Use of nicorandil is Associated with Increased Risk for Gastrointestinal Ulceration and Perforation- A Nationally Representative Population-based study

Abstract

Nicorandil is a vasodilatory drug used to relieve angina symptoms. Several healthcare products regulatory agencies have issued a warning associating the use of nicorandil and gastrointestinal (GI) ulceration. We aimed to evaluate the association between use of nicorandil and GI ulceration/perforation. A population-based cohort study involving 1 million randomly sampled participants in Taiwan’s National Health Insurance Research Database was carried out. We estimated the association between use of nicorandil and GI ulceration/perforation by a Cox proportional hazards regression model. A nicorandil-specific propensity score (PS) was also created for adjustment of 75 covariates and matching. 25.8% (183/710) of nicorandil-treated patients developed new GI ulcer events and 1.6% (20/1254) developed new GI perforation events in the three-year follow-up period, as compared to 9.3% (61,281/659,081) and 0.3% (2,488/770,537) in the general population comparator cohort. Patients treated with nicorandil were at significantly increased risk of GI ulcer (PS adjusted hazard ratio 1.43, 95% CI, 1.23 to 1.65, 6848 excess cases per 100,000 person years) or GI perforation (aHR 1.60, 95% CI 1.02–2.51, 315 excess cases per 100,000 person years) compared with the nicorandil unexposed population. Our finding may warn the clinicians to weigh the overall risk-benefit balance of nicorandil treatment in patients.

Démarche diagnostique devant une ulcération linguale unique. Cas clinique et revue de la littérature

“…Depuis 2002, des localisations extra-orales des ulcérations dues au nicorandil ont été rapportées, principalement au niveau du tractus gastro-intestinal et de la zone péri-anale [22,23], de la cornée et de la conjonctive [24], de l'appareil génital [25] et de la peau [26]. Les lésions du tractus digestif peuvent être responsables d'hémorragies, fistules et perforations, complications graves, nécessitant une prise en charge urgente et adéquate.…”

Potassium Channelopathies and Gastrointestinal Ulceration

“…The chance of this rare but potentially severe side effect increases with higher doses and long term use of this drug, and heals after drug withdrawal. A recent population-based study of this drug’s association with GI ulceration or perforation has been reported 75. This study, based on more than 600,000 randomly selected patients, found a 43% increase in the risk of GI ulceration and a 60% increase in the risk of GI perforation.…”

Painful perianal ulcers with nicorandil

“…Patients may present with ulcers, which are usually painful, in the mouth, around the anus, or on the cornea, skin, or genitalia 214151617. Those with ulcers in the bowel may present with gastrointestinal haemorrhage.…”