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The PPI dilemma: miracle pills or enemies of the state?

Janelle Jones, Dev Jayaraman, Todd C. Lee. The PPI dilemma: miracle pills or enemies of the state?. Outline . PPI over-prescription PPI adverse effects PPI indications The PPI project and how you can help!. Here’s the problem…. Gastrointestinal complaints are incredibly common

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The PPI dilemma: miracle pills or enemies of the state?

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  1. Janelle Jones, Dev Jayaraman, Todd C. Lee The PPI dilemma: miracle pills or enemies of the state?

  2. Outline • PPI over-prescription • PPI adverse effects • PPI indications • The PPI project and how you can help!

  3. Here’s the problem… • Gastrointestinal complaints are incredibly common • Heartburn • Reflux • “Indigestion” • Bloating

  4. And the solution? • Marketed direct to consumer and physician alike • The proton pump inhibitor!

  5. PPI Overprescription

  6. PPI Overprescription • Naunton (2000) Retrospective study. 200 pts on PPI- approved indications 37%. Median duration of PPI use 450 days. • Zink (2005) Retrospective. 60% on PPI without indication during hospitalization. 34% discharged on PPI. Longer length of stay predictive. At 3 months- 80% and 6 months – 50% still on PPI inappropriately. • Pham (2006) Retrospective. 29% on acid suppressive, 33% PPIs. During Admission – increased to 84% PP1. Only 10% had indication.

  7. Adverse effects – random PPI monograph • 1% to 10%: • CNS: Headache (7%), dizziness (2%) • Derm: Rash (2%) • GI: Abdominal pain (5%), diarrhea (4%), nausea (4%), vomiting (3%), flatulence (3%), acid regurgitation (2%), constipation (2%) • Resp: Upper respiratory infection (2%), cough (1%) • ≤1% (Limited to important or life-threatening; adverse event occurrence may vary based on formulation): Abdominal swelling, abnormal dreams, aggression, agitation, agranulocytosis, alkaline phosphatase increased, allergic reactions, alopecia, ALT increased, anaphylaxis, anemia, angina, angioedema, anorexia, anxiety, apathy, AST increased, atrophic gastritis, benign gastric polyps, bilirubin increased, blurred vision, bradycardia, bronchospasm, chest pain, cholestatic hepatitis, confusion, creatinine increased, depression, double vision, dry skin, epistaxis, erythema multiforme, esophageal candidiasis, fatigue, fecal discoloration, fever, fracture, gastroduodenal carcinoids, GGT increased, glycosuria, gynecomastia, hallucinations, hematuria, hemolytic anemia, hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatitis, hepatocellular hepatitis, hyperhidrosis, hypersensitivity, hypertension, hypoglycemia, hypomagnesemia, hyponatremia, insomnia, interstitial nephritis, irritable colon, jaundice, joint pain, leg pain, leukocytosis, leukopenia, liver disease (hepatocellular, cholestatic, mixed), malaise, microscopic colitis, microscopic pyuria, mucosal atrophy (tongue), muscle cramps, muscle weakness, myalgia, nervousness, neutropenia, ocular irritation, optic atrophy, optic neuritis, optic neuropathy (anterior ischemic), osteoporosis-related fracture, pain, palpitation, pancreatitis, pancytopenia, paresthesia, peripheral edema, petechiae, pharyngeal pain, photosensitivity, proteinuria, pruritus, psychiatric disturbance, purpura, skin inflammation, sleep disturbance, somnolence, Stevens-Johnson syndrome, stomatitis, tachycardia, taste perversion, testicular pain, thrombocytopenia, tinnitus, toxic epidermal necrolysis, tremor, urinary frequency, urinary tract infection, urticaria, vertigo, weight gain, xerophthalmia, xerostomia

  8. Adverse effects – the “special problems” • Dial et al. (2006) – CMAJ – cohort/case-control study- use of PPI was associated with C. diff diarrhea OR 2.7 (95%CI 1.4-5.2). • Aseeri et al. (2008) – AJG –retrospective case control – CDAD was associated with use of PPI OR 3.6 (95%CI 1.7-8.3)

  9. Continued. • Chun Shing Kwok et al. (2011) – AJG – meta-analysis of 42 observational studies including 313000 patients. Association between PPI and risk of CDAD – OR 1.74 (95% CI 1.47-2.85). Concomitant PPI and Abx CI 1.96 (95%CI 1.03-3.70).

  10. Other “special problems”: fractures • Fracture risk- • Yu et al. (2011) – Am J med – meta-analysis of 11 international studies including 1,084 560 patients. • Hip # RR 1.30 (95%CI 1.19-1.43) • No increase with H2 blockers

  11. Other harmful associations in literature? • Pneumonia • Hospital Acquired Pneumonia • Functional decline in elderly • Falls in elderly • All cause mortality post-discharge • B12 deficiency • There are more…

  12. Are PPIs all bad? • Of course not • One needs to balance the therapeutic benefit with the potential risks • For certain indications the evidence is in favor of using these medications

  13. Indications • Ulcer with documented bleed or symptoms within 3 months • Pathological secretatory conditions (i.e. Zollinger-Ellison) • GERD or severe indigestion with exacerbation within 3 months and non-responsive to H2 blocker • Erosive esophagitis • Helicobacter therapy • Dual Antiplatelet therapy • Antiplatelet and Anticoagultion • Antiplatelet and previous complicated ulcer • Antiplatelet/NSAID and more than one of: Age >60, Corticosteroids, Previous Uncomplicated Ulcer, Concomittant NSAID/Antiplatelet

  14. PPI Audit • What can YOU do to help this project? • Find out if your patient is on a PPI and ask them WHY. • Discuss the reasons why stopping the PPI is important if there is no ongoing indication. • Enter the patient in the web tool (the link was given to them here) • Ensure the patient receives a copy of the letter to community MD if you stop the therapy

  15. Our success story so far- the data. • This slide would be updated monthly during the intervention

  16. Thank you!

  17. References. • M. Naunton, G. M. Peterson, M. D. Bleasel (2000) Overuse of proton pump inhibitors. J Clin Pharm Ther. 2000 October; 25(5): 333–340. • Zink D.A., Pohlman M., Barnes M., Cannon M.E. (2005) Long-term use of acid suppression started inappropriately during hospitalization. Aliment PharmacolTher 21: 1203–1209. • Pham C.Q.D., Regal R.E., Bostwick T.R., Knauf K.S. (2006) Acid suppressive therapy use on an inpatient internal medicine service. Ann Pharmacother 40: 1261–1266. • Dial S., Delaney J.A.C., Barkun A.N., Suissa S. (2005) Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA 294: 2989–2995. • Aseeri M., Schroeder T., Kramer J., Zackula R. (2008) Gastric acid suppression by proton pump inhibitors as a risk factor for Clostridium-difficile-associated diarrhea in hospitalized patients. Am J Gastroenterol 103: 2308–2313. • Chun Shing Kwok et al. (2011) Risk of Clostridium difficile Infection With Acid Suppressing Drugs and Antibiotics: Meta-Analysis. The American Journal of Gastroenterology 107 (7), 2012, p.1011 • Yu EW, Bauer SR, Bain PA, Bauer DC.(2011) Proton pump inhibitors and risk of fractures: a meta-analysis of 11 international studies Am J Med. 2011 Jun;124(6):519-26.

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