P2472 - Healthcare Resource Use Before and After the Initiation of Prucalopride Treatment: A Real World Study in Patients With Constipation in the U.S.
University of Texas Health Science Center at Houston Houston, TX, United States
Brooks D. Cash, MD, FACG1, Mei Lu, MSc, MD2, Emi Terasawa, PhD3, Brian Terreri, PharmD, MBA4, Shawn Du, PhD3, Rajeev Ayyagari, PhD5, Paul Feuerstadt, MD6, Anthony Lembo, MD7, Baha Moshiree, MD8, Linda Nguyen, MD9, Mena Boules, MD4, Philip Schoenfeld, MD, MSEd, MSc (Epi), FACG10 1University of Texas Health Science Center at Houston, Houston, TX; 2Takeda Development Center Americas, Inc., Lexington, MA; 3Analysis Group, Inc., New York, NY; 4Takeda Pharmaceuticals USA, Inc., Lexington, MA; 5Analysis Group, Inc., Boston, MA; 6Yale University School of Medicine and PACT-Gastroenterology Center, Hamden, CT; 7Beth Israel Deaconess Medical Center, Boston, MA; 8Atrium Health, Charlotte, NC; 9Stanford University, Redwood City, CA; 10John D. Dingell VA Medical Center, Redwood City, CA
Introduction: Prucalopride is a selective high-affinity serotonin type-4 receptor agonist indicated for the treatment of chronic idiopathic constipation in adults. While its safety and efficacy have been established in clinical trials, there are no real-world data on the impact of prucalopride on healthcare resource utilization (HRU). The aim of this real-world study was to assess HRU following initiation of prucalopride in the USA.
Methods: An observational retrospective cohort analysis was performed using data from the MarketScan Commercial Claims and Encounters and Medicare Supplemental databases from 2015 to Q2, 2020. Key inclusion criteria were: aged ≥18 years, diagnosis of constipation based on ICD-10 codes, ≥1 prescription filled for prucalopride, and continuous health plan enrolment during the study (≥6 months before [baseline] and ≥6 months after [study period] the initiation of prucalopride treatment). Exclusion criteria included: diagnosis of irritable bowel syndrome with constipation, drug-induced constipation, post-operative ileus or opioid use. HRU included outpatient visits, emergency room visits, inpatient stays, pharmacy utilization and constipation-related diagnostic tests, procedures and surgeries. All-cause and constipation-related HRU were compared at baseline and during the study period using a McNemar test or Wilcoxon signed-rank test.
Results: A total of 690 patients were included in the study (88% female; mean age, 48 years); the majority (92%) were < 65 years old. The mean number of gastroenterologist visits per patient was significantly lower after initiating prucalopride compared with baseline (0.93 vs 1.61; p< 0.001). The proportions of patients with constipation-related outpatient office/clinic or urgent care visits and all-cause and constipation-related outpatient hospital/surgical center visits, and the proportions of patients requiring diagnostic tests (i.e., colonoscopies, plain film radiography) and prescription laxative use, were also significantly lower during the study period compared with baseline (all p< 0.05; Image).
Discussion:
Study limitations include those inherent to analyses based on claims data, such as no recording of over-the-counter drug use and limited generalizability of commercially insured populations to other patient populations. However, this real-world study found that prucalopride treatment for constipation is associated with reductions in all-cause and constipation-related HRU.
Figure: Image. Healthcare resource utilization (A) and diagnostic tests (B) before (baseline) and after (study period) the initiation of prucalopride
***p<0.001; **p<0.01; *p<0.05. All p-values were generated using a McNemar test. CIC, chronic idiopathic constipation; IMO, intestinal methanogen overgrowth. NB. ‘Baseline’ was defined as ≥6 months before initiation of prucalopride, and the ‘study period’ was defined as the ≥6 months after initiation of prucalopride.
Mei Lu: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).
Emi Terasawa: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Brian Terreri: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Grant/Research Support.
Shawn Du: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Rajeev Ayyagari: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.
Mena Boules: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).
Brooks D. Cash, MD, FACG1, Mei Lu, MSc, MD2, Emi Terasawa, PhD3, Brian Terreri, PharmD, MBA4, Shawn Du, PhD3, Rajeev Ayyagari, PhD5, Paul Feuerstadt, MD6, Anthony Lembo, MD7, Baha Moshiree, MD8, Linda Nguyen, MD9, Mena Boules, MD4, Philip Schoenfeld, MD, MSEd, MSc (Epi), FACG10. P2472 - Healthcare Resource Use Before and After the Initiation of Prucalopride Treatment: A Real World Study in Patients With Constipation in the U.S., ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.
.jpg)