COPENHAGEN — Some patients with dyspepsia not caused by reflux or a peptic ulcer who don't respond to a proton-pump inhibitor during the first week of treatment will respond after a few more weeks, based on results from two studies.
The first week on a proton-pump inhibitor (PPI) “is only moderately useful for predicting responses after 4 and 8 weeks of treatment,” Dr. Sander Veldhuyzen van Zanten said at the 13th United European Gastroenterology Week. “It therefore makes sense to treat for 4–8 weeks” to see if the patient will respond.
Also, “the data clearly show that in a primary care setting, unless a patient has alarming symptoms, there's no reason to start with a double dose of a PPI,” said Dr. van Zanten, a gastroenterologist and professor of medicine at Dalhousie University, Halifax, N.S.
One of the studies enrolled 1,250 patients, aged 18–50, who had epigastric pain or burning for at least 3 months, were negative for Helicobacter pylori, and had not been investigated by endoscopy. The study excluded patients whose predominant symptom was heartburn or acid regurgitation and those with more than one episode of heartburn or acid regurgitation per week.
Patients were randomized to start with 40 mg of esomeprazole once or twice daily for 1 week. About 44% of patients responded to both regimens, with no difference between the two groups. After the initial week, patients were rerandomized to continue on 40 mg of esomeprazole once daily or placebo for 7 more weeks. The full 8 weeks were completed by 1,084 patients.
Of the 716 patients who were on esomeprazole for 8 weeks, 339 patients (47%) responded. Among the 339 responders, 198 also had responded after 1 week but 141 patients (42% of all responders) had not shown any response during the first week of treatment.
Similar results were seen in a second study that enrolled 1,589 patients. The design of the second study was generally similar to the first, and 743 patients received esomeprazole treatment for 8 weeks. The 295 patients who responded after 8 weeks included 158 patients (54% of all responders) who had not responded during the first week of treatment.
The studies were sponsored by AstraZeneca, which markets esomeprazole (Nexium).