Page last updated: 2024-11-04

rofecoxib and Gastrointestinal Hemorrhage

rofecoxib has been researched along with Gastrointestinal Hemorrhage in 35 studies

Gastrointestinal Hemorrhage: Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.

Research Excerpts

ExcerptRelevanceReference
" We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis."9.09Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. ( Bombardier, C; Burgos-Vargas, R; Davis, B; Day, R; Ferraz, MB; Hawkey, CJ; Hochberg, MC; Kvien, TK; Laine, L; Reicin, A; Schnitzer, TJ; Shapiro, D, 2000)
"To evaluate the potential clinical and economic consequences of rofecoxib prescription in Ontario, Canada, for patients with osteoarthritis (OA) aged >65 years who did not respond to paracetamol (acetaminophen) therapy."7.71Incremental cost-effectiveness analysis comparing rofecoxib with nonselective NSAIDs in osteoarthritis: Ontario Ministry of Health perspective. ( Attard, CL; Kong, SX; Marentette, MA; Marshall, JK; Pellissier, JM, 2001)
"In healthy subjects, treatment with rofecoxib, at 2 to 4 times the doses that are currently recommended for the treatment of patients with osteoarthritis, produced significantly less fecal blood loss than a therapeutic dose of ibuprofen and was equivalent to placebo."5.09A randomized trial measuring fecal blood loss after treatment with rofecoxib, ibuprofen, or placebo in healthy subjects. ( Bolognese, JA; Bowen, B; Cagliola, A; Hunt, RH; James, C; Mortensen, ER; Quan, H; Simon, TJ, 2000)
" We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis."5.09Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. ( Bombardier, C; Burgos-Vargas, R; Davis, B; Day, R; Ferraz, MB; Hawkey, CJ; Hochberg, MC; Kvien, TK; Laine, L; Reicin, A; Schnitzer, TJ; Shapiro, D, 2000)
"To update the results of a previously performed analysis of the incidence of upper GI perforations, symptomatic gastroduodenal ulcers, and upper GI bleeding (PUBs) with rofecoxib compared with non-selective NSAIDs."4.82The upper gastrointestinal safety of rofecoxib vs. NSAIDs: an updated combined analysis. ( Bolognese, JA; Reicin, AS; Simon, TJ; Watson, DJ; Yu, Q, 2004)
"Prespecified analysis of all 8 double-blind, randomized phase 2b/3 rofecoxib osteoarthritis trials conducted from December 1996 through March 1998, including one 6-week dose-ranging study, two 6-week efficacy studies vs ibuprofen and placebo, two 1-year efficacy studies vs diclofenac, two 6-month endoscopy studies vs ibuprofen and placebo, and one 6-week efficacy study vs nabumetone and placebo."4.80Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. ( Bolognese, JA; Harper, SE; Jensen, DM; Langman, MJ; Quan, H; Simon, TJ; Watson, DJ; Zhao, PL, 1999)
"It was predicted from the mechanism of action that, compared to older non-steroidal anti-inflammatory drugs, rofecoxib (Vioxx) would reduce gastrointestinal bleeding, but also that it would increase the occurrence of cardiovascular thrombosis."3.76Unbalanced reporting of benefits and harms in abstracts on rofecoxib. ( Gøtzsche, PC; Jørgensen, AW; Jørgensen, KJ, 2010)
"To investigate trends in mortality rates due to both myocardial infarction and gastrointestinal haemorrhage before and after rofecoxib withdrawal and the release of regulatory guidance regarding the use of other COX-2 inhibitors."3.76International regulatory activity restricting COX-2 inhibitor use and deaths due to gastrointestinal haemorrhage and myocardial infarction. ( Gunnell, D; Martin, RM; Metcalfe, C; Wheeler, BW, 2010)
" Rofecoxib taken at supra-therapeutic dosage was recognised to increase the incidence of myocardial infarction."3.72[Safety of selective inhibitors of inducible cyclooxygenase-2 taken for a long period]. ( Lamarque, D, 2004)
"To evaluate the potential clinical and economic consequences of rofecoxib prescription in Ontario, Canada, for patients with osteoarthritis (OA) aged >65 years who did not respond to paracetamol (acetaminophen) therapy."3.71Incremental cost-effectiveness analysis comparing rofecoxib with nonselective NSAIDs in osteoarthritis: Ontario Ministry of Health perspective. ( Attard, CL; Kong, SX; Marentette, MA; Marshall, JK; Pellissier, JM, 2001)
" Our patient had arthritis of the hips and chronic atrial fibrillation and was on warfarin therapy for stroke prevention; less than a week after starting celecoxib therapy, gastrointestinal bleeding and hypoprothrombinemia occurred."3.70Cyclooxygenase-2 inhibitor celecoxib: a possible cause of gastropathy and hypoprothrombinemia. ( Davis, JV; Linder, JD; Mönkemüller, KE; Wilcox, CM, 2000)
"Rofecoxib is a selective cyclooxygenase-2 inhibitor that has been approved for the treatment of osteoarthritis and management of acute pain."1.33Ischemic colitis associated with rofecoxib. ( Feltri, M; Meucci, G; Minoli, G; Radaelli, F; Spinzi, G; Terruzzi, V, 2005)
" Dyspepsia and nausea were the most frequently reported adverse events."1.32Safety profile of rofecoxib as used in general practice in England: results of a prescription-event monitoring study. ( Layton, D; Riley, J; Shakir, SA; Wilton, LV, 2003)

