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Publications

Published: 7 September 2017

Nicorandil — Updated Indication and Risk of Ulcerations

Prescriber Update 38(3): 46-47
September 2017

Key Messages

  • Nicorandil is indicated for symptomatic treatment of stable angina pectoris that is inadequately controlled or in patients who have a contraindication or intolerance to first-line anti-anginal therapies.
  • Patients should be reviewed to make sure they are receiving nicorandil for the correct indication.
  • Nicorandil can cause serious skin, mucosal, and eye ulceration, including gastrointestinal ulcers, which may progress to perforation, haemorrhage, fistula, or abscess.
  • Stop nicorandil treatment if ulceration occurs — consider the need for alternative treatment or specialist advice if angina symptoms worsen.

 

Nicorandil (Ikorel) is a vasodilator agent that works by relaxing the muscles in the walls of the blood vessels that supply the heart thereby improving blood flow to the heart muscle and relieving the symptoms of angina1.

The indication for nicorandil has been updated after a review by the European Medicines Agency1. Nicorandil is indicated for second line treatment of stable angina in patients whose angina is inadequately controlled by first line anti-anginal therapies, or who have a contraindication or intolerance to first line anti-anginal therapies such as beta-blockers or calcium antagonists1,2.

On rare occasions, Nicorandil use may lead to gastrointestinal, skin, mucosal, corneal or conjunctival ulceration, which may be serious. Ulcers may develop at different sites in the same patient, at the same time or one after another. Ulceration can occur at any time during nicorandil treatment, including years after starting treatment3.

Ulcers that result following nicorandil treatment do not respond to conventional treatment, including surgery. Treatment with nicorandil should be withdrawn if ulceration occurs and the need for alternative treatment or specialist advice should be considered if angina symptoms worsen. It may take weeks or months for the ulcers to heal, depending on the severity3.

Patients with risk factors such as diverticular disease may be at risk of fistula formation or bowel perforation. Concomitant use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids with nicorandil increases the risk of gastrointestinal ulceration, perforations or haemorrhage3.

At 30 June 2017, the Centre for Adverse Reactions Monitoring (CARM) had received one case of ulceration associated with the use of nicorandil. Ulcerative stomatitis and pharyngitis were reported in a 61-year-old female who was treated with nicorandil for less than a week.

Please continue to report any adverse reactions for nicorandil, and any other medicine, to CARM. Reports can be submitted on paper or electronically (https://nzphvc.otago.ac.nz/).

References
  1. European Medicines Agency. 2015. Ikorel and Dancor. 27 March 2015. URL: ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ikorel_and_Dancor/human_referral_000387.jsp&mid=WC0b01ac05805c516f (accessed 27 July 2017).
  2. Sanofi-Aventis New Zealand Limited. 2016. Ikorel Data Sheet. 25 November 2016. URL: medsafe.govt.nz/profs/Datasheet/i/ikoreltab.pdf (accessed 14 July 2017).
  3. Medicines and Healthcare Products Regulatory Agency. 2016. Updated advice on use of nicorandil as second-line treatment for stable angina — some ulcers may progress to complications unless treatment is stopped. Drug Safety Update. 21 January 2016. URL: gov.uk/drug-safety-update/nicorandil-ikorel-now-second-line-treatment-for-angina-risk-of-ulcer-complications (accessed 27 June 2017).
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