Relamorelin reduces symptoms in diabetic gastroparesis

CHICAGO — Data from a study of patients with diabetic gastroparesis showed that relamorelin reduced symptoms; however, data also showed the placebo effect was also strong, according to a presentation at Digestive Disease Week.

“The prokinetic relamorelin demonstrated substantially improved core diabetic gastroparesis symptoms individually and using a composite total score,” Michael Camilleri, MD, said during his presidential plenary presentation. “Relamorelin was generally safe; postprandial hyperglycemia may result from the acceleration of gastric emptying and enhanced nutritional intake achievable with relamorelin treatment.”

Michael Camilleri

Camilleri presented a 12-week, randomized, double blind, placebo-controlled study of 393 patients with diabetic gastroparesis who tested with the gastroparesis breath test, had a history of recent vomiting (two or more times in the past 2 weeks) and had a Gastroparesis Cardinal Symptom Index score of 2.6 or greater. The researchers randomly assigned these patients to receive twice-daily subcutaneous injections of placebo (n = 104) or relamorelin 10 µg (n = 98), 30 µg (n = 109) or 100 µg (n = 82).

Using the zero to 10 scale in the electronic Diabetic Gastroparesis Symptom Severity Diary (DGSSD), patients reported their symptoms such as nausea, abdominal pain, post-prandial fullness and bloating as well as vomiting frequency.

Camilleri mentioned that another presentation at DDW analyzed the DGSSD.

“The measurement properties are generally strong for weekly averages of daily item and composite scores,” he said. “On the other hand, ... vomiting frequency data are highly skewed.”

Looking at the primary endpoint of change from baseline to week 12 in weekly vomiting, Camilleri showed that the three treatment groups produced “quite remarkable” results, but the placebo effect was also strong.

When the four-symptom composite score was analyzed, the relamorelin groups showed decreases from baseline: –7.91 for 10 µg; –8.41 for 30 µg and –8.64 for 100 µg (P = .027 for all compared to placebo at –6.07).

“It appears the 30-mg dose has the most efficacy,” Camilleri said, showing graphs where this was shown to be most effective in the four-symptom score as well as each individual symptom.

Looking at gastric emptying, he showed significant differences between all three doses and placebo.

“There was an enhancement of gastric emptying,” Camilleri said. “It was also an improvement in the daily diary score compared to placebo.”

There were some treatment-related serious adverse events: 7.7% in the placebo group, 7.1% in the 10 µg group, 9.2% in the 30 µg group and 7.3% in the 100 µg group. Of note, hyperglycemia was observed in the three treatment groups and increased in a dose-dependent manner: 8.2% in the 10 µg group, 15.6% in the 30 µg group and 20.7% in the 100 µg group.

“This is certainly something we need to learn how to address and adjust,” Camilleri said. “Hyperglycemia resulted in serious adverse events.” Although these events did have contributing concurrent factors, he said. – by Katrina Altersitz

References: Camilleri M. Abstract 638. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosures: Camilleri reports no relevant financial disclosures.