COPENHAGEN — Some patients with dyspepsia not caused by reflux or a peptic ulcer who do not respond to a proton-pump inhibitor during the first week of treatment will respond after a few more weeks of ongoing treatment, according to 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 eventually respond, said Dr. van Zanten, a gastroenterologist and professor of medicine at Dalhousie University in Halifax, N.S.
The results also showed that a double dose of a PPI was no more effective than the standard dose when starting treatment.
One of the studies enrolled 1,250 patients, aged 18–50 years, 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. The severity of epigastric pain or burning was rated by patients on a 4-point scale on which 0 indicated no symptoms and 3 indicated severe symptoms. The average severity score at enrollment was 1.3.
Patients were randomized to start treatment with 40 mg of esomeprazole either once or twice daily for 1 week. About 44% of patients responded to both regimens, with no difference between the two groups. Patients were considered responders if they had a score of 0 or 1 during the last 3 days of treatment.
After this initial week, the patients were rerandomized either to continue on 40 mg of esomeprazole once daily or to placebo for 7 more weeks. The full 8 weeks of the study were completed by 1,084 patients.
Of the 716 patients who were on esomeprazole for 8 weeks, 339 patients (47%) responded. In this phase, responders were defined as patients with a symptom score of 0 or 1 on each of the final 7 days of treatment. Of 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 of 1,589 patients. The design of that study was 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.
AstraZeneca, which markets esomeprazole (Nexium), funded both studies.