What this study adds
This study developed a clinical risk score to predict the risk of
serious GI complications in elderly by using data from the entire Korean
population, and demonstrated good performance through external
validation.
This study identified new risk prediction factors not included in the
current guidelines: male sex, very old age, and concomitant use of
selective serotonin reuptake inhibitors.
Compared to the risk classification system of the current guidelines
that count the number of risk factors, this newly developed risk score
model included the concomitant use of a GPA as an offset factor, which
enabled to capture expanded cases where use of proton pump inhibitors or
H2-receptor antagonists was not sufficient to offset serious GI
complications.
1. Introduction
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most
frequently used medicines to treat musculoskeletal and rheumatic
diseases [1]. NSAID use is a common cause of gastrointestinal (GI)
bleeding, and mortality from GI bleeding has been reported to be 5–10%
worldwide [2].
Several risk factors for GI injury in patients taking NSAIDs have been
reported, including a history of GI ulcer, older age, and concomitant
use of low-dose aspirin (ASA), other antiplatelet agents,
anticoagulants, and corticosteroids [3]. Older age is a major risk
factor for serious GI complications. In Italy, the prevalence of NSAID
use among the elderly was estimated at 24.7% [4], and in the United
States, 40% of the elderly people were prescribed with NSAIDs at least
once a year [5]. The hospitalization rate for GI complications due
to NSAIDs was 12 per 1,000 person-years in the elderly compared to
< 1 per 1,000 person-years in the population aged <
50 years [5].
In 2014, a model for predicting the risk of upper GI bleeding in NSAID
users was developed and verified [6], and a model for predicting the
incidence rate of upper GI bleeding in NSAID users using a case-control
study was developed [1]. There was a report on the risk score
calculated for major toxicity, including adverse cardiovascular events,
major GI events, acute kidney injury, and death in NSAID users from the
PRECISION trial data in 2019 [7]; however, the outcome of this study
was not specific for GI complications.
Although GI bleeding in the
elderly is a burden due to the high mortality and disability rates
[4], there is no risk stratification scheme to quantify the risk
factors for GI complications in elderly NSAID users. Most geriatric
focused criteria regarding the appropriate use of medication recommend
the concomitant use of a gastroprotective agent (GPA) with chronic NSAID
use [8]. However, GPA use might not eliminate the risk of serious GI
complications in high-risk situations [8]. Few studies have included
the use of a GPA in the prediction of GI complications.
Identifying high-risk patients in the elderly population would be
helpful in preventing serious GI complications; therefore, developing a
predictive risk score is important. We aimed to develop a risk
prediction score to identify high-risk patients for severe GI
complications in the elderly using NSAIDs and to validate it externally
using nationwide claims datasets.