Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study

Parkman, Henry P.; Carlson, Marilyn R.; Gonyer, Dave

doi:10.1016/j.cgh.2014.12.030

Cited by 79 publications

(61 citation statements)

References 11 publications

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“…In a prespecified analysis by sex, female patients showed significantly greater symptom relief to metoclopramide than placebo nasal spray. Metoclopramide was generally well tolerated, although dysgeusia, headache, and dizziness occurred more frequently than with placebo [35]. As this trial did not require documented delayed gastric emptying, it remains unclear how many of these patients truly had gastroparesis and how many had dyspeptic symptoms with normal emptying.…”

Section: Prokineticsmentioning

confidence: 90%

“…In a placebo-controlled follow-up trial, the metoclopramide nasal spray was studied in diabetic patients with a clinical diagnosis of 'gastroparesis', based on scores on a gastroparesis daily diary. In this US multicenter study, 285 diabetic gastroparesis patients (82.5% type 2 diabetes) were randomized to 4 weeks of placebo, metoclopramide 10 mg or 14 mg sprays t.i.d., 30 min before meals [35]. Symptom assessment used a modified Gastroparesis Cardinal Symptom Index Daily Diary, which assessed the severity of four symptoms (nausea, bloating, early satiety, and upper abdominal pain) on a 0-5 scale.…”

Section: Prokineticsmentioning

confidence: 99%

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Gastroparesis

Tack

Carbone

Rotondo

2015

Current Opinion in Gastroenterology

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The relationship between delay in gastric emptying, symptom pattern, and response to prokinetic therapy in gastroparesis is poor. In diabetes, gastroparesis is characterized by loss of ICCs, and this is inversely correlated to the number of CD206+ macrophages. Dietary interventions may help to alleviate symptoms. Tricyclic antidepressants do not provide symptomatic benefit to patients with idiopathic gastroparesis.

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Section: Prokineticsmentioning

confidence: 90%

Section: Prokineticsmentioning

confidence: 99%

Gastroparesis

Tack

Carbone

Rotondo

2015

Current Opinion in Gastroenterology

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“…Metoclopramide had been reported to have a more favorable effect in women than in men. 16 Interestingly, obese patients, defined as BMI > 30 kg/m 2 , tended to have a higher response rate to GTS than lower weight patients. Obese patients have been reported to have a higher response rate than other patients in other clinical trials which was suggested to be a higher placebo response rate.…”

Section: Discussionmentioning

confidence: 99%

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

Midani

Parkman

2016

J Neurogastroenterol Motil

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Background/AimsSerotonin receptor (eg, 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. MethodsPatients 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. ResultsFifty-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. ConclusionsGTS 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.

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“…A nasal spray formulation is currently undergoing clinical trials [ 37 ]. The adult dose is 10 mg three to four times daily.…”

Section: Metoclopramidementioning

confidence: 99%