Hospital Pharmacy - October 2020 - 298

298

2009

Szucs et al13
(Switzerland)

* Open-label,

randomized, multicenter study comparing the
2 long-term management options with esomeprazole 20
mg-continuous daily or on-demand treatment during 26
weeks-in endoscopically uninvestigated patients seeking
primary care in Switzerland for symptoms suggestive of
GERD who demonstrated complete relief of symptoms
after an initial treatment of 4 weeks with esomeprazole
40 mg.
* Patients found to meet all the inclusion criteria and
none of the exclusion criteria at the end of the initial
treatment course were randomized in equal proportions
to continuous treatment with esomeprazole 20 mg
every day. or on-demand treatment with esomeprazole
20 mg. For the randomization, a centrally compiled,
computer-generated list was used, which was based on
a block size of 4. Each site received a kit consisting of a
list of randomization numbers and sealed randomization
envelopes for 4 patients.
* The investigator was instructed to consecutively allocate
the lowest available randomization number, but open the
randomization envelopes containing the information on
the allocated treatment group only at randomization. It
had been planned that each site would recruit 4 patients
(or an exact multiple of 4). Each patient in the continuous
treatment arm was instructed to take 1 tablet once daily.
* In the on-demand arm, the patient was instructed to take 1
tablet daily if needed for the relief of heartburn and to stop
when the heartburn is adequately controlled. The study
drugs were packed in bottles, and every patient received in
total 2 bottles of 100 tablets esomeprazole 20 mg free of
charge. The distribution schedule of the study drugs from
general practitioner to patient was at the discretion of
the general practitioner, ie, the treating physician decided
when to distribute study drugs and whether to distribute
them all at once or at several occasions. Compliance was
determined by counting the tablets returned by the patient.

Methodology
* At
the end of the 6-month
maintenance phase, 93% of the
patients treated continuously
were classified as "satisfied"
(score = 1-4) with their
treatment, whereas 77% of the
patients, were reported to be
"very satisfied" (score = 1-2),
Wilcoxon rank sum test (score
= 1-7): P < .056.
* The mean number of clinic
visits to the investigator for any
reason required per patient was
0.50 (SD = 0.647) for those in
the continuous group.

Outcome
* The

data clearly
demonstrate
that on-demand
esomeprazole
20 mg therapy is
associated with
significantly better
effectiveness and
lower costs than a
strategy consisting
of intermittent
4-week treatment
courses of
omeprazole 20
mg once daily.
However, the
treatment with
continuous
esomeprazole
was more efficient
than the ondemand therapy
with regard to
remission of
heartburn.

Conclusion

Limitation
* The

endpoint used in this primary care
study (symptoms of any severity on at least
2 days during the previous week), may not
correspond to a definition of relapse in
clinical practice.

Note. PPI = proton pump inhibitor; QALYs = quality-adjusted life in years; GERD = gastroesophageal reflux disease; H2RA = histamine 2 receptor antagonists; RCT = randomized controlled trial.

Year

Author

Table 4. (continued)

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