Objective: To analyse and compare the adverse drug reactions (ADRs) associated with the use of oral nimesulide, diclofenac, ketoprofen, and piroxicam which were spontaneously reported in a northern Italian area (Veneto and Trentino). Methods: Data were obtained from the spontaneous reporting system database of Veneto-Trentino, the principal contributor to the Italian spontaneous surveillance system. All reports of ADRs that occurred in association with the non-steroidal anti-inflammatory drugs (NSAIDs) under investigation during the period from January 1988 to December 2000 were analysed in detail. An estimate of drug consumption during June 1996-May 1999 was made by calculating the number of defined daily doses for each drug. Results: During the study period, 10,608 reports describing 16,571 reactions were entered into the system. We found 207 reports for nimesulide, 187 for diclofenac, 174 for ketoprofen, and 137 for piroxicam. Some differences were found regarding the age- and sex-related reporting rate among these NSAIDs. Ketoprofen showed the highest number of serious ADR reports/consumption, while the lowest number was found for nimesulide. Significantly different toxicity profiles among these drugs emerged. In particular, nimesulide was associated with fewer and less severe gastrointestinal (GI) ADRs compared with the other NSAIDs. The percentage of GI reactions to nimesulide (10.4%) was about one-half of those reported for the other three NSAIDs (21.2 for diclofenac, 21.7%n for ketoprofen, 18.6 for piroxicam). Conclusions: Nimesulide appears a well tolerated drug, with a lower reports/consumption ratio compared with diclofenac, piroxicam and ketoprofen. Age-related reporting analysis suggests a higher toxicity of diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. In line with its COX-2 selectivity profile, nimesulide showed the best GI tolerability, with few reports of severe GI reactions. The analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their safety profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics.

Adverse drug reactions related the use of NSAIDs with a focus on nimesulide. Results of spontaneous reporting from a northern Italian area.

LEONE, Roberto;MORETTI, Ugo;VELO, Giampaolo
2001

Abstract

Objective: To analyse and compare the adverse drug reactions (ADRs) associated with the use of oral nimesulide, diclofenac, ketoprofen, and piroxicam which were spontaneously reported in a northern Italian area (Veneto and Trentino). Methods: Data were obtained from the spontaneous reporting system database of Veneto-Trentino, the principal contributor to the Italian spontaneous surveillance system. All reports of ADRs that occurred in association with the non-steroidal anti-inflammatory drugs (NSAIDs) under investigation during the period from January 1988 to December 2000 were analysed in detail. An estimate of drug consumption during June 1996-May 1999 was made by calculating the number of defined daily doses for each drug. Results: During the study period, 10,608 reports describing 16,571 reactions were entered into the system. We found 207 reports for nimesulide, 187 for diclofenac, 174 for ketoprofen, and 137 for piroxicam. Some differences were found regarding the age- and sex-related reporting rate among these NSAIDs. Ketoprofen showed the highest number of serious ADR reports/consumption, while the lowest number was found for nimesulide. Significantly different toxicity profiles among these drugs emerged. In particular, nimesulide was associated with fewer and less severe gastrointestinal (GI) ADRs compared with the other NSAIDs. The percentage of GI reactions to nimesulide (10.4%) was about one-half of those reported for the other three NSAIDs (21.2 for diclofenac, 21.7%n for ketoprofen, 18.6 for piroxicam). Conclusions: Nimesulide appears a well tolerated drug, with a lower reports/consumption ratio compared with diclofenac, piroxicam and ketoprofen. Age-related reporting analysis suggests a higher toxicity of diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. In line with its COX-2 selectivity profile, nimesulide showed the best GI tolerability, with few reports of severe GI reactions. The analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their safety profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics.
Nimesulide; adverse drug reactions; NSAIDs
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11562/305853
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