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Volumn 55, Issue 2, 2003, Pages 166-174

Safety profile of rofecoxib as used in general practice in England: Results of a prescription-event monitoring study

Author keywords

Adverse events; COX 2 selective inhibitors; Drug safety; Prescription event monitoring; Rofecoxib

Indexed keywords

ACETYLSALICYLIC ACID; ANTACID AGENT; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; CYCLOOXYGENASE 2 INHIBITOR; HISTAMINE H2 RECEPTOR ANTAGONIST; MISOPROSTOL; NONSTEROID ANTIINFLAMMATORY AGENT; PROTON PUMP INHIBITOR; ROFECOXIB;

EID: 0037329150     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.2003.01763.x     Document Type: Article
Times cited : (39)

References (41)
  • 2
    • 0032610899 scopus 로고    scopus 로고
    • COX-2: Separating myth from reality
    • McKenna F. COX-2: separating myth from reality. Scand J Rheumatol Suppl 1999; 109: 19-29.
    • (1999) Scand J Rheumatol Suppl , vol.109 , pp. 19-29
    • McKenna, F.1
  • 3
    • 0034062380 scopus 로고    scopus 로고
    • Cyclo-oxygenase isoenzymes: Physiological and pharmacological role
    • Kam PC, See AU. Cyclo-oxygenase isoenzymes: physiological and pharmacological role. Anaesthesia 2000; 55: 442-449.
    • (2000) Anaesthesia , vol.55 , pp. 442-449
    • Kam, P.C.1    See, A.U.2
  • 4
    • 0032851480 scopus 로고    scopus 로고
    • A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis
    • Rofecoxib Osteoarthritis Endoscopy Study Group
    • Laine L, Harper S, Simon T et al. A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Rofecoxib Osteoarthritis Endoscopy Study Group. Gastroenterol 1999, 117: 776-783.
    • (1999) Gastroenterol , vol.117 , pp. 776-783
    • Laine, L.1    Harper, S.2    Simon, T.3
  • 5
    • 0033601079 scopus 로고    scopus 로고
    • Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs
    • Langman MJ, Jensen DM, Watson DJ et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999; 282: 1929-1933.
    • (1999) JAMA , vol.282 , pp. 1929-1933
    • Langman, M.J.1    Jensen, D.M.2    Watson, D.J.3
  • 6
    • 0034041594 scopus 로고    scopus 로고
    • Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: Results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip
    • Rofecoxib Phase III Protocol 035 Study Group
    • Cannon GW, Caldwell JR, Holt P et al. Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip. Rofecoxib Phase III Protocol 035 Study Group. Arthritis Rheum 2000; 43: 978-987.
    • (2000) Arthritis Rheum , vol.43 , pp. 978-987
    • Cannon, G.W.1    Caldwell, J.R.2    Holt, P.3
  • 7
    • 0034707105 scopus 로고    scopus 로고
    • Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis
    • VIGOR Study Group
    • Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000; 343: 1520-1528.
    • (2000) N Engl J Med , vol.343 , pp. 1520-1528
    • Bombardier, C.1    Laine, L.2    Reicin, A.3
  • 8
    • 0034121667 scopus 로고    scopus 로고
    • Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial
    • The Rofecoxib Osteoarthritis Endoscopy Multinational Study Group
    • Hawkey C, Laine L, Simon T et al. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: a randomized, double-blind, placebo-controlled trial. The Rofecoxib Osteoarthritis Endoscopy Multinational Study Group. Arthritis Rheum 2000; 43: 370-377.
    • (2000) Arthritis Rheum , vol.43 , pp. 370-377
    • Hawkey, C.1    Laine, L.2    Simon, T.3
  • 9
    • 0031696868 scopus 로고    scopus 로고
