Study Finds No Major Cardiovascular Risk From Nicotinamide

TOPLINE:

In a retrospective cohort study, nicotinamide exposure showed no increased risk for MACE. Prior MACE history, however, was strongly associated with subsequent MACE.

METHODOLOGY:

• To address recent safety concerns regarding the risk for MACE with nicotinamide, widely used to reduce the risk for skin cancer, researchers evaluated 13,108 patients (mean age 66.8 years; 91% men) from the Vanderbilt University Medical Center (VUMC) and Million Veteran Program (MVP) cohorts between January 1989 and February 2024.
• Overall, 5291 patients had confirmed exposure to nicotinamide.
• The primary outcome was MACE.

TAKEAWAY:

• In the VUMC cohort, the risk for MACE associated with nicotinamide use was not significantly different between participants who had no history of MACE compared with those without exposure (cause-specific hazard ratio [HR], 2.02; 95% CI, 0.81-5.05) or among those with prior MACE (cause-specific HR, 0.46; 95% CI, 0.22-0.95).
• The MVP cohort analysis also found no significant association between nicotinamide exposure and MACE in patients without prior MACE (cause-specific HR, 1.07; 95% CI, 0.75-1.17) or with prior MACE (cause-specific HR, 1.04; 95% CI, 0.53-2.06).
• Prior MACE was strongly associated with subsequent MACE development in both the VUMC (HR, 10.29; 95% CI, 6.70-15.80) and MVP cohorts (HR, 2.90; 95% CI, 2.21-3.81).
• In the MVP cohort, there was no difference in cumulative incidence of MACE among those with low, medium, or high exposure to nicotinamide among patients without prior MACE.

IN PRACTICE:

“Our study was underpowered to conclude clinically meaningful equivalence between exposed and unexposed groups, but our data should reassure clinicians that nicotinamide does not appear to convey increased risks of MACE,” the authors wrote.

SOURCE:

The study was led by Lee Wheless, MD, PhD, Department of Dermatology, VUMC, Nashville, Tennessee. It was published online on February 26 in JAMA Dermatology.

LIMITATIONS:

Limitations included misclassification bias and heterogeneity in the cohort composition. Also, inclusion of mainly men could limit generalizability.

DISCLOSURES:

The research was supported by the Department of Veterans Affairs Clinical Science Research & Development, Department of Defense, and the National Center for Advancing Translational Sciences. Wheless reported receiving grants from the Department of Veterans Affairs. Three authors also reported receiving grants and personal fees during this study.

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