ESC: Colchicine Effective in Acute Pericarditis
Published: Sep 1, 2013 | Updated: Sep 1, 2013
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AMSTERDAM -- The anti-inflammatory agent colchicine -- used mostly in the treatment of gout -- appears to be effective for treating acute pericarditis and in preventing recurrences of the condition, researchers reported here.
Action Points
- The anti-inflammatory agent colchicine, used mostly in the treatment of gout, appears to be effective for treating acute pericarditis and in preventing recurrences of the condition, a study found.
- Note that treatment with colchicine also did not result in a significant increase in adverse events compared with placebo.
A total of 16.7% of 120 patients treated with colchicine experienced incessant or recurrent pericarditis, compared with 37.5% of the 120 patients assigned to placebo (P<0.01), according to Massimo Imazio, MD, of Maria Vittorio Hospital in Turin, Italy.
"In patients with acute pericarditis, colchicine, when added to conventional anti-inflammatory therapy of aspirin or ibuprofen, significantly reduced the rate of incessant or recurrent pericarditis over an 18-month period," he reported at the annual meeting of the acute pericarditis and in preventing recurrences of the condition, researchers reported here.
In a Hot-Line research oral presentation, Imazio reported that 16.7% of 120 patients treated with colchicine experienced incessant or recurrent pericarditis compared with 37.5% of the 120 patients assigned to placebo (P<0.01).
"In patients with acute pericarditis, colchicine, when added to conventional anti-inflammatory therapy of aspirin or ibuprofen, significantly reduced the rate of incessant or recurrent pericarditis over an 18-month period," he reported at the annual meeting of the European Society of Cardiology. The study was published simultaneously online by the New England Journal of Medicine.
Colchicine (Colcrys), is the only single-ingredient oral colchicine product available on the U.S. market. It was approved by the FDA in 2009; however, it is not approved for the treatment of pericarditis either in the U.S. or in Europe, the researchers noted.
The drug is currently approved in the U.S. for daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF). It also has been studied in other heart disease conditions. In addition, an earlier study performed by Imazio and colleagues -- known as the Colchicine for Acute Pericarditis (COPE) study -- found that adding colchicine to conventional treatment cut the rate of pericarditis recurrences in half, the investigators noted.
After it approved Colcrys, the FDA subsequently ordered other manufacturers of colchicine to stop selling unapproved versions of the drug.
For the study, researchers enrolled 240 patients in the international trial who were admitted to the hospital with a diagnosis of acute pericarditis. Patients were randomized to receive – in addition to standard background anti-inflammatories – colchicine in two doses, depending on weight, or placebo.
The patients were about 50 years old, and 60% were men. More than 90% of the patients were diagnosed with idiopathic pericarditis. "We believe that most of these cases were caused by some form of viral infection," Imazio told MedPage Today.
Treatment with colchicine was associated with a significant reduction in symptom persistence at 72 hours – with 40% of placebo patients still experiencing symptoms compared with 19.2% of patients taking colchicine (P=0.001).
About 85% of colchicine patients achieved remission of symptoms at one week, compared with 58.3% of those on placebo (P<0.001), Imazio reported.
He said treatment with colchicine also was significantly more effective than placebo:
- In protecting patients from incessant disease
- In protecting patients from recurrent disease
- In reducing the number of recurrences per patient
- In increasing the time to a first recurrence
- In preventing pericarditis-related hospitalizations
Treatment with colchicine also did not result in a significant increase in adverse events, Imazio noted. Overall, 10% of colchicine patients reported adverse events -- mainly gastrointestinal discomfort, as well as gastrointestinal events -- compared with 11.7% of placebo patients (P=0.84). Drug discontinuation occurred among 8.3% of those on colchicine and in 11.7% of those on placebo (P=0.52). "This is a very safe drug," he said.
"I think that doctors should consider colchicine as a first-line treatment for pericarditis," Imazio said.
Imazio noted that the 3-month treatment schedule for colchicine was an arbitrary time period based on information in clinical trial reports. He said that a 4-6-week interval in which the patient was free of symptoms differentiated patients with incessant disease and those with recurrent disease.
Kim Williams, MD, chief of cardiology at Wayne State University in Detroit and vice president of the American College of Cardiology, told MedPage Today "this study is reassuring for clinicians who now use colchicine in the treatment of acute pericarditis."
"We tend to treat pericarditis -- which is a rare disorder -- with anti-inflammatory medications such as non-steroidal anti-inflammatory drugs. Some doctors also use the steroid prednisone, although there is some belief that prednisone is associated with recurrence of the disease."
Williams said the more vexing complications of pericarditis -- cardiac tamponade and constrictive pericarditis -- occurred infrequently in the study, so that it was not possible to draw conclusions about the effectiveness of colchicine in those conditions. There were no cases of tamponade or constrictive pericarditis with colchicine; there were 3 cases of tamponade among the placebo patients (P=0.25); and one case of constrictive pericarditis among the placebo patients (P=1.00).
"The length of time of the study, from 2005 to 2013, speaks to the rarity of this disease," Williams noted.
Imazio and co-authors disclosed no conflicts of interest.
