NSAIDs and the Risk of Lower GI Adverse Events
NSAIDs and the Risk of Lower GI Adverse Events
Objective Only limited studies have evaluated the risk of non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) and coxibs for lower gastrointestinal (GI) adverse outcomes. The objective of this study was to evaluate risks of lower GI adverse events associated with use of celecoxib, oral and parenteral nsNSAIDs.
Design Retrospective case–crossover study.
Setting Records of all patients aged ≥20 years hospitalised for lower GI adverse events (bleeding from small or large intestine, perforation, and complicated diverticular disease) in 2006 were retrieved using ICD-9-CM diagnosis codes from inpatient claims from the Taiwan National Health Insurance database.
Interventions Case periods were defined for each patient as 1–30 days prior to hospital admission date and control period as 91–120 days prior to hospital admission date. The pharmacy prescription database was searched for NSAID use during case and control periods.
Main outcome measures We calculated adjusted self-matched ORs and 95% CIs with a conditional logistic regression model to determine the associations between NSAID use and lower GI adverse outcomes.
Results A total of 1297 patients hospitalised for lower GI adverse events were included. Celecoxib was associated with an adjusted OR of 2.33 (95% CI 0.97 to 5.59); the association became statistically significant (OR: 3.26, 95% CI 1.07 to 9.91) when a different control period (31–60 days) was applied. Both oral and parenteral nsNSAIDs significantly increased risk for lower GI adverse events (OR: 2.26, 95% CI 1.78 to 2.85 and OR: 5.64, 95% CI 3.24 to 9.82, respectively).
Conclusions Oral and parenteral NSAIDs were associated with significantly increased risk for lower GI adverse events. Celecoxib also increased risk to a comparable extent, despite risk estimates being affected slightly by the control period chosen for comparison. The association of NSAIDs with specific lower GI adverse events and long-term complications requires further investigation.
Use of non-steroidal anti-inflammatory drugs (NSAIDs) is an important cause of upper gastrointestinal (GI) adverse events. Meanwhile, increasing evidence indicates that NSAID-induced GI toxicity also involves the lower GI tract. Lesions induced de novo, or pre-existing conditions aggravated by NSAIDs, may manifest clinically as bleeding of the small or large intestine, perforation, or complicated diverticular disease. Previous reports suggest that among NSAID users, lower GI events may account for 13% to 40% of all GI events. During the past decade, studies have reported a clear decreasing trend in upper GI events and a significant increase in lower GI events in Western countries. However; lower GI adverse events associated with NSAID use are less clearly characterised than upper GI effects in the Asian population.
Compared to studies of upper GI adverse events, fewer studies have evaluated the lower GI safety profiles of both cyclooxygenase-2 enzyme non-selective and selective NSAIDs (cyclooxygenase-2 inhibitors and nsNSAIDs, respectively). Controversies exist concerning the frequency and severity of a variety of adverse effects with the use of nsNSAIDs and cyclooxygenase-2 inhibitors. Additionally, although evidence suggests a marked variability in terms of upper GI safety among traditional NSAIDs, information about the effects of individual NSAIDs on lower GI adverse events is not available. Therefore, the aim of this nationwide study was to examine the risks of lower GI adverse events associated with use of individual oral and parenteral NSAIDs, including celecoxib, among the general population in Taiwan.
Abstract and Introduction
Abstract
Objective Only limited studies have evaluated the risk of non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) and coxibs for lower gastrointestinal (GI) adverse outcomes. The objective of this study was to evaluate risks of lower GI adverse events associated with use of celecoxib, oral and parenteral nsNSAIDs.
Design Retrospective case–crossover study.
Setting Records of all patients aged ≥20 years hospitalised for lower GI adverse events (bleeding from small or large intestine, perforation, and complicated diverticular disease) in 2006 were retrieved using ICD-9-CM diagnosis codes from inpatient claims from the Taiwan National Health Insurance database.
Interventions Case periods were defined for each patient as 1–30 days prior to hospital admission date and control period as 91–120 days prior to hospital admission date. The pharmacy prescription database was searched for NSAID use during case and control periods.
Main outcome measures We calculated adjusted self-matched ORs and 95% CIs with a conditional logistic regression model to determine the associations between NSAID use and lower GI adverse outcomes.
Results A total of 1297 patients hospitalised for lower GI adverse events were included. Celecoxib was associated with an adjusted OR of 2.33 (95% CI 0.97 to 5.59); the association became statistically significant (OR: 3.26, 95% CI 1.07 to 9.91) when a different control period (31–60 days) was applied. Both oral and parenteral nsNSAIDs significantly increased risk for lower GI adverse events (OR: 2.26, 95% CI 1.78 to 2.85 and OR: 5.64, 95% CI 3.24 to 9.82, respectively).
Conclusions Oral and parenteral NSAIDs were associated with significantly increased risk for lower GI adverse events. Celecoxib also increased risk to a comparable extent, despite risk estimates being affected slightly by the control period chosen for comparison. The association of NSAIDs with specific lower GI adverse events and long-term complications requires further investigation.
Introduction
Use of non-steroidal anti-inflammatory drugs (NSAIDs) is an important cause of upper gastrointestinal (GI) adverse events. Meanwhile, increasing evidence indicates that NSAID-induced GI toxicity also involves the lower GI tract. Lesions induced de novo, or pre-existing conditions aggravated by NSAIDs, may manifest clinically as bleeding of the small or large intestine, perforation, or complicated diverticular disease. Previous reports suggest that among NSAID users, lower GI events may account for 13% to 40% of all GI events. During the past decade, studies have reported a clear decreasing trend in upper GI events and a significant increase in lower GI events in Western countries. However; lower GI adverse events associated with NSAID use are less clearly characterised than upper GI effects in the Asian population.
Compared to studies of upper GI adverse events, fewer studies have evaluated the lower GI safety profiles of both cyclooxygenase-2 enzyme non-selective and selective NSAIDs (cyclooxygenase-2 inhibitors and nsNSAIDs, respectively). Controversies exist concerning the frequency and severity of a variety of adverse effects with the use of nsNSAIDs and cyclooxygenase-2 inhibitors. Additionally, although evidence suggests a marked variability in terms of upper GI safety among traditional NSAIDs, information about the effects of individual NSAIDs on lower GI adverse events is not available. Therefore, the aim of this nationwide study was to examine the risks of lower GI adverse events associated with use of individual oral and parenteral NSAIDs, including celecoxib, among the general population in Taiwan.
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