Fear of adverse events leads clinicians down an erroneous and dangerous path
• by Ed Susman
Contributing Writer, MedPage Today May 07, 2017
Action Points
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
• When given the choice of stopping proton pump inhibitors that reduce the risk of gastrointestinal bleeding but have a risk of adverse side effects, doctors tended to make the wrong decision.
• Note that according to the American Board of Internal Medicine’s “Choosing Wisely” campaign, among patients with uncomplicated gastroesophageal reflux disease, an attempt at stopping proton pump inhibitors or reducing the dose may be appropriate.
CHICAGO — When given the choice of stopping proton pump inhibitors that reduce the risk of gastrointestinal bleeding but have a risk of adverse side effects, doctors tended to make the wrong decision – continuing treatment in patients with the least need for PPIs to prevent bleeding and stopping the treatment in patients most likely to have fatal bleeds, researchers reported here.
In the simulation-based survey, 68% of clinicians would continue giving proton pump inhibitors to patients at low risk for GI bleeding, but 62% of clinicians would discontinue the drug in the patients at the highest risk of lethal bleeding, said Jacob Kurlander, MD, of the University of Michigan in Ann Arbor.
“These results are exactly the opposite of what they should be,” Kurlander told MedPage Today at his poster presentation at Digestive Disease Week 2017. “If the wrong person is targeted for proton pump inhibitor deprescribing, there is the potential to cause harm.”
He said 80% to 85% of patients with the least risk of serious bleeding should discontinue PPIs because their side effects outweigh the possible benefit.
On the other hand, the benefits of proton pump inhibitors outweigh their adverse event risk in people at intermediate and high risk of fatal bleeds. Kurlander said that discontinuation of the proton pump inhibitors in those patients should have been zero. But in the simulation 47% of doctors would have discontinued treatment in the intermediate risk patients and 62% of doctors would have discontinued treatment in the highest risk group.
“If physicians manage proton pump inhibitors in practice as these results suggest, they may cause avoidable harms in both patients who would benefit from long-term use as well as in those would would benefit from stopping the drugs,” he said.
“For patients with an increased risk for upper gastrointestinal bleeding or other appropriate indications, proton pump inhibitor therapy at the lowest effective dose very likely outweighs the risk,” Kurlandar suggested.
According to the American Board of Internal Medicine’s “Choosing Wisely” campaign, among patients with uncomplicated gastroesophageal reflux disease, an attempt at stopping proton pump inhibitors or reducing the dose may be appropriate. Kurlander said one might want to stop treatment in the low-risk patients for concern about drug-drug interactions, costs or other adverse events.
For other indications, such as concomitant use of anticoagulation and low dose aspirin, indefinite proton pump inhibitor therapy is recommended. “In these patients the risk of death from bleeding is greater than the risk from any of the other adverse events mentioned in the medical literature,” Kurlander said. “With upper gastrointestinal bleeding, the risk of death in the hospital is between 2% and 5%. That is a very real risk.”
For the study, he and colleagues surveyed a cross-section of the American College of Physicians, getting 487 of 914 physicians contacted to participate. They were presented with a scenario involving a 70-year-old woman taking omeprazole 20 mg and recently diagnosed with osteopenia. The doctors were then given a series of other scenarios for the fictitious women’s medical history and asked whether they would change medications.
Proton pump inhibitors are associated with multiple adverse events including bone fracture, chronic kidney disease, Clostridium difficile infection, and dementia. The clinical question is the balance between these risks and those of life-threatening GI bleeds.
In the study, Kurlander and his fellow researchers had hypothesized that the doctors would do the right thing and would stop proton pump inhibitors in the low risk patients.
“This is really sad, isn’t it?” said James Freston, MD, PhD, of the University of Connecticut Health Center, Farmington, in commenting on the poster presentation. “This is the direct results of scare tactics in the medical literature and in the popular media, in my opinion,” he told MedPage Today. He said these studies which highlight certain adverse events are picked up by the lay media and influence patients and doctors alike.
“But in these scenarios the benefits of proton pump inhibitors way outweigh the risks to the patients,” Preston said.
Also in agreement was Ryan Madanick, MD, of the University of North Carolina, Chapel Hill. “When I look at the groups that I would not stop medication in, this high-risk group are the ones I would not stop treatment – and that’s who they would have stopped treatment.”
“The reason for the fear among clinicians and patients about proton pump inhibitors is due to real research, but a mis-proliferation of that research” that fails to put the risks discussed into proper medical context, Madanick told MedPage Today.