Pantoprazole Improves Multiple Symptoms of Reflux Disease: Presented at UEGW
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Pantoprazole Improves Multiple Symptoms of Reflux Disease: Presented at UEGW

By Jill Stein

PARIS, FRANCE -- October 30, 2007 -- Pantoprazole decreases a range of symptoms reported by patients with erosive gastroesophageal reflux disease (GERD) instead of only addressing acid complaints, investigators reported here at the 15th United European Gastroenterology Week (UEGW).

Ronnie Fass, MD, Professor of Medicine, University of Arizona School of Medicine, Tucson, Arizona, United States, and colleagues compared the effects of pantoprazole and placebo on a broad spectrum of symptoms in patients with endoscopically confirmed GERD (Grade A to D according to Los Angeles classification).

Study participants in the trial had GERD-related symptoms for at least 6 months and had heartburn for at least 4 days during the prior week.

After a 7- to 21-days screening period, patients were randomised to treatment with either pantoprazole 40 mg or placebo once daily for 7 days followed by an open-label pantoprazole treatment phase of 7 weeks.

Patients completed the ReQuest in Practice™ self-assessment questionnaire on each day of the screening phase and of the placebo-controlled treatment period. The questionnaire is a validated and GERD-sensitive questionnaire that permits assessment of the broad spectrum of GERD-associated symptoms.

The investigators compared the pretreatment and post-treatment differences of the ReQuest™-GI scores in the treatment groups at baseline and after 7 days of treatment. ReQuest™-GI is a subscale that assesses acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea.

Results showed that the sum score was significantly reduced in the pantoprazole group versus placebo for each of the ReQuest™ dimensions except for the dimension "other complaints," Dr. Fass said in his presentation on October 30. These reductions were not confined to classical acid symptoms but additionally included "lower abdominal/digestive complaints" that are often denied to be GERD-associated symptoms.

Mean pretreatment versus post-treatment differences of the sum scores were 1.84 for acid complaints in the pantoprazole 40 mg group versus 0.65 in the placebo group (P <.0001).

Mean pre versus post differences for upper abdominal/stomach complaints were 1.11 versus 0.53 in the two groups, respectively (P <.0001); 0.56 versus 0.25 for lower abdominal/digestive complaints (P =.0007); 0.51 versus 0.24 for nausea (P =.0279); 0.84 versus 0.35 for general wellbeing (P <.0001); 0.62 versus 0.19 for sleep disturbances (P <.0001); and 0.21 versus 0.16 for other complaints (P =.3195).

The average symptom load above threshold was about twice as high in the placebo as in the pantoprazole treatment group.

In addition to demonstrating that pantoprazole improved GERD symptoms beyond heartburn, the study showed that ReQuest™ is an efficient tool to measure comprehensively and accurately symptom improvement in GERD patients, Dr. Fass said.

[Presentation title: Pantoprazole Improves Symptoms of Gastroesophageal Reflux Disease Beyond Heartburn. Abstract Tue-G-118]

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