Clinical Drug Investigation

, Volume 18, Issue 2, pp 89–98

The PAIN Study: Paracetamol, Aspirin and Ibuprofen New Tolerability Study

A Large-Scale, Randomised Clinical Trial Comparing the Tolerability of Aspirin, Ibuprofen and Paracetamol for Short-Term Analgesia
  • Nicholas Moore
  • Eric Van Ganse
  • Jean-Marie Le Parc
  • Richard Wall
  • Hélène Schneid
  • Mahdi Farhan
  • François Verrière
  • François Pelen
Clinical Use

DOI: 10.2165/00044011-199918020-00001

Cite this article as:
Moore, N., Ganse, E.V., Parc, JM.L. et al. Clin. Drug Investig. (1999) 18: 89. doi:10.2165/00044011-199918020-00001

Abstract

Objective: This study aimed to compare directly aspirin (acetylsalicylic acid), ibuprofen and paracetamol (acetaminophen), first-line analgesics which are generally well tolerated, from a safety perspective in general practice.

Methods: This was a blinded, multicentre study in general practice of up to 7 days of aspirin, paracetamol (both up to 3g daily) or ibuprofen (up to 1.2g daily), administered for common painful conditions, using patient-generated data with physician assistance. The main outcome was the rate of significant adverse events (serious, severe or moderate events, events resulting in treatment discontinuation or a physician visit). Statistical analysis tested for equivalence between ibuprofen and paracetamol, and for difference with aspirin.

Results: 1108 general practitioners included 8677 adults (2900 aspirin, 2886 ibuprofen, 2888 paracetamol; three patients had no code label number). 8633 (99.5%) were evaluable, of whom 8233 (95%) adhered to the study protocol. The main indications were musculoskeletal or back pain (48%), sore throat, the common cold and flu (31%). Rates of significant adverse events were: aspirin 18.7%, ibuprofen 13.7%, and paracetamol 14.5%. Ibuprofen was statistically equivalent to paracetamol. Both were significantly better tolerated than aspirin (p < 0.001). Total gastrointestinal events (including dyspepsia) and abdominal pain were less frequent with ibuprofen (4 and 2.8%, respectively) than with paracetamol (5.3 and 3.9%) or aspirin (7.1 and 6.8%) [all p < 0.035]. There were six cases of non-serious gastrointestinal bleeding, four with paracetamol and two with aspirin, and one case of peptic ulcer with aspirin.

Conclusion: The overall tolerability of ibuprofen in this large-scale study was equivalent to that of paracetamol and better than that of aspirin. These findings could lead to a reassessment of the use of first-line analgesics for the short-term management of painful conditions in general practice, recommending ibuprofen first, because of the poor tolerability of aspirin and the potential risks of paracetamol overdose.

Copyright information

© Adis International Limited 1999

Authors and Affiliations

  • Nicholas Moore
    • 1
  • Eric Van Ganse
    • 2
  • Jean-Marie Le Parc
    • 3
  • Richard Wall
    • 4
  • Hélène Schneid
    • 5
  • Mahdi Farhan
    • 4
  • François Verrière
    • 5
  • François Pelen
    • 5
  1. 1.Department of PharmacologyUniversité Victor Segalen, Hôpital PellegrinBordeauxFrance
  2. 2.Clinical Pharmacology DepartmentUniversity of LyonLyonFrance
  3. 3.Service de RhumatologieHôpital Ambroise ParéBoulogne-BillancourtFrance
  4. 4.Boots Healthcare InternationalNottinghamEngland
  5. 5.Boots HealthcareCourbevoieFrance

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