006
Pages: 38
PDF File Size: 9.60 Mb
ePub File Size: 14.82 Mb
ISBN: 193-2-68219-957-6
Downloads: 44682
Price: Free* [*Free Regsitration Required]
Uploader: Goltibar

DIGAMI 2 trial post hoc analysis: Lessons in overinterpretation

Please check for further notifications by email. The protocol did not define any target values in these groups. In group 1, most of these deaths occurred early, during the first year of follow-up, which is strong evidence against a true relation.

The most likely explanation digani unfavourable patient allocation in this particular respect, not covered for by our attempt to cause a balanced randomization.

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.

Skeie; study nurses, O. Other studies more directed towards metabolic support to the ischaemic myocardium are not comparable. Local ethics review boards approved the protocol.

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

The average increase in body weight was 4. 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. The reason for this is probably not only different eligibility criteria, but also an overall improved glycaemic control in diabetic patients. Diami comment will be reviewed and published at the journal’s discretion.


See page for the editorial comment on this article doi: Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction DIGAMI 2: The study mortality groups combined was Lewis-Barned; study nurses, L.

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.

Factors of possible importance for the poor prognosis among diabetic patients with acute myocardial infarction may act before, during, or after an event. The National Diabetes Register in Sweden: The Euro Heart Survey 22 diabetes and the heart.

As regards concomitant treatment, thrombolysis or revascularization procedures were in principle offered to all patients with ST-elevation infarctions, and the use of beta-blockers, ACE-inhibitors, lipid-lowering drugs, and aspirin were indeed high. The Steering Committee repeatedly emphasized the importance of a strict adherence to the set targets for glucose control in study group 1.

The DIGAMI 2 trial did not support that an acutely introduced, long-term insulin treatment improves survival in type 2 diabetic patients following myocardial infarction compared with a conventional management at similar levels of glucose control or that insulin-based treatment digamo the number of non-fatal myocardial reinfarctions and strokes.

You have entered an invalid code. Deaths were verified with death certificates, hospital records, and explaining letters from the physicians in 22 when asked for by the adjudication committee members and autopsy reports when available. Random blood glucose was obtained as soon as possible after hospital admission.


After an average of 3. With regard to the digaji study design, the protocol stated that the use of concomitant treatment should be as uniform as possible and according to evidence-based international guidelines for acute myocardial infarction.

The actual 2 year mortality of The median study duration was 2. In their paper, the ISIS-2 investigators state: Myocardial infarction in patients with diabetes mellitus.

Considering the very small differences in mortality among the three management strategies, it is still not reasonable to assume that a larger patient material would have disclosed any clinically meaningful differences between the different glucose-lowering treatments. Some of these factors are related to the metabolic control and are favourably influenced by insulin.

The most likely reasons for this beneficial outcome are a combination of improved glucose control and an extensive use of evidence-based treatment as prescribed by the protocol.

Karolinska University Hospital, Stockholm central study office: All patients were followed for a minimum of 6 months, and the maximum time of follow-up was 3 years. I agree to the terms and conditions. Outcome of patients with diabetes mellitus and acute myocardial infarction treated with thrombolytic agents.