Among individuals with gastroparesis, prucalopride has demonstrated significant efficacy in improving quality of life, emptying of the stomach, and disease symptoms, according to results published recently in The American Journal of Gastroenterology

This double-blind crossover trial included 34 individuals with gastroparesis, 28 of whom had idiopathic disease and 7 of whom were men (mean age, 42±13 years). All participants were treated with daily prucalopride 2 mg or placebo, with a 2-week separation for washout. Change in symptom severity from baseline to 4 weeks was the primary end point of the study, with the Gastroparesis Cardinal Symptom Index (GCSI) used to assess changes. The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL), Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, C-octanoic acid breath test to assess gastric emptying rate, and daily diaries constituted secondary end points. Mixed-model statistical analysis was chosen for analytical purposes.

Prucalopride was associated with significant 4-week GCSI improvement compared with placebo (1.65±0.19 vs 2.28±0.20, respectively; P <.0001), including improvements in nausea/vomiting (1.02±0.20 vs 1.42±0.24; P =.01), bloating/distension (1.58±0.28 vs 2.50±0.29; P <.0005), and fullness/satiation (2.16±0.26 vs 2.81±0.26; P <.0005). PAGI-QOL score and its clothing and diet subscales also improved with prucalopride vs placebo (1.15±0.16 vs 1.44±0.16, respectively; P <.05).


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Prucalopride significantly improved gastric half-emptying time compared with placebo (98±10 vs 143±11 minutes, respectively; P =.005) and baseline (98±10 vs 126±13 minutes, respectively; P <.001). Isolating the idiopathic gastroparesis subgroup maintained these improvements. A small bowel volvulus among the intervention group comprised the sole serious adverse event, while nausea and headache caused 3 participants to drop out of intervention.

Limitations to this study included a proof-of-concept design, a potential lack of generalizability, a small subgroup of individuals with diabetes, and a short treatment duration.

Study researchers concluded that “this single-center crossover study of prucalopride showed symptomatic benefit of the drug in gastroparesis and in the subgroup of patients with idiopathic gastroparesis. These encouraging findings should be confirmed in a larger, multisetting, parallel-group design study, and prucalopride’s efficacy in postprandial distress syndrome without delayed emptying also merits studying.”

Disclosure: This clinical trial was supported by Shire Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.

Reference

Carbone F, Van den Houte K, Clevers E, et al. Prucalopride in gastroparesis: a randomized placebo-controlled crossover study [published online July 5, 2019]. Am J Gastroenterol. doi:10.14309/ajg.0000000000000304