Uses of Carafate (Sucralfate)
Carafate (sucralfate) is primarily indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and for maintenance therapy at reduced dosage after healing of acute ulcers. 1
Primary FDA-Approved Indications
- Sucralfate is approved for short-term treatment (up to 8 weeks) of active duodenal ulcers 1, 2
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers 1
Mechanism of Action
- Forms an ulcer-adherent complex at duodenal ulcer sites, protecting the ulcer and promoting healing 2
- Binds with proteinaceous material, neutralizing local acidity without affecting gastric pH 2
- Creates a protective barrier at the ulcer site, inhibiting the diffusion of hydrogen ions 2
- Inhibits the action of pepsin and adsorbs bile salts 2, 3
- Minimally absorbed after oral administration (approximately 3-5%), with more than 90% excreted unchanged in feces 2, 4
Clinical Efficacy
- Healing rates for duodenal ulcers range from 60-90% at 4-6 weeks 5
- In controlled trials, sucralfate 1g four times daily is effective in increasing the rate of healing of duodenal and gastric ulcers over 4-8 weeks 4
- Studies show sucralfate is more effective than placebo and comparable with cimetidine and intensive antacid therapy for duodenal ulcers 2
- In one multicenter, double-blind trial, 91.7% of sucralfate-treated patients showed complete healing of duodenal ulcers after 4 weeks compared to 58.1% in the placebo group 6
Off-Label Uses
- Not recommended for stress ulcer prophylaxis: The American College of Cardiology recommends PPIs as the preferred agents for therapy and prophylaxis of NSAID- and ASA-associated GI injury 7
- Sucralfate is not effective in the treatment or prevention of NSAID-related gastric ulcers 7
- Mixed evidence for radiation-induced diarrhea: Some European trials showed decreased diarrhea in patients receiving 1-2g sucralfate during pelvic radiation therapy, while other studies showed no improvement or worsening of GI symptoms 7
- Not recommended for stress ulcer prophylaxis in critically ill patients: PPIs or H2-receptor antagonists are typically preferred over sucralfate 8, 9
Administration Considerations
- Recommended dose: 1g four times daily, one hour before meals and at bedtime 2
- Should be administered at least 2 hours apart from drugs that decrease gastric acidity (PPIs or H2-blockers) to avoid interaction 10
- Constipation is the most common side effect, occurring in approximately 2-4% of patients 2, 4
- Other reported side effects include dry mouth (1%) and skin eruptions (0.6%) 2
Limitations and Alternatives
- PPIs are generally considered first-line agents for treating and preventing gastrointestinal ulcers, with sucralfate recommended as a second-line agent 8, 9
- For H. pylori-associated ulcers, eradication therapy should be used in addition to sucralfate 9
- For NSAID-induced ulcers, discontinuation of NSAIDs is recommended when possible 9