J Am Heart Assoc. 2026 Jul 10:e047605. doi: 10.1161/JAHA.125.047605. Online ahead of print.
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 patients with baseline C-reactive protein elevation, C-reactive protein was normal at Week 8 in 8 patients (80%). During the extension period, 17 (71%) of 24 patients remained free of pericarditis recurrence. A serious adverse event leading to cannabidiol discontinuation occurred in 1 patient.
CONCLUSIONS: In symptomatic patients with recurrent pericarditis, pharmaceutically manufactured cannabidiol appears safe and associated with reductions in pericarditis pain and systemic inflammation.
REGISTRATION: URL: clinicaltrials.gov; Unique Identifier: NCT05494788.
PMID:42432451 | DOI:10.1161/JAHA.125.047605