Research

Studies (35)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's2 (5.71)18.2507
2000's31 (88.57)29.6817
2010's2 (5.71)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Jaksch, W1
Dejaco, C1
Schirmer, M1
Jørgensen, AW1
Jørgensen, KJ1
Gøtzsche, PC1
Metcalfe, C1
Wheeler, BW1
Gunnell, D1
Martin, RM1
Mamdani, M1
Rochon, PA1
Juurlink, DN1
Kopp, A1
Anderson, GM1
Naglie, G1
Austin, PC1
Laupacis, A1
Gornet, JM1
Hassani, Z1
Modiglian, R1
Lémann, M1
Layton, D1
Riley, J1
Wilton, LV1
Shakir, SA1
James, MW1
Hawkey, CJ2
MacDonald, TM1
Morant, SV1
Goldstein, JL1
Burke, TA1
Pettitt, D1
Oviedo, JA1
Wolfe, MM1
Takeuchi, K2
Tanaka, A2
Hayashi, Y1
Kubo, Y1
Lamarque, D1
Watson, DJ2
Yu, Q1
Bolognese, JA3
Reicin, AS1
Simon, TJ3
Bannwarth, B1
Logeart, I1
Vergult, G1
Psaty, BM1
Furberg, CD1
Drazen, JM1
Moride, Y1
Ducruet, T1
Boivin, JF1
Moore, N1
Perreault, S1
Zhao, S1
Radaelli, F1
Feltri, M1
Meucci, G1
Spinzi, G1
Terruzzi, V1
Minoli, G1
McCarthy, DM1
Rahme, E1
Nedjar, H1
Langman, MJ1
Jensen, DM1
Harper, SE1
Zhao, PL1
Quan, H2
Hunt, RH1
Bowen, B1
Mortensen, ER1
James, C1
Cagliola, A1
Linder, JD1
Mönkemüller, KE1
Davis, JV1
Wilcox, CM1
Bombardier, C1
Laine, L1
Reicin, A1
Shapiro, D1
Burgos-Vargas, R1
Davis, B1
Day, R1
Ferraz, MB1
Hochberg, MC1
Kvien, TK1
Schnitzer, TJ1
Delgado Fernández, M1
Zambrana García, JL1
Diez García, F1
Caroli, A1
Monica, F1
Patrono, C1
Patrignani, P1
García Rodríguez, LA1
Wardle, EN1
Marshall, JK1
Pellissier, JM1
Attard, CL1
Kong, SX1
Marentette, MA1
Brinker, AD1
Bonnel, RA1
Feight, AG1
Nourjah, P1
de La Serna Higuera, C1
Rodríguez-Gómez, SJ1
Martín Arribas, MI1
Martínez Moreno, J1
Foral, PA1
Wilson, AF1
Nystrom, KK1
Freitas, J1
Farricha, V1
Nascimento, I1
Borralho, P1
Paramés, A1
Araki, H1
Hase, S1
Komoike, Y1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pre-Emptive Analgesic Effects of a Selective COX-2 Inhibitor (Rofecoxib) in the Oral Surgery Model[NCT00026819]Phase 2150 participants Interventional2001-11-30Completed
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer[NCT02343614]Phase 258 participants (Actual)Interventional2003-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Reviews

7 reviews available for rofecoxib and Gastrointestinal Hemorrhage

ArticleYear
4 years after withdrawal of rofecoxib: where do we stand today?
    Rheumatology international, 2008, Volume: 28, Issue:12

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Contraindications; Cyclooxygenase

2008
Assessment of non-steroidal anti-inflammatory drug (NSAID) damage in the human gastrointestinal tract.
    British journal of clinical pharmacology, 2003, Volume: 56, Issue:2

