Treatment of NSAID-induced gastrointestinal lesions with cimetidine: an international multicentre collaborative study

The efficacy of cimetidine 800 mg nocte in the treatment of erosions or ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs) was evaluated in an uncontrolled multicentre study of 187 patients requiring continuation of their NSAID therapy. After 4 weeks of treatment, endoscopic healing was achieved in 62% of patients. After 8 weeks of therapy, 88% of patients were lesion-free. Patients with ulcer had a healing rate of 49% at week 4, which increased to 81% at the completion of 8 weeks. The majority of patients (82%) with erosions healed in 4 weeks. By week 8, erosions were healed in 97% of patients. Following endoscopically verified lesion healing, 113 patients entered a maintenance phase of the study, which assessed the efficacy of cimetidine 400 mg nocte in preventing recurrence of erosions or ulcers while continuing NSAID therapy. During a 6-month observation period, the cumulative probability of endoscopically observed recurrence of lesions was 12% (with a mean time to recurrence of 116 days), which is similar to the incidence of relapse achieved with cimetidine 400 mg nocte in patients with uncomplicated peptic ulcer. The results of this study suggest that cimetidine 800 mg nocte is effective in healing NSAID-induced lesions despite continued NSAID use, and that maintenance treatment with cimetidine 400 mg nocte can prevent lesions and reduce lesion recurrence during chronic NSAID administration.