This article is more than 5 years old. Information may no longer be current.
Lesogaberan modestly improved GERD symptoms when added to PPI therapy
Patients with GERD who were partially responsive to proton pump inhibitor therapy experienced a slight improvement in symptoms with the addition of lesogaberan compared with placebo in a recent study.
In the double blind, placebo-controlled multicenter trial, researchers randomly assigned 661 patients with GERD to receive 60 mg, 120 mg, 180 mg or 240 mg lesogaberan or placebo twice daily, in addition to proton pump inhibitor (PPI) therapy, for 4 weeks. All participants already had been receiving PPI treatment for at least 4 weeks before baseline but 20% to 30% still had GERD symptoms.
Treatment response occurred in 20.9% of the 60 mg group, 25.6% of the 120 mg group, 23.5% of the 180 mg group and 26.2% of the 240 mg group, compared with 17.9% of those with placebo. The 240 mg dose was associated with a better response than placebo (OR=1.63; 80% CI, 1.11-2.41), but the 180 mg dose was not (P=.1213).
Patients reported an increased number of days with no worse than mild symptoms of regurgitation and burping during treatment compared with baseline (P<.05 compared with placebo group). Participants receiving 120 mg lesogaberan or more also reported a similar increase generally in days with mild or better symptoms compared with baseline (P<.05 compared with placebo group).
Adverse events were reported by 37.0% of the 60 mg group, 38.7% of the 120 mg group, 44.1% of the 180 mg group and 46.0% of the 240 mg group, compared with 30.7% of the placebo group. The most common events were paresthesia, diarrhea, dizziness and nausea. No serious treatment-related events occurred during the study.
“The results presented here show a modest treatment effect of lesogaberan on reflux symptoms when used as an add-on to PPI therapy in patients who have a partial response to PPIs,” the researchers concluded. “The development of better treatment alternatives … would be aided by a better understanding of the pathophysiology of the condition [including the mechanism of symptom generation] and better identification of the proportion of these patients whose symptoms are functional or nonreflux related.”
Disclosure: See the study for a full list of relevant disclosures.