WASHINGTON (March 30, 2014) -- A medication traditionally used to treat gout is also effective at treating recurrent pericarditis, an inflammation of the sac-like covering around the heart, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.
In the first multicenter, double-blind trial to look at the use of colchicine for multiple recurrences of pericarditis, 240 patients were randomly assigned to either the study drug or placebo to examine the primary endpoint of recurrent pericarditis. The rate of disease recurrence was nearly twice as high in the placebo group as in the colchicine group (42.5 percent compared to 21.6 percent).
In addition, colchicine reduced patients' symptoms at 72 hours from 44.2 percent with the placebo to 19.2 percent in the colchicine group. It also reduced the number of recurrences per patient from 0.63 with placebo to 0.28 and reduced the hospitalization rate from 10 percent in the placebo group to 1.7 percent in the colchicine group. The drug also significantly improved patients' remission rates, with 59.2 percent in remission at one week in the placebo compared to 83.3 percent in the colchicine group.
"Based on this study, health care providers should feel confident with the use of colchicine as a first line drug in patients with multiple recurrences of pericarditis," said Massimo Imazio, M.D., cardiologist, Maria Vittoria Hospital, Torino, Italy, and lead investigator of the study. "Our study shows this is a safe and effective treatment solution for these patients."
Recurrent pericarditis is a syndrome in which inflammation of the sac around the heart recurs, even after the original cause is treated. Although the reason is often unknown, possible causes include infections, diseases such as cancer or kidney failure, and heart surgery or trauma.
Patients assigned to the colchicine group took 0.5 mg once (if they weighed 154 pounds or less) or twice (if more than 154 pounds) daily for six months, in addition to conventional anti-inflammatory therapy with aspirin, ibuprofen or indomethacin.
While colchicine is currently approved only for use with gout and Familial Mediterranean Fever (a genetic inflammatory disease), previous studies have also looked at the off-label use of colchicine added to conventional therapy in treating acute pericarditis. No clinical trials had examined the use of colchicine for multiple recurrences of pericarditis.
"A recurrence [of pericarditis] is often perceived by either the physician or the patient as a failure of previous treatments and a need for new therapies," Imazio said. "Other therapies, such as immunosuppressive options, are often more expensive and have more complications and side effects. We now know that colchicine can be added to the traditional treatment regimen [of anti-inflammatories and corticosteroids] and provide more cost-effective and easy-to-manage treatment with fewer side effects."
Gastrointestinal upset was the major limiting side effect in the colchicine group, reported in less than eight percent of patients. No serious adverse effects were recorded.
Imazio recommends additional research to better understand the causes of recurrent pericarditis and the optimal duration of treatment with colchicine.
Support for the study came from the Italian National Health Service, and study drugs were provided through an unrestricted grant from Acarpia, Madeira, Portugal.
The study will be published simultaneously in The Lancet medical journal online.
The ACC's Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC14 for the latest news from the meeting.
The American College of Cardiology is a nonprofit medical society comprised of 47,000 physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College is dedicated to transforming cardiovascular care, improving heart health and advancing quality improvement, patient-centered care, payment innovation and professionalism. The ACC also leads the formulation of important cardiovascular health policy, standards and guidelines. It bestows credentials upon cardiovascular specialists, provides professional education, supports and disseminates cardiovascular research, and operates national registries to measure and promote quality care. For more information, visit CardioSource.org.