COMPARISON OF IMMEDIATE RELEASE ORAL OXYCODONE HYDROCHLORIDE(KAPPA 2 RECEPTOR AGONIST) WITH ORAL PANTOPRAZOLE IN THE TREATMENT OF FUNCTIONAL DYSPEPSIA
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Date
2012-05
Authors
AZAHARIM, OMAR
Journal Title
Journal ISSN
Volume Title
Publisher
Pusat Pengajian Sains Perubatan Universiti Sains Malaysia
Abstract
TITLE: Comparison of Immediate Release Oral Oxycodone Hydrochloride(Kappa 2 receptor
agonist) with Oral Pantoprazole in the treatment of Functional Dyspepsia
BACKGROUND: The treatment of patients with functional dyspepsia remains unsatisfactory.
We assessed the efficacy and safety of Oxycodone Hydrochloride-Kappa 2 receptor agonist, in
patients with functional dyspepsia.
METHODS: Patients with functional dyspepsia were randomly assigned to receive either Oral
Oxycodone Hydrochloride 5mg prn basis and Oral Pantoprazole 40mg od. After eight weeks of
treatment, three primary efficacy end points were analyzed: the change from baseline in the
severity of symptoms of functional dyspepsia(as assessed by the Leeds Dyspepsia
Questionnaire(LDQ)), patients' global assessment of efficacy using Global Assessment
Score(GAS) (the proportion of patients poor and good improvement), and the severity of pain
and bloatedness as rated by LDQ severity scale. The safety of Oxycodone Hydrochloride
assessed by the presence of significant side effect.
RESULTS: We randomly assigned 60 patients for this study. After eight weeks, overall patients
in Oxycodone Hydrochloride group had marked improvement of symptoms, as compared with
patients receiving Pantoprazole daily. Analysis of patients' global assessment of efficacy(GAS)
also revealed that Oxycodone Hydrochloride group was significantly superior to Pantoprazole
with excellent proportion of good(26 vs 1)(P value<0.001). The total LDQ symptom score
improved significantly in Oxycodone Hydrochloride groups(13.00±3.29 vs 20.40±3.07)(P
value<0.001), with the greatest symptom-score improvement is less than 15(P<0.05). Epigastric
pain and bloatedness improvement were greater in Oxycodone Hydrochloride than Pantoprazole;
LDQ severity scale for epigastric pain(2.0±1 vs 4.0±1) (P<0.001) and bloatedness(2.0±1 vs
3.0±1) (P<0.001). The side effects of Oxycodone Hydrochloride was giddiness(13 vs
0)(P<0.001). However when comparing it amongst the Oxycodone Hydrochloride group, it was
statistically insignificant(13 vs 17)(p=0.465).
CONCLUSIONS: Oxycodone Hydrochloride significantly improves symptoms in patients with
functional dyspepsia with tolerable side effects.
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Keywords
Anaesthesiology