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.
BACKGROUND
Recent trials suggest that perioperative beta-blockade reduces the risk of cardiac events in patients with a risk of myocardial ischemia who are undergoing noncardiac surgery. Patients with diabetes mellitus are at a high-risk for postoperative cardiac morbidity and mortality. They may, therefore, benefit from perioperative beta-blockade.


METHODS
The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial is an investigator-initiated and -controlled, centrally randomized, double-blind, placebo-controlled, multicenter trial. We compared the effect of metoprolol with placebo on mortality and cardiovascular morbidity rates in patients with diabetes mellitus who were beta-blocker naive, >or=40 years old, and undergoing noncardiac surgery. The study drug was given during hospitalization for a maximum of 7 days beginning the evening before surgery. The primary outcome measure is the composite of all-cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure leading to hospitalization or discovered or aggravated during hospitalization. Follow-up involves re-examination of patients at 6 months and collection of mortality and morbidity data via linkage to public databases. The study was powered on the basis of an estimated 30% 1-year event rate in the placebo arm and a 33% relative risk reduction in the metoprolol arm. The median follow-up period was 18 months.


RESULTS
Enrollment started in July 2000 and ended in June 2002. A total of 921 patients were randomized, and 54% of these patients had known cardiac disease, hypertension, or both.


CONCLUSIONS
The results of this study may have implications for reduction of perioperative and postoperative risk in patients with diabetes mellitus who are undergoing major noncardiac surgery.
Juul
Anne Benedicte
AB
Copenhagen Trial Unit, Center for Clinical Intervention Research, H:S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. anne.j@ctu.rh.dk
Wetterslev
Jørn
J
Kofoed-Enevoldsen
Allan
A
Callesen
Torben
T
Jensen
Gorm
G
Gluud
Christian
C
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D017202:Myocardial Ischemia / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D019990:Perioperative Care; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013514:Surgical Procedures, Operative / Q000401:mortality*
D000319:Adrenergic beta-Antagonists; D008790:Metoprolol