Efficacy and Safety of Pancrelipase/Pancreatin in Patients With Exocrine Pancreatic Insufficiency and a Medical History of Diabetes Mellitus.
OBJECTIVE
The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM).


METHODS
This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period.


RESULTS
Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms.


CONCLUSIONS
Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.
From the *Department of Medicine, University of Pittsburgh and University of Pittsburgh Medical Center, Pittsburgh, PA; †AbbVie Inc, North Chicago, IL; and ‡Abbott Laboratories GmbH, Hannover, Germany.
David C
DC
Whitcomb
Amit
A
Bodhani
Katrin
K
Beckmann
Suntje
S
Sander-Struckmeier
Shufang
S
Liu
Mahesh
M
Fuldeore
Paul F
PF
Pollack
Rupal P
RP
Khurmi
D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D003920:Diabetes Mellitus / Q000503:physiopathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D056947:Enzyme Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000009:adverse effects / Q000379:methods; D010194:Pancreatin / Q000009:adverse effects / Q000627:therapeutic use*; D050500:Pancreatitis, Chronic / Q000150:complications; D020799:Pancrelipase / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome
D020799:Pancrelipase; D010194:Pancreatin