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WASHINGTON – Adding colchicine to standard anti-inflammatory treatment for patients with recurrent pericarditis led to significantly fewer subsequent recurrences than did standard treatment alone in a randomized trial with 240 patients.
The findings cement colchicine as a first-line treatment for pericarditis patients who need drug treatment, Dr. Massimo Imazio said at the annual meeting of the American College of Cardiology. "Taken together with results from other randomized controlled trials, these findings suggest that colchicine should probably be regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications."
Concurrent with Dr. Imazio’s report at the meeting, the results of the study were published online. (Lancet 2014 [doi:10.1016/S0140-6736(13)62709-9]).
The CORP 2 (Colchicine for Recurrent Pericarditis 2) trial was conducted at four centers in Italy during 2005-2012 and enrolled 240 adults with an episode of pericarditis and a documented prior pericarditis episode that had been followed by a symptom-free interval of at least 6 weeks.
For the study, Dr. Imazio and his associates randomized patients to received colchicine, either at 0.5 mg b.i.d. or once daily in patients weighing 70 kg or less, with no loading dose to avoid potential gastrointestinal adverse effects. Patients also received standard anti-inflammatory treatment with aspirin, ibuprofen, or indomethacin, and select patients could receive corticosteroid treatment. Treatment was continued for 6 months. Patients averaged 49 years of age; more than 80% had idiopathic pericarditis with the rest divided nearly equally between cardiac injury syndrome and connective tissue disease. Enrollment excluded patients with bacterial or neoplastic etiologies for their pericarditis.
Pericarditis occurred in 22% of patients treated with colchicine and 43% of those on placebo during an average follow-up of 20 months, a statistically significant difference for the study’s primary endpoint, reported Dr. Imazio, a cardiologist at Maria Vittoria Hospital in Torino, Italy. This benefit translated into a number needed to treat of five patients to prevent one pericarditis recurrence during 18 months of follow-up, he said. Colchicine was as effective in patients previously treated with the drug as in colchicine-naive patients, and was equally effective in all of the etiologies studied.
The dosage of colchicine used was well tolerated with no excess adverse effects or treatment discontinuations compared with placebo and no serious adverse effects. Overall, colchicine cut recurrence rates by about half based on a meta-analysis of these results along with those from six prior reports from randomized controlled trials of colchicine in a total of 1,275 patients with either a first episode or recurrent pericarditis, Dr. Imazio said. The meta-analysis also showed a consistent safety profile, with no excess adverse events or need for treatment withdrawal. The 6-month duration of treatment was selected arbitrarily; a future study could evaluate the drug for a longer treatment period, he added.
A concern with colchicine is that it morphed a few years ago from a cheap generic drug to a rebranded trade drug, Colcrys, with a large rise in price. Takeda, the company that now solely markets colchicine in the United States, had no role in the CORP 2 study.
Dr. Imazio said that he had no relevant financial disclosures.
On Twitter @mitchelzoler
These results are a major and important advance. Patients with recurrent pericarditis often require treatment with a corticosteroid that is effective, but patients frequently relapse when you try to taper the dose. It can be a very difficult down titration, and persistent corticosteroid treatment can cause salt retention and hypertension.
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Mitchel L. Zoler/Frontline Medical News
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In my practice colchicine is the drug of choice for patients with either a first episode or a recurrence of pericarditis. The dosing schedule used in the current study avoided the adverse effects that had been seen in prior studies with colchicine.
Colchicine is better than standard anti-inflammatory drugs, but it is not widely used for pericarditis in the United States, in part because the price has risen dramatically in recent years. But even at its current price, I use colchicine for all pericarditis patients, except those with a mild, brief episode that can be treated with aspirin alone. Patients with persistent and recurrent pericarditis can have persistent pain and can really suffer. Pericarditis is difficult to treat, but colchicine markedly helps. It ought to be used more than it currently is, although it has no labeling for this indication.
Dr. Allan S. Jaffe is a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. He said that he has been a consultant to or received honoraria from 10 drug or device companies but has no relationship with Takeda, the company that markets colchicine. He made these remarks in an interview and as a discussant for the report at the meeting.
