ESC Report 2013 – Colchicine effective in acute pericarditis

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.

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 Vittoria Hospital in Turin, Italy.

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 , 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.

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,” explained Imazio.

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 to 6 week interval in which the patient was free of symptoms differentiated patients with incessant disease and those with recurrent disease.

“We tend to treat pericarditis — which is a rare disorder — with anti-inflammatory medications such as nonsteroidal 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 three 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.

Reference:

New England Journal of Medicine

Source reference:

Imazio et al, “A Randomized trial of colchicine for acute pericarditis” NEJM 2013; DOI: 10.1056/NEJMoa1208536.