S1637 Outcomes in Patient With Refractory Gastroparesis on Domperidone-A 12-Year Experience

Abstract

Introduction: Domperidone (Domp), a prokinetic with less side effects than metoclopramide, the only FDA-approved medication for gastroparesis (GP), is only available via the FDA IND program. Our aim was to examine clinical response and side effects profiles of patients (pts) enrolled in our program to identify those most likely to benefit. Methods: Records of pts enrolled from 2010 through 2021 were examined. Pts who completed an initial (PAGI sym) were contacted for a repeat PAGI-sym. Pts self-reported quality of life. Records of disenrolled (DE) pts were reviewed for cause for disenrollment, adverse effects if any and improvement of symptoms on Domp. Data is reported at percentages and mean ± SD. Variables were compared using Chi-squared test (categorical) and t-test. P< 0.05 was considered significant. Results: 301 pts (85.7% F), were consented. 189 pts were disenrolled (DE), of which 31 never started drug, and 67 charts were reviewed in detail. 41 pts still enrolled (E) had initial and followup PAGI-sym. Of these, 32 (78%) were female, mean age on entry was 50 yrs, with 70.1% older than 40 yrs. Mean treatment duration was 39±39.3 mo. Top GP causes were idiopathic (43.9%), diabetes (24.4%) and post-surgical (12.2%). There was no significant difference in causes or initial symptom severity between genders. There was significant improvement in the severity of all symptoms on PAGI-sym scale after Domp treatment (Table). Gender and age groups did not affect this improvement. Overall self-reported quality of life (QoL) improved regardless of gender, age group and use of psychotropic medication. Reasons for disenrollment for all 189 DE pts are shown in Figure. Six had QTc prolongation (3.2%). In the 67 pts with detailed review, the GP cause was similar in those with symptom remission as in all the DE and E pts. Treatment duration of DE pts was 22.2±22.8 months, shorter than the 41 E pts (P< 0.005). Pts with symptom remission were on Domp treatment for 45.7 ± 26.74 mo, longer than pts withdrawn for other reasons (mean 14.83±15.54 mo, P< 0.001). Most (72%) DE pts reported improvement in symptoms. Conclusion: In summary, Domp improves symptoms related to GP regardless of etiology. Nearly 2 thirds disenrolled over time, but very few have prolonged QTc. Detailed review in a subset of pts suggest no specific etiologies result in better symptom response to domperidone, or predict likelihood of adverse events. Symptom remission can take several years to be sufficient to discontinue treatment.Figure 1.: Reasons for Disenrollemnt in 189 DE Patients. Table 1. - Comparison of Symptom Improvement in All Enrolled Patients PAGISYM-1 (mean +/- SD) PAGISYM-2 (mean +/-SD) P value Regurgitation 2.23 +/- 1.55 1.27 +/- 1.1 < 0.001 Nausea 3 +/- 1.7 1.66 +/- 1.15 < 0.001 Upper Abdominal Pain 2.66 +/- 1.59 1.37 +/- 1.18 < 0.001 Stomach Fullness 3.45 +/- 1.48 2.41 +/- 1.32 0.003 Loss of Appetite 2.9 +/- 1.74 1.46 +/- 1.4 < 0.001 Upper Abdominal discomfort 2.7 +/- 1.54 1.46 +/- 1.29 < 0.001 Bloating 3.48 +/- 1.55 2.2 +/- 1.5 < 0.001 Retching 1.4 +/- 1.53 0.61 +/- 0.92 < 0.001 Stomach or Belly Visibly Larger 2.69 +/- 1.89 1.55 +/- 1.45 0.001 Vomiting 1.89 +/- 1.84 0.78 +/- 1.17 0.001 Not Able to Finish a Normal Sized Meal 3.5 +/- 1.52 2.05 +/- 1.45 < 0.001 Feeling Excessively Full After Meals 3.75 +/- 1.28 1.93 +/- 1.44 < 0.001