Domperidone to Treat Symptoms of Gastroparesis: Benefits and Side Effects from a Large Single-Center Cohort.

BACKGROUND: There is increased awareness about risks and benefits of using domperidone to treat gastroparesis. AIM: To describe the outcome of treating patients with refractory gastroparesis symptoms with domperidone. METHODS: Domperidone 10 mg QID or TID was prescribed to patients with refractory gastroparesis symptoms; follow-up obtained at 2-3 months assessing symptoms and side effects. Patients filled out Patient Assessment of Upper GI Symptoms prior to treatment and at follow-up along with Clinical Patient Grading Assessment Scale (CPGAS, +7 = completely better; 0 = no change). RESULTS: Of 125 patients initially prescribed domperidone, 7 did not take this medication and 3 were lost to follow-up. Of the 115 known patients treated with domperidone, 88 had idiopathic, 16 diabetic, and 9 postsurgical gastroparesis. Side effects were reported by 44 patients (most common-headache, tachycardia/palpitations, diarrhea); 14 patients stopped treatment. Hundred and one patients were seen at follow-up taking domperidone (2.4 ± 2.7 months, average dose 36 ± 13 mg/day). CPGAS averaged 2.7 ± 2.7 (p < 0.01) with 69 patients reporting symptom improvement and 45 patients at least moderately improved with CPGAS ≥ 4. Improvements were seen in most symptoms, especially postprandial fullness, nausea, vomiting, and stomach fullness. CONCLUSIONS: In this large single-center study of patients treated with domperidone, side effects necessitating discontinuing treatment occurred in 12 %. The majority of patients remaining on treatment experienced an improvement in symptoms of gastroparesis, particularly postprandial fullness, nausea, vomiting, and stomach fullness. Thus, domperidone treatment is beneficial for many patients with symptoms of gastroparesis. This study provides needed benefit and risk information concerning treating patients with domperidone. FDA IND Number: 71,089.

Granisetron Transdermal System for Treatment of Symptoms of Gastroparesis: A Prescription Registry Study.

BACKGROUND/AIMS: Serotonin receptor (eg, 5-HT3) antagonists are used to treat nausea and vomiting from a variety of causes. Granisetron transdermal system (GTS) is an appealing delivery system for patients with gastroparesis. To assess if GTS improves nausea and vomiting and other gastroparesis symptoms in patients with gastroparesis. METHODS: Patients with gastroparesis and symptoms of nausea and vomiting refractory to conventional treatment were treated with GTS. Symptoms of gastroparesis were assessed using a modified Gastroparesis Cardinal Symptom Index (GCSI). Following 2 weeks of treatment, patients were asked to assess their symptoms and indicate their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS) reporting if symptoms of nausea and vomiting improved on a scale: 0 = no change to +7 = completely better. RESULTS: Fifty-one patients received GTS by prescription: average age was 40 ± 17 years, 44 female, 11 diabetics, 23 ± 20% retention at 4 hours on gastric emptying scintigraphy. Thirty-nine of the 51 (76%) patients stated improvement with GTS. There was significant improvement in nausea and vomiting as assessed with CPGAS at 2 weeks (2.28 ± 2.53; P < 0.05). Symptoms of nausea and vomiting significantly improved. Other symptoms including postprandial fullness, loss of appetite, upper abdominal pain, and early satiety improved. Side effects reported included redness at the site of the patch in 7 patients, pruritus in 5, and constipation in 5. CONCLUSIONS: GTS was moderately effective in reducing nausea and/or vomiting in 76% of gastroparesis patients. In addition to nausea and vomiting, symptoms of postprandial fullness, loss of appetite, upper abdominal pain, and early satiety also improved.