In a phase 2 trial, researchers randomly assigned 204 patients with diabetic gastroparesis (DG) (mean age, 55.1 years; 32.3% men) into a double blind, placebo-controlled study for 28 days. Patients were enlisted to take two daily injections of relamorelin-131 10 mcg (RM-131; Rhythm) before an evening meal (n=67), RM-131 10 mcg before breakfast and an evening meal (n=68) or placebo (n=69). Patients' daily symptoms were recorded on a 0-10 scale, and a gastric emptying breath test (GEBT) was performed at baseline and on day 28.
Patients who received RM-131 before breakfast and evening meals showed accelerated GE (P<.03), the study's primary endpoint, and an improvement in vomiting (P=.033), compared with placebo patients. Results for patients who took RM-131 only before evening meals were not presented.
Post-hoc analysis of 119 patients with baseline vomiting revealed that RM-131 had a positive effect on GE, and overall weekly vomiting was reduced by 63%. This subgroup also exhibited improvements in nausea, bloating, early satiety and abdominal pain, compared with the placebo arm (P<.043). Few adverse events occurred, according to the study.
Anthony Lembo, MD, gastroenterologist at Beth Israel Deaconess Medical Center, Boston, stated that, "In summary, RM-131 10 mcg twice daily showed more efficacy than once daily." "In post-hoc analysis in the subgroup of patients, RM-131 10 mcg twice daily is effective in all endpoints. There were no safety concerns seen in the studies."
- Selective ghrelin pentapeptide relamorelin-131, showed positive results in treating gastroparesis
- The results of this study are preliminary and no conclusions should be made until it has been reviewed and published.
Presented at: Digestive Disease Week 2014; May 3-6; Chicago. Lembo A. #929a.