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

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The PAIN Study: Paracetamol, Aspirin and Ibuprofen New Tolerability Study See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/238225654 The PAIN Study: Paracetamol, Aspirin and Ibuprofen New Tolerability Study Article in Clinical Drug Investigation · August 1999 DOI: 10.2165/00044011-199918020-00001 CITATIONS READS 120 1,004 5 authors, including: Nicholas D Moore Jean-Marie Leparc Université de Bordeaux Assistance Publique – Hôpitaux de Paris 900 PUBLICATIONS 13,391 CITATIONS 16 PUBLICATIONS 264 CITATIONS SEE PROFILE SEE PROFILE Mahdi Farhan Dbiopharm 10 PUBLICATIONS 381 CITATIONS SEE PROFILE Some of the authors of this publication are also working on these related projects: Bioavailability of phytoestrogens in humans and rodent models View project Traditional Uyghur Medicine View project All content following this page was uploaded by Nicholas D Moore on 08 November 2018. The user has requested enhancement of the downloaded file. Clin Drug Invest 1999 Aug; 18 (2): 89-98 CLINICAL USE 1173-2563/99/0008-0089/$05.00/0 © Adis International Limited. All rights reserved. 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,1 Eric Van Ganse,2 Jean-Marie Le Parc,3 Richard Wall,4 Hélène Schneid,5 Mahdi Farhan,4 François Verrière 5 and François Pelen 5 1 Department of Pharmacology, Université Victor Segalen, Hôpital Pellegrin, Bordeaux, France 2 Clinical Pharmacology Department, University of Lyon, Lyon, France 3 Service de Rhumatologie, Hôpital Ambroise Paré, Boulogne-Billancourt, France 4 Boots Healthcare International, Nottingham, England 5 Boots Healthcare, Courbevoie, France 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 com- mon 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 para- cetamol overdose. 90 Moore et al. Aspirin (acetylsalicylic acid), ibuprofen and (Hôpital Ambroise Paré, Boulogne-Billancourt, paracetamol (acetaminophen) are first-line anal- France). The study was conducted according to gesics, generally available over the counter (OTC). Good Clinical Practices and the Declaration of Paracetamol has a reputation for good tolerability, Helsinki (as revised in 1989). somewhat offset by severe hepatic toxicity in Non-inclusion criteria were mainly limited to suicidal or accidental overdose.[1-4] Acommon the contraindications for the drugs from their concern with NSAIDs is gastro-toxicity, which is Summary of Product Characteristics (SPC), or to dose- and product-dependent. Case-control studies methodological or legal requirements (details of have shown an increased risk of gastrointestinal inclusion and non-inclusion criteria are available (GI) bleeding even with low-dose aspirin as used from the authors upon request). [5,6] in cardiovascular prevention, whereas at all Patients were given treatment for at least 1 and doses ibuprofen seems to carry a lower risk of at most 7 days, to be started within 24 hours of [7] gastro-toxicity than other NSAIDs. In some consultation unless the GP recommended other- studies at OTC doses this risk has been shown to be wise (e.g. for dysmenorrhoea). They were provided [8,9] similar to or less than placebo or paracetamol. with a diary on which to record adverse events and No study has addressed the relative tolerability their severity, medication taken (trial and concom- of aspirin, ibuprofen and paracetamol, as used in itant medication), and any comments. The diary daily practice to treat mild to moderate acute pain included specific instructions on the reporting of in adults. Because these drugs are widely used and events and their severity. Patients gave a global the disorders treated are not life-threatening, this opinion of the treatment at the end of the diary, question is a major public health issue. The present according to a 4-point scale. The diary and unused study was therefore designed to compare directly medication were to be returned to the prescriber at the tolerability of aspirin, ibuprofen and para- the end of treatment in a sealed envelope. cetamol in situations mimicking everyday use at Patients were not required to see their physician OTC doses and durations for various common again. Physicians called the patients on the day acute pain indications. This study relied mainly after the expected start of treatment to ensure that on patient data, which a previous study had shown to be feasible.[10] Basedonexistingdataonthe medication had been started, to record or qualify relative safety of aspirin, ibuprofen and para- any early adverse event, and to verify that the cetamol,[8,9,11] the basic premise tested in this study patients understood and would complete the diary. was that paracetamol and ibuprofen would have They called again 7 to 9 days after the start of treat- equivalent tolerability, and that ibuprofen would be ment to make sure the diary would be returned, better tolerated than aspirin. and/or to record any adverse event. Any second consultation and its reason were also recorded. Adverse events were identified and graded Patients and Methods from the patient diary, from the telephone calls, and The PAIN study (Paracetamol, Aspirin, from further GP visits. Classification and coding Ibuprofen New tolerability study) was a random- (COSTART) of events were checked by a Study ised, multicentre, blinded, parallel-group trial. Safety Committee before unblinding. Events that French general practitioners (GPs) were to include were identical to treatment indication were consid- patients aged 18 to 75 years requiring short-term ered as lack of treatment effect. Those not identifi- analgesic treatment of mild to moderate pain. able were coded as ‘unevaluable reaction’. Events All patients gave written informed consent to were graded as serious, severe, moderate or mild. participate in the study, which had been previously Serious events were those causing hospitalisation, approved by the Committee for the Protection of that were fatal or life-threatening, or that resulted Persons participating in Biomedical Research in sequelae. Severe events were those rendering © Adis International Limited. All rights reserved. Clin Drug Invest 1999 Aug; 18 (2) PAIN Study of Aspirin, Ibuprofen and Paracetamol 91 daily activities impossible, moderate events were The study medications were all white round those interfering with daily activities, and mild unmarked tablets of approximately the same size. events were those without impact on daily acti- The physicians never saw the tablets, and patients vities. Severity grading was considered first from saw only their own treatment. The envelopes the patient diary, then from the physician consult- containing returned medication were retrieved ations or telephone contacts. If severity was not intact by the study monitors, to ensure physician indicated, it was classified by the Safety Commit- blinding throughout the study. tee as missing. Statistical Analysis Primary Outcome Measure The study analysis tested two primary hypo- The number of patients with at least one signi- theses, that of equivalence between ibuprofen and ficant adverse event, defined as an event that was paracetamol, and that of difference between serious, severe or moderate, resulted in a second ibuprofen and aspirin. The study was not powered physician consultation, led to cessation of treat- to assess the difference between paracetamol and ment, or was of missing intensity. aspirin, since this difference was deemed estab- lished from the literature and current practice.
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