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Related Experiment Videos

Tolerability of nimesulide. Epidemiological data

G Fusetti1, E Magni, M C Armandola

  • 1Department of Regulatory Affairs, Helsinn Healthcare SA, Chiasso, Switzerland.

Drugs
|January 1, 1993
PubMed
Summary

Nimesulide demonstrates a favorable tolerability profile, with adverse events comparable to placebo. This non-steroidal anti-inflammatory drug (NSAID) was well-tolerated across various organ systems in a global clinical data assessment.

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Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Safety

Background:

  • Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with a well-documented clinical history.
  • Assessing the long-term tolerability of NSAIDs is crucial for patient safety and therapeutic efficacy.

Purpose of the Study:

  • To evaluate the overall tolerability profile of nimesulide.
  • To analyze adverse events and withdrawal rates from a comprehensive global dataset.

Main Methods:

  • Global assessment of clinical data from 151 trials involving nimesulide.
  • Analysis included between-treatment (vs. placebo) and within-treatment comparisons.
  • Utilized case report forms and study reports as primary source information.

Main Results:

  • Out of 4945 subjects, 7.1% experienced adverse events, and 1.1% withdrew.
  • Most frequent adverse events involved the digestive system, body, skin, and nervous system.
  • Nimesulide showed similar adverse event incidence and nature compared to placebo and was well-tolerated by the liver, lungs, kidneys, and blood.

Conclusions:

  • Nimesulide exhibits a favorable tolerability profile across a large patient population.
  • The safety profile of nimesulide is comparable to placebo, indicating good systemic tolerability.

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