In vitro comparative studies on pancreatic enzyme preparations

SIRS, As a result of an FDA decision regarding new drug applications for pancreatic enzyme preparations (PEPs), manufacturers are now required to provide data as part of the application process. This created new interest in research into pancreatic enzyme replacement therapy. Two recent studies investigated PEPs in vitro, but reached very different outcomes and conclusions. 3 When evaluating the adequacy of the experimental protocols, the pathophysiology of pancreatic exocrine insufficiency (PEI) must be taken into account. PEI patients with intact gastric acid production benefit from enteric coated PEPs. In mild chronic pancreatitis, the duodenal pH is similar to that of healthy patients and standard enteric coated PEPs should be employed. The acid resistance of various PEPs is strikingly different, as has been demonstrated in several studies. In severe chronic pancreatitis (and cystic fibrosis), intraduodenal pH may drop as low as 2–3, thus asking for acid suppression, e.g. with a PPI. Without actually measuring the intraduodenal pH, which is far from a routine clinical investigation, one cannot conclude that a majority of PEI patients actually have a pH of 2–3 and then claim that clinically proven products such as Creon (Solvay Pharmaceuticals, Hannover, Germany) are inferior. In particular, it should be noted that in the study by Aloulou, only one batch of each product was investigated and enzyme activity was not assessed; only the protein mass was determined, not its efficacy at the point of action. If lipase is released in an intestine with a pH of <5, it will be permanently and irreversibly inactivated. In severe PEI, acid suppression is required to achieve a duodenal pH >6 in order to ensure optimal lipase activity.