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyc

2003
Gastroprotection by coxibs: what do the Celecoxib Long-Term Arthritis Safety Study and the Vioxx Gastrointestinal Outcomes Research Trial tell us?
    Rheumatic diseases clinics of North America, 2003, Volume: 29, Issue:4

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Celecoxib; Cyclooxygenase Inhibitors; Di

2003
The upper gastrointestinal safety of rofecoxib vs. NSAIDs: an updated combined analysis.
    Current medical research and opinion, 2004, Volume: 20, Issue:10

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Double-Blind Method; Duodenal Ul

2004
Ulcers, Helicobacter pylori infection, platelets and gastrointestinal complications of non-steroidal anti-inflammatory drugs: what are the connections?
    The European journal of surgery. Supplement. : = Acta chirurgica. Supplement, 2002, Issue:587

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Blood Platelets; Cyclooxygenase Inhibitors; Diclofenac; Gas

2002
Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs.
    JAMA, 1999, Nov-24, Volume: 282, Issue:20

    Topics: Adult; Aged; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Butanones; Cyclooxyg

1999
Cyclooxygenase-selective inhibition of prostanoid formation: transducing biochemical selectivity into clinical read-outs.
    The Journal of clinical investigation, 2001, Volume: 108, Issue:1

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticarcinogenic Agents; Aspirin; Blood Platelets; Cardiova

2001

Trials

2 trials available for rofecoxib and Gastrointestinal Hemorrhage

ArticleYear
A randomized trial measuring fecal blood loss after treatment with rofecoxib, ibuprofen, or placebo in healthy subjects.
    The American journal of medicine, 2000, Aug-15, Volume: 109, Issue:3

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Chromium Radioisotopes; Cyclooxygenase 2; Cyclooxyge

2000
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.
    The New England journal of medicine, 2000, 11-23, Volume: 343, Issue:21

    Topics: Adult; Arthritis, Rheumatoid; Cardiovascular Diseases; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors

2000
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.
    The New England journal of medicine, 2000, 11-23, Volume: 343, Issue:21

    Topics: Adult; Arthritis, Rheumatoid; Cardiovascular Diseases; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors

2000
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.
    The New England journal of medicine, 2000, 11-23, Volume: 343, Issue:21

    Topics: Adult; Arthritis, Rheumatoid; Cardiovascular Diseases; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors

2000
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.
    The New England journal of medicine, 2000, 11-23, Volume: 343, Issue:21

    Topics: Adult; Arthritis, Rheumatoid; Cardiovascular Diseases; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors

2000

Other Studies

26 other studies available for rofecoxib and Gastrointestinal Hemorrhage

ArticleYear
Unbalanced reporting of benefits and harms in abstracts on rofecoxib.
    European journal of clinical pharmacology, 2010, Volume: 66, Issue:4

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Gastrointest

2010
International regulatory activity restricting COX-2 inhibitor use and deaths due to gastrointestinal haemorrhage and myocardial infarction.
    Pharmacoepidemiology and drug safety, 2010, Volume: 19, Issue:8

    Topics: Acute Disease; Aged; Aged, 80 and over; Cyclooxygenase 2 Inhibitors; Female; Gastrointestinal Hemorr

2010
Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs.
    BMJ (Clinical research ed.), 2002, Sep-21, Volume: 325, Issue:7365

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Cohort Studies; Cyclooxygenase 2; Diclofen

2002
Exacerbation of Crohn's colitis with severe colonic hemorrhage in a patient on rofecoxib.
    The American journal of gastroenterology, 2002, Volume: 97, Issue:12

    Topics: Adult; Colonic Diseases; Crohn Disease; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorrha

2002
Safety profile of rofecoxib as used in general practice in England: results of a prescription-event monitoring study.
    British journal of clinical pharmacology, 2003, Volume: 55, Issue:2

    Topics: Adverse Drug Reaction Reporting Systems; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inh

2003
[Gastrointestinal complications caused by NSAIDs. Over 60% of arthrosis patients are endangered].
    MMW Fortschritte der Medizin, 2003, Mar-06, Volume: 145, Issue:10

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Celecoxib; Clinical Trials as Topic; Cyclo

2003
Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs.
    Gut, 2003, Volume: 52, Issue:9

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Bias; Celecoxib; Cohort Studies; Databases, Factual; Family

2003
Functional mechanism underlying COX-2 expression following administration of indomethacin in rat stomachs: importance of gastric hypermotility.
    Digestive diseases and sciences, 2004, Volume: 49, Issue:2

