Z Gastroenterol 2008; 46 - A70
DOI: 10.1055/s-2008-1079674

Factors influencing gastric ulcer healing in H. pylori positive patients

P Nagy 1, M Gottlow 1, Z Tulassay 2
  • 1AstraZeneca R&D Mölndal Sweden
  • 22nd Medical Clinic, Semmelweis University Budapest, Hungary

H. pylori (Hp) eradication with a PPI based triple therapy for 7 days followed by additional PPI therapy until ulcer healing is the current practice in patients with Hp+ gastric ulcers (GU).

The objective of this post hoc analysis is to investigate which factors have an influence on ulcer healing rate. (The primary study has been reported elsewhere Tulassay et al in press)

Methods: In this double blind, randomized, parallel-group study (AstraZeneca study code: D9612C09991) patients with one or two GU (max 2cm in diameter one ulcer had to be at least 5mm) who were Hp+ (at least 2 out 3 tests including UBT, histology and culture) received one of three treatment regimens: esomeprazole 20mg (E)+ amoxicillin 1000mg (A)+ clarithromycin 500mg (C) for 1 week, followed by either placebo (P) (EAC+P) or E20mg (EAC+E) for 3 weeks or E+placebo antibiotics for 1 week followed by E20mg for 3 weeks (EP+E). GU healing was confirmed by endoscopy at week 4, if GU was not healed E20mg was administered for an additional 4 weeks. Hp eradication was confirmed if both UBT and histology were negative. Ulcer healing rates at week 4 were analyzed with logistic regression and Cochran-Mantel-Haenszel test for stratified tables considering ulcer size, presence or absence of Hp, diabetes mellitus, age, gender, BMI, smoking status, NSAID, aspirin use.

Results: 401 patients were analysed in the ITT population. The treatment groups were well balanced with regard to baseline characteristics. The healing rates for the EAC+P; EAC+E and EP+E treatment groups were 63.9% (95% CI:55.5–72.5); 81.7% (95% CI:74,7–88,7) and 84.7% (95%CI:78.3–91.1) respectively. The analysis demonstrated that the size of ulcer was the most important predictor of healing among the factors and it influenced the healing rate more in the EAC+P treatment group. In patients with GU size less than 1cm the EAC+P treatment resulted as high healing rate as it was seen with additional 3 weeks PPI therapy.

Conclusion: Size of GU is an important predictor of healing. If size of GU <1cm no additional 3 week esomeprazole therapy is necessary.