Introduction.- The relative gastrointestinal toxicity of newer non-steroidal anti-inflammatory drugs (NSAIDs) in usual practice is unknown. We aimed at estimating the risk of upper gastrointestinal bleeding (UGIB) associated to analgesic and NSAIDs, with special emphasis on those introduced in recent years. Design.- Multicentre case-control study. Participants.- All incident community cases of UGIB from a gastric or duodenal lesion in patients over 18 years of age (4,309 cases). After secondary exclusions 2,813 cases and 7,193 matched controls were included in the analysis. Setting.- Eighteen hospitals in Spain and in Italy with a total study experience of 10,734,897 person-years. Main outcome measure.- Odds ratios of UGIB for each drug, with adjustment for potential confounders. For each individual drug the reference category was defined as the non-exposed to such a drug. Results.- The incidence of UGIB was 401.4 per million inhabitants older than 18 years. Thirty-eight percent of cases were attributable to NSAIDs. Individual risks for each NSAID were dose-dependent. Ketorolac was associated with the highest risk estimate (24.7 [95% confidence interval, 8.0-77.0]). For newer NSAIDs, the risks were aceclofenac 1.4 (0.6-3.3), celecoxib 0.3 (0.0-4.1), dexketoprofen 4.9 (1.7-13.9), meloxicam 5.7 (2.2-15.0), nimesulide 3.2 (1.9-5.6), and rofecoxib 7.2 (2.3-23.0). The risk was significantly increased in patients with a history of peptic ulcer and/or UGIB, and in those taking antiplatelet drugs. Conclusions.- NSAID-induced UGIB is a common cause of hospital admission. Apart from the patient’s history of peptic ulcer, its risk depends on the particular drug and its dose and on concomitant treatments. Our results do not confirm that greater selectivity for COX-2 confers less risk of UGIB.
The epidemiology of upper gastrointestinal bleeding in relation to the use of analgesics and non-steroidal anti-inflammatory drugs
LEONE, Roberto
2004-01-01
Abstract
Introduction.- The relative gastrointestinal toxicity of newer non-steroidal anti-inflammatory drugs (NSAIDs) in usual practice is unknown. We aimed at estimating the risk of upper gastrointestinal bleeding (UGIB) associated to analgesic and NSAIDs, with special emphasis on those introduced in recent years. Design.- Multicentre case-control study. Participants.- All incident community cases of UGIB from a gastric or duodenal lesion in patients over 18 years of age (4,309 cases). After secondary exclusions 2,813 cases and 7,193 matched controls were included in the analysis. Setting.- Eighteen hospitals in Spain and in Italy with a total study experience of 10,734,897 person-years. Main outcome measure.- Odds ratios of UGIB for each drug, with adjustment for potential confounders. For each individual drug the reference category was defined as the non-exposed to such a drug. Results.- The incidence of UGIB was 401.4 per million inhabitants older than 18 years. Thirty-eight percent of cases were attributable to NSAIDs. Individual risks for each NSAID were dose-dependent. Ketorolac was associated with the highest risk estimate (24.7 [95% confidence interval, 8.0-77.0]). For newer NSAIDs, the risks were aceclofenac 1.4 (0.6-3.3), celecoxib 0.3 (0.0-4.1), dexketoprofen 4.9 (1.7-13.9), meloxicam 5.7 (2.2-15.0), nimesulide 3.2 (1.9-5.6), and rofecoxib 7.2 (2.3-23.0). The risk was significantly increased in patients with a history of peptic ulcer and/or UGIB, and in those taking antiplatelet drugs. Conclusions.- NSAID-induced UGIB is a common cause of hospital admission. Apart from the patient’s history of peptic ulcer, its risk depends on the particular drug and its dose and on concomitant treatments. Our results do not confirm that greater selectivity for COX-2 confers less risk of UGIB.
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