Proton Pump Inhibitors (PPIs), which include well-known brands, Prilosec, Nexium and Prevacid, are among the most commonly prescribed drugs in the world. In the United States, about 10% of adults take these medications for heartburn, acid reflux, and frequent gastroesophageal reflux. Given their prevalence, researchers at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego, have exploited the FDA Adverse Reaction Reporting System (FAERS) database. ) concerning the unforeseen consequences of the consumption of PPIs.
In the study published on February 19, 2019 by Scientific reports, the team found that patients under IPP were more likely to suffer from kidney disease than those under histamine 2 receptor antagonists, another form of antacid that treats the same conditions and includes the brands Pepcid and Zantac.
"The post-marketing data collected by the FDA and deposited in the FAERS database allow us to search for potential adverse effects beyond those found in a clinical trial, which may have to not last as long or include as much diversity as FAERS does, "says lead author Ruben Abagyan, Ph.D., professor of pharmacy.
Mr. Abagyan led the study with pharmacy students Tigran Makunts and Isaac Cohen, and Linda Awdishu, PharmD, Clinical Associate Professor and Chair of the Division of Clinical Pharmacy, all at the Skaggs School of Pharmacy.
The FAERS database contains more than 10 million patient records, all of which report voluntary adverse events when taking a drug. The research team focused on patients on PPIs and no other drugs, reducing their population to approximately 43,000 patients. They applied a mathematical algorithm to search for statistically significant differences in renal complications reported between patients under IPP and the control group, approximately 8,000 patients under histamine 2 receptor antagonists, such as Zantac or Pepcid, and no other medicine.
Here's what they found: Patients who took only PPIs reported a kidney-related adverse reaction at a rate of 5.6%, compared with 0.7% for patients taking only histamine-2.
In digging, the team found that, compared to the control group, patients taking only PPIs were 28.4 times more likely to report chronic renal failure, as well as acute kidney injury (4.2 times more likely ), end stage renal failure (35.5%). renal insufficiency unspecified (8 times more likely). PPI patients were also more likely to have electrolyte abnormalities, but this varied more from one PPI to another, while the effects on the kidneys were valid for the five PPIs examined.
Abagyan cautioned that this study does not reveal the absolute frequency of these kidney-related complaints for all people taking PPIs, as reporting in the FAERS is voluntary. He also says that it is possible, though unlikely, that the effect is due to unidentified confounders. A large randomized controlled clinical trial would be needed to conclusively demonstrate the causal link between the use of PPI and the absolute risk of kidney disease in humans.
As noted by the World Health Organization, PPIs are essential medicines for many people because they help them control symptoms that are often painful and disrupt everyday life. But Abagyan hopes that this initial data will prompt health care providers to provide appropriate alerts, education, and follow-up to patients requiring a PPI, especially if they already have a high risk of kidney disease and electrolytic abnormalities. Researchers made similar recommendations following a study conducted in 2017 by the University of San Diego's Faculty of Medicine (UC San Diego), which had been found in mice and at the University of California. Man that PPIs favored chronic liver disease.
PPIs are relatively inexpensive drugs, priced at approximately $ 7 for a two-week recommended course of generic and over-the-counter Prilosec (omeprazole). But the frequency of use adds up: a study estimates that Americans spend $ 11 billion in PPIs each year. There are inexpensive and readily available alternatives to PPIs. However, non-IPP antacids (eg Pepto-Bismol, Tums, histamine 2 receptor antagonists) may not be as effective.
Medications for reflux related to chronic renal failure and kidney failure
Tigran Makunts et al., The analysis of postmarketing safety data of proton pump inhibitors reveals an increased propensity for kidney damage, electrolyte abnormalities and nephrolithiasis. Scientific reports (2019). DOI: 10.1038 / s41598-019-39335-7
University of California – San Diego
Common Acid Reflux Drugs Associated with Increased Risk of Kidney Failure (February 19, 1919)
recovered on February 19, 2019
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