Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label phase I-II study of tolerance.
BACKGROUND
Transdermal nicotine provides benefit in active ulcerative colitis but is often associated with adverse events (AEs). An oral formulation has been developed to minimize AEs. This study was undertaken to make initial observations on the safety and tolerance of oral nicotine therapy in inflammatory bowel disease; the effect on disease activity was also noted.


METHODS
Twenty-six patients with ulcerative colitis, 11 with active disease, and 5 patients with Crohn's colitis (2 with active disease) were given oral nicotine in 3-mg capsules, gradually increasing the dose to the maximum tolerated. AEs were recorded, concomitant prednisolone and/or azathioprine were reduced where possible, and disease activity was reassessed at the end of nicotine treatment.


RESULTS
Patients were followed for up to 12 months. Twenty-nine of 31 could tolerate at least 6 mg of nicotine each day, and 5 patients tolerated at least 18 mg daily. Twenty-four patients had nicotine-related nonserious AEs; over one half occurred during the period of dose escalation, but 7 discontinued treatment because of them. Six of the 13 patients with active disease became asymptomatic, whereas 3 patients in remission developed active symptoms; 11 patients reduced their concomitant medication.


CONCLUSIONS
Oral nicotine is a safe potential treatment of inflammatory bowel disease, but there is considerable variation in tolerance.
Ingram
John Robert
JR
Department of Gastroenterology, Cardiff and Vale NHS Trust, Cardiff, United Kingdom.
Rhodes
John
J
Evans
Brian K
BK
Thomas
Gareth A O
GA
D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D009538:Nicotine