A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery

N. Gubergrits, E. Malecka-Panas, Glen Lehman, G. Vasileva, Y. Shen, S. Sander-Struckmeier, S. Caras, D. C. Whitcomb

Research output: Contribution to journalArticle

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Abstract

Aliment Pharmacol Ther 2011; 33: 1152-1161 Summary Background Pancreatic enzyme replacement therapy (PERT) is necessary to prevent severe maldigestion and unwanted weight loss associated with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Aim To assess the long-term safety and efficacy of pancrelipase (pancreatin) delayed-release capsules (Creon) in this population. Methods This was a 6-month, open-label extension of a 7-day, double-blind, placebo-controlled study enrolling patients â¥18 years old with confirmed EPI due to CP or PS who were previously receiving PERT. Patients received individualised pancrelipase doses as directed by investigators (administered as Creon 24 000-lipase unit capsules). Results Overall, 48 of 51 patients completed the open-label phase; one withdrew due to the unrelated treatment-emergent adverse event (TEAE) of cutaneous burns and two were lost to follow-up. The mean age was 50.9 years, 70.6% of patients were male, 76.5% had CP and 23.5% had undergone PS. The mean ± s.d. pancrelipase dose was 186 960 ± 74 640 lipase units/day. TEAEs were reported by 22 patients (43.1%) overall. Only four patients (7.8%) had TEAEs that were considered treatment related. From double-blind phase baseline to end of the open-label period, subjects achieved a mean ± s.d. body weight increase of 2.7 ± 3.4 kg (P < 0.0001) and change in daily stool frequency of -1.0 ± 1.3 (P < 0.001). Improvements in abdominal pain, flatulence and stool consistency were observed. Conclusions Pancrelipase was well tolerated over 6 months and resulted in statistically significant weight gain and reduced stool frequency in patients with EPI due to CP or PS previously managed with standard PERT.

Original languageEnglish
Pages (from-to)1152-1161
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume33
Issue number10
DOIs
StatePublished - May 2011

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Pancrelipase
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Capsules
Clinical Trials
Enzyme Replacement Therapy
Lipase
Pancreatin
Flatulence
Lost to Follow-Up
Burns
Abdominal Pain
Weight Gain
Weight Loss
Placebos
Body Weight
Research Personnel
Safety
Skin

ASJC Scopus subject areas

  • Pharmacology (medical)

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A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. / Gubergrits, N.; Malecka-Panas, E.; Lehman, Glen; Vasileva, G.; Shen, Y.; Sander-Struckmeier, S.; Caras, S.; Whitcomb, D. C.

In: Alimentary Pharmacology and Therapeutics, Vol. 33, No. 10, 05.2011, p. 1152-1161.

Research output: Contribution to journalArticle

Gubergrits, N. ; Malecka-Panas, E. ; Lehman, Glen ; Vasileva, G. ; Shen, Y. ; Sander-Struckmeier, S. ; Caras, S. ; Whitcomb, D. C. / A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. In: Alimentary Pharmacology and Therapeutics. 2011 ; Vol. 33, No. 10. pp. 1152-1161.
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abstract = "Aliment Pharmacol Ther 2011; 33: 1152-1161 Summary Background Pancreatic enzyme replacement therapy (PERT) is necessary to prevent severe maldigestion and unwanted weight loss associated with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Aim To assess the long-term safety and efficacy of pancrelipase (pancreatin) delayed-release capsules (Creon) in this population. Methods This was a 6-month, open-label extension of a 7-day, double-blind, placebo-controlled study enrolling patients {\^a}¥18 years old with confirmed EPI due to CP or PS who were previously receiving PERT. Patients received individualised pancrelipase doses as directed by investigators (administered as Creon 24 000-lipase unit capsules). Results Overall, 48 of 51 patients completed the open-label phase; one withdrew due to the unrelated treatment-emergent adverse event (TEAE) of cutaneous burns and two were lost to follow-up. The mean age was 50.9 years, 70.6{\%} of patients were male, 76.5{\%} had CP and 23.5{\%} had undergone PS. The mean ± s.d. pancrelipase dose was 186 960 ± 74 640 lipase units/day. TEAEs were reported by 22 patients (43.1{\%}) overall. Only four patients (7.8{\%}) had TEAEs that were considered treatment related. From double-blind phase baseline to end of the open-label period, subjects achieved a mean ± s.d. body weight increase of 2.7 ± 3.4 kg (P < 0.0001) and change in daily stool frequency of -1.0 ± 1.3 (P < 0.001). Improvements in abdominal pain, flatulence and stool consistency were observed. Conclusions Pancrelipase was well tolerated over 6 months and resulted in statistically significant weight gain and reduced stool frequency in patients with EPI due to CP or PS previously managed with standard PERT.",
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AU - Malecka-Panas, E.

AU - Lehman, Glen

AU - Vasileva, G.

AU - Shen, Y.

AU - Sander-Struckmeier, S.

AU - Caras, S.

AU - Whitcomb, D. C.

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N2 - Aliment Pharmacol Ther 2011; 33: 1152-1161 Summary Background Pancreatic enzyme replacement therapy (PERT) is necessary to prevent severe maldigestion and unwanted weight loss associated with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Aim To assess the long-term safety and efficacy of pancrelipase (pancreatin) delayed-release capsules (Creon) in this population. Methods This was a 6-month, open-label extension of a 7-day, double-blind, placebo-controlled study enrolling patients â¥18 years old with confirmed EPI due to CP or PS who were previously receiving PERT. Patients received individualised pancrelipase doses as directed by investigators (administered as Creon 24 000-lipase unit capsules). Results Overall, 48 of 51 patients completed the open-label phase; one withdrew due to the unrelated treatment-emergent adverse event (TEAE) of cutaneous burns and two were lost to follow-up. The mean age was 50.9 years, 70.6% of patients were male, 76.5% had CP and 23.5% had undergone PS. The mean ± s.d. pancrelipase dose was 186 960 ± 74 640 lipase units/day. TEAEs were reported by 22 patients (43.1%) overall. Only four patients (7.8%) had TEAEs that were considered treatment related. From double-blind phase baseline to end of the open-label period, subjects achieved a mean ± s.d. body weight increase of 2.7 ± 3.4 kg (P < 0.0001) and change in daily stool frequency of -1.0 ± 1.3 (P < 0.001). Improvements in abdominal pain, flatulence and stool consistency were observed. Conclusions Pancrelipase was well tolerated over 6 months and resulted in statistically significant weight gain and reduced stool frequency in patients with EPI due to CP or PS previously managed with standard PERT.

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