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Purpose <p>Treatment for exocrine pancreatic insufficiency (EPI) includes pancreatic enzyme replacement therapy (PERT). Although PERT may improve symptoms, there are currently no EPI symptom measures to monitor PERT treatment. This analysis evaluated the utility of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) in patients with chronic pancreatitis and EPI treated with pancrelipase.</p> Methods <p>This prospective, observational study (NCT04949828) included adult patients with chronic pancreatitis and EPI who were recommended pancrelipase 72,000 lipase units per meal and 36,000 lipase units per snack by an independent physician. Outcomes included the change from baseline to 1&#xa0;month and 3&#xa0;months after treatment initiation in PEI-Q symptom score, PEI-Q symptom severity categories, and health-related quality of life (HRQoL) as measured by the PEI-Q impact domain score.</p> Results <p>The per-protocol population included 32 and 29 patients with data at 1 and 3&#xa0;months after pancrelipase initiation, respectively. A significant reduction in mean PEI-Q symptom scores was observed from baseline to 1&#xa0;month (−&#xa0;1.0; <i>p</i> &lt; 0.001) and 3&#xa0;months (−&#xa0;1.1; <i>p</i> &lt; 0.001). Despite all patients having moderate/severe EPI symptoms at baseline, 62.5% and 62.1% of patients reported mild/no EPI symptoms after 1 and 3&#xa0;months, respectively. There was also a significant reduction in mean PEI-Q impact scores from baseline to 1&#xa0;month (−&#xa0;1.0; <i>p</i> &lt; 0.001) and 3&#xa0;months (−&#xa0;1.2; <i>p</i> &lt; 0.001), indicating improved HRQoL.</p> Conclusion <p>Pancrelipase improved patient-reported EPI symptoms and HRQoL based on the PEI-Q, which may be a useful tool for monitoring PERT treatment in patients with chronic pancreatitis and EPI.</p>

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Pancrelipase Improves Symptoms of Exocrine Pancreatic Insufficiency and Health-Related Quality of Life in a Real-World Population of Patients with Chronic Pancreatitis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月13日

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  • Mohamed O. Othman,
  • Jens J. Kort,
  • Mitchell L. Ramsey,
  • Tamas A. Gonda,
  • Luis F. Lara,
  • Saad Jazrawi,
  • Tara Keihanian,
  • Walter Park,
  • Neil R. Brett,
  • Diala Harb,
  • Moming Li,
  • Guru Trikudanathan

摘要

Purpose

Treatment for exocrine pancreatic insufficiency (EPI) includes pancreatic enzyme replacement therapy (PERT). Although PERT may improve symptoms, there are currently no EPI symptom measures to monitor PERT treatment. This analysis evaluated the utility of the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) in patients with chronic pancreatitis and EPI treated with pancrelipase.

Methods

This prospective, observational study (NCT04949828) included adult patients with chronic pancreatitis and EPI who were recommended pancrelipase 72,000 lipase units per meal and 36,000 lipase units per snack by an independent physician. Outcomes included the change from baseline to 1 month and 3 months after treatment initiation in PEI-Q symptom score, PEI-Q symptom severity categories, and health-related quality of life (HRQoL) as measured by the PEI-Q impact domain score.

Results

The per-protocol population included 32 and 29 patients with data at 1 and 3 months after pancrelipase initiation, respectively. A significant reduction in mean PEI-Q symptom scores was observed from baseline to 1 month (− 1.0; p < 0.001) and 3 months (− 1.1; p < 0.001). Despite all patients having moderate/severe EPI symptoms at baseline, 62.5% and 62.1% of patients reported mild/no EPI symptoms after 1 and 3 months, respectively. There was also a significant reduction in mean PEI-Q impact scores from baseline to 1 month (− 1.0; p < 0.001) and 3 months (− 1.2; p < 0.001), indicating improved HRQoL.

Conclusion

Pancrelipase improved patient-reported EPI symptoms and HRQoL based on the PEI-Q, which may be a useful tool for monitoring PERT treatment in patients with chronic pancreatitis and EPI.