Nicotinamide, a form of vitamin B3, has been shown to reduce the effects of ultraviolet radiation and the incidence of skin cancers and actinic keratoses in high-risk patients with normal immune response. Researchers of a phase 3 controlled trial evaluated if oral nicotinamide could improve skin cancer outcomes in immunocompromised organ transplant recipients.
According to the study’s lead author, Nicholas C Allen, MPH, oral nicotinamide therapy did not yield any improvements in the incidence of keratinocyte cancers or actinic keratoses in immunosuppressed solid-organ transplant recipients. The findings were published in The New England Journal of Medicine.
Nicotinamide in Immunosuppressed Organ Transplant Patients
The study equally randomized a total of 158 participants, and the 79 patients in either group received 500 mg of nicotinamide or placebo twice daily for 12 months. Both groups were examined by dermatologists at 3-month intervals. Authors noted the trial was closed early due to poor recruitment.
The primary end point was new keratinocyte cancers over 12 months, while secondary end points included squamous- and basal-cell carcinomas over 12 months, actinic keratoses over the first 6 months of therapy, safety, and quality of life.
At month 12, authors observed 207 new keratinocyte cancers in the nicotinamide group versus 210 in the placebo group (rate ratio, 1.0; 95% CI, 0.8-1.3; P=.96). Likewise, no significant differences were seen between the groups across secondary outcomes, adverse events, or blood and urine laboratory values.
Ultimately, Allen and colleagues concluded that oral nicotinamide therapy did not reduce the incidence of skin cancers or actinic keratoses compared to placebo in immunocompromised solid-organ transplant recipients.
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