Prucalopride in diabetic and connective tissue disease-related gastroparesis: Randomized placebo-controlled crossover pilot trial.

Abstract

BACKGROUND:

Gastroparesis, defined by delayed gastric emptying in the absence of mechanical outlet obstruction, is a frequent neuropathic complication of diabetes mellitus, and effective treatments are lacking. Prucalopride is a pan-gut prokinetic with selective agonist effects on serotonin 5-HT4 receptors in the gut. This study aimed to assess the effect of prucalopride 4 mg daily on Gastroparesis Cardinal Symptom Index (GCSI), meal-related symptom score (MRSS), and gastric emptying rate in diabetic or connective tissue disease (CTD)-related gastroparesis patients.

METHODS:

This was a double-blind crossover trial of four-week treatment periods with prucalopride or placebo divided by two weeks of washout. GSCI, MRSS, gastric emptying scintigraphy, PAGI-SYM, and PAGI-QoL were assessed at baseline and the end of each treatment period. Daily bowel movement (BM) frequency and gastrointestinal symptoms were recorded in each period.

KEY RESULTS:

Fifteen gastroparesis patients (13 diabetic, 2 CTD) were enrolled. GCSI scores were lower than baseline but not different between treatment arms. MRSS scores over time or cumulative score were not significantly different between groups. Gastric emptying was more rapid in the prucalopride treatment period, with mean four-hour meal retention of 22 ± 6% in PRU period vs 40 ± 9% in the placebo period (P = 0.05). Weekly BM frequency was significantly higher in prucalopride than placebo periods (10.5 ± 1.8 vs 7.5 ± 0.8, P < 0.0001). Perception of weight loss was higher in patients on prucalopride. Analysis of diabetic gastroparesis (n = 13) population did not change the conclusions.

CONCLUSION AND INFERENCE:

Prucalopride at 4 mg accelerates gastric emptying and bowel movement frequency but does not appear to ameliorate gastroparesis or meal-related symptoms in this study.

• Authors: Christopher N Andrews, Matthew Woo, Michelle Buresi, Michael Curley, Milli Gupta, Jan Tack, Lynn Wilsack, Yasmin Nasser
• Journal: Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society (Neurogastroenterol Motil) Vol. 33 Issue 1 Pg. e13958 (01 2021) ISSN: 1365-2982 [Electronic] England
• PMID: 32743954 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 John Wiley & Sons Ltd.

Chemical References

• Benzofurans
• Serotonin 5-HT4 Receptor Agonists
• prucalopride

Topics

• Adult
• Benzofurans (therapeutic use)
• Cross-Over Studies
• Diabetes Complications (diagnostic imaging, drug therapy, etiology, physiopathology)
• Diabetes Mellitus, Type 1 (complications)
• Diabetes Mellitus, Type 2 (complications)
• Female
• Gastric Emptying
• Gastroparesis (diagnostic imaging, drug therapy, etiology, physiopathology)
• Humans
• Male
• Middle Aged
• Mitral Valve Prolapse (complications)
• Myopia (complications)
• Pilot Projects
• Quality of Life
• Radionuclide Imaging
• Scleroderma, Systemic (complications)
• Serotonin 5-HT4 Receptor Agonists (therapeutic use)
• Skin Diseases (complications)
• Treatment Outcome