Safety experience with sucralfate in Japan

Area of Science:

• Gastroenterology
• Clinical Pharmacology

Background:

• Sucralfate is a medication used for gastrointestinal conditions.
• Assessing the safety profile of sucralfate is crucial for its clinical application.

Purpose of the Study:

• To evaluate the clinical safety and tolerability of sucralfate in a Japanese population.
• To compare the incidence of side effects between sucralfate and placebo groups.

Main Methods:

• Two double-blind trials involving 163 sucralfate-treated patients and 154 placebo patients.
• Long-term safety monitoring across 137 medical institutions over 4 years, including follow-up of 2,298 patients.
• Literature review of 91 papers assessing sucralfate safety in 2,306 patients.

Main Results:

• Low incidence of side effects, comparable between sucralfate and placebo groups (e.g., constipation 3.7% vs 3.9%).
• Follow-up data showed constipation (2.3%) and oral dryness (0.7%) as primary side effects.
• Laboratory findings remained within normal limits, and no significant abnormalities were noted in approximately 500 patients.

Conclusions:

• Sucralfate is established as safe, effective, and well-tolerated.
• Constipation is the most notable side effect, occurring at low rates similar to placebo.
• Concomitant use of anticholinergics may increase constipation and oral dryness incidence.