    Topics: Animals; Atropine; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Dinopro

2004
[Safety of selective inhibitors of inducible cyclooxygenase-2 taken for a long period].
    Bulletin du cancer, 2004, Volume: 91 Spec No

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; C

2004
[Prescribing patterns of rofecoxib in the primary care setting: results of a French survey].
    La Revue de medecine interne, 2004, Volume: 25, Issue:10

    Topics: Age Factors; Aged; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Arthritis; Arth

2004
COX-2 inhibitors--lessons in drug safety.
    The New England journal of medicine, 2005, Mar-17, Volume: 352, Issue:11

    Topics: Cardiovascular Diseases; Celecoxib; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase In

2005
COX-2 inhibitors--a lesson in unexpected problems.
    The New England journal of medicine, 2005, Mar-17, Volume: 352, Issue:11

    Topics: Adverse Drug Reaction Reporting Systems; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Dis

2005
Prescription channeling of COX-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs: a population-based case-control study.
    Arthritis research & therapy, 2005, Volume: 7, Issue:2

    Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Ca

2005
Ischemic colitis associated with rofecoxib.
    Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2005, Volume: 37, Issue:5

    Topics: Abdominal Pain; Colitis, Ischemic; Colon; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorr

2005
Risks and benefits of COX-2 inhibitors vs non-selective NSAIDs: does their cardiovascular risk exceed their gastrointestinal benefit? A retrospective cohort study.
    Rheumatology (Oxford, England), 2007, Volume: 46, Issue:3

    Topics: Acetaminophen; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Celecoxib; Cyclooxygenase 2 I

2007
Rofecoxib for osteoarthritis and pain.
    The Medical letter on drugs and therapeutics, 1999, Jul-02, Volume: 41, Issue:1056

    Topics: Analgesics; Cyclooxygenase Inhibitors; Diarrhea; Drug Interactions; Dyspepsia; Edema; Enzyme Inhibit

1999
Cyclooxygenase-2 inhibitor celecoxib: a possible cause of gastropathy and hypoprothrombinemia.
    Southern medical journal, 2000, Volume: 93, Issue:9

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Arthritis; Atrial Fibrillation; Bicar

2000
Upper gastrointestinal toxicity of rofecoxib and naproxen.
    The New England journal of medicine, 2001, May-03, Volume: 344, Issue:18

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Ethics, Medical; Gastrointestinal Hemorr

2001
Severe upper gastrointestinal bleeding during treatment with rofecoxib for osteoarthritis.
    The American journal of gastroenterology, 2001, Volume: 96, Issue:5

    Topics: Aged; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorrhage; Humans; Lactones; Osteoarthrit

2001
Cyclo-oxygenase-2 inhibitors to treat gastrointestinal bleeding.
    Lancet (London, England), 2001, Nov-03, Volume: 358, Issue:9292

    Topics: Cyclooxygenase Inhibitors; Gastrointestinal Hemorrhage; Humans; Hypertension; Kidney; Lactones; Sulf

2001
Incremental cost-effectiveness analysis comparing rofecoxib with nonselective NSAIDs in osteoarthritis: Ontario Ministry of Health perspective.
    PharmacoEconomics, 2001, Volume: 19, Issue:10

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Cost-Benefit Analysis; Cyclooxygenase 2; Cyclooxygena

2001
Celecoxib and rofecoxib.
    Journal of the American Dental Association (1939), 2001, Volume: 132, Issue:11

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Cyclooxygenase Inhibitors; Gastrointestinal Hemo

2001
[Rofecoxib-induced upper gastrointestinal bleeding].
    Medicina clinica, 2002, Feb-23, Volume: 118, Issue:6

    Topics: Cyclooxygenase Inhibitors; Gastrointestinal Hemorrhage; Humans; Lactones; Sulfones

2002
Gastrointestinal bleeds associated with rofecoxib.
    Pharmacotherapy, 2002, Volume: 22, Issue:3

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Gastrointestinal Hemorrhag

2002
Rofecoxib: a possible cause of acute colitis.
    Journal of clinical gastroenterology, 2002, Volume: 34, Issue:4

    Topics: Acute Disease; Colitis; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorrhage; Humans; Lact

2002
Up-regulation of COX-2 by inhibition of COX-1 in the rat: a key to NSAID-induced gastric injury.
    Alimentary pharmacology & therapeutics, 2002, Volume: 16 Suppl 2

    Topics: Amino Acid Sequence; Animals; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase 1; Cyclooxygen

2002