Last month a medical journal published a study out of Stanford that links the use of Nexium (esomeprazole) and other proton pump inhibitors (PPIs) with an increased risk of heart attack.
This is another study that used “big data”—the information from thousands (if not millions) of patients’ electronic health records—to identify risks from drugs and other medical treatments.
Nexium, or “the Purple Pill”, is widely prescribed to treat heartburn and gastroesophogeal reflux disease (GERD). Other commonly used PPIs include Prevacid (lansoprazole) and Prilosec (omeprazole). These drugs are also readily available over-the-counter, and are heavily marketed to the general population.
(Another common type of drugs used to treat heartburn, called histamine H2-receptor antagonists (Tagamet, Zantac, Pepcid), did not show an increased risk of heart attack.)
So what does this latest study mean for the general population? Perhaps you take one of these drugs and are now worried that you will be trading your heartburn for a heart attack.
A gastroenterologist wrote a good post in response to this study on KevinMD: Do proton pump inhibitors cause heart attacks?
The authors conclude that PPI use is associated with heart attack, with an odds ratio of 1.16 (not a very strong effect, approximately 4000 patients would have to take PPIs for one heart attack to occur).
These conclusions, taken at face value, are concerning. However, a good little scientist reads a study then tries to tear it apart and see if it stands up to scrutiny. In my opinion, this study does not make the cut.
The doctor makes the excellent point that these huge data mining studies have to identify and allow for many variables among all the patients.
The authors state they controlled for “age, gender, race, length of observation, and … the number of unique drug and disease concepts mentioned” as a surrogate for patient complexity. More important however, is what they did not control for: How about obesity, diet, smoking status, history of myocardial infarction, use of aspirin or NSAIDS, cholesterol levels, inflammatory markers, blood pressure … the list can go on and on.
So the authors conclusions are (at best) that patients who use PPI drugs are often also the same patients that have heart attacks.
To be fair, the authors of the study are aware of its limitations. However, they feel there is enough concern that a larger, more decisive randomized controlled trial (RCT) needs to be done.
The best advice at this time is to use all medications, prescription or over-the-counter, with caution. All drugs come with risks. Before taking a drug, know what those risks are, and whether the benefits outweigh those risks.
Talk to your health care providers. Read labels!
The gastroenterologist concludes, and I agree:
What is the bottom line? As usual, one should only take the smallest effective dose of any drug, to treat a real disease, for the shortest period of time necessary, after exhausting other reasonable treatment options. Medication should not be an alternative to diet or lifestyle changes.
But considering the number of prescriptions written every year, and the amount of money being spent on both prescription and over-the-counter drugs (not just Nexium) in this country, I’m not sure most physicians or patients are following that advice.