Table 4.
Clinical trials for treatment of pancreatic exocrine insufficiency in extrapancreatic diseases and diabetes
| Authors | Study design, duration, and number of subjects | Disease/drug | Results | Adverse effects | Evidence level |
|---|---|---|---|---|---|
| Evans et al70 | Prospective study, months to 4 years, 19 adults | Celiac disease/Creon® (pancreatin) | There was an increase in fecal elastase-1 levels over time, with median of 90 μg/g at 0 months, 212 μg/g at 6 months, and 365 μg/g at follow-up (P < 0.0001) in patients who received PERT throughout | Overall, 8/19 patients had discontinued supplementation because their diarrhea had improved; only 1/11 reported no symptomatic benefit | 3 |
| Leeds et al72 | Open-label, up to 2 years 20 adults | Celiac disease Unknown | In 18 of 20, stool frequency reduced following pancreatic enzyme supplementation from four daily to one daily (P < 0.001); no weight increase was observed; all patients had duodenal histological improvement | No description regarding TEAEs | 4 |
| Leeds et al74 | Open-label, 6 and 12 weeks, 34 adults | Irritable bowel syndrome Creon | Improvements in stool frequency (from median 6 to less than 2 daily, P < 0.001), stool consistency (P < 0.001), and abdominal pain (P = 0.003) were observed in patients with fecal elastase-1 levels less than 100 μg/g stool | No major side effects were reported; some patients felt nausea but no patients stopped therapy | 3 |
| Ewald et al85 | DBRPC, 16 week, 80 adults (Creon 39 and placebo 41) | Type 1 diabetes Creon (pancreatin) | There were no significant differences between pancreatin group and placebo group concerning HbA1c, fasting glucose levels, and 2-hour glucose levels after oral glucose tolerance test, clinical parameters | TEAEs occurred in 33 patients (84.6%) in pancreatin group and in 35 (85.4%) in placebo group; most frequent adverse events were headache, infection, diarrhea, and dyspepsia | 3 |
| Knop et al86 | Open-label, postprandial (test meal) response 8 male adults | Chronic pancreatitis Creon | The postprandial responses of total GLP-1 and total GIP were increased (both P = 0.01) along with increased plasma insulin and total insulin secretion after pancreatic enzyme substitution | No description regarding TEAEs | 3 |
Abbreviations: DBRPC, double-blind, randomized, placebo-controlled trial; TEAEs, treatment-emergent adverse events; GLP-1, glucagon-like peptide-1; GIP, gastric inhibitory polypeptide; HbA1c, glycosylated hemoglobin.