title: Nicorandil associated anal ulcers: an estimate of incidence.
abstract: BACKGROUND
  Nicorandil is a commonly prescribed antianginal medication that has been found to be associated with painful anal ulceration. The incidence of this complication is unknown. We have used the best data available to us to make an estimate of this figure in a health district  with a remarkably stable population of approximately 200,000 people.
  
  
  METHODS
  using an electronic search of all letters generated from colorectal and gastroenterology clinics as well as endoscopy reports from January 2004 to November 2010, patients with anal ulceration who were taking  nicorandil were identified. Other causes of ulceration were excluded by biopsy in the majority of cases. The central hospital and community pharmacy database was interrogated to estimate the number of patients who were prescribed nicorandil over a six-year period (2004-2010).
  
  
  RESULTS
  A total of 30 patients (24 men, 6 women) with a median age of 79.5 years were identified who fulfilled the criteria of: taking nicorandil; having no other identified cause for anal ulceration; and achieving eventual healing after withdrawal of nicorandil. In the six-year period an estimated  mean of 1,379 patients were prescribed nicorandil each year. The mean annual incidence of anal ulcers among nicorandil users is therefore calculated to be in the region of 0.37%.
  
  
  CONCLUSIONS
  Anal ulceration appears to occur in approximately four in every thousand patients prescribed nicorandil  each year. Prescribing physicians should explain the risk of this unpleasant complication to their patients.
authors.affiliation: North Cumbria University Hospitals NHS Trust, UK. hcolvin@doctors.org.uk
authors.forename: H S
authors.initials: HS
authors.lastname: Colvin
authors.forename: T
authors.initials: T
authors.lastname: Barakat
authors.forename: O
authors.initials: O
authors.lastname: Moussa
authors.forename: H
authors.initials: H
authors.lastname: Babu
authors.forename: T
authors.initials: T
authors.lastname: Slaughter
authors.forename: J G
authors.initials: JG
authors.lastname: Palmer
authors.forename: F L
authors.initials: FL
authors.lastname: Hinson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000188:drug therapy; D004739:England / Q000453:epidemiology; D005260:Female; D005401:Fissure in Ano / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000009:adverse effects*; D014665:Vasodilator Agents / Q000009:adverse effects*
chemical_list: D014665:Vasodilator Agents; D020108:Nicorandil