Study Questions PPI Overuse in Elderly
UHCOP-led Study Raises Concerns of Non-evidenced Based Use of Proton Pump Inhibitor Therapy in Elderly Population at Risk for Rare, But Serious Adverse Events
Nearly half (45 percent) of patients in nursing homes on proton pump inhibitors (PPIs) have been prescribed this therapy without an evidence-based indication, according to a retrospective, cross-sectional study led by UH College of Pharmacy health outcomes researchers using national U.S. data. Studies have repeatedly demonstrated that PPIs are being over prescribed, but the evidence of non-indicated therapy in the elderly raises particular concern.
Although PPIs are exceptionally well tolerated, rare but serious adverse events such as increased risk of enteric infections and impairments of bone metabolism are most likely to occur in the elderly.
“Given the safety concerns, it is critical to appropriately use PPIs in the vulnerable elderly population,” said Pratik Rane, a Ph.D. candidate in the UHCOP's Department of Pharmaceutical Health Outcomes and Policy who conducted the research under the guidance of UHCOP Professor Rajender Aparasu, Ph.D., and University of Texas Health Science Center gastroenterologist Sushovan Guha, M.D., Ph.D.
Rane's study, entitled "Prevalence and Predictors of Non-evidence Based Proton Pump Inhibitor Use Among Elderly Nursing Home Residents in the USA," was presented at the Digestive Disease Week 2015 meeting May 16-19 in Washington, D.C. Rane received an "Early Stage Investigator" Certificate of Recognition from the American Gastroenterology Association for the abstract, which was among the presentations highlighted on the association's website.
The evidence of overuse was drawn from the National Nursing Home Survey (NNHS), which is overseen by the Centers for Disease Control (CDC) and captures a broad array of utilization data from a representative sample of U.S. nursing homes. Several nursing home surveys have been conducted, the most recent of which was in 2004 and provided data for this analysis. Over a single year, nearly 27 percent of nursing home residents (or 355,000 individuals) received at least one PPI. However, only 55 percent of patients had one of the conditions, such as gastroesophageal reflux disease (GERD), concomitant use of NSAIDs, or GI hemorrhage, for which use is approved either by the U.S. FDA or the U.K.’s National Institute for Health and Care Excellence (NICE).
Interestingly, however, patients with osteoporosis, when compared to patients without osteoporosis, were substantially less likely to receive a prescription of a non-evidence based PPI. The odds ratio (OR) for PPI use in patients with a diagnosis of osteoporosis was 0.59. In contrast, patients with chronic cough were more than twice as likely (OR 2.62) to receive a non-evidence based PPI. The authors also found that non-evidence-based PPI use was more common in nursing homes located in metropolitan areas.
PPIs are one of the most prescribed therapies in the United States, Rane said. The rates of adverse events have been low and risk of serious adverse events even lower, but the risks are not negligible and increase in significance among vulnerable groups, such as the elderly. In another, much smaller study undertaken in the elderly in Europe and published in a 2010 issue of the Scandanavian Journal of Primary Health Care, the incidence rates of diarrhea and bone fracture were approximately 50 percent higher in PPIs users than non-users. Those authors particularly emphasized the risks posed by unnecessary PPIs when employed long-term.
The Houston researchers also cautioned that elderly patients on indefinite regimens of PPIs are likely to face the greatest risks, particularly for impaired bone metabolism. They suggested that additional studies evaluating risk of complications relative to duration of use are warranted. Many of the risks, including impaired metabolism of vitamin D and iron as well as risk of fracture, are likely to increase over time in the elderly. As a result, it may be important to consider the benefit-to-risk ratio of long-term treatment with these agents even in those elderly patients for whom there is a valid indication.