    • Prescription-event monitoring - Recent progress and future horizons
    • Mann RD. Prescription-event monitoring - recent progress and future horizons. Br J Clin Pharmacol 1998; 46: 195-201.
    • (1998) Br J Clin Pharmacol , vol.46 , pp. 195-201
    • Mann, R.D.1
  • 10
    • 0344639121 scopus 로고    scopus 로고
    • Special topics
    • eds Altman D, Machin D, Bryant T, Gardner MJ. Bristol: BMJ Books
    • Campbell M, Daly L, Machin D. Special topics. In Statistics with Confidence, eds Altman D, Machin D, Bryant T, Gardner MJ. Bristol: BMJ Books, 2000.
    • (2000) Statistics with Confidence
    • Campbell, M.1    Daly, L.2    Machin, D.3
  • 11
    • 0028678334 scopus 로고
    • The CIOMS guidelines for biomedical research involving human subjects
    • Legemaate J. The CIOMS guidelines for biomedical research involving human subjects. Eur J Health Law 1994; 1: 161-165.
    • (1994) Eur J Health Law , vol.1 , pp. 161-165
    • Legemaate, J.1
  • 15
    • 0032437504 scopus 로고    scopus 로고
    • Joint British recommendations on prevention of coronary heart disease in clinical practice
    • British Cardiac Society, British Hyperlipidaemia Association, British Hypertension Society, endorsed by the British Diabetic Association. Joint British recommendations on prevention of coronary heart disease in clinical practice. Heart 1998; 80 (Suppl 2): S1-S29.
    • (1998) Heart , vol.80 , Issue.SUPPL. 2
  • 16
    • 84889377091 scopus 로고    scopus 로고
    • Study designs available for pharmacoepidemiology studies
    • Strom B, ed. Chichester: John Wiley & Sons Ltd.
    • Strom B. Study designs available for pharmacoepidemiology studies. In Pharmacoepidemiology, Strom B, ed. Chichester: John Wiley & Sons Ltd., 2000: 17-29.
    • (2000) Pharmacoepidemiology , pp. 17-29
    • Strom, B.1
  • 17
    • 0032508249 scopus 로고    scopus 로고
    • Underreporting of suspected adverse drug reactions to newly marketed ('black triangle') drugs in general practice: Observational study
    • Martin RM, Kapoor KV, Wilton LV, Mann RD. Underreporting of suspected adverse drug reactions to newly marketed ('black triangle') drugs in general practice: observational study. BMJ 1998; 317: 119-120.
    • (1998) BMJ , vol.317 , pp. 119-120
    • Martin, R.M.1    Kapoor, K.V.2    Wilton, L.V.3    Mann, R.D.4
  • 18
    • 0035651985 scopus 로고    scopus 로고
    • Prescription-event monitoring and reporting of adverse drug reactions
    • Heeley E, Riley J, Layton D, Wilton LV, Shakir SA. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872-1873.
    • (2001) Lancet , vol.358 , pp. 1872-1873
    • Heeley, E.1    Riley, J.2    Layton, D.3    Wilton, L.V.4    Shakir, S.A.5
  • 20
    • 0029785701 scopus 로고    scopus 로고
    • General practice postal surveys: A questionnaire too far?
    • McAvoy BR, Kaner EF. General practice postal surveys: a questionnaire too far? BMJ 1996; 313: 732-733.
    • (1996) BMJ , vol.313 , pp. 732-733
    • McAvoy, B.R.1    Kaner, E.F.2
  • 21
    • 0031017513 scopus 로고    scopus 로고
    • The effect of cash and other financial inducements on the response rate of general practitioners in a national postal study
    • Deehan A, Templeton L, Taylor C, Drummond C, Strang J. The effect of cash and other financial inducements on the response rate of general practitioners in a national postal study. Br J General Pract 1997; 47: 87-90.
    • (1997) Br J General Pract , vol.47 , pp. 87-90
    • Deehan, A.1    Templeton, L.2    Taylor, C.3    Drummond, C.4    Strang, J.5
