Michelle Buresi, MD, PhD1, Mathew Woo, MD1, Joel David, MSC, CCRP2, Milli Gupta, MD1, Yasmeen Nasser, MD, PhD1, Christopher Andrews, MD1, Dorothy Li, MD1; 1University of Calgary, Calgary, AB, Canada; 2Alberta Health Services, Calgary, AB, Canada
Introduction: Ineffective esophageal motility (IEM) is a manometric diagnosis defined by the Chicago Classification (v3.0) as ≥50% of swallows achieving a distal contractile integral (DCI) of < 450 mmHg-cm-s and maybe associated with dysphagia. This pilot study assesses the effectiveness of prucalopride a 5-HT4 enterokinetic drug in IEM patients with dysphagia Methods: Symptomatic patients with dysphagia diagnosed with IEM following high-resolution manometry (HRM) with impedance at a tertiary care motility lab were enrolled between August 2017 and September 2019. Patients with uncontrolled GERD (DeMeester score >14.7), endoscopic erosive esophagitis, eosinophilic esophagitis, use of other prokinetic drugs, or narcotics were excluded. Patients received prucalopride 4mg PO once daily for 5 days and then underwent repeat HRM. Outcome measures included pre- and post- prucalopride esophageal HRM values, dysphagia symptom questionnaire (DSQ), and quality of life (Eq5d-3L). These outcomes were compared with paired T-test, Wilcoxon signed ranks test and McNemar test as appropriate. Patients were classified into definite or indefinite for heartburn, acid regurgitation, and GERD based on the MDQ-30 subscale. IRB-approved study (NCT03244553). Results: Twenty-nine patients were enrolled; analysis was performed on twenty-five patients (13M:12F; mean age of 53.3 yrs (±13.97SD) who completed the study. All patients had symptoms of dysphagia to solids. 76% of patients were on a PPI. The median time and IQR between baseline and post-HRM were 12[8-18] wks. 18 patients (72%) had an improvement in mean DCI. There was a significant increase in DCI (mean727.1±548.7vs439.5±286.7,p=.006), maximum DCI (mean1198.7±1198.67819.8±540.5,p =.013), and decrease in the percentage of failed swallows (median 40[IQR 25–70]vs20[10–50],p=.05), and acid regurgitation(p=.05) after prucalopride use. No improvement was seen in dysphagia or quality of life. Change in DCI correlated weakly with IRP (Spearman’s r =.461,p=.021). The most common side effects were headaches (48%) and diarrhea (52%). A majority of patients (88%) reported a side effect, leading to discontinuation in 4%. Discussion: In this short duration pilot study, prucalopride significantly improved the DCI, maximum DCI, number of failed swallows, and acid regurgitation in patients with IEM; however, no improvement in dysphagia or quality of life was seen. This pilot study warrants a larger study.
Table 1. Pairwise comparison of manometric values and patient-reported outcomes pre- and post- prucalopride therapy
Figure 1. Representative Pre and post-HRM picture of 3 patients who displayed significant improvement after prucalopride
Disclosures: Michelle Buresi indicated no relevant financial relationships. Mathew Woo indicated no relevant financial relationships. Joel David indicated no relevant financial relationships. Milli Gupta indicated no relevant financial relationships. Yasmeen Nasser indicated no relevant financial relationships. Christopher Andrews indicated no relevant financial relationships. Dorothy Li indicated no relevant financial relationships.