Is Nikorandil (nicorandil) effective in the treatment of gastrointestinal (GI) bleed?

Nicorandil CAUSES Gastrointestinal Bleeding and Ulceration - It Must Be Stopped Immediately

Nicorandil is not a treatment for GI bleeding; it is a well-established cause of severe gastrointestinal ulceration throughout the entire GI tract from mouth to anus, and must be discontinued immediately if a patient presents with GI bleeding or ulceration. 1, 2

Mechanism of Harm

Nicorandil, a vasodilator used for angina prophylaxis, causes:

• Chronic, painful ulceration anywhere in the GI tract - from oral mucosa through the esophagus, stomach, small intestine, colon, rectum, and perianal region 1, 3
• Severe complications including bowel perforation (50% in patients with diverticular disease), enteric fistula formation (92% in diverticular disease patients), and parastomal ulceration (100% in stoma patients taking nicorandil) 4
• Significantly increased risk with hazard ratio of 1.43 for GI ulceration (6,848 excess cases per 100,000 person-years) and 1.60 for GI perforation (315 excess cases per 100,000 person-years) 2

Clinical Recognition

Key diagnostic features when nicorandil is the culprit:

• Patients present with new-onset lower GI symptoms, colonic ulceration (solitary or multiple), and often refractory painful ulcers 3, 5
• Colonoscopy reveals ulcers with only nonspecific inflammation on biopsy - no other identifiable cause 3, 5
• Ulceration may occur in isolation or with concomitant anal/perianal ulceration 5, 4
• The lesions can be extensive enough to warrant surgery (colostomy) or immunosuppressant treatment if nicorandil is not recognized and stopped 1

Management Algorithm

Immediate action required:

1. Stop nicorandil immediately if any GI ulceration or bleeding is present 1, 3, 5
2. Recovery typically occurs within 6 weeks of cessation without additional active treatment 5
3. Complete healing of ulcers is expected after drug withdrawal 3
4. Switch to alternative anti-anginal therapy such as beta-blockers, which do not carry this risk 1

Critical Pitfall

The most dangerous error is failing to recognize nicorandil as the causative agent in patients with "idiopathic" GI ulceration, leading to unnecessary invasive procedures, immunosuppressive therapy, or continued drug exposure with progressive ulceration and potential perforation 1, 4. Always obtain a complete medication history including cardiac medications in any patient with unexplained GI ulceration 3, 5.

Risk-Benefit Consideration

Nicorandil should not be considered standard treatment for angina given these serious GI complications 1. The 25.8% incidence of new GI ulcer events within 3 years in nicorandil-treated patients compared to 9.3% in the general population represents an unacceptable risk 2. For patients with pre-existing diverticular disease, the association with fistula formation and perforation is particularly strong, making alternative nitrates or other anti-anginal agents strongly preferable 4.