Gender-Specific Benefits Seen With Inhaled Tx for Diabetic Gastroparesis
(HealthDay News) — For women, but not men, with diabetes, metoclopramide nasal spray reduces symptoms of gastroparesis, according to a study published in the July issue of Clinical Gastroenterology and Hepatology.
Henry P. Parkman, MD, from the Temple University School of Medicine in Philadelphia, and colleagues conducted a randomized phase 2b study to examine the efficacy and safety of 10mg and 14mg metoclopramide nasal spray vs. placebo. Two hundred eighty-five subjects (71% female) with type 1 or 2 diabetes and a prior diagnosis of gastroparesis were randomized to metoclopramide nasal spray (given 30 minutes before meals and bedtime) or placebo for 28 days.
The researchers found that although there was no significant difference in the reduction in symptom scores between the metoclopramide and placebo groups, there was an overall reduction in symptom scores in the metoclopramide group. In female subjects, there was a significant reduction in gastroparesis symptom scores with either dose of metoclopramide vs. placebo (mean reduction from 10mg dose, 1.2 ± 1.18: P=0.0247; mean reduction from 14mg dose, 1.3 ± 0.94; P=0.0215). The symptom scores decreased more in the placebo group than the metoclopramide group in men. Dysgeusia, headache, and fatigue were the most common treatment-emergent adverse effects.
"Patient sex therefore might be considered in the selection of treatment for diabetic gastroparesis," the authors write.
Several authors disclosed financial ties to Evoke Pharma, which is pursuing additional studies with metoclopramide nasal spray, and funded the study.