Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in
patients with gastro-oesophageal reflux disease.
Author(s): Peura DA(1), Pilmer B, Hunt B, Mody R, Perez MC.
Affiliation(s): Author information:
(1)Department of Gastroenterology & Hepatology, University of Virginia Health
Sciences Center, Charlottesville, VA, USA.
Publication date & source: 2013, Aliment Pharmacol Ther. , 38(10):1303-11
BACKGROUND: Gastro-oesophageal reflux disease (GERD) is characterised by
symptomatic heartburn and regurgitation. Treatment with proton pump inhibitors
(PPI) effectively decreases heartburn symptoms, but their effects on symptomatic
regurgitation are less clear.
AIM: To determine the impact of PPI therapy on heartburn and regurgitation
severity in patients with either non-erosive GERD (NERD) or erosive oesophagitis
(EE).
METHODS: Endoscopically-confirmed NERD patients received dexlansoprazole 30 or 60
mg or placebo in a randomised, blinded, 4-week study. Endoscopically-confirmed EE
patients received dexlansoprazole 60 mg or lansoprazole 30 mg in two 8-week,
randomised, blinded healing studies. The Patient Assessment of Upper
Gastrointestinal Symptom Severity questionnaire, which includes a
heartburn/regurgitation subscale, was administered to assess symptom severity at
baseline, and at weeks 2 and 4 of the NERD study and at weeks 4 and 8 during the
EE trials. We defined separate subscales for heartburn and regurgitation for this
post-hoc analysis. Among patients with both symptoms at baseline, improvements in
individual heartburn and regurgitation subscales along with the original combined
heartburn/regurgitation subscale were determined.
RESULTS: In the NERD and EE studies, 661 and 1909 patients, respectively, had
both heartburn and regurgitation at baseline. NERD patients receiving
dexlansoprazole 30 and 60 mg experienced significantly greater improvements in
symptom severity for both heartburn and regurgitation compared with placebo. EE
patients receiving dexlansoprazole 60 mg had significantly greater improvements
in heartburn/regurgitation and heartburn-only subscales at week 4 compared with
those receiving lansoprazole.
CONCLUSIONS: Dexlansoprazole appears to be effective in improving both heartburn
and regurgitation, and this improvement is maintained for the duration of
treatment.
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