BACKGROUND AND OBJECTIVES: The PAIN (Paracetamol, Aspirin and Ibuprofen New tolerability) study published in 1999 assessed the tolerability of over-the- counter (OTC) analgesics in a French general practitioner (GP)-controlled population and found no apparent difference between the tolerability of ibuprofen and paracetamol (acetaminophen). However, patient selection in that study could cast doubt over the relevance of the results to a more generalised OTC population. The aim of our survey was to prospectively determine what proportion of a French GP-controlled population is able to take ibuprofen and paracetamol in order to allow appropriate interpretation of the PAIN study. METHODS: This was a prospective survey to identify all contraindications/warnings on product labelling for ibuprofen and paracetamol in 5000 patients aged 18-75 years. 100 French GPs each collected anonymised data on 50 patients over a 1-week period using a standardised form. GPs were stratified by geographical location and size of practice. Demographic data for patients were summarised. Contraindications/warnings for ibuprofen and paracetamol were summarised overall and by individual criterion. RESULTS: The mean age of patients was 45.8 (+/- 16.5) years; 42% were males and 58% females. Of these patients, 49.9% would have been ineligible for the PAIN study because of at least one contraindication/warning for ibuprofen, whereas only 6.8% would have been ineligible because of at least one contraindication/warning for paracetamol. More specifically, contraindications to use of ibuprofen was noted in 12.3% of patients and 37.6% of patients should have consulted a doctor before use of this drug. In contrast, contraindications to use of paracetamol were noted in only 0.7% of patients and only 6.1% should have consulted a doctor before use of this drug. CONCLUSIONS: Our survey demonstrates how careful patient selection can limit the generalisability of a study. The PAIN study excluded individuals 'at-risk' from ibuprofen and the tolerability results of this study should therefore be interpreted with extreme caution because the patient population may not be representative of unsupervised OTC analgesic users.
BACKGROUND AND OBJECTIVES: The PAIN (Paracetamol, Aspirin and Ibuprofen New tolerability) study published in 1999 assessed the tolerability of over-the- counter (OTC) analgesics in a French general practitioner (GP)-controlled population and found no apparent difference between the tolerability of ibuprofen and paracetamol (acetaminophen). However, patient selection in that study could cast doubt over the relevance of the results to a more generalised OTC population. The aim of our survey was to prospectively determine what proportion of a French GP-controlled population is able to take ibuprofen and paracetamol in order to allow appropriate interpretation of the PAIN study. METHODS: This was a prospective survey to identify all contraindications/warnings on product labelling for ibuprofen and paracetamol in 5000 patients aged 18-75 years. 100 French GPs each collected anonymised data on 50 patients over a 1-week period using a standardised form. GPs were stratified by geographical location and size of practice. Demographic data for patients were summarised. Contraindications/warnings for ibuprofen and paracetamol were summarised overall and by individual criterion. RESULTS: The mean age of patients was 45.8 (+/- 16.5) years; 42% were males and 58% females. Of these patients, 49.9% would have been ineligible for the PAIN study because of at least one contraindication/warning for ibuprofen, whereas only 6.8% would have been ineligible because of at least one contraindication/warning for paracetamol. More specifically, contraindications to use of ibuprofen was noted in 12.3% of patients and 37.6% of patients should have consulted a doctor before use of this drug. In contrast, contraindications to use of paracetamol were noted in only 0.7% of patients and only 6.1% should have consulted a doctor before use of this drug. CONCLUSIONS: Our survey demonstrates how careful patient selection can limit the generalisability of a study. The PAIN study excluded individuals 'at-risk' from ibuprofen and the tolerability results of this study should therefore be interpreted with extreme caution because the patient population may not be representative of unsupervised OTC analgesic users.
Authors: Nicholas Moore; Andrew Charlesworth; Eric Van Ganse; Jean-Marie LeParc; Judith K Jones; Richard Wall; Hélène Schneid; François Verrière Journal: Pharmacoepidemiol Drug Saf Date: 2003 Oct-Nov Impact factor: 2.890
Authors: Eric Van Ganse; Judith K Jones; Nicholas Moore; Jean Marie Le Parc; Richard Wall; Helene Schneid Journal: Pharmacoepidemiol Drug Saf Date: 2005-04 Impact factor: 2.890
Authors: S C Lewis; M J S Langman; Joan-Ramon Laporte; John N S Matthews; Michael D Rawlins; Bengt-Erik Wiholm Journal: Br J Clin Pharmacol Date: 2002-09 Impact factor: 4.335