A randomised prospective study comparing the effectiveness of esomeprazole treatment strategies in clinical practice for 6 months in the management of patients with symptoms of gastroesophageal reflux disease

HANSEN, A. NORMAN
BERGHEIM, R.
FAGERTUN, H.
LUND, H.
MOUM, B.

¹Harbitzallèen Legesenter, Harbitzallèen, Oslo, Norway
²GI/CNS, AstraZeneca, Oslo, Norway
³3S-Scandinavian Statistical Services AS, Kjeller, Norway
⁴Medical Department, AstraZeneca AS, Oslo, Norway
⁵Medical Department, Øestfold Central Hospital, Fredrikstad, Norway

Correspondence to: Aage Norman Hansen, Harbitzalléen Legesenter, N-0213 Oslo, Norway. Tel.: +47 22 51 58 58, Fax: + 47 22 51 58 51, Email: [email protected]

Paper received April 2004, accepted February 2005

International Journal of Clinical Practice 59(6):p 665-671, June 2005.

SUMMARY

One option for patients with symptoms of gastroesophageal reflux disease (GERD) is treatment with proton pump inhibitors without prior endoscopy. Continuous or on-demand maintenance therapy are options for symptom-free patients. This study assessed the efficacy of three different treatment options in GERD patients in Norway.

About 395 General Practitioners enrolled 2156 patients with symptoms of GERD in an open, randomised, parallel group trial. Following a 4-week symptom control phase [esomeprazole 40 mg once daily (od)], patients received either esomeprazole 20 mg od continuously or on-demand or ranitidine 150 mg twice-daily continuously for 6 months.

The percentage of patients with no heartburn at the end of the study was maintained most effectively in the esomeprazole 20 mg continuous group (72.2%) and least effectively in the ranitidine group (32.5%). Significantly, more patients were completely/very satisfied with esomeprazole continuous (82.2%) and esomeprazole on-demand (75.4%) than with ranitidine continuous (33.5%) treatment (p < 0.0001).

More patients were kept in remission, symptom free and were overall more satisfied with esomeprazole treatment than ranitidine.