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POPE: Postoperative therapy with diclofenac yielded no effect on size of pericardial effusion
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Treatment with diclofenac neither reduced the size of pericardial effusions nor decreased the rate of tamponade in patients recovering from surgery, study results suggested.
Researchers for the POPE study enrolled 196 patients at high risk for tamponade due to moderate to large persistent pericardial effusion of grade 2, 3 or 4 more than seven days after surgery. Pericardial effusion was assessed using echocardiography. Patients were randomly assigned to either 50 mg of the nonsteroidal antiinflammatory drug diclofenac (n=98) or placebo (n=98) twice a day for 14 days. The primary study endpoint was the mean change from baseline in the grade of pericardial effusion at 14 days.
The mean change for pericardial effusion from baseline was –1.08 grades in the placebo group vs. –1.36 in the diclofenac group (P=.11). Diclofenac therapy did not modify the secondary study endpoint of tamponade frequency (P=.49). The researchers reported that the mean change in the width for pericardial effusion was –4.8 mm in the placebo group vs. –6.7 mm in the diclofenac group, with a –1.92-mm mean difference between groups (P=.07).
“Diclofenac therapy did not seem to have a significant effect on the evolution of moderate to severe pericardial effusion that persists more than seven days after cardiac surgery,” the researchers concluded.
In an accompanying editorial, Massimo Imazio, MD, a cardiologist at Maria Vittoria Hospital in Turin, Italy, cautioned against routine use of antiinflammatory therapies until more evidence of benefit has been demonstrated.
“The POPE study and other available evidence suggest that until we have further data, clinicians should avoid the routine use of antiinflammatory therapies in the absence of evidence of inflammation, such as elevated C-reactive protein levels or other symptoms,” Imazio wrote. “However, careful monitoring of postoperative pericardial effusions is warranted, especially for large effusions.”
Meurin P. Ann Intern Med. 2010;152:137-143.