A groundbreaking study involving 13,108 patients from the Vanderbilt University Medical Center (VUMC) and Million Veteran Program (MVP) cohorts found no significant cardiovascular risks associated with nicotinamide exposure. The study, led by Dr. Lee Wheless of VUMC's Department of Dermatology, aimed to assess the impact of nicotinamide on Major Adverse Cardiovascular Events (MACE). Published online on February 26 in JAMA Dermatology, the research provides key insights into the cardiovascular safety of nicotinamide.
The study participants had a mean age of 66.8 years, with a predominantly male demographic comprising 91% of the sample. The research received support from multiple prestigious organizations, including the Department of Veterans Affairs Clinical Science Research & Development, the Department of Defense, and the National Center for Advancing Translational Sciences.
The primary focus was on MACE, with prior occurrences strongly predicting subsequent events in both the VUMC and MVP cohorts. The hazard ratio for developing subsequent MACE was notably higher in those with a history of such events, measured at 10.29 (95% CI, 6.70-15.80) for the VUMC cohort and 2.90 (95% CI, 2.21-3.81) for the MVP cohort.
Despite these associations, the study found no significant link between nicotinamide exposure and MACE among patients without prior incidents. In the VUMC cohort, those with no history of MACE showed no significant difference in risk compared to those without exposure. Similarly, in the MVP cohort, there was no variance in MACE incidence across varying levels of nicotinamide exposure.
In a statement on the study's findings, Dr. Wheless commented:
"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."
- Lee Wheless, MD, PhD, Department of Dermatology, VUMC, Nashville, Tennessee.
The research was conducted over a lengthy period from January 1989 to February 2024. While three authors involved reported receiving grants and personal fees during the study, these disclosures do not detract from the study's implications for clinical practice.
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