A large simple clinical trial prototype for assessment of OTC drug effects using patient-reported data

Pharmacoepidemiology and Drug Safety

Volumn 14, Issue 4, 2005, Pages 249-255

  Van Ganse, Eric ^a,g   Jones, Judith K ^b   Moore, Nicholas ^c   Le Parc, Jean Marie ^d   Wall, Richard ^e   Schneid, Helene ^f  

^a HOSPICES CIVILS DE LYON   (France)

^b The Degge Group Ltd   (United States)

^c UNIVERSITÉ DE BORDEAUX   (France)

^d HÔPITAL AMBROISE PARÉ   (France)

^e The Boots Company PLC   (United Kingdom)

^f Boots Healthcare   (France)

^g U de Pharmacoepidemiologie EA3091   (France)

Author keywords

Analgesics; Patient recorded adverse events; Prototype large simple randomised trial; Tolerability

Indexed keywords

ACETYLSALICYLIC ACID; ANALGESIC AGENT; IBUPROFEN; NON PRESCRIPTION DRUG; PARACETAMOL;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG INFORMATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOMES RESEARCH; PAIN; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SELF EVALUATION; SELF REPORT; SHORT COURSE THERAPY; SIDE EFFECT;

ACETAMINOPHEN; ADOLESCENT; ADULT; AGED; ANALGESICS; ASPIRIN; DRUGS, NON-PRESCRIPTION; FEMALE; HUMANS; IBUPROFEN; MALE; MIDDLE AGED; PAIN; PATIENTS; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS; TREATMENT OUTCOME;

EID: 17244375480     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.1083     Document Type: Article

References (27)

1. Moore N, Noblet C, Breemeersch C. Focus on the safety of ibuprofen at the analgesic-antipyretic dose. Therapie 1996; 51 458-463.
2. Halpern SM, Fitzpatrick R, Volans GN. Ibuprofen toxicity: a review of adverse reactions and overdose. Adverse Drug React Toxicol Rev 1993; 12: 107-128.
3. Furey SA, Waksman JA, Dash BE Nonprescription ibuprofen: side effect profile. Pharmacotherapy 1992; 12: 403-407.
4. Rainsford KD, Roberts SC, Brown S lbuprofen and paracetamol: relative safety in non-prescription dosages. J Pharm Pharmacol 1997; 49: 345-376.
5. Henry D, Lim LL, Garcia Rodriguez LA, et al. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis. Br Med J 1996; 312: 1563-1566.
6. Smalley WE, Ray WA, Daugherty JR, Griffin MR. Nonsteroidal anti-inflammatory drugs and the incidence of hospitalizations for peptic ulcer disease in elderly persons. Am J Epidemiol 1995; 141: 539-545.
7. Strom BL, Schinnar R, Bilker WB, Feldman H, Farrar JT, Carson JL. Gastrointestinal tract bleeding associated with naproxen sodium vs. ibuprofen. Arch Intem Med 1997; 157: 2626-2631.
8. Shapiro S. The role of automated record linkage in the post-marketing surveillance of drug safety: a critique Clin Pharmacol Ther 1989; 46: 371-386.
9. MacDonald TM, Beard K, Bruppacher R, et al. The safety of drugs for OTC use: what evidence is required for an NSAID switch? Phannacoepidemiol Drug Safe 2002; 11: 577-584.
10. Moore N, Van Ganse E, Le Parc J, et al. The PAIN study: Paracetamol, Aspirin and lbuprofen New tolerability study: a large scale, randomized clinical trial comparing the tolerability of aspirin, ibuprofen and paracetamol for short-term analgesia Clin Drug Invest 1999; 18: 89-98
11. Agence Frana̧ise de Sécurité Sanitaire des Produits de Santé. Good Pharmacovigilance Practices. AFSSaPS: Paris, 1994.
12. Altman D Comparability of Randomised Groups. Statistician 1985; 34: 125-136.
13. Dunnett C, Goldsmith C. When and how to do multiple comparisons. In Statistics in the Pharmaceutical Industry, Buncher C, Tsay J (eds). Dekker: New York, 1981; 397-433.
14. US Food and Drug Administration. COSTART. Coding Symbol Thesaurus for Adverse Reaction Terms (3rd edn). Center for Drugs and Biologics, Division of Drug and Biological Products Experience: Rockville, MD, 1989.
15. Fisher S, Bryant SG Postmarketing surveillance: accuracy of patient drug attribution judgments. Clin Pharmacol Ther 1990; 48 102-107.
16. Moore N, Charlesworth A, Van Ganse E, et al. Risk factors for adverse events in analgesic drug users: results from the PAIN study. Pharmacoepidemiol Drug Safe 2003; 12: 601-610.
17. Langman MJ, Weil J, Wainwright P, et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 1075-1078.
18. Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial. JAMA 1995; 273: 929-933.
19. Mitchell AA, Lesko SM. When a randomised controlled trial is needed to assess drug safety: the case of paediatric ibuprofen. Drug Saf 1995; 13: 15-24.
20. Temple R. Meta-analysis and epiderniologic studies in drug development and postmarketing surveillance. JAMA 1999; 281: 941-844.
21. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999; 281: 824-829.
22. O'Neil AC, Petersen LA, Cook EF, Bates DW, Lee TH, Brennan TA. Physician reporting compared with medical-record review to identify adverse medical events. Ann Intern Med 1993; 119: 370-376.
23. Fries JF, Bruce B. Rates of serious gastrointestinal events from low dose use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis. J Rheumatol 2003; 30: 2226-2233.
24. Mitchell AS, Henry DA, Sanson-Fisher R, O'Connell DL. Patients as a direct source of information on adverse drug reactions. Br Med J 1988; 297: 891-893.
25. Miremont G, Haramburu F, Begaud B, Pere JC, Dangoumau J. Adverse drug reactions: physicians' opinions versus a causality assessment method. Eur J Clin Pharmacol 1994; 46: 285-289.
26. Macquart-Moulin G, Viens P, Bouscary ML, et al. Discordance between physicians' estimations and breast cancer patients' self-assessment of side-effects of chemotherapy: an issue for quality of care. Br J Cancer 1997; 76: 1640-1645.
27. Ottervanger JP, Valkenburg HA, Grobbee DE, Stricker BH. Differences in perceived and presented adverse drug reactions in general practice. J Clin Epidemiol 1998; 51: 795-799.