Valutazione economica della terapia di mantenimento al bisogno con esomeprazolo nella malattia da reflusso gastroesofageo. ONE- Studio economico longitudinale in Italia

Translated title of the contribution: Economic evaluation of on demand maintenance therapy with esomeprazole in GERD patients

Cristina Negrini, P. Wahlqvist, C. Rossi, A. Dubini, V. Savarino

Research output: Contribution to journalArticlepeer-review


Objective: Gastro-esophageal reflux disease (GERD) is a common medical problem with a board spectrum of symptoms and varying degrees of severity and frequency. Most patients with GERD, regardless of endoscopic status, suffer symptomatic relapses within few months from stopping acid suppressant therapy, thus requiring long term management of their disease to prevent relapses. On-demand therapy (i.e., medication taken as needed to relieve symptoms) might be an effective modality of long-term treatment in patients with non-erosive gastro-esophageal reflux disease. An economic evaluation, the ONE (ON-demand treatment with Esomeprazole) study, was conducted to assess costs and consequences over a 6-month period with the 20 mg esomeprazole on-demand strategy compared to the 20 mg once continuous therapy in patients with GERD. Methods: The ONE study was a multicentre, randomised, open-label, parallel-group trial in 451 specialist clinics in Italy. A cost-consequence analysis was performed in the societal and NHS perpective. Resource utilisation data associated with direct medical costs, direct non-medical costs and indirect costs were collected in the study. Time to first relapse was defined as time to the patient's first contact with the investigator because of unsatisfactory symptoms' control. In addition, investigators assessed the presence of GERD symptoms at each scheduled visit. In total 6017 patients aged ≥18 years with symptoms suggesting GERD (heartburn, with or without acid regurgitation, for at least 4 days/week during the last 2 weeks) were enrolled into the study and underwent endoscopic examination (EGDS) to excluded patients with grade II-IV esophagitis, according to the Savary-Miller's classification. The treatment maintenance phase started after resolution of symptoms achieved with 4-week acute treatment with esomeprazole 40 mg once daily. Results: Results of the 4-week treatment confirmed the efficacy of esomeprazole 40 mg once daily in the acute treatment of GERD, as shown by the high response rate, with 87.5% of patients achieving symptom resolution. Patients treated on-demand had the same relapse rate over 6 months than patients maintained on continuous treatment, but their control of symptoms was less effective. A statistically significant difference between the continuous treatment arm and the on demand treatment arm emerged from the analysis of direct and total medical costs. The cost of study medication was the most relevant variable because of the reduced consumption with the on demand strategy versus the continuous treatment strategy. Conclusion: Results of this trial suggest that on-demand treatment with esomeprazole 20 mg may be an advantageous therapeutic alternative in the long-term treatment of GERD patients without esophagitis, requiring a careful management by the treating physician in order to constantly monitor the effectiveness in symptoms control.

Translated title of the contributionEconomic evaluation of on demand maintenance therapy with esomeprazole in GERD patients
Original languageItalian
Pages (from-to)67-80
Number of pages14
JournalPharmacoEconomics - Italian Research Articles
Issue number1
Publication statusPublished - 2005

ASJC Scopus subject areas

  • Pharmacology
  • Health Policy


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