A pharmaceutically manufactured cannabidiol (CBD) formulation has a good overall safety profile with no cardiac safety concerns, reported a new study recently presented at Heart Failure 2025, a scientific congress of the European Society of Cardiology.
“We knew that patients with cardiovascular disease (CVD) or CVD risk factors who were hospitalized for COVID-19 infection may be at high risk of cardiac inflammation. We conducted a placebo-controlled trial of an oral pharmaceutically manufactured (GMP) cannabidiol formulation to assess its efficacy and safety,” co-principal investigator, Dr. Leslie Cooper from the Mayo Clinic, Jacksonville, Florida, said in a press release.
"The pandemic ended before we had recruited sufficient participants to analyze whether GMP-cannabidiol had a positive effect on the primary efficacy endpoint, but we thought that the lack of safety signals was important data to share," he added.
The study included 89 patients with an average age of 61 years old. Recruitment criteria included a history of cardiovascular disease and/ or at least one major CVD risk factor and having been hospitalized for non-critical COVID-19. Altogether, 45 patients received GMP-cannabidiol titrated up to 7.5 mg/kg twice daily, and 44 received a placebo. The primary safety endpoint was serious adverse events during the 28-day treatment period and through to a 60-day safety follow-up visit.
Both groups ultimately reported similar safety profiles. Treatment-related adverse events occurred in 24.4% of those treated with GMP-cannabidiol and 22.7% of those treated with placebo. While 11.1% of those treated with GMP-cannabidiol experienced a serious adverse event, the same was true for 9.1% of those on the placebo.
Both groups also reported a similar cardiovascular safety profile- with cardiac disorders occurring in 9% of both groups. There were no deaths in the GMP-cannabidiol group, although two deaths were reported among those taking a placebo- both due to respiratory failure.
“GMP-cannabidiol was well tolerated overall and most importantly, the rate of cardiac side effects was low and similar compared with placebo. These safety data are encouraging as two larger trials assessing efficacy and safety are underway with GMP-cannabidiol,” said Dr. Cooper.
“The phase II ARCHER trial3 in patients with acute myocarditis is expected to report later in 2025, while results from the phase III MAVERIC trial4 in patients with recurrent pericarditis are expected in 2026,” he added.
Sources: EurekAlert, Heart Failure 2025
