Wachsender Kostendruck im Gesundheitswesen kann zu einer Beeinträchtigung der Behandlungsqualität bei Refluxpatienten führen

Zusammenfassung

Ziel: Direktvergleich der Behandlungsqualität bei Patienten mit gastroösophagealer Refluxkrankheit (GERD) von 40 mg Pantoprazol und 20 mg Omeprazol. Material und Methodik: 915 Patienten mit GERD B-D (Los-Angeles-Klassifikation) wurden in einer doppelblinden randomisierten multizentrischen Studie sechs Wochen mit Pantoprazol 40 mg einmal täglich oder Omeprazol 20 mg einmal täglich behandelt. Primäres Zielkriterium war die Zeit bis zur ersten Symptombefreiung, gemessen mit dem Tagebuch ReQuest^TM-GI. Ergebnisse: Unter Pantoprazol 40 mg war die Zeit bis zur ersten Symptombefreiung signifikant kürzer als unter Omeprazol 20 mg (p = 0,0298). Dabei wurde die Symptombefreiung in den Leitsymptomen von GERD (ermittelt mit dem ReQuest^TM-Tagebuch) unter Pantoprazol 40 mg 2 Tage früher erreicht als unter 20 mg Omeprazol. Auch eine dauerhafte Symptombefreiung wurde mit Pantoprazol früher erzielt. Dabei war die tägliche Symptomlast unter Pantoprazol geringer als unter Omeprazol. Am Studienende nach 6 Wochen waren in beiden Gruppen über 90 % der Patienten symptomfrei (93,7 % unter Pantoprazol vs. 91,8 % unter Omeprazol, PP). Beide Medikamente waren gut verträglich. Schlussfolgerung: Pantoprazol 40 mg befreit GERD-Patienten signifikant schneller von ihren Leitsymptomen als Omeprazol 20 mg. Ein Austausch von Pantoprazol 40 mg durch Omeprazol 20 mg ist daher nicht ohne Verlust an Behandlungsqualität möglich.

Abstract

Aims: To directly compare the efficacy and safety of pantoprazole 40 mg vs. omeprazole 20 mg in patients with gastroesophageal reflux disease (GERD). Material and Methods: 915 Patients suffering from symptomatic GERD B-D (Los Angeles classification) were included in a double-blind randomized multicenter clinical trial and treated with either pantoprazole 40 mg od or omeprazole 20 mg od for six weeks. Primary efficacy criterion was the first time to reach normal symptoms as assessed by the questionnaire ReQuest^TM-GI. Results: Compared to omeprazole 20 mg, pantoprazole 40 mg achieved a significantly faster rate of symptom relief (p = 0.0298). Thus, as assessed with the ReQuest^TM questionnaire, patients treated with pantoprazole 40 mg experienced relief from the 7 leading GERD symptoms 2 days earlier than those treated with omeprazole 20 mg. Long-lasting sustained relief from symptoms was also achieved earlier with pantoprazole than with omeprazole; in patients treated with pantoprazole, the daily symptom load was lower than in those treated with omeprazole. After 6 weeks of treatment, over 90 percent of patients were free from symptoms in both treatment groups (93.7 % in the pantoprazole, vs. 91.8 % in the omeprazole group, PP). Both medications were well tolerated. Conclusions: GERD patients treated with pantoprazole 40 mg experience a significantly faster relief from their leading symptoms than those treated with omeprazole 20 mg.

Schlüsselwörter

GERD - Refluxösophagitis - Reflux - Refluxkrankheit - Symptom - Symptomscore - Pantoprazol - Omeprazol - ReQuest^TM

Key words

GERD - refluxesophagitis - reflux - esophagitis - symptoms - symptomscore - pantoprazole - omeprazole - ReQuest^TM

