Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial
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Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial. / Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian; Kofoed-Enevoldsen, Allan; Jensen, Gorm; Callesen, Torben; Nørgaard, Peter; Fruergaard, Kim; Bestle, Morten; Vedelsdal, Rune; Miran, André; Jacobsen, Jon; Roed, Jakob; Mortensen, Maj-Britt; Jørgensen, Lise; Jørgensen, Jørgen; Rovsing, Marie-Louise; Petersen, Pernille Lykke; Pott, Frank; Haas, Merete; Albret, Rikke; Nielsen, Lise Lotte; Johansson, Gun; Stjernholm, Pia; Mølgaard, Yvonne; Foss, Nikolai Bang; Elkjaer, Jeanie; Dehlie, Bjørn; Boysen, Klavs; Zaric, Dusanka; Munksgaard, Anne; Madsen, Jørn Bo; Øberg, Bjarne; Khanykin, Boris; Blemmer, Tine; Yndgaard, Stig; Perko, Grazyna; Wang, Lars Peter; Winkel, Per; Hilden, Jørgen; Jensen, Per; Salas, Nader; DIPOM Trial Group; Juul, AB; Wetterslev, J; Gluud, C; Jensen, Gorm; Foss, Nikolai Bang; Pott, Frank; Zaric, Dusanka; Jensen, Per; DIPOM Trial Group.
In: B M J, Vol. 332, No. 7556, 24.06.2006, p. 1482.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial
AU - Juul, Anne Benedicte
AU - Wetterslev, Jørn
AU - Gluud, Christian
AU - Kofoed-Enevoldsen, Allan
AU - Jensen, Gorm
AU - Callesen, Torben
AU - Nørgaard, Peter
AU - Fruergaard, Kim
AU - Bestle, Morten
AU - Vedelsdal, Rune
AU - Miran, André
AU - Jacobsen, Jon
AU - Roed, Jakob
AU - Mortensen, Maj-Britt
AU - Jørgensen, Lise
AU - Jørgensen, Jørgen
AU - Rovsing, Marie-Louise
AU - Petersen, Pernille Lykke
AU - Pott, Frank
AU - Haas, Merete
AU - Albret, Rikke
AU - Nielsen, Lise Lotte
AU - Johansson, Gun
AU - Stjernholm, Pia
AU - Mølgaard, Yvonne
AU - Foss, Nikolai Bang
AU - Elkjaer, Jeanie
AU - Dehlie, Bjørn
AU - Boysen, Klavs
AU - Zaric, Dusanka
AU - Munksgaard, Anne
AU - Madsen, Jørn Bo
AU - Øberg, Bjarne
AU - Khanykin, Boris
AU - Blemmer, Tine
AU - Yndgaard, Stig
AU - Perko, Grazyna
AU - Wang, Lars Peter
AU - Winkel, Per
AU - Hilden, Jørgen
AU - Jensen, Per
AU - Salas, Nader
AU - DIPOM Trial Group
AU - Juul, AB
AU - Wetterslev, J
AU - Gluud, C
AU - Jensen, Gorm
AU - Foss, Nikolai Bang
AU - Pott, Frank
AU - Zaric, Dusanka
AU - Jensen, Per
AU - DIPOM Trial Group
N1 - Keywords: Adrenergic beta-Antagonists; Adult; Aged; Delayed-Action Preparations; Diabetes Complications; Double-Blind Method; Female; Hemodynamics; Humans; Intraoperative Care; Male; Metoprolol; Middle Aged; Patient Compliance; Surgical Procedures, Operative; Treatment Outcome
PY - 2006/6/24
Y1 - 2006/6/24
N2 - Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome measures The composite primary outcome measure was time to all cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure. Secondary outcome measures were time to all cause mortality, cardiac mortality, and non-fatal cardiac morbidity. Results Mean duration of intervention was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459 patients in the placebo group (20%) (hazard ratio 1.06, 0.80 to 1.41) during a median follow-up of 18 months (range 6-30). All cause mortality was 16% (74/462) in the metoprolol group and 16% (72/459) in the placebo group (1.03, 0.74 to 1.42). The difference in risk for the proportion of patients with serious adverse events was 2.4% (- 0.8% to 5.6%). Conclusions Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment. Trial registration Current Controlled Trials ISRCTN58485613 [controlled-trials.com] .
AB - Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome measures The composite primary outcome measure was time to all cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure. Secondary outcome measures were time to all cause mortality, cardiac mortality, and non-fatal cardiac morbidity. Results Mean duration of intervention was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459 patients in the placebo group (20%) (hazard ratio 1.06, 0.80 to 1.41) during a median follow-up of 18 months (range 6-30). All cause mortality was 16% (74/462) in the metoprolol group and 16% (72/459) in the placebo group (1.03, 0.74 to 1.42). The difference in risk for the proportion of patients with serious adverse events was 2.4% (- 0.8% to 5.6%). Conclusions Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment. Trial registration Current Controlled Trials ISRCTN58485613 [controlled-trials.com] .
U2 - 10.1136/bmj.332.7556.1482
DO - 10.1136/bmj.332.7556.1482
M3 - Journal article
C2 - 16793810
VL - 332
SP - 1482
JO - The BMJ
JF - The BMJ
SN - 0959-8146
IS - 7556
ER -
ID: 14309267