Prucalopride, a selective high-affinity serotonin type 4 receptor agonist, is associated with statistically significant reductions in constipation-related symptoms and complications in adults with chronic idiopathic constipation (CIC), according to a recent real-world study using US insurance claims data. The retrospective cohort analysis, which utilized the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental Database, suggests that prucalopride may offer tangible benefits in routine clinical practice.
The study, which was published in the journal Clinical and Translational Gastroenterology, included 690 patients aged 18 years and older who had at least one prescription fill for prucalopride between April 2019 and June 2020. Researchers compared the proportions of patients with constipation-related symptoms and complications in the 6 months before and after prucalopride initiation.
Symptom and Complication Reduction
The results indicated a significant decrease in several constipation-related symptoms following prucalopride treatment. Specifically, the proportion of patients reporting abdominal pain decreased from 50.4% to 33.3% (P < 0.001), abdominal distension from 23.9% to 13.3% (P < 0.001), and nausea from 22.6% to 17.7% (P < 0.01). There was no significant change in incomplete defecation.
Furthermore, the study revealed a reduction in constipation-related complications. The proportion of patients with hemorrhoids decreased from 10.7% to 7.0% (P < 0.05), intestinal obstruction from 4.9% to 2.0% (P < 0.001), and rectal bleeding from 4.1% to 1.7% (P < 0.05).
Age-Stratified Analysis
When the data were analyzed by age group, the statistically significant reductions in symptoms and complications were primarily observed in patients aged 18-64 years. While patients aged 65 years and older showed numerical reductions, these were not statistically significant, possibly due to the smaller sample size in this subgroup (n = 56).
Context and Implications
Chronic idiopathic constipation affects approximately 35 million adults in the United States, with many relying on over-the-counter medications for symptom management. Prucalopride, approved for CIC treatment, offers an alternative for those who do not respond adequately to OTC options. The American Gastroenterological Association and the American College of Gastroenterology recommend prucalopride for adults who have failed to respond to OTC medications.
"Understanding the real-world clinical challenges of CIC and treatment outcomes in a more heterogeneous patient population and setting is therefore important to facilitate informed decision-making in routine clinical practice," the authors stated.
Study Limitations
The authors noted several limitations to the study. These include the lack of generalizability to uninsured or Medicaid populations, the relatively short 6-month study period, and potential inaccuracies in diagnosis coding. Additionally, the study relied on insurance claims data, which may not fully capture the severity or nuances of individual patient symptoms.
Despite these limitations, the study provides valuable insights into the real-world effectiveness of prucalopride in managing CIC and its associated symptoms and complications. Further research, particularly with longer follow-up periods and larger sample sizes, is warranted to confirm these findings and explore the long-term benefits of prucalopride treatment.
