Purpose of review: In 2010, the Food and Drug Administration required manufacturers of pancreatic enzymes replacement therapy (PERT) to have approval for marketing, rescinding the distribution of PERT that had been available for decades without definitive studies of efficacy and safety. Therefore, many patients on PERT had to change preparation in the last year and be placed on new formulations of PERT or switched to a new branded product altogether. This review summarizes the clinical data on these new products and reviews their general use.
Recent findings: The three new commercially available PERTs all demonstrated similar (as good as or slightly improved) abilities to increase the absorption of fat and nitrogen compared with previous PERT preparations. All preparations tests demonstrated superiority over placebo-controlled portions of the clinical trials. Side-effects seem to be no different compared with placebo. Additional PERTs are being evaluated including a nonporcine preparation which may be available in the future.
Summary: These new preparations, Creon, Zenpep, and Pancreaze, demonstrated improvement in the absorption of fat and nitrogen in patients with pancreatic insufficiency related to cystic fibrosis. Some patient variability to response continues, so clinicians need to continue to titrate dose and preparations based on weight gain and patient response.