  • 22
    • 0036233150 scopus 로고    scopus 로고
    • Results of a postal survey of the reasons for non-response by doctors in a Prescription Event Monitoring study of drug safety
    • Key C, Layton D, Shakir SA. Results of a postal survey of the reasons for non-response by doctors in a Prescription Event Monitoring study of drug safety. Pharmacoepidemiol Drug Saf 2002; 11: 143-148.
    • (2002) Pharmacoepidemiol Drug Saf , vol.11 , pp. 143-148
    • Key, C.1    Layton, D.2    Shakir, S.A.3
  • 23
    • 0033153178 scopus 로고    scopus 로고
    • Effect of mailed reminders on the response rate in surveys among patients in general practice
    • Wensing M, Mainz J, Kramme O, Jung HP, Ribacke M. Effect of mailed reminders on the response rate in surveys among patients in general practice. J Clin Epidemiol 1999; 52: 585-587.
    • (1999) J Clin Epidemiol , vol.52 , pp. 585-587
    • Wensing, M.1    Mainz, J.2    Kramme, O.3    Jung, H.P.4    Ribacke, M.5
  • 24
    • 0030948099 scopus 로고    scopus 로고
    • Giving feedback to questionnaire responders - Essential task?
    • Whitfield M. Giving feedback to questionnaire responders - essential task? Br J General Pract 1997; 47: 241-243.
    • (1997) Br J General Pract , vol.47 , pp. 241-243
    • Whitfield, M.1
  • 25
    • 0034706411 scopus 로고    scopus 로고
    • Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis
    • Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ. Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med 2000; 160: 2998-3003.
    • (2000) Arch Intern Med , vol.160 , pp. 2998-3003
    • Watson, D.J.1    Harper, S.E.2    Zhao, P.L.3    Quan, H.4    Bolognese, J.A.5    Simon, T.J.6
  • 26
    • 0035112660 scopus 로고    scopus 로고
    • Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient
    • Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001; 120: 594-606.
    • (2001) Gastroenterology , vol.120 , pp. 594-606
    • Laine, L.1
  • 28
    • 0002085896 scopus 로고    scopus 로고
    • Non-steroidal anti-inflammatory drugs and ulcer complications: A risk factor analysis for clinical decision-making
    • Hansen JM, Hallas J, Lauritsen JM, Bytzer P. Non-steroidal anti-inflammatory drugs and ulcer complications: a risk factor analysis for clinical decision-making. Scand J Gastroenterol 1996; 31: 126-130.
    • (1996) Scand J Gastroenterol , vol.31 , pp. 126-130
    • Hansen, J.M.1    Hallas, J.2    Lauritsen, J.M.3    Bytzer, P.4
  • 29
    • 0030716411 scopus 로고    scopus 로고
    • Association of upper gastrointestinal toxicity of non-steroidal antiinflammatory drugs with continued exposure: Cohort study
    • MacDonald TM, Morant SV, Robinson GC et al. Association of upper gastrointestinal toxicity of non-steroidal antiinflammatory drugs with continued exposure: cohort study. BMJ 1997; 315: 1333-1337.
    • (1997) BMJ , vol.315 , pp. 1333-1337
    • MacDonald, T.M.1    Morant, S.V.2    Robinson, G.C.3
  • 30
    • 0025998097 scopus 로고
    • Risk for serious gastrointestinal complications related to use of non steroidal anti-inflammatory drugs. A meta-analysis
    • Gabriel SE, Jaakkimainen L, Bombardier C. Risk for serious gastrointestinal complications related to use of non steroidal anti-inflammatory drugs. A meta-analysis. Ann Intern Med 1991; 115: 787-796.
    • (1991) Ann Intern Med , vol.115 , pp. 787-796
    • Gabriel, S.E.1    Jaakkimainen, L.2    Bombardier, C.3
  • 31
    • 0033620703 scopus 로고    scopus 로고
