How would you handle a patient who wants to begin long-term PPI use?

Proton  pump inhibitors are a class of novel drugs that are the most potent  acid suppressors on the market today.  Since omeprazole’s introduction  in 1990, they have been clinically proven to be better than H2RAs.  Over  the past decade their use has been scrutinized because of several  harmful disease associations.

• C. difficile infection: FDA’s analysis of over 28  studies revealed that patients taking PPIs were at a 1.4-2.75 times  greater risk of developing an infection
• Fractures: FDA reviewed several studies and have concluded that PPIs  in high doses, multiple daily doses, and/or continued therapy for  longer than a year increase a person’s risk of osteoporosis related  fracture
• Magnesium: PPIs may decrease magnesium level, which can lead to  muscle spasms, arrhythmias, seizures, and fatigue.  This typically  occurs after long-term administration of PPIs, usually longer than a  year.  Treatment may require magnesium replacement and PPI  discontinuation
• Dementia: Although several theories exist to possibly explain the  mechanism, the association needs to be validated in large cohorts and  tested in case-control studies. For now, it is probably safe to say a  causal link is plausible.
• H. Pylori infection causes gastritis, PUD, gastric cancer  and mucosa-associated lymphoid tissue (MALT) lymphoma and the  association between the presence of H. pylori and NSAIDs and an increased incidence of PUD is well documented.

How would you handle a patient who wants to begin long-term PPI use?

What would your discussion with them entail?

In what patients or disease states would you not recommend PPI use?

What if H. Pylori is found to be present?

The following FDA warning appears in the clopidogrel package insert:  “Drug interactions: Co-administration of Plavix with omeprazole, a  proton pump inhibitor that is an inhibitor of CYP2C19, reduces the  pharmacological activity of Plavix if given concomitantly or if given 12  hours apart. ” Plavix (clopidogrel) [package insert] Bristol-Myers  Squibb/Sanofi Pharmaceuticals Partnership Bridgewater, NJ. 2009.

Evidence-based guidelines such as those provided by the AGA state:  “PPI therapy does not need to be altered in concomitant clopidogrel  users as there does not appear to be an increased risk for adverse  cardiovascular events”. (Strong recommendation, high level of  evidence) Am J Gastroenterol 2013; 108:308–328;  doi:10.1038/ajg.2012.444.

This leaves the provider to make a professional decision.

You may wish to read the portion of clopidogrel’s package insert  [link below] regarding pharmacogenomics as well as the article found in  Medscape [link below] regarding genetics in pharmacotherapy before  answering the last question. Pharmacogenomics is, and will become, an  increasingly bigger part of care as we move forward.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s044lbl.pdf
https://www.medscape.com/viewarticle/888159_2

After reviewing the package insert for clopidrogel and available  evidence regarding this combination, what would you recommend if a  patient is taking esomeprazole and clopidrogel together?

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