Tuesday, March 20, 2012

PPIs - An Argument for Paternalism in Medicine?

Case Scenario:  A healthy physician presents to the local ED due to palpitations and questionable syncope.  His past medical history is significant for heartburn, for which he has taken a proton pump inhibitor (PPI) for many years.  In the ED his ECG demonstrated a supraventricular tachycardia (SVT). Why did this healthy man with no risk factors develop SVT?  His labs demonstrated a markedly low magnesium of 1.0.  Again, why?  Answer: Chronic PPI use.

The Gist:  Proton Pump Inhibitors (PPIs) are overused by patients and providers, which may result in significant harms including: hypomagnesemia, B12 deficiency, dyspepsia, clostridium difficile infection, osteoporosis, and hip fracture.  Providers should probably do a better job enforcing limits on PPI use but this remains difficult as these pharmaceuticals bring such relief to patients. Drugs are easy, lifestyle changes are more difficult.  Furthermore, these medications are addictive.  Upon discontinuation, gastric acid rebound secretion occurs, leading patients to experience worsening dyspepsia.  While I believe both of these statements are true, the data is perhaps equivocal regarding rebound acid secretion, as papers published by Waldum, et al suggests that the caliber of the studies on rebound secretion are not solid enough to support this argument.

The Growing Problem:  PPIs represent an increasingly popular class of medications to combat reflux, heartburn, and peptic ulcer disease.  They've largely replaced surgical means of ulcer management.  Many of these medications are now available directly to patients in the United States as over the counter (OTC) preparations.  While the fine print on these OTC formulations recommends that patients take the medication for under one week prior to consulting a physician, there is no data on whether patients are actually compliant with these instructions, inscribed in miniscule print.

Recently the BMJ published a study demonstrating an increased risk of hip fractures in individuals who took PPIs.  The risk was highest in women who had ever smoked.  This study is fraught with limitations as it is an observational study and merely ascertains association rather than causation.  However, it seems that at least once a month a journal features a study demonstrating a negative side effect of PPIs.  I find it implausible that any significant percentage of consumers of OTC PPIs know that if they have osteoporosis, smoke, are a strict vegetarian, or are a person, in general, they should probably be careful about PPI use.

Whose duty is it to educate consumer of these harms?  It's easier to regulate a patient's risks by careful prescribing practices, but when a drug has OTC availability, one loses all control over that aspect of patient care.  It appears that we've ceded quality centered patient care for convenience centered patient care.  

The Partial Solution:  Physicians must be prudent in doling out PPIs and make an effort to utilize PPIs as short term therapy.  Patient education and reinforcement of lifestyle modification must take precedent in treatment of GERD, including targeting increased intra-abdominal pressure (obesity), diet, and other modifiable factors.  This is of particular importance as the OTC status of PPIs is unlikely to be revoked.

Gillen D, Wirz AA, Ardill JE, et al. Rebound hypersecretion after omeprazole and its relation to on-treatment acid suppression and Helicobacter pylori status. Gastroenterology 1999; 116: 239–47.
Gillen D, Wirz AA, Neithercut WD, et al. Helicobacter pylori infection potentiates the inhibition of gastric acid secretion by omeprazole. Gut 1999; 44: 468–75.
Hunfeld NG, Geus WP, Kuipers EJ. Systematic review: rebound acid hypersecretion after therapy with proton pump inhibitors. Aliment Pharmacol Ther 2007; 25:

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  • Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors:  a prospective cohort study.  BMJ 2012; 344 doi: 10.1136/bmj.e372 (Published 31 January 2012)

    Waldum HL, Arnestad JS, Brenna E, et al. Marked increase in gastric acid secretory capacity after omeprazole treatment.Gut 1996; 39: 649–53.

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