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WASHINGTON -- Colchicine may be as effective at reducing multiple recurrences of pericarditis as it is in treating acute episodes and first recurrences.

In a double-blind study in four hospitals in Italy, adding colchicine to standard autoinflammatory therapy halved the risk of recurrence compared with controls, a relative risk reduction of 51% (95% CI 0.24-0.65 P=0.0009) which means that treating just five patients would prevent one, Massimo Imazio, MD of the Maria Vittoria Hospital in Turin, Italy reported in a late-breaking clinical trials presentation at the meeting here.

Twenty-six of the 120 patients randomized to weight-titrated colchicine (0.5 mg bid for patients weighing more than 70 kg or 0.5 once daily for those less than 70 kg) had recurrent pericarditis versus 51 of the 120 patients in the group that received placebo plus standard therapy with aspirin, ibuprofen, or indometacin.

The CORP-2 results were also published online in

director of the Center for Diagnosis and Treatment of Pericardial Diseases at Cleveland Clinic Foundation, said the findings from CORP-2 did appear to "perhaps confirm its utility as first-line therapy for recurrent pericarditis."

He said the typical dose in the U.S. is higher at 0.6 mg versus the 0.5 mg used in Europe (and in CORP-2), and label indication is for gout and familial Mediterranean fever. "But in pericardial practice it is used all the time."

Despite its apparent benefit, the drug can cause diarrhea and can also be problematic in patients with decreased renal function, Klein told 乌鸦传媒.

In a commentary published with the article, an INSERM researcher, cautioned that the study did not address the safety or efficacy of colchicine in patients with non-idiopathic pericarditis, and it also left unanswered the question of colchicine without a background of anti-inflammatory treatment.

In CORP-2, nine patients in the colchicine group and nine controls reported gastrointestinal intolerance and there were three cases of hepatotoxicity in the colchicine group and none in the placebo group.

Patients in the colchicine arm who weighed more than 70 kg received 0.5 mg bid or 0.5 once daily for those less than 70 kg for 6 months.

The mean age of patients was 49 and a little over half of the patients in the study were men. A majority of the patients had idiopathic pericarditis.

Aside from provision of the study drug and placebo by Acarpia, the trial did not receive industry support. But the findings represent a potential boon for Takeda, maker of Colcrys -- the only colchicine product marketed in the U.S.

Colchicine is an old drug that was long available for a price of about 9 cents per pill, but because it was "old," it never underwent a rigorous review by the FDA, which began to purge such nonreviewed drugs from its approved substances a few years ago.

With generic colchicine no longer available, Mutual Pharmaceutical sought and received FDA approval for its colchicine product, Colcrys, in 2009. when it purchased Mutual's parent company URL Pharma in 2012. Since that time, Takeda, which charges $5 per Colcrys pill, has vigorously defended the Colcrys patents and successfully blocked generic drugmakers' attempts to break into the colchicine market.