Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial

摘要: Abstract The purpose of this clinical study was to determine the efficacy, tolerability, and impact on quality life domperidone—a specific peripherally acting dopamine antagonist—in management symptoms gastroparesis, a common potentially debilitating condition in patients with diabetes mellitus. In first phase multicenter, two-phase withdrawal study, 287 diabetic gastroparesis at least 6 months' duration received domperidone 20 mg QID single-masked fashion for 4 weeks. Efficacy evaluated using four-point rating scale (0 = none, 1 mild, 2 moderate, 3 severe) each following symptoms: nausea, abdominal distention/bloating, early satiety, vomiting, pain. At end phase, sufficient improvement their total symptom score (a ≤6 decrease ≥5 units from baseline [selection] visit) were eligible 4-week, randomized, placebo-controlled, double-masked study. determined Medical Outcomes Study Short Form-36 (SF-36). Of 269 data 208 (77%) qualified entry into based statistically significant score, mean 10.32 (initial 3.79 after weeks therapy. During placebo group had significantly greater deterioration scores compared (mean changes 1.84 0.85, respectively). Similar differences favor seen secondary efficacy variables (ie, patients' diary global assessments symptoms). tolerability profile similar that placebo. Patients who responded experienced improvements life, as indicated by SF-36 physical mental component summary scores. randomized group. results suggest provides upper gastrointestinal is well tolerated condition.