Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis

Parkman, Henry P.; Hallinan, Erin; Hasler, William L.; Farrugia, Gianrico; Koch, Kenneth L.; Calles, Jorge; Snape, William J.; Abell, Thomas L.; Sarosiek, Irene; McCallum, Richard W.; Nguyen, Linda Anh B.; Pasricha, Pankaj J.; Clarke, John O.; Miriel, Laura; Lee, L.; Tonascia, James; Hamilton, Frank A.

doi:10.1111/nmo.12893

Cited by 68 publications

(61 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In a prior study of ours, we described the characteristics of nausea and vomiting in patients with gastroparesis [21]. The characteristics of nausea (severity, timing) were similar in diabetic and idiopathic patients.…”

Section: Discussionmentioning

confidence: 75%

Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Heckert

Schey

Parkman

2018

JPT

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 75%

Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Heckert

Schey

Parkman

2018

JPT

View full text Add to dashboard Cite

show abstract

“…Since some patients had vomited their test-meal, their exclusion could have led to a selection bias since excluding the more severe patients imply not reflecting anymore the dyspeptic population of origin. 40 However, the number of those patients is very small (4 patients, 2%). Finally, we did not realize any subgroup analysis according to treatments, especially as patients had to stop every treatment that could interact with the measurement of gastric emptying before the test.…”

Section: Discussionmentioning

confidence: 97%

Association Between Symptoms, Quality of Life, and Gastric Emptying in Dyspeptic Patients

Wuestenberghs

Juge

Melchior

et al. 2019

J Neurogastroenterol Motil

View full text Add to dashboard Cite

Background/Aims Association between symptoms, quality of life and gastric emptying in dyspepsia is inconsistent in the literature. The aim of our study is to investigate if gastric emptying is associated with specific symptoms and quality of life in dyspeptic patients. Methods We reviewed retrospectively gastric emptying measured by 13 C-labelled octanoate breath testing for more than 6 hours in 198 consecutive patients with dyspepsia complaints. Gastrointestinal symptoms were assessed using a 5-points Likert scale and by a symptomatic composite score, whereas quality of life was measured by the GIQLI. Results In our cohort, 90 patients (45%) had a delayed gastric emptying (half emptying time above 166 minutes when assessed over 6-8 hours). There was no difference in symptoms or quality of life between patients with or without delayed gastric emptying. However, patients with severely delayed gastric emptying (half emptying time above 200 minutes) had increased postprandial fullness (P = 0.012), abdominal pain (P = 0.026), bloating (P = 0.044), early satiety (P = 0.018), symptomatic composite score (P = 0.005), and a lower quality of life (P = 0.018). This association was no longer observed if the calculation of gastric emptying was limited to the first 4-hour samples. Conclusions There is no association between symptoms, quality of life and gastric emptying in an overall dyspeptic population. However, there is an association between symptoms, quality of life of delayed gastric emptying in the subgroup of patients with severely delayed gastric emptying. An 8-hour measurement of gastric emptying should be recommended.

show abstract

“…Blocking NK-1R in smooth muscle could increase gastric emptying, as it has been reported that aprepitant can increase gastric accommodation volume and maximum calorie volume tolerated in healthy volunteers 28 . Delayed emptying is a predictor of more severe upper gastrointestinal symptoms 29,6 ; however, improvement in gastric emptying rate does not always correlate well with improvement in symptoms 22,30,31,32,33 . The effect of gastric emptying will be assessed in future studies, although we predict tradipitant to be useful for treatment of gastroparesis with or without an effect on gastric emptying rate.…”

Section: Discussionmentioning

confidence: 98%

Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

Carlin

Lieberman

Dahal

et al. 2020

Preprint

View full text Add to dashboard Cite

Background and Aims: There is a high unmet need for the treatment of gastroparesis and studies of NK1-R antagonists suggest potential benefit in reducing the symptoms of nausea and vomiting. We hypothesized that tradipitant, an NK1-R antagonist, would be effective in treating patients with idiopathic or diabetic gastroparesis. Methods: In a randomized, double-blind, placebo-controlled study across 47 U.S. sites, 152 gastroparesis patients were randomized to receive oral 85mg BID tradipitant (n=77) or placebo (n=75) daily for four weeks. Symptoms were assessed using a daily symptom dairy, Gastroparesis Cardinal Symptom Index (GCSI), and other patient reported questionnaires. Results: Patients receiving tradipitant had a significant decrease in nausea score at Week 4 compared to placebo (-1.2 improvement vs -0.7, respectively, p=0.0099), and a significant increase in nausea-free days (28.8% increase on tradipitant vs 15.0% on placebo p=0.0160). Patients with both nausea and vomiting at baseline (n=101) showed an even greater decrease in nausea score (-1.4 improvement on tradipitant vs -0.4 on placebo p<0.0001) and an increase in nausea free days (32.3% improvement on tradipitant vs 7.6% on placebo p=0.0003). 32.9% of patients treated with tradipitant were nausea responders (average nausea score ≤ 1 at week 4) compared to 11.8% of patients on placebo (p=0.0013). 46.6% of patients treated with tradipitant had a greater than 1-point improvement in GCSI score compared to 23.5% of patients on placebo (p=0.0053). Conclusions: Tradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. These robust efficacy results suggest tradipitant has the potential to become a useful pharmacological treatment for gastroparesis.

show abstract

Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis

Cited by 68 publications

References 27 publications

Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Association Between Symptoms, Quality of Life, and Gastric Emptying in Dyspeptic Patients

Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

Contact Info

Product

Resources

About