    • Gastrointestinal effects of nonsteroidal antiinflammatory therapy
    • Raskin JB. Gastrointestinal effects of nonsteroidal antiinflammatory therapy. Am J Med 1999; 106: 3S-12S.
    • (1999) Am J Med , vol.106
    • Raskin, J.B.1
  • 32
    • 0033619490 scopus 로고    scopus 로고
    • Visual field defect associated with vigabatrin: Observational cohort study
    • Wilton LV, Stephens MD, Mann RD. Visual field defect associated with vigabatrin: observational cohort study. BMJ 1999; 319: 1165-1166.
    • (1999) BMJ , vol.319 , pp. 1165-1166
    • Wilton, L.V.1    Stephens, M.D.2    Mann, R.D.3
  • 33
    • 0034630270 scopus 로고    scopus 로고
    • Unresolved issues in the role of cyclooxygenase-2 in normal physiologic processes and disease
    • Lipsky PE, Brooks P, Crofford LJ et al. Unresolved issues in the role of cyclooxygenase-2 in normal physiologic processes and disease. Arch Intern Med 2000; 160: 913-920.
    • (2000) Arch Intern Med , vol.160 , pp. 913-920
    • Lipsky, P.E.1    Brooks, P.2    Crofford, L.J.3
  • 34
    • 0003744138 scopus 로고    scopus 로고
    • Food and Drug Administration Advisory Committee. Cardiovascular safety review of rofecoxib. http:/http://www.fda.gov/ohrms/dockets/ac/01/briefing/367762_06_cardio.pdf 8-9-2001. 2001.
    • (2001) Cardiovascular Safety Review of Rofecoxib
  • 35
    • 0000448936 scopus 로고    scopus 로고
    • Cardiovascular safety profile of rofecoxib in controlled clinical trials
    • Daniels B, Seidenberg B. Cardiovascular safety profile of rofecoxib in controlled clinical trials. Arthritis Rheum 1999; 42 (Suppl. S143).
    • (1999) Arthritis Rheum , vol.42 , Issue.SUPPL. S143
    • Daniels, B.1    Seidenberg, B.2
  • 36
    • 0033673612 scopus 로고    scopus 로고
    • Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers
    • Van Hecken A, Schwartz JI, Depre M et al. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000; 40: 1109-1120.
    • (2000) J Clin Pharmacol , vol.40 , pp. 1109-1120
    • Van Hecken, A.1    Schwartz, J.I.2    Depre, M.3
  • 37
    • 0023874412 scopus 로고
    • The physicians' health study: Aspirin for the primary prevention of myocardial infarction
    • The physicians' health study: aspirin for the primary prevention of myocardial infarction. N Engl J Med 1988; 318: 924-926.
    • (1988) N Engl J Med , vol.318 , pp. 924-926
  • 38
    • 0027250074 scopus 로고
    • Evaluation of flurbiprofen for prevention of reinfarction and reocclusion after successful thrombolysis or angioplasty in acute myocardial infarction. The Flurbiprofen French Trial
    • Brochier ML. Evaluation of flurbiprofen for prevention of reinfarction and reocclusion after successful thrombolysis or angioplasty in acute myocardial infarction. The Flurbiprofen French Trial. Eur Heart J 1993; 14: 951-957.
    • (1993) Eur Heart J , vol.14 , pp. 951-957
    • Brochier, M.L.1
  • 39
    • 0035925909 scopus 로고    scopus 로고
    • NSAIDS selective COX-2 inhibitors: Competition between gastroprotection and cardioprotection
    • Boers M. NSAIDS and selective COX-2 inhibitors: competition between gastroprotection and cardioprotection. Lancet 2001; 357: 1222-1223.
    • (2001) Lancet , vol.357 , pp. 1222-1223
    • Boers, M.1
  • 40
    • 0344639118 scopus 로고    scopus 로고
    • In focus ... Rofecoxib (Vioxx)
    • CSM/MCA. In focus ... Rofecoxib (Vioxx). Current Problems Pharmacovigilance 2000; 26: 13.
    • (2000) Current Problems Pharmacovigilance , vol.26 , Issue.13


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