Treatment of Duodenal Ulcers with Carafate (Sucralfate)
Sucralfate is FDA-approved for short-term treatment (up to 8 weeks) of active duodenal ulcers at a dose of 1 g four times daily, as well as for maintenance therapy at reduced dosage after healing of acute ulcers. 1
Standard Treatment Regimen
- The FDA-approved dosage for active duodenal ulcer treatment is 1 g four times daily, taken 1 hour before meals and at bedtime for 4-8 weeks 1, 2
- An alternative dosing regimen of 2 g twice daily (upon waking and at bedtime) has been shown to be equally effective and may improve patient compliance 3, 4, 5
- Treatment should continue for 4-8 weeks unless healing has been demonstrated by x-ray or endoscopic examination 1
- After healing, maintenance therapy can be continued at a reduced dosage 1
Efficacy
- Clinical trials demonstrate that sucralfate is significantly more effective than placebo for duodenal ulcer healing 1
- In controlled studies, sucralfate achieved healing rates of 75-92% after 4 weeks of treatment compared to 58-64% with placebo 1, 6
- Cumulative healing rates after 8 weeks reach 83-95% with sucralfate treatment 4, 5
Mechanism of Action
- Sucralfate works by binding to proteinaceous material at the ulcer site, forming a protective barrier 2
- It neutralizes local acidity without affecting gastric pH, inhibits hydrogen ion diffusion, inhibits pepsin action, and adsorbs bile salts 2
- Approximately 3-5% of an orally administered dose is absorbed; more than 90% is excreted unchanged in feces 2
Important Considerations
- Sucralfate should be administered at least 2 hours apart from drugs that decrease gastric acidity (PPIs or H2-blockers) to avoid interaction 7
- For H. pylori-associated ulcers, eradication therapy should be used in addition to sucralfate 7
- Sucralfate is not effective for NSAID-related gastric ulcers; PPIs are preferred for this indication 7
- Most common side effects include constipation (3-4%), dry mouth (1%), and skin eruptions (0.6%) 2
Alternative Treatments
- Proton pump inhibitors (PPIs) are generally considered first-line agents for treating gastrointestinal ulcers, with sucralfate recommended as a second-line agent 7
- For NSAID-induced ulcers, discontinuation of NSAIDs is recommended when possible 7
- Potassium-competitive acid blockers (P-CABs) are not recommended as first-line therapy for peptic ulcer disease according to the American Gastroenterological Association 8
Monitoring and Follow-up
- Endoscopic evaluation is recommended at 4 weeks to assess healing 1
- If the ulcer is not healed at 4 weeks, treatment should continue for an additional 4 weeks with repeat endoscopy 1, 4
- For maintenance therapy after healing, sucralfate has been shown to significantly reduce recurrence rates compared to placebo (27% vs 65% at 12 months) 1