Is Pancrelipase Delayed Release Capsule (Creon) Safe for Use in Patients’ ≥7 Years Old Who Suffer From Pancreatic Insufficiency Due to Cystic Fibrosis?

Objective: The objective of this selective EBM review is to determine whether or not Pancrelipase Delayed Release Capsule (Creon) is safe for use in patients’ ≥7 years old who suffer from pancreatic insufficiency due to cystic fibrosis. Study Design: Systemic review of 3 English language primary studies, published between 2000-2010. Data Sources: Two double blind randomized controlled trials (RCTs) as well as an open label phase study with a double blind phase comparing the safety of Pancrelipase Delayed Release Capsule (Creon) in treating pancreatic insufficiency in those suffering from Cystic Fibrosis. These studies were found using Cochrane Systematic Reviews and PubMed. Outcomes Measured: The outcomes of each study measured the safety and tolerability of Creon by monitoring vital signs, weight, BMI, safety laboratory values, and adverse events. Adverse events were tracked in all studies. Results: Graff et al demonstrated that for every three participants who took Creon, there was one fewer incidence of Treatment Emergent Adverse Events (TEAE’s) than in the group of participants taking the placebo. TEAE’s were reported in 5 patients (29.4%) while taking Creon and in 9 patients (53.6%) while receiving the placebo. There were also no discontinuations due to treatment adverse events and no serious adverse events noted during the trial. Trapnell et al demonstrated that for every four participants who took Creon there was one fewer incidence of TEAE’s than in the group of participants taking the placebo. Stern et al demonstrated that during the double blind phase in both the adult and pediatric/adolescent studies, higher percentages of placebo-treated patients (67% and 70% respectively) reported treatment emergent adverse events than Creon treated patients (39% and 61% respectively). Conclusion: Creon does appear to be safe and tolerable for those over the age of 7 suffering from pancreatic insufficiency due to cystic fibrosis. The TEAE’s reported in each study proved the tolerance of Creon to surpass that of other treatment modalities. These studies also address the other benefits of Creon in allowing for significant improvements in stool fat, weight, and nitrogen and a significant reduction in daily stool frequency. Although these are promising results more RCTs must be conducted with wider age groups in order to compare the safety of Creon