HARTFORD – At the American Heart Association meeting last week, researchers from Denmark assessed the risk of stroke in patients taking proton pump inhibitors like Prilosec and Nexium. They found an alarming 21 percent increase in strokes and the greater the dose used, the higher the risk. They also found that H2 blockers, drugs like Pepcid and Zantac, did not have an elevated risk. This comes in light of other studies suggesting that proton pump inhibitors increase the risk of heart attacks, as well.
The studies showing increased risks of heart attacks and strokes are observational studies so it is impossible to distinguish whether the proton pump inhibitor worsens atherosclerosis or if people with severe heartburn or ulcers are just at higher risk over time. Overeating, obesity, stress, and smoking all can cause atherosclerosis and gastrointestinal issues so they are what scientists call collinear and hard to tease out. Since the H2 antagonists are weak drugs for heartburns and ulcers, people who can use them and get good results are not likely to be the same people seeking relief from the more effective proton pump inhibitors.
Studies like these usually pave the way for a randomized, double-blind, placebo controlled study, the gold standard studies. The COGENT trial is the only clinical trial available to answer this question so let’s talk about it. This trial was published in 2010 in the New England Journal of Medicine and included people with cardiac disease. Almost 4,000 patients had the same chance of getting placed in the proton pump inhibitor group or the placebo group and were treated for a median of 106 days and neither the patients or doctors knew which treatment they had gotten.
The proton pump inhibitor group had a 64 percent lower risk of gastrointestinal bleeding and heartburn and their rates of cardiovascular events were 5 percent in the proton pump inhibitor group and 6 percent in the placebo group, almost identical. This included no increases in the risk of heart attacks, strokes, or deaths of any kind. So in this trial, omeprazole 20mg, a regular starting dose of the drug, was perfectly safe for moderate term therapy. Most people with ulcers and heartburn use proton pump inhibitors in regular doses for a few days to several weeks and they should not be worried about these cardiovascular risks at all. However, the COGENT trial does not give us information regarding the safety of therapy spanning years and years and did not explore the risk of higher dose therapy.
If you fall into that category, you may have reason to be concerned and should discuss the benefits and risks of continuing therapy. If you have erosive esophagitis or another high risk acid disorder, the benefits might be worth these risks. If it just for regular heartburn relief and you can get away with lifestyle changes like weight loss, eating smaller meals, avoiding meals right before bedtime, and limiting alcohol and smoking you might find that you can get off these drugs altogether, lower your dose, or be treated with H2 antagonists. You would also be doing something great for your heart in the process and no one can dispute that.
Dr. Michael White of the UConn School of Pharmacy
