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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Patient recruitment started in January and ended in May For Permissions, please e-mail: Random blood glucose was obtained as soon as possible after hospital admission. Creating certainty out of uncertainty. All patients were followed for a minimum of 6 months, and the maximum time of follow-up was 3 years. 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.

Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction DIGAMI study: This underlines the importance of efforts finding pharmaceutical agents and management strategies that can effectively normalize blood glucose levels.

One week following hospital discharge, patients returned to a nurse-based outpatient clinic, in particular focusing on the treatment of diabetes.

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

The prevalence of abnormal glucose regulation in patients with coronary artery disease across Europe. There was a trend towards fewer secondary events in groups 2 dgiami 3 compared with group 1. 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.


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The most likely explanation is unfavourable patient allocation in this particular respect, not covered for by our attempt to cause a digammi randomization. View large Download slide. Deaths were verified with death certificates, hospital records, and explaining letters from the physicians in charge when asked for by the adjudication committee members and autopsy reports when available.

Non-cardiovascular deaths, including malignancies, were adjudicated according the same principles as cardiovascular events. Outcome benefit of insulin therapy in the crtitical ill: The study used 3 treatment strategies: 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.

The 12 Most Read Stories of 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. Am J Manag Care. Follow-up for mortality and morbidity was concluded in December The National Diabetes Register in Sweden: Citing articles via Web of Science Thereafter, fasting blood glucose was recorded daily until hospital discharge and at each follow-up visit.

Finally, use of secondary end points in post hoc analyses, especially when they were negative in the original report, is especially prone to overinterpretation. The Diabetic Coronary Patient.

DIGAMI 2 trial post hoc analysis: Lessons in overinterpretation

The primary endpoint was all-cause mortality between groups 1 and 2, and a difference was hypothesized as the primary objective. Sign In or Create an Account. Comparisons among groups were accordingly done both for crude and for adjusted HRs.


European Guidelines on cardiovascular disease prevention in clinical practice. In group 1, most of these deaths occurred early, during the first year of follow-up, which is strong digaji against a true relation.

Deaths were labelled as cardiovascular or non-cardiovascular, and those without any obvious non-cardiovascular cause were considered cardiovascular. The study mortality groups 1—3 combined was The grey area A represents the target levels for blood glucose. Adjustment for prognostic variables was applied in a secondary analysis. After 2 years of follow-up, the Kaplan—Meier estimated mortality was Receive exclusive offers and updates from Oxford Academic. The dilemma of professional and industry relations for medical education.

The median study duration was 2. Intensive treatment of coronary artery disease in diabetic patients in clinical pactice: Mortality remains high among patients with diabetes and myocardial infarction as shown by recent registry studies, also reporting on a suboptimal use of established treatment modalities in these patients. The protocol stated that patients in groups 2 and 3 should be treated at the discretion of the attending physician.

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Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction DIGAMI 2: Management of acute myocardial infarction in patients presenting with ST-segment elevation. Outcome of patients with diabetes mellitus and acute myocardial infarction treated with thrombolytic agents. Local ethics review boards approved the protocol.

Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening.

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