Is there any evidence to support the use of enteric coated (EC) over uncoated prednisolone tablets?

· London and South East Regional Medicines Information Service

When this topic was reviewed in the two Drug and Therapeutics Bulletins (DTBs) several decades ago, no convincing evidence was found to support the claim that enteric coated (EC) prednisolone reduces the risk of peptic ulceration (PU). Since these publications, the literature has remained sparse on this topic. Most of the published pharmacokinetic studies have noted lower- and slower time to- peak plasma concentration with EC than uncoated prednisolone tablets, though bioavailability was generally found to be similar. A small number of case reports have indicated problems with disease control with use of EC or with switch to EC from the uncoated formulation. From the limited available data, it would seem that EC tablets may be associated with less predictable absorption; and in certain clinical conditions where plasma levels of prednisolone need to be stable and predictable, some authors recommend the use of the uncoated tablets, particularly in the absence of robust evidence to suggest that enteric coating confers GI protection. There may be theoretical clinical implications to consider when switching between formulations but the evidence base is too limited to gauge the extent to which this could be problematic, and thus patient monitoring may be required when switching. In the absence of supporting published data, the conclusion of the DTB on this subject from 1987 that uncertainty remains as to whether enteric coating decreases the tendency of steroids to cause ulcers, remains unchanged. This is reflected in the BNF which states there is no conclusive evidence that the use of EC preparations of prednisolone reduces the risk of PU.