ORIGINAL ARTICLE
Pancreatic Enzyme Replacement Therapy in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis A 1-Year Disease Management Study on Symptom Control and Quality of Life Jan G. D’Haese, MD,* Gu¨ralp O. Ceyhan, MD,* Ihsan Ekin Demir, MD,* Peter Layer, MD,Þ Waldemar Uhl, MD,þ Matthias Lo¨hr, MD,§ Reinhard Rychlik, PhD,|| Konstantinos Pirilis, MD,¶ York Zo¨llner, PhD,# Birgit Gradl, MSc,** Douglas Foerster, MSc,**ÞÞ Julia Mo¨bius, PhD,þþ Friederike Henniges, PhD,§§ and Helmut Friess, MD*
Objective: Exocrine pancreatic insufficiency (EPI) is frequent in patients with chronic pancreatitis (CP). This 1-year, prospective, multicenter, observational, disease management study aimed to assess symptom improvement and quality of life in patients with CP with EPI who were receiving pancreatic enzyme replacement. Methods: Patients with CP and chronic EPI were either assigned to cohort 1 that consisted of patients already taking pancreatin (Kreon; Abbott Arzneimittel GmbH, Hannover, Germany) or cohort 2 that consisted of patients with newly diagnosed EPI without prior pancreatic enzyme treatment. Symptoms were documented, and quality of life was assessed using the gastrointestinal quality of life index (GIQLI) at baseline, 6 months, and 1 year. Results: A total of 294 patients were evaluated (cohort 1, n = 206; cohort 2, n = 88). The proportion of patients experiencing gastrointestinal symptoms and recurrent pain after 1 year was significantly reduced in both cohorts (P G 0.001). The alleviation of symptoms was reflected in GIQLI score improvements at 1 year in both cohorts (P G 0.001), independent of CP severity and etiology. Improvements in GIQLI score were more pronounced in cohort 2 (P G 0.001). Conclusions: Pancreatin demonstrated symptom relief and improvement in quality of life in patients with CP-related EPI in this disease management study. Key Words: disease management research, exocrine pancreatic insufficiency, gastrointestinal quality of life index, Kreon/Creon, pancreatic enzyme replacement (Pancreas 2014;43: 834Y841)
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hronic pancreatitis (CP) is a chronic inflammatory disorder that is characterized by permanent and progressive destruction of the pancreas, leading to exocrine and endocrine insufficiency.1,2 Indeed, the most common cause of chronic exocrine pancreatic From the *Department of Surgery, Klinikum Rechts der Isar, Technische Universita¨t Mu¨nchen, Munich; †Department of Internal Medicine, Israelitisches Krankenhaus, Hamburg; ‡Department of Surgery, St Josef-Hospital, RuhrUniversity Bochum, Bochum, Germany; §Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden; ||Institut fu¨r Empirische Gesundheitso¨konomie, Burscheid; ¶Leibniz University, Hannover; #Hamburg University of Applied Sciences, Hamburg, Germany; **Abbott Products Operations AG, Allschwil, Switzerland; ††School of Public Health, University Bielefeld, Bielefeld; ‡‡Abbott Arzneimittel GmbH, Hannover; and §§Abbott Products, Hannover, Germany. Received for publication August 19, 2013; accepted February 5, 2014. Reprints: Helmut Friess, MD, Department of Surgery, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen, Ismaninger Str 22, 81675 Munich, Germany (e
Pancreatic Enzyme Replacement Therapy in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis A 1-Year Disease Management Study on Symptom Control and Quality of Life Jan G. D’Haese, MD,* Gu¨ralp O. Ceyhan, MD,* Ihsan Ekin Demir, MD,* Peter Layer, MD,Þ Waldemar Uhl, MD,þ Matthias Lo¨hr, MD,§ Reinhard Rychlik, PhD,|| Konstantinos Pirilis, MD,¶ York Zo¨llner, PhD,# Birgit Gradl, MSc,** Douglas Foerster, MSc,**ÞÞ Julia Mo¨bius, PhD,þþ Friederike Henniges, PhD,§§ and Helmut Friess, MD*
Objective: Exocrine pancreatic insufficiency (EPI) is frequent in patients with chronic pancreatitis (CP). This 1-year, prospective, multicenter, observational, disease management study aimed to assess symptom improvement and quality of life in patients with CP with EPI who were receiving pancreatic enzyme replacement. Methods: Patients with CP and chronic EPI were either assigned to cohort 1 that consisted of patients already taking pancreatin (Kreon; Abbott Arzneimittel GmbH, Hannover, Germany) or cohort 2 that consisted of patients with newly diagnosed EPI without prior pancreatic enzyme treatment. Symptoms were documented, and quality of life was assessed using the gastrointestinal quality of life index (GIQLI) at baseline, 6 months, and 1 year. Results: A total of 294 patients were evaluated (cohort 1, n = 206; cohort 2, n = 88). The proportion of patients experiencing gastrointestinal symptoms and recurrent pain after 1 year was significantly reduced in both cohorts (P G 0.001). The alleviation of symptoms was reflected in GIQLI score improvements at 1 year in both cohorts (P G 0.001), independent of CP severity and etiology. Improvements in GIQLI score were more pronounced in cohort 2 (P G 0.001). Conclusions: Pancreatin demonstrated symptom relief and improvement in quality of life in patients with CP-related EPI in this disease management study. Key Words: disease management research, exocrine pancreatic insufficiency, gastrointestinal quality of life index, Kreon/Creon, pancreatic enzyme replacement (Pancreas 2014;43: 834Y841)
C
hronic pancreatitis (CP) is a chronic inflammatory disorder that is characterized by permanent and progressive destruction of the pancreas, leading to exocrine and endocrine insufficiency.1,2 Indeed, the most common cause of chronic exocrine pancreatic From the *Department of Surgery, Klinikum Rechts der Isar, Technische Universita¨t Mu¨nchen, Munich; †Department of Internal Medicine, Israelitisches Krankenhaus, Hamburg; ‡Department of Surgery, St Josef-Hospital, RuhrUniversity Bochum, Bochum, Germany; §Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden; ||Institut fu¨r Empirische Gesundheitso¨konomie, Burscheid; ¶Leibniz University, Hannover; #Hamburg University of Applied Sciences, Hamburg, Germany; **Abbott Products Operations AG, Allschwil, Switzerland; ††School of Public Health, University Bielefeld, Bielefeld; ‡‡Abbott Arzneimittel GmbH, Hannover; and §§Abbott Products, Hannover, Germany. Received for publication August 19, 2013; accepted February 5, 2014. Reprints: Helmut Friess, MD, Department of Surgery, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen, Ismaninger Str 22, 81675 Munich, Germany (e
