0
0
A recent retrospective cohort study has found no significant association between nicotinamide exposure and an increased risk of major adverse cardiovascular events (MACE). However, individuals with a history of MACE were strongly associated with subsequent MACE development.
Study Methodology
To address concerns regarding the cardiovascular safety of nicotinamide, a vitamin B3 derivative widely used to reduce the risk of skin cancer, researchers analyzed data from 13,108 patients. The study spanned from January 1989 to February 2024 and included participants from the Vanderbilt University Medical Center (VUMC) and Million Veteran Program (MVP) cohorts. The mean age of the participants was 66.8 years, with 91% being male. A total of 5,291 patients had confirmed exposure to nicotinamide.
The primary outcome measured in the study was the occurrence of MACE.
Key Findings
In the VUMC cohort, the study found no significant difference in MACE risk among patients exposed to nicotinamide compared to those who were not exposed. The cause-specific hazard ratio (HR) for those without a prior MACE event was 2.02 (95% CI, 0.81-5.05), while for those with prior MACE, the HR was 0.46 (95% CI, 0.22-0.95). Similarly, in the MVP cohort, the HR for those without prior MACE was 1.07 (95% CI, 0.75-1.17), and for those with prior MACE, it was 1.04 (95% CI, 0.53-2.06).
One of the most striking findings was that prior MACE was strongly associated with subsequent MACE development. In the VUMC cohort, the HR was 10.29 (95% CI, 6.70-15.80), while in the MVP cohort, the HR was 2.90 (95% CI, 2.21-3.81).
Additionally, in the MVP cohort, the cumulative incidence of MACE did not vary significantly among patients with low, medium, or high exposure to nicotinamide who had no prior history of MACE.
Clinical Implications
“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 study authors noted.
Study Limitations and Disclosures
The researchers acknowledged several limitations, including potential misclassification bias and cohort heterogeneity. Furthermore, the predominance of male participants could limit the study’s generalizability to a broader population.
The research was supported by the Department of Veterans Affairs Clinical Science Research & Development, the Department of Defense, and the National Center for Advancing Translational Sciences. Lead author Dr. Lee Wheless, from the Department of Dermatology at VUMC, reported receiving grants from the Department of Veterans Affairs. Three additional authors disclosed receiving grants and personal fees related to the study.
Conclusion
While further research is needed to fully establish nicotinamide’s cardiovascular safety profile, this study provides reassurance that the supplement does not appear to significantly increase the risk of MACE. Patients with a history of MACE should, however, continue to monitor their cardiovascular health closely.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should consult healthcare professionals before making any decisions regarding their medication or supplement use.
