Simons, Madison

INTRODUCTION: There is an urgent need for effective and safe treatment of gastroparesis. Metopimazine, a selective, peripherally restricted dopamine D 2 receptor antagonist, is used in France for the symptomatic treatment of nausea and vomiting and chemotherapy-induced nausea and vomiting. The aim of this study is to assess the safety and efficacy of oral NG101, the mesylate salt of metopimazine, for the treatment of gastroparesis. METHODS: We conducted a 12-week phase 2 multicenter trial with NG101 5, 10, and 20 mg 4 times a day versus placebo. The primary end point was the change in mean nausea severity from the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) during weeks 7–12 of the Treatment Period from baseline. The DIGS-DD measured nausea, abdominal pain, early satiety, postprandial fullness, and vomiting at their worst in the past 24 hours using a 0-10 point numeric rating scale. Patient Global Impression of Change questionnaires, including nausea, were assessed weekly using a 7-point balanced ordinal score. RESULTS: Of 161 randomized participants (45.3% diabetic and 54.7% idiopathic), mean DIGS-DD nausea severity scores decreased from baseline during weeks 7–12 in all treatment groups, but these improvements were not statistically significant compared with placebo. However, there were statistically significant improvements in nausea Patient Global Impression of Change during weeks 1–12 for all treatment groups compared with placebo. Trends in safety and efficacy favored patients with idiopathic gastroparesis compared with those with diabetic gastroparesis. DISCUSSION: While NG101 did not meet statistical significance in its primary end point for reducing nausea severity, it demonstrated a favorable safety profile and significant improvement in some secondary end points. Further study is needed to determine whether NG101 is an effective treatment for patients with idiopathic gastroparesis.

ABSTRACTBackground/AimsMany patients with digestive symptoms describe underlying urinary or gynecologic symptoms, which may increase visceral sensitivity in the abdominopelvic region and amplify distress around digestive symptoms. The aim of this study was to describe the prevalence of urinary and gynecologic symptoms in patients with disorders of gut–brain interaction (DGBI).MethodsConsecutive adult patients with a female reproductive tract who were referred for GI behavioral medicine evaluation for DGBI at a tertiary care center between 2022 and 2023 were prospectively evaluated for symptoms associated with urinary and gynecologic dysfunction. Descriptive statistics were conducted to assess the prevalence of these symptoms within this population by anatomic region affected (esophagus, stomach, and bowel).ResultsA total of 432 patients were included in our cohort with a mean (SD) age of 40.0 years [Q1;Q3 29.0–52.0], with a predominantly White population (86.1%). Dysmenorrhea (61.0%) and menorrhagia (58.6%) were commonly reported among women with digestive symptoms. Urinary symptoms were less common, with 18.7% reporting pain with urination, 33.0% reporting difficulty voiding urine, and 26.1% reporting a history of frequent UTIs. 23% of women experienced ≥ 4 urinary/gynecologic symptoms. There were no significant differences in the type of urogynecologic symptoms reported based on the affected area of the GI tract.ConclusionUrogynecologic symptoms are common among patients with DGBIs affecting the entirety of the GI tract. We presume the presence of these comorbid symptoms is likely to impact symptom severity, quality of life, and could affect treatment response. Future studies are necessary to understand the mechanisms behind these shared conditions as well as develop effective treatments that address their overlap.

Abstract Endometriosis is a chronic painful condition affecting 10% of reproductive-aged women with a high prevalence of overlapping gastrointestinal symptoms. There is a significant diagnostic delay for endometriosis and current screening practices for endometriosis in gastroenterology clinic populations have not been evaluated. 112 gastroenterology providers (57.5% females, 64.3% physicians) completed an anonymized exploratory survey (40.1% response rate). Most respondents (59.4%) currently do not screen for endometriosis, but the majority (72.1%) reported they would be “extremely likely” or “somewhat likely” to screen for endometriosis after being presented with data on the high prevalence of chronic GI symptoms in patients with endometriosis.