Methodology of therapeutic trials: Lessons from the late evidence of the cardiovascular toxicity of some coxibs

Joint Bone Spine

Volumn 72, Issue 6, 2005, Pages 451-455

  Ravaud, Philippe ^a   Tubach, Florence ^a  

^a INSERM   (France)

Author keywords

Cardiovascular toxicity; Coxib; Side effects; Therapeutic trial

Indexed keywords

CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; MELOXICAM; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; ROFECOXIB; VALDECOXIB;

CANCER PREVENTION; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL TRIAL; COLON POLYPOSIS; CONFERENCE PAPER; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; HEALTH SERVICE; HEART INFARCTION; HUMAN; MARKET; METHODOLOGY; MUSCULOSKELETAL DISEASE; OBSERVATIONAL STUDY; OSTEOARTHRITIS; PHYSICIAN; PULMONARY HYPERTENSION; REGISTRATION; RISK ASSESSMENT; THROMBOSIS; TOXIC EPIDERMAL NECROLYSIS;

CLINICAL TRIALS DATA MONITORING COMMITTEES; CYCLOOXYGENASE 2 INHIBITORS; DRUG APPROVAL; DRUG EVALUATION; HUMANS; LACTONES; META-ANALYSIS; OBSERVATION; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS; SULFONES;

EID: 29244490585     PISSN: 1297319X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbspin.2005.10.003     Document Type: Conference Paper

References (13)

1. S. Okie Safety in numbers-monitoring risk in approved drugs N. Engl. J. Med. 352 2005 1173 1176
2. M.A. Friedman, J. Woodcock, M.M. Lumpkin, J.E. Shuren, A.E. Hass, and L.J. Thompson The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281 1999 1728 1734
3. W.A. Ray, C.M. Stein, J.R. Daugherty, K. Hall, P.G. Arbogast, and M.R. Griffin COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease Lancet 360 2002 1071 1073
4. D. Layton, K. Hughes, S. Harris, and S.A. Shakir Comparison of the incidence rates of thromboembolic events reported for patients prescribed celecoxib and meloxicam in general practice in England using Prescription-Event Monitoring (PEM) data Rheumatol. 42 2003 1354 1364
5. Maetzel A. Longitudinal observational studies after RCTs: lessons from the coxibs. EULAR congress. Ann. Rheum. Dis. 2005; (in press).
6. J.P. Ioannidis, A.B. Haidich, M. Pappa, N. Pantazis, S.I. Kokori, and M.G. Tektonidou Comparison of evidence of treatment effects in randomized and nonrandomized studies JAMA 286 2001 821 830
7. M. McKee, A. Britton, N. Black, K. McPherson, C. Sanderson, and C. Bain Methods in health services research. Interpreting the evidence: choosing between randomised and non-randomised studies BMJ 319 1999 312 315
8. P.A. Rochon, J.H. Gurwitz, K. Sykora, M. Mamdani, D.L. Streiner, and S. Garfinkel Reader's guide to critical appraisal of cohort studies: 1. Role and design BMJ 330 2005 895 897
9. DAMOCLES Study Group Programme NHTA. A proposed charter for clinical trial data monitoring committees: helping them to do their job well Lancet 365 2005 711 722
10. R.S. Bresalier, R.S. Sandler, H. Quan, J.A. Bolognese, B. Oxenius, and K. Horgan Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial N. Engl. J. Med. 352 2005 1092 1102
11. S.D. Solomon, S. Zelenkofske, J.J. McMurray, P.V. Finn, E. Velazquez, and G. Ertl Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both N. Engl. J. Med. 352 2005 2638 2640
12. P. Juni, L. Nartey, S. Reichenbach, R. Sterchi, P.A. Dieppe, and M. Egger Risk of cardiovascular events and rofecoxib: cumulative meta-analysis Lancet 364 2005 2021 2029
13. M. Lievre, E. Abadie French Marketing Authorization Committee Lancet 365 2005 23 24