Background/Purpose: Non-steroidal anti-inflammatory drugs (NSAIDs) are the long established first-line treatment for the management of pain associated with rheumatic diseases but carry a risk of gastrointestinal (GI) disturbance. The recognized GI risk factors are age >60 years; concomitant use of acetylsalicylic acid (ASA), oral corticosteroids or anticoagulants; previous history of ulcer, bleeding, or dyspepsia; and use of two NSAIDs or high dose of one NSAID. Evidence-based guidelines recommend the concomitant use of gastroprotective agents (GPAs) in NSAID users with one or more risk factors. Current evidence suggests that a significant proportion of patients at risk for GI events do not receive a GPA.

Methods: The RATIONAL study was conducted in Asia, Russia and Latin America and had an observational, multicenter, cross-sectional design to evaluate the prevalence of GI risk factors in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS). The single study visit was part of standard practice. Patients were aged >21 years with a documented diagnosis of RA (ACR/EULAR 2010 criteria), OA (ACR 1991 criteria) or AS (New York 1984 criteria or ESSG 2002 criteria) and had taken at least one dose of NSAIDs in the 15 days before enrolment. Information collected included NSAID treatment over the year preceding the study visit, GPA use, and occurrence of any of a defined range of GI events.

Results:

The distribution of rheumatic disorders in the 5373 patients was OA 2996 (55.8%), RA 1882 (35.0%), AS 283 (5.3%), and a combination of these 212 (3.9%). One or more GI risk factors were present in 87.7% of patients.  The prevalence of individual risk factors and treatment with GPAs is shown in the Table 1. GPA use in patients aged ≥60 years or concomitantly using anticoagulants was close to the study average (57.9%). A modest numerical increase from this mean value was observed in patients taking concomitant ASA (63.8%) or high doses of an NSAID (64.1%). A greater numerical increase in this percentage was seen for all of the other risk factors with values of 96.6% and 93.3% for those with histories of GI complications and GI ulcer, respectively. There was a strong preference for using proton pump inhibitors as the class of GPA and the most commonly used individual treatment was omeprazole (36.4% of total patients).

 

Table 1: Prevalence of risk factors

Conclusion: Risk factors that appeared to influence the provision of treatment with a GPA were those related to a previous history of GI-related symptoms or events and concomitant use of corticosteroids. Most of the other risk factors appeared to have little influence on the prescription of a GPA. Although 87.8% of the study population had one or more GI risk factors, only 57.9% received any form of GPA. Age does not appear to be recognized as a risk factor for GI symptoms and GPAs are under prescribed. Study identifier [NCT01577563]

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/prevalence-of-risk-factors-for-gastrointestinal-side-effects-of-drugs-for-the-treatment-of-pain-in-rheumatic-diseases-and-the-provision-of-gastroprotective-treatment-results-of-a-large-non-i/