NEW YORK (Reuters Health) – Privately insured patients who take newly prescribed proton pump inhibitors (PPIs) are no more likely than their peers on prescription histamine-2 receptor antagonists (H2RAs) to have a myocardial infarction (MI) over the next three years, according to new findings.
Safety concerns have been raised about PPIs – for example, that they may increase the risk of Clostridium difficile infection or fracture, Suzanne Landi, a PhD student at the University of North Carolina at Chapel Hill, and her colleagues report in Gastroenterology, online November 6. In 2009, the U.S. Food and Drug Administration warned that omeprazole could reduce the effectiveness of clopidogrel, thereby increasing the risk of cardiovascular events.
The few epidemiological studies of PPIs and MI risk have had mixed results, Landi and her team add. While it is plausible that the drugs could harm coronary blood vessels by increasing asymmetrical dimethylarginine (ADMA), they say, studies showing this effect were done in animals and ex vivo human tissue.
To investigate whether PPIs were independently associated with MI risk, the researchers looked at 2001-2014 administrative claims data from commercial insurers and Medicare Supplemental plans on more than 5 million people who started using prescription PPIs or H2RAs.
The commercial claims cohort included close to 3.7 million PPI initiators and more than 800,000 patients starting H2RAs. In the PPI group, 29.4% had a recorded ICD-9 code for gastroesophageal reflux disease (GERD) in the past year, compared to 15% of the H2RA group.
The Medicare Supplemental group included nearly 900,000 PPI initiators and close to 200,000 patients starting H2RAs, 21.1% and 14.4% of whom had GERD diagnoses, respectively.
The overall annual weighted risk of MI was 2 per 1,000 for the commercial plan enrollees and 8 per 1,000 for those on Medicare Supplemental plans.
There was no overall difference in MI risk between the patients on PPIs and those on H2RAs. When Dr. Landi and her colleagues analyzed commercial and Medicare Supplemental patients separately, they found that PPIs were not associated with an increased MI risk in the younger patients (compared to H2RAs), while PPIs were linked to reduced MI risk in patients age 65 or older, although the absolute risk reduction was small.
Most patients taking prescription PPIs or H2RAs did not have an ICD-9 code referring to GERD, Landi noted in an interview with Reuters Health.
“This suggests that proton pump inhibitors and histamine-2 receptor antagonists are frequently used outside their typical indications,” she said. “This does mean that these medications may be prescribed without a clear medical indication, and they are used widely.”
“We recommend more biological research focused on how proton pump inhibitors work in the body,” she said. “This line of research could help inform future efforts.”
SOURCE: http://bit.ly/2ijaU75
Gastroenterology 2017.
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