Literatur

• 1 Holtmann G. Reflux disease: the disorder of the third millenium.  Eur J Gastroenterol Hepatol. 2001;  13 (Suppl 1) 5-11
• 2 Richardson P, Hawkey C J, Stack W A. Proton pump inhibiotors. Pharmacology and rationale for use in gastrointestinal disorders.  Drugs. 1998;  56 (3) 307-335
• 3 Chiba N, De Gara C J, Wilkinson J M. et al . Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis.  Gastroenterology. 1997;  112 (6) 1798-1810
• 4 Körner T, Schutze K, van Leendert R J. et al . Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis. Results of a multinational study.  Digestion. 2003;  67 (1 - 2) 6-13
• 5 Gillessen A, Beil W, Modlin I M. et al . 40 mg pantoprazole and 40 mg esomeprazole are equivalent in the healing of esophageal lesions and relief from gastroesophageal reflux disease-related symptoms.  J Clin Gastroenterol. 2004;  38 (4) 332-340
• 6 Scholten T, Gatz G, Hole U. Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms.  Aliment Pharmacol Ther. 2003;  18 (6) 587-594
• 7 Bardhan K D, van Rensburg C. Comparable clinical efficacy and tolerability of 20 mg pantoprazole and 20 mg omeprazole in patients with grade I reflux esophagitis.  Aliment Pharmacol Ther. 2001;  15 (10) 1585-1591
• 8 Mönnikes H, Bardhan K D, Pfaffenberger B. et al . Pantoprazole 20 mg is at least as effective as esomeprazole 20 mg for first and sustained symptom relief in patients with endoscopy-negative gastroesophageal reflux disease.  Gut. 2003;  53 (Suppl VI) A127
• 9 Lauritsen K, Jaup B, Carling L. et al . Vergleichbare Wirksamkeit von Pantoprazol und Omeprazol in der Rezidivprophylaxe der Refluxösophagitis.  Z Gastroenterol. 2003;  41 956-957
• 10 Kromer W. Relative efficacies of gastric proton-pump inhibitors on a milligram basis: desired and undesired SH reactions. Impact of Chirality.  Scand J Gastroenterol Suppl. 2001;  234 3-9
• 11 Klok R M, Postma M J, van Hout B A. et al . Meta-analysis: comparing the efficacy of proton pump inhibitors in short-term use.  Aliment Pharmacol Ther. 2003;  17 (10) 1237-1245
• 12 Gillessen A, Virchow J C. Gastroesophagealer Reflux und Asthma.  Dtsch Med Wochenschr. 2003;  128 2427-2430
• 13 Dent J, Brun J, Fendrick A M. et al . An evidence based appraisal of reflux disease management - the Genval Workshop Report.  Gut. 1999;  44 (Suppl 2) 1-16
• 14 Moss F, Armstrong D, Arnold R. et al . GERD 2003 - a consensus on the way ahead.  Digestion. 2003;  67 111-117
• 15 Stanghellini V, Armstrong D, Mönnikes H. et al . Systematic review: do we need a new gastro-oesophageal reflux disease questionnaire?.  Aliment Pharmacol Ther. 2004;  19 (5) 463-479
• 16 Bardhan K D, Stanghellini V, Armstrong D. et al . Evaluation of GERD symptoms during therapy. Part I: Development of the new GERD questionnaire ReQuest™.  Digestion. 2004;  69 229-237
• 17 Mönnikes H, Bardhan K D, Stanghellini V. et al . Evaluation of GERD Symptoms during Therapy. Part II: Psychometric Evaluation and Validation of the New Questionnaire ReQuest™ in erosive GERD.  Digestion. 2004;  69 238-244
• 18 Bardhan K D, Stanghellini V, Armstrong D. et al . International Validation of ReQuest™ in Patients with Endoscopy Negative Gastroesophageal Reflux Disease.  Aliment Pharmacol Ther. 2004;  in press 2004
• 19 Schaltenbrand R, Huber R, Cotoraci C A. et al . Bioequivalence between omeprazole MUPS 20 mg as tablet and omeprazole MUPS 20 mg as tablet encaspulated in a hard gelatine capsule.  Int J Clin Pharmacol Ther. 2001;  39 (10) 453-459
• 20 Sachs G, Shin J M, Pratha V. et al . Synthesis or Rupture: Duration of Acid Inhibition by Proton Pump Inhibitors.  Drugs of Today. 2003;  39 (Suppl A) 11-14
• 21 Bate C M, Booth S N, Crowe J P. et al . Does 40 mg omeprazole daily offer additional benefit over 20 mg daily in patients requiring more than 4 weeks of treatment for symptomatic reflux oesophagitis?.  Aliment Pharmacol Ther. 1993;  7 (5) 501-507
• 22 Richter J E, Bochenek W. et al . Oral Pantoprazole for Erosive Esophagitis: A Placebo-Controlled, Randomized Clinical Trial.  Am J Gastroenterol. 2000;  95 (11) 3071-3080
• 23 Kahrilas P J, Falk G W, Johnson D A. et al . Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients.  Aliment Pharmacol Ther. 2000;  14 1249-1258
• 24 Nexium. US-Fachinformation (SPC). 
• 25 Vaezi M. Gastroesophageal Reflux Disease and the Larynx.  J Clin Gastroenterol. 2003;  36 (3) 198-203
• 26 Meier J, McNally P, Punja M. et al . Does Omeprazole Improve Respiratory Function in Asthmatics with Gastroesophageal Reflux?.  Digestive Diseases and Sciences. 1994;  39 (10) 2127-2133