The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences. Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.
Tablets identical in colour, shape, and taste were provided in blister packs.
Internal Medicine Dpt. Ospedali Riuniti
Bergamo, Bergamo, Italy
Department of Cardiology, San Maurizio Regional Hospital
Bolzano, Bolzano, Italy
Cardiology Dpt. Ospedale SS Annunziata
Savigliano, CN, Italy
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Torino, Torino, Italy
Recurrence rate at 18 months
Symptom persistence at 72 hours, remission rate at 1 week
Number of recurrences
Time to recurrence
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
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Ospedale di Rivoli
Rivoli, Italy