Abstract
Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p<0.05) during treatment when compared to the baseline week. Nausea significantly decreased on day 5 (p<0.01) of treatment. Episodes of vomiting did not significantly change. Side effects included pruritus (2 patients) and redness (1) at the patch site, headache (1), constipation (1), and poor patch adherence (5). Conclusions & Inferences: GTS significantly reduced nausea severity in patients with gastroparesis. There were also significant improvements in early satiety, postprandial fullness, and abdominal pain. Nausea improvement occurred on the fifth day of treatment. Thus, GTS has therapeutic effect on nausea, as well as other gastroparesis symptoms, in patients with gastroparesis as captured using a daily diary for gastroparesis.
Highlights
Symptoms of gastroparesis, a chronic motility disorder of the stomach characterized by delayed gastric emptying, include nausea, vomiting, early satiety, postprandial fullness, and abdominal pain [1]
The aim of this study was to evaluate the efficacy of Granisetron transdermal system (GTS) in reducing gastroparesis symptoms using a daily diary, to determine the specific symptoms that improve with treatment with GTS, to determine the duration of treatment until symptom reduction, and to document the side effects of GTS
We evaluated the efficacy of GTS in patients with nausea and gastroparesis using the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD), which records individual symptoms on a daily basis over time
Summary
A chronic motility disorder of the stomach characterized by delayed gastric emptying, include nausea, vomiting, early satiety, postprandial fullness, and abdominal pain [1]. Nausea and vomiting are important symptoms in gastroparesis, as these symptoms impact on quality of life. Nausea and vomiting are mediated by a number of neural pathways, including serotonergic (5-HT) receptors [3]. Many patients with gastroparesis have nausea and vomiting which may make oral medication administration problematic; the transdermal route may be helpful for these patients. GTS has improved nausea and vomiting in 50-76% of gastroparesis patients [6,7]. Some patients reported improvement in other gastroparesis symptoms such as early satiety, loss of appetite, abdominal pain, and postprandial fullness [7]
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