Colchicine Drug Interactions May Not Affect Safety, Efficacy

TOP LINE:

The presence of ORCA class 3 or 4 drug-drug interactions (DDIs) did not increase the risk of colchicine-related adverse events or modify the effect of colchicine on death or survival. hospitalized due to COVID-19. death in ambulatory patients with COVID-19.

WORK:

• This second analysis of the COLCORONA trial aimed to evaluate whether the possible DDI of colchicine is related to changes in its pharmacokinetics or has changed its clinical safety and effectiveness in patients with COVID-19.
• In total, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or placebo. (n = 2227).
• All participants had at least one risk factor such as age ≥ 70 years, diabetes, heart disease, systolic blood pressure ≥ 150 mm Hg, respiratory disease, heart, body temperature ≥ 38.4 ° C during the last 48 hours, dyspnea. , bicytopenia, pancytopenia, or a high neutrophil count with a low lymphocyte count.
• Medicines that could interact with colchicine were selected and classified under ORCA categories 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (low risk).
• The primary outcome was any gastrointestinal adverse event assessed during the 30-day follow-up period.

TAKE AWAY:

• Among all participants, 1% received medication with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most commonly used drugs.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without DDI and those with DDI, respectively, by the effect of colchicine is stable despite the presence of drug interactions.Q = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on the combined risk of hospitalization or death from COVID-19 (Q = .80 for interaction).

USE:

“Once potential DDIs are identified through screening, they must be evaluated,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, they wrote in an invited commentary published online. on September 6 JAMA Network Open. “Theoretical DDIs may not translate to real-world risks,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. Published online on September 6 JAMA Network Open.

ACTIONS:

This study focused on medications used by participants at baseline, which may not have captured all potential DDIs. The studies did not provide information on rare adverse events, such as rhabdomyolysis, which often occur months after starting drug treatment. In addition, all study participants confirmed SARS-CoV-2 infection, which may increase their likelihood of experiencing adverse reactions associated with colchicine use.

DISCLOSURE:

Other authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, the American Heart Association, and other sources. The authors also declared that they serve on advisory boards or boards of directors; receiving personal fees, grants, research support, or speaking fees; or have other ties to many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors have reviewed this content before publication.