Written by Julia Korenman, M.D.
Co-Author Marsha Seidelman, M.D.
June 19, 2015
Millions of patients in the United States take the acid blocking medications called proton pump inhibitors (PPIs). The most common indication for long term usage is acid reflux or heartburn (GERD). PPIs include omeprazole and other “– azoles” whose brand names include Aciphex, Dexilant, Nexium, Prevacid, Prilosec, and Protonix. Last week, an article was published in the online journal PLOS entitled “Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population”. This was a “data-mining study” where the authors performed a computer search of certain patient electronic medical records using the diagnosis codes for GERD and checking for use of acid blocking medications, in patients without a history of heart attack then checked for subsequent mention of heart attack in their charts.
This article was published on June 10 and by June 11, the phone in our office was ringing constantly with concerned patients wanting to know what to do about their acid blocking medications.
Here’s the info in a nutshell:
— The data reveals an ‘association’ of PPI use and heart attacks in the same patients, but does not determine that the PPI use caused the heart attacks.
— Even if this data is taken at face value, it would take 4000 PPI users to cause 1 heart attack, so the risk increase is modest at best.
— Results were obtained by data mining (examining 16 million documents regarding 3 million patients in electronic medical records). Based on this method, the study could not take into account the other risk factors PPI users had that would cause cardiac problems. People with reflux tend to have other risk factors for heart attacks, namely obesity, insulin resistance and smoking. It is possible that some patients had chest pain that was thought to be heartburn, but was actually chest pain from the heart (thus signifying underlying heart disease to begin with). These other factors could be responsible for the extra heart disease.
— PPIs are effective in decreasing GERD symptoms and preventing bleeding. Both the benefits and risks need to be considered in using any medication.
— In support of the study’s findings, suggesting PPIs were responsible for the increased heart risk, another class of meds for GERD, H2 antagonists (such as cimetidine and other “- idine” meds like Zantac or Pepcid) were NOT shown to increase the risk of heart disease.
— Information wasn’t provided regarding dose or duration of use of the PPIs. If higher doses or longer duration of use was shown to be important, that would be more convincing evidence of the risk of PPIs.
The study was useful in generating a hypothesis which will need to be verified by further studies with more information about the patients. For now, there is no reason to change our practice.
As doctors we constantly weigh the risks vs the benefits of treatments that we use. The PPIs in particular have come under scrutiny for various possible long term side effects and also for their cost, so gastroenterologists are used to trying to balance these issues with their patients. Although GERD is often a benign condition, it can lead to pre-cancerous changes called Barrett’s esophagus, esophageal cancer, ulcers in the esophagus, narrowing of the esophagus (strictures) which leads to swallowing difficulties. It can also significantly interfere with patients’ quality of life if poorly controlled.
Therefore, we recommend that each patient be assessed individually, as to their need to be on chronic acid blockade, and as to the dose needed. We try to use the lowest effective dose. Many of the PPIs are now available over the counter. They are labeled for a 2 week course only. This is because any patient who has symptoms which requires them to take the medication for longer than that, should be assessed by a doctor.
As a patient, if you wonder if you should try to go off your PPI, you should discuss this with your doctor. In general, if your symptoms were very hard to control or you have complications of GERD, it is unlikely that you will be able to go off the medication altogether, though you may be able to reduce your dose.
From the Discussion within the article:
“… we recognize that … a prospective randomized study in the general population (inclusive of both lean and obese individuals) is required before changing clinical practice.”
And from the American Gastroenterological Association website, www.gastro.org :
“While the study has generated headlines, it shouldn’t spur changes in practice.
As we await further study of this issue, you can remind patients that there are risks and benefits to all treatments. PPIs, like any other drugs, should be given for clear indications and in the lowest effective dose.”
REFERENCE:
Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population
Nigam H. Shah, et al.
Tags: GERD, heart attack, MI, PPI