The effect of alcohol abuse on the risk of NSAID-related gastrointestinal events.
OBJECTIVE
Non-steroidal anti-inflammatory drugs (NSAIDs) are known to increase the risk of gastrointestinal (GI) complications. Excessive alcohol consumption may further increase this risk and the FDA is requiring warnings on over-the-counter (OTC) NSAIDs. Our objective is to evaluate the risk of NSAID-related GI events for persons with a history of alcohol abuse.


METHODS
This case control study used data from Saskatchewan Health. Cases consisted of 1083 patients hospitalized for severe GI events, whereas the control group consisted of 14,754 persons without such hospitalizations.


RESULTS
Five percent of cases and 1.9% of controls had a history of treatment for alcohol abuse. The presence of either NSAID use or a history of alcohol abuse led to an odds ratio (OR) of 2.9* for severe GI events, whereas the presence of both risk factors simultaneously led to an OR of 10.2* (additive would be 5.8). Similarly, the presence of ibuprofen and naproxen use, which are OTC in the USA, without alcohol abuse led to an OR of 1.9*, whereas alcohol abuse by itself led to an OR of 2.4*. The presence of both OTC NSAIDs and alcohol abuse simultaneously, led to an OR of 6.5 (additive would be 4.3). Thus with both risk factors present, the resulting risk ratio is greater than the additive risk of the separate risk factors.


CONCLUSIONS
The Food and Drug Administration (FDA) warning concerns concurrent use of alcohol with NSAIDs, whereas the present study presents the effect of long term alcohol abuse. Further research is needed to separate these two issues to allow physicians to provide the best advice to their patients. *Statistically significant at p<0.05.
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Bureau of Drug Surveillance, Therapeutic Products Programme, Health Canada, Ottawa, Ontario, Canada.
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D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D000437:Alcoholism / Q000150:complications / Q000453:epidemiology*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D016022:Case-Control Studies; D015897:Comorbidity; D016001:Confidence Intervals; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology* / Q000209:etiology; D006306:Health Surveys; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012016:Reference Values; D012307:Risk Factors; D017678:Sex Distribution
D000894:Anti-Inflammatory Agents, Non-Steroidal