Appropriate Use and Stewardship of Proton-Pump Inhibitors

Dylan Ren, 2020 PharmD Candidate; Erin Gurney, 2020 PharmD Candidate; Jaime R. Hornecker, PharmD, BCPS, CDE, DPLA


US Pharmacist. 2019;44(12):25-31. 

In This Article


Because of their exceptional efficacy and long-believed tolerability and safety, the resultant exponential increase in usage has ultimately led and contributed to their inappropriate and growing overuse.[7] This had led the FDA to release numerous safety statements and publish recommendations for PPI use for the following areas only, either as short-term use or long-term therapy. (See Table 1 for FDA-approved indications and doses for PPI therapy.[2])

Peptic Ulcer Disease

The term peptic ulcer disease (PUD) refers to peptic acid injury of the digestive tract, primarily in the stomach and duodenum, that results in mucosal breakage reaching the submucosa.[8] This can be further categorized into a gastric or duodenal ulcer based upon the location. Traditionally believed to be caused from stress and/or dietary factors, the discovery of Helicobactor pylori and studies regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDs) have shifted this ideology, and these are currently cited as the main risk factors for the development of PUD.[9]

PPIs are FDA-approved and indicated for the eradication of H pylori (when used with antibiotics). PPIs in combination with amoxicillin and clarithromycin for 7 to 14 days (termed PPI-based triple therapy) have historically been the standard first-line therapy option for the treatment of PUD associated with H pylori infection. However, as the prevalence of antibiotic resistance has increased over the years, treatment regimens have altered to include alternative agents such as bismuth subsalicylate, metronidazole, and various others. Still, PPIs remain the base of all of the various combinations and therapy modalities available.[9]

NSAID-induced gastroduodenal ulcers are estimated to account for thousands of gastrointestinal (GI) complications each year, including GI bleeds, gastric pain, or even death.[8] Currently, PPIs are recommended and FDA-approved as chronic prophylaxis in individuals with high risk due to concurrent and planned long-term NSAID use, as well as acutely for the treatment and healing of active ulcers, with most cases resolving with 6 to 8 weeks of therapy.[9,10]