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Using administrative data from the US Department of Veterans Affairs, we identified patients who received an outpatient H2 blockers or PPI prescription between 1 October 2006 and 30 September 2008 (n=1 762 908).

In order to select new users of acid suppression therapy (incident user design), we excluded 1 356 948 patients who received any outpatient H2 blockers or PPI prescriptions between 1 October 1998 and 30 September 2006.

See: Proton pump inhibitors (PPI) are widely prescribed and are also available for sale over the counter without prescription in several countries.1 2 Several observational studies suggest that PPI use is associated with increased risk of a number of adverse health outcomes.1 A number of studies have shown that PPI use is associated with significant risk of acute interstitial nephritis.3–5 Recent studies established an association between exposure to PPI and risk of chronic kidney disease (CKD), kidney disease progression and end-stage renal disease.2 6 7 Results from a large prospective observational German cohort suggest that patients receiving PPI had a higher risk of incident dementia.8 Several reports highlighted a rare but potentially fatal risk of hypomagnesemia among users of PPI.9–11 PPI use has been associated with increased risk of both incident and recurrent infections.12 Several observational analyses have shown that PPI use was also associated with increased risk of osteoporotic fractures, including hip and spine fractures.13 14 Less convincing—and to some extent inconsistent—evidence suggests a relationship between PPI use and risks of community-acquired pneumonia and cardiovascular events.15–17 Emerging—and far from conclusive—in vitro evidence suggests that PPI results in inhibition of lysosomal acidification and impairment of proteostasis, leading to increased oxidative stress, endothelial dysfunction, telomere shortening and accelerated senescence in human endothelial cells.18 The experimental work provides a putative mechanistic link to explain some of the adverse events associated with PPI use.18 The adverse outcomes associated with PPI use are serious, and each is independently associated with higher risk of mortality.

Evidence from several small cohort studies of older adults who were recently discharged from the hospital or institutionalised in long-term care facilities suggests inconsistently that PPI use may be associated with increased risk of 1 year mortality.19–22 Whether PPI use is associated with excess risk of death is not known and has not been examined in large epidemiological studies spanning a sufficiently long duration of follow-up.

Results Over a median follow-up of 5.71 years (IQR 5.11–6.37), PPI use was associated with increased risk of death compared with H2 blockers use (HR 1.25, CI 1.23 to 1.28).

Risk of death associated with PPI use was higher in analyses adjusted for high-dimensional propensity score (HR 1.16, CI 1.13 to 1.18), in two-stage residual inclusion estimation (HR 1.21, CI 1.16 to 1.26) and in 1:1 time-dependent propensity score-matched cohort (HR 1.34, CI 1.29 to 1.39).

We hypothesised that owing to the consistently observed associations between PPI use and risk of adverse health outcomes, PPI use is associated with excess risk of death, and that the risk of death would be more pronounced with increased duration of use.

We therefore used the Department of Veterans Affairs national databases to build a longitudinal cohort of incident users of acid suppression therapy, including PPI and histamine H2 receptor antagonists (H2 blockers), to examine the association between PPI use and risk of all-cause mortality and to determine whether risk of death is increased with prolonged duration of use.

The photos, articles, links, and other information posted here are the property of MMBA and/or the members and entities who have provided them.The risk of death was increased when considering PPI use versus no PPI (HR 1.15, CI 1.14 to 1.15), and PPI use versus no PPI and no H2 blockers (HR 1.23, CI 1.22 to 1.24).Risk of death associated with PPI use was increased among participants without gastrointestinal conditions: PPI versus H2 blockers (HR 1.24, CI 1.21 to 1.27), PPI use versus no PPI (HR 1.19, CI 1.18 to 1.20) and PPI use versus no PPI and no H2 blockers (HR 1.22, CI 1.21 to 1.23).Limiting PPI use and duration to instances where it is medically indicated may be warranted.This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.

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