Randomised clinical trial: the efficacy and safety of pancreatin enteric‐coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis ‐ a double‐blind, placebo‐controlled study

Abstract

SummaryBackgroundPancreatic exocrine insufficiency (PEI) results in maldigestion, leading to abdominal pain, steatorrhoea, malnutrition and weight loss.AimTo assess the efficacy and safety of pancreatin (Creon 40000 MMS) in treating PEI due to chronic pancreatitis (CP).MethodsThis was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Men and women ≥18 years of age with proven CP and PEI [defined as a coefficient of fat absorption (CFA) ≤80% during run-in phase] were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in CFA from baseline to end of double-blind treatment (analysis of covariance).ResultsOf 62 patients randomised (34 pancreatin, 28 placebo), 61 completed treatment; one patient in the placebo arm withdrew consent before completion. Patient characteristics were similar in both groups except for the proportion of men (pancreatin 82% vs. placebo 68%). Patients receiving pancreatin had a statistically significant greater improvement in fat absorption from baseline to the end of double-blind treatment compared with those receiving placebo, with a least squares mean change (95% CI) in CFA of 18.5% (15.8–21.2) vs. 4.1% (1.0–7.2), respectively. This resulted in a treatment difference of 14.4% (10.3–18.5); P = 0.001. Patients receiving pancreatin also had a statistically significant greater improvement in nitrogen absorption and greater reductions in mean stool fat, stool frequency and stool weight compared with those receiving placebo. Treatment-emergent adverse events occurred in 12 patients on pancreatin and in seven on placebo; none led to study discontinuation.ConclusionsThe results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile, at the dose administered.

Pancreatic exocrine insufficiency in pancreatic cancer: A review of the literature

“…Improvement, but incomplete resolution of subjective and objective steatorrhea was reported. In addition, PERT also had a higher incidence of adverse drug reactions like pain, dyspepsia, and flatulence [81][82][83][84].…”

Efficacy of pancreatic enzyme replacement therapy in chronic pancreatitis: systematic review and meta-analysis

“…Study design and quality assessment are shown in table 1. There were four 32 33 40 45 conducted in the USA, nine 34-39 41 43 44 in Europe, two 46 47 in the USA and Europe, one 42 in South Africa and one 48 …”

“…Gender was reported in most studies ( pooled 76.4% males). Ethnicity was reported in only four [45][46][47][48]. None reported residence data, smoking, socioeconomic status or profession.Five 41 42 46-48 reported body mass index.…”

Chronic pancreatitis

“…The benefit of 90 000 USP U of pancreatin [two capsules of CREON (Abbott Laboratories, Abbott Park, Illinois) 40 000 containing 45 000 USP U lipase with meals and one capsule with snacks] compared with placebo was assessed in a multicenter, randomized controlled trial (RCT) in 62 patients with chronic pancreatitis and a coefficient of fat absorption (CFA) less than 80% [22 ■ ]. Pancreatin increased the CFA from 66.5 to 86.1% (mean change of CFA vs. placebo, 18.5 vs. 4.1%; P = 0.001) and the coefficient of nitrogen absorption (CNA) from 78.8 to 83.8% (mean change of CNA vs. placebo 4.7 vs. 0.8%; P = 0.005) and decreased stool frequency and weight.…”