Omeprazol Vs Pantoprazol

Aliment Pharmacol Ther 2001; 15: 1585±1591.

Comparable clinical ef®cacy and tolerability of 20 mg pantoprazole
and 20 mg omeprazole in patients with grade I re¯ux oesophagitis
K. D. BA RDHAN * & C. VA N R ENSBURG   (ON BEHALF OF THE INVESTIGATORS)
*Rotherham District General Hospital, Rotherham, UK; and  University of Stellenbosch & Tygerberg Hospital, Tygerberg,
South Africa
Accepted forpublication 4 June 2001

SUMMARY

Background: Several clinical trials have shown that
pantoprazole (40 mg) and omeprazole (40 or 20 mg)
have similar ef®cacy and safety in the treatment of
grade II±IV re¯ux oesophagitis (Savary±Miller classi®cation).
Aim: To compare the ef®cacy and safety of once-daily
doses of pantoprazole (20 mg) and omeprazole (20 mg)
with respect to symptom reliefand healing of patients
with grade I re¯ux oesophagitis.
Methods: Patients with endoscopically established
grade I re¯ux oesophagitis (non-con¯uent, patchy red
lesions with/without white ®brin coating) were
enrolled into this randomized, open, parallel-group,
multicentre study. A total of 328 patients (n ˆ 166 in
the pantoprazole group, n ˆ 162 in the omeprazole
group) were recruited in 23centres. Patients received

INTRODUCTION

The proton pump inhibitor pantoprazole has linear
pharmacokinetics and a high and constant bioavailability of 80% which results in powerful acid inhibition,
making it useful for the treatment of gastro-oesophageal
re¯ux disease (GERD).1±3
Dose-®nding studies and comparative trials have
demonstrated that pantoprazole, 40 mg, is the optimal
dose forthe treatment of moderate to severe re¯ux
Correspondence to: Dr K. D. Bardhan, Rotherham District General Hospital,
Moorgate Road, Rotherham, South Yorkshire S60 2UD, UK.
E-mail: bardhan.sec@rgh-tr.trent.nhs.uk
Ó 2001 Blackwell Science Ltd

4 weeks of treatment. If the re¯ux oesophagitis was
not completely healed, the treatment was extended to
8 weeks.
Results: After 2 and 4 weeks oftreatment with either
pantoprazole or omeprazole, the rate of symptom relief
was similar (70% vs. 79% and 77% vs. 84%, respectively). High healing rates were observed after 4 and
8 weeks (pantoprazole: 84% and 90%, respectively;
omeprazole: 89% and 95%, respectively). Both treatments were well tolerated. The most frequently reported
adverse events on pantoprazole and omeprazole,
respectively,were nausea (8% vs. 7%), diarrhoea (5%
vs. 6%) and headache (6% vs. 3%).
Conclusions: After 4 and 8 weeks of treatment with
pantoprazole (20 mg) or omeprazole (20 mg), patients
with mild gastro-oesophageal re¯ux disease (grade I)
showed comparably high rates of symptom relief and
healing. Both treatments were safe and well tolerated.

oesophagitis and 20 mg for mild disease.4±6 Our aim
wasto compare a once-daily dose of pantoprazole,
20 mg, with omeprazole, 20 mg, in the treatment of
grade I re¯ux oesophagitis as de®ned by Savary and
Miller.7 Because omeprazole, 10 mg, does not consistently provide adequate control of acid secretion and
re¯ux symptoms, a comparative dosage of 20 mg was
chosen.8±11 An even higher dose of 40 mg omeprazole
offers only marginal bene®t over 20mg, and hence
20 mg omeprazole has previously been recommended
as the standard dose for the treatment of symptomatic
re¯ux oesophagitis.12 In this study, patients received
pantoprazole and omeprazole at the optimal dose or
standard dose, respectively.
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K. D. BARDHAN & C. VAN RENSBURG

M ETHODS

The study was conducted in accordance with the
current version of theDeclaration of Helsinki. Approvals
from the appropriate Ethics Committees/Institutional
Review Boards were obtained in each centre. Written
informed consent to participate in the study was
obtained prior to enrolment by the physicians from all
patients. Out-patients ful®lling the inclusion criteria
were enrolled and randomized (see Figure 1 for inclusion criteria).
Major exclusion criteria were:...