Diverticular fistulation is associated with nicorandil usage

Abstract

INTRODUCTION We observed that a number of patients presenting to our clinic with diverticular fistulation were taking nicorandil for angina. Recognised side effects of nicorandil include gastrointestinal and genital ulceration. The aim of our study was to determine whether nicorandil is an aetiological agent in diverticular fistulation. PATIENTS AND METHODS We conducted a case-control study of patients with diverticular disease related enteric fistulae. Two patient groups were identified: a study group of patients with diverticular fistulae, and a control group with uncomplicated diverticular disease. The proportion of patients who had ever used nicorandil was compared between the two groups. RESULTS A total of 153 case notes were analysed, 69 patients with fistulae and 84 control patients with uncomplicated diverticular disease. Female to male ratio in both groups was 2:1. The mean age was 71 years in the fistula group and 69 years in the control diverticular disease group (P = ns). Of those with colonic fistulae, 16% were taking nicorandil compared with 2% of the control group (odds ratio 7.8; 95% confidence interval 1.5-39.1; P = 0.008). There was no significant difference in rates of ischaemic heart disease between fistula and control groups. CONCLUSIONS Nicorandil is associated with fistula formation in diverticular disease.

Efficacy of Topical Zinc Sulphate on Wound Healing of Experimentally Induced Skin Ulcers by Nicorandil and Induction Effect on Transforming Growth Factor-β

“…Third, the intensity of inflammation, inflammatory cell infiltration was more and intense in the groups with ulcer induced by Aspirin or by Nicorandil than the group with ulcer induced by excision. This finding agrees with the reports of Nicorandil inducing ulceration, a number of reports have linked its use with oral, anal, vulval and parastomal ulceration, it also include anal fistulation, fistula between nasolabial fold, colorectal, ileal, peristomal, foreskin, and genital ulceration like penile ulcerations [7,[21][22][23][24][25]. This is the first study of using topical Nicorandil for the induction of skin ulcer in rabbits.…”

An 80-year-old man with caecal ulceration

“…Colonic ulceration typically affects the caecum and ascending colon often causing large deep ulcers that may be mistaken for malignancy or Crohn’s disease leading to a delay in diagnosis and potentially unnecessary interventions 3 4. Nicorandil usage has also been associated with fistula formation in diverticular disease 5…”

Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review

“…McDaid [107] conducted a casecontrol study among patients suffering from diverticular disease, to prove that nicorandil confers an increased risk of developing colonic fistulae: the odds ratio was 7.8 (CI 1.5-39.1; p = 0.008). Two important confounders, age and ischaemic heart disease, were found to be equally distributed between the two groups.…”