These results are a major and important advance. Patients with recurrent pericarditis often require treatment with a corticosteroid that is effective, but patients frequently relapse when you try to taper the dose. It can be a very difficult down titration, and persistent corticosteroid treatment can cause salt retention and hypertension.
|
Mitchel L. Zoler/Frontline Medical News
|
In my practice colchicine is the drug of choice for patients with either a first episode or a recurrence of pericarditis. The dosing schedule used in the current study avoided the adverse effects that had been seen in prior studies with colchicine.
Colchicine is better than standard anti-inflammatory drugs, but it is not widely used for pericarditis in the United States, in part because the price has risen dramatically in recent years. But even at its current price, I use colchicine for all pericarditis patients, except those with a mild, brief episode that can be treated with aspirin alone. Patients with persistent and recurrent pericarditis can have persistent pain and can really suffer. Pericarditis is difficult to treat, but colchicine markedly helps. It ought to be used more than it currently is, although it has no labeling for this indication.
Dr. Allan S. Jaffe is a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. He said that he has been a consultant to or received honoraria from 10 drug or device companies but has no relationship with Takeda, the company that markets colchicine. He made these remarks in an interview and as a discussant for the report at the meeting.
These results are a major and important advance. Patients with recurrent pericarditis often require treatment with a corticosteroid that is effective, but patients frequently relapse when you try to taper the dose. It can be a very difficult down titration, and persistent corticosteroid treatment can cause salt retention and hypertension.
|
Mitchel L. Zoler/Frontline Medical News
|
In my practice colchicine is the drug of choice for patients with either a first episode or a recurrence of pericarditis. The dosing schedule used in the current study avoided the adverse effects that had been seen in prior studies with colchicine.
Colchicine is better than standard anti-inflammatory drugs, but it is not widely used for pericarditis in the United States, in part because the price has risen dramatically in recent years. But even at its current price, I use colchicine for all pericarditis patients, except those with a mild, brief episode that can be treated with aspirin alone. Patients with persistent and recurrent pericarditis can have persistent pain and can really suffer. Pericarditis is difficult to treat, but colchicine markedly helps. It ought to be used more than it currently is, although it has no labeling for this indication.
Dr. Allan S. Jaffe is a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn. He said that he has been a consultant to or received honoraria from 10 drug or device companies but has no relationship with Takeda, the company that markets colchicine. He made these remarks in an interview and as a discussant for the report at the meeting.
WASHINGTON – Adding colchicine to standard anti-inflammatory treatment for patients with recurrent pericarditis led to significantly fewer subsequent recurrences than did standard treatment alone in a randomized trial with 240 patients.
The findings cement colchicine as a first-line treatment for pericarditis patients who need drug treatment, Dr. Massimo Imazio said at the annual meeting of the American College of Cardiology. "Taken together with results from other randomized controlled trials, these findings suggest that colchicine should probably be regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications."
Concurrent with Dr. Imazio’s report at the meeting, the results of the study were published online. (Lancet 2014 [doi:10.1016/S0140-6736(13)62709-9]).
The CORP 2 (Colchicine for Recurrent Pericarditis 2) trial was conducted at four centers in Italy during 2005-2012 and enrolled 240 adults with an episode of pericarditis and a documented prior pericarditis episode that had been followed by a symptom-free interval of at least 6 weeks.
For the study, Dr. Imazio and his associates randomized patients to received colchicine, either at 0.5 mg b.i.d. or once daily in patients weighing 70 kg or less, with no loading dose to avoid potential gastrointestinal adverse effects. Patients also received standard anti-inflammatory treatment with aspirin, ibuprofen, or indomethacin, and select patients could receive corticosteroid treatment. Treatment was continued for 6 months. Patients averaged 49 years of age; more than 80% had idiopathic pericarditis with the rest divided nearly equally between cardiac injury syndrome and connective tissue disease. Enrollment excluded patients with bacterial or neoplastic etiologies for their pericarditis.
Pericarditis occurred in 22% of patients treated with colchicine and 43% of those on placebo during an average follow-up of 20 months, a statistically significant difference for the study’s primary endpoint, reported Dr. Imazio, a cardiologist at Maria Vittoria Hospital in Torino, Italy. This benefit translated into a number needed to treat of five patients to prevent one pericarditis recurrence during 18 months of follow-up, he said. Colchicine was as effective in patients previously treated with the drug as in colchicine-naive patients, and was equally effective in all of the etiologies studied.
