ArticleDrug safety2001
Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide: results of spontaneous reporting from a Northern Italian area.
Article in Drug safety, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 53 citations in OpenAlex.
- Human safety study of a selective neuronal adenylate cyclase 1 inhibitor NB001 which relieves the neuropathic pain and blocks ACC in adult mice.Molecular pain · 2022Trial
- Article
- Synthesis, characterization, biological evaluation, and molecular modeling of novel nimesulide urea derivatives as potential MetAP2 inhibitors.Scientific reports · 2026Article
- Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage?World journal of gastroenterology · 2010Review
- Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs.BMC clinical pharmacology · 2009Review
- Prescriptions of NSAIDs to patients undergoing third molar surgery : an observational, prospective, multicentre survey.Clinical drug investigation · 2008Article
- Applying the evidence in osteoarthritis: strategies for pain management.Clinical drug investigation · 2007Review
- The impact of recent data on our understanding of the roles of COX-1 and COX-2 in gastrointestinal pathophysiology.Clinical drug investigation · 2007Article
- Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs.BMJ (Clinical research ed.) · 2003Article
- [Cyclooxygenase 2 selective antirheumatic analgesics].Wiener medizinische Wochenschrift (1946) · 2003Article
- Article
- Mechanisms of NSAID-induced hepatotoxicity: focus on nimesulide.Drug safety · 2002Review
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo analyse and compare the adverse drug reactions (ADRs) associated with the use of nimesulide with those associated with diclofenac, ketoprofen, and piroxicam, reported spontaneously in a northern Italian area (Veneto and Trentino).
methodsData were obtained from the spontaneous reporting system database of Veneto-Trentino, the principal contributor to the Italian spontaneous surveillance system. All case reports that occurred in association with all formulations of the nonsteroidal anti-inflammatory drugs (NSAIDs) under investigation during the period from January 1988 to December 2000, were analysed in detail. Sales data from June 1996 to May 1999 and prescription data, from 1997 to 2000 from the Veneto region were utilised to select the most widely used NSAIDs to be included in the study. The prescription data were also used to look at the drug use in relation to age.
resultsDuring the study period, 10 608 reports describing 16 571 adverse reactions were entered into the surveillance system. We found 207 case reports for nimesulide, 187 for diclofenac, 174 for ketoprofen, and 137 for piroxicam. Analysis of sales and prescription data revealed that in the Veneto region nimesulide was the most widely prescribed drug followed at a long distance by diclofenac, piroxicam and ketoprofen. No age-related difference in the use of the four drugs was found. Analysis of the case reports revealed significantly different toxicity profiles for the four drugs. In particular, nimesulide was associated with fewer and less severe gastrointestinal (GI) ADRs compared with the other NSAIDs. Nimesulide was associated with about half the number of GI reactions (10.4%) than the other three NSAIDs (21.2% for diclofenac, 21.7% for ketoprofen, 18.6% for piroxicam). Two previously unreported reactions were also found for piroxicam and ketoprofen.
conclusionsNimesulide is the most frequently used NSAID in Italy. Spontaneous reporting data suggest that nimesulide has the most favourable GI tolerability profile of the NSAIDs investigated, with few reports of severe GI reactions. A few reports of hepatic and renal impairment associated with nimesulide suggest caution in patients at risk. Age-related reporting analysis suggests a higher toxicity for diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. This analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their tolerability profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics.
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