Formulary management of eradication therapies for Helicobacter pylori - Drug selection by means of the SOJA method

Objective: To use the System of Objectified Judgement Analysis (SOJA) metho d for the rational selection of Helicobacter pylori eradication therapies f or formulary inclusion. Design: Drug selection for the eradication therapy of H. pylori is made by means of the SOJA method. In this formulary decision-making model, selectio n criteria for a given class of drugs are prospectively defined and weighte d by a panel of experts. The following criteria (relative weight) were used : variability of pharmacokinetics; drug interactions; resistance to antibac terials; efficacy; general adverse effects; complexity of the regimen; acqu isition cost and clinical documentation. Only published studies with at lea st 30 evaluable patients were considered, at least 3 studies had to be avai lable per treatment regimen and efficacy had to be assessed on an intent-to -treat basis. Main outcome measures and results: The regimens containing clarithromycin a nd an imidazole antibacterial in combination with omeprazole or ranitidine bismutrex showed the highest scores for eradication of H. pylori. The combi nations amoxicillin/ clarithromycin and omeprazole or lansoprazole showed s lightly lower eradication rates and were more costly. The eradication rates obtained with 2-drug regimens were low, resulting in a low overall SOJA sc ore. No quadruple regimens could be included, as none of the regimens fulfi lled the inclusion criteria. This was also true for the classical triple th erapy with bismuth/metronidazole/tetracycline. Conclusion: The present score is specific for the Netherlands, as Dutch acq uisition costs and data on resistance were used. In other countries, with d ifferent degrees of imidazole and clarithromycin resistance, other regimens may be more appropriate. The SOJA score will be regularly updated through the internet to include relevant new studies or new successful eradication regimens. The interactive program offers groups of physicians the opportuni ty to discuss the optimal H. pylori eradication regimen, based on their wei ghting of the criteria.