The dosage of colchicine used was well tolerated with no excess adverse effects or treatment discontinuations compared with placebo and no serious adverse effects. Overall, colchicine cut recurrence rates by about half based on a meta-analysis of these results along with those from six prior reports from randomized controlled trials of colchicine in a total of 1,275 patients with either a first episode or recurrent pericarditis, Dr. Imazio said. The meta-analysis also showed a consistent safety profile, with no excess adverse events or need for treatment withdrawal. The 6-month duration of treatment was selected arbitrarily; a future study could evaluate the drug for a longer treatment period, he added.
A concern with colchicine is that it morphed a few years ago from a cheap generic drug to a rebranded trade drug, Colcrys, with a large rise in price. Takeda, the company that now solely markets colchicine in the United States, had no role in the CORP 2 study.
Dr. Imazio said that he had no relevant financial disclosures.
On Twitter @mitchelzoler
WASHINGTON – Adding colchicine to standard anti-inflammatory treatment for patients with recurrent pericarditis led to significantly fewer subsequent recurrences than did standard treatment alone in a randomized trial with 240 patients.
The findings cement colchicine as a first-line treatment for pericarditis patients who need drug treatment, Dr. Massimo Imazio said at the annual meeting of the American College of Cardiology. "Taken together with results from other randomized controlled trials, these findings suggest that colchicine should probably be regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications."
Concurrent with Dr. Imazio’s report at the meeting, the results of the study were published online. (Lancet 2014 [doi:10.1016/S0140-6736(13)62709-9]).
The CORP 2 (Colchicine for Recurrent Pericarditis 2) trial was conducted at four centers in Italy during 2005-2012 and enrolled 240 adults with an episode of pericarditis and a documented prior pericarditis episode that had been followed by a symptom-free interval of at least 6 weeks.
For the study, Dr. Imazio and his associates randomized patients to received colchicine, either at 0.5 mg b.i.d. or once daily in patients weighing 70 kg or less, with no loading dose to avoid potential gastrointestinal adverse effects. Patients also received standard anti-inflammatory treatment with aspirin, ibuprofen, or indomethacin, and select patients could receive corticosteroid treatment. Treatment was continued for 6 months. Patients averaged 49 years of age; more than 80% had idiopathic pericarditis with the rest divided nearly equally between cardiac injury syndrome and connective tissue disease. Enrollment excluded patients with bacterial or neoplastic etiologies for their pericarditis.
Pericarditis occurred in 22% of patients treated with colchicine and 43% of those on placebo during an average follow-up of 20 months, a statistically significant difference for the study’s primary endpoint, reported Dr. Imazio, a cardiologist at Maria Vittoria Hospital in Torino, Italy. This benefit translated into a number needed to treat of five patients to prevent one pericarditis recurrence during 18 months of follow-up, he said. Colchicine was as effective in patients previously treated with the drug as in colchicine-naive patients, and was equally effective in all of the etiologies studied.
The dosage of colchicine used was well tolerated with no excess adverse effects or treatment discontinuations compared with placebo and no serious adverse effects. Overall, colchicine cut recurrence rates by about half based on a meta-analysis of these results along with those from six prior reports from randomized controlled trials of colchicine in a total of 1,275 patients with either a first episode or recurrent pericarditis, Dr. Imazio said. The meta-analysis also showed a consistent safety profile, with no excess adverse events or need for treatment withdrawal. The 6-month duration of treatment was selected arbitrarily; a future study could evaluate the drug for a longer treatment period, he added.
A concern with colchicine is that it morphed a few years ago from a cheap generic drug to a rebranded trade drug, Colcrys, with a large rise in price. Takeda, the company that now solely markets colchicine in the United States, had no role in the CORP 2 study.
Dr. Imazio said that he had no relevant financial disclosures.
On Twitter @mitchelzoler
AT ACC 14
Major finding: Patients with recurrent pericarditis treated with colchicine had a 22% recurrence rate compared with a 43% rate in control patients.
Data source: A randomized placebo-controlled trial with 240 patients enrolled at four centers in Italy.
Disclosures: Dr. Imazio said he had no relevant financial disclosures. Takeda, the sole company marketing colchicine (Colcrys) in the United States, played no role in the CORP 2 study. Dr. Jaffe said that he has been a consultant to or received honoraria from 10 drug or device companies, but he has no relationship with Takeda.
