Diabetic Postoperative Mortality and Morbidity Trial - DIPOM
The goal of the trial was to evaluate whether perioperative beta-blocker administration is associated with a reduction in cardiac events in diabetic patients undergoing noncardiac surgery.
Patients Screened: 2,066
Patients Enrolled: 921
Mean Follow Up: Median 18 months
Beta-blocker naive diabetic patients age ≥40 years undergoing noncardiac surgery
Composite of all-cause mortality, acute MI, unstable angina, or congestive heart failure
Patients were randomized to either placebo (n=459) or metoprolol (n=462). Study drug was administered the evening prior to surgery (50 mg) and was continued during the hospitalization for up to seven days (100 mg/day).
The mean study drug duration was 4.6 days in the metoprolol group and 4.9 days in the placebo group. The majority of patients in the trial underwent either orthopedic or intra-abdominal surgery. Heart rate was significantly lower in the metoprolol group compared with placebo (75 vs. 84 BPM, p<0.001).
There was no difference by treatment group in the primary endpoint of death, acute myocardial infarction (MI), unstable angina, or congestive heart failure at follow-up (21% for metoprolol vs. 20% for placebo, p=0.66). Even after adjustment for age, gender, history of coronary heart disease, and malignant disease, no difference was observed (hazard ratio 1.10, p=0.53). There was also no difference in the endpoint of all-cause mortality at follow-up (16% each, p=0.88). Serious adverse events occurred in 7.1% of the metoprolol group and 5.2% of the placebo group (p=NS).
Among diabetic patients undergoing noncardiac surgery, treatment with the beta-blocker metoprolol was not associated with a reduction in the primary composite endpoint or in all-cause mortality compared with placebo.
Current guidelines recommend perioperative beta-blocker use in patients with diabetes undergoing noncardiac surgery. The recommendation was driven in part by the results of a subgroup analysis of diabetic patients in a study by Mangano DT, et al., which showed a reduction in mortality in the atenolol patients compared with placebo in the setting of noncardiac surgery. While there was no benefit with perioperative metoprolol at the dose and duration given in the present study, it is unknown if similar results would be observed with other doses, duration of administration, or different beta-blockers.
Presented by Anne Juul at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.
Juul AB, Wetterslev J, Kofoed-Enevoldsen A, Callesen T, Jensen G, Gluud C; Diabetic Postoperative Mortality and Morbidity group.The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial: rationale and design of a multicenter, randomized, placebo-controlled, clinical trial of metoprolol for patients with diabetes mellitus who are undergoing major noncardiac surgery. Am Heart J. 2004 Apr;147(4):677-83.
Keywords: Myocardial Infarction, Follow-Up Studies, Heart Failure, Metoprolol, Heart Rate, Diabetes Mellitus
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