Efficacy and Safety of Pharmaceutically Manufactured Cannabidiol in Recurrent Pericarditis: A Phase II Clinical Trial
Abstract
Background: Recurrent pericarditis may be mediated through inappropriate activation of the NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome. Pharmaceutically manufactured cannabidiol is an oral formulation that inhibits NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome activation and development of pericarditis in a preclinical model.
Methods: This Phase 2, open-label, multicenter trial included adult patients with symptomatic recurrent pericarditis: pericarditis chest pain ≥4 on an 11-point numerical rating scale with an elevated C-reactive protein (≥1 mg/dL) or at least mild pericardial inflammation on cardiac magnetic resonance imaging. At enrollment, patients were on stable doses of non-steroidal anti-inflammatory drugs, colchicine, and/or corticosteroids. Cannabidiol was administered during an 8-week treatment period and an optional 18-week extension period when background therapy was tapered and discontinued. The primary efficacy end point was change in patient-reported pericarditis pain. Secondary end points included normalization of C-reactive protein and percentage of patients with recurrences.
Results: Among 27 patients (18 women, mean age 53 years), baseline maximal numerical rating scale pain score was 5.8±1.7, and 10 patients had elevated C-reactive protein. At Week 8, maximal numerical rating scale pain score was 2.1±1.8, and median time to numerical rating scale score ≤2 was 5 days. Among the 10…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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