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[A critical evaluation of side effect data on COX-2 inhibitors]

https://arctichealth.org/en/permalink/ahliterature13970
Source
Tidsskr Nor Laegeforen. 2002 Feb 20;122(5):476-80
Publication Type
Article
Date
Feb-20-2002
Author
Erik Pomp
Author Affiliation
Regionalt Legemiddelinformasjonssenter Haukeland Sykehus 5021 Bergen. erik.pomp@haukeland.no
Source
Tidsskr Nor Laegeforen. 2002 Feb 20;122(5):476-80
Date
Feb-20-2002
Language
Norwegian
Publication Type
Article
Keywords
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Arthritis, Rheumatoid - drug therapy
Comparative Study
Cyclooxygenase Inhibitors - adverse effects
English Abstract
Humans
Lactones - adverse effects
Osteoarthritis - drug therapy
Peptic Ulcer - chemically induced - prevention & control
Pyrazoles
Sulfonamides - adverse effects
Sulfones
Abstract
BACKGROUND: Celecoxib and rofecoxib have been used in Norway since 2000. These cyclooxygenase 2 inhibitors (COX-2 inhibitors) have no better clinical efficacy than older non-steroid anti-inflammatory drugs (NSAIDs) in the treatment of rheumatoid arthritis or osteoarthritis, but may possibly lead to a lower incidence of upper gastrointestinal ulcers. MATERIAL AND METHODS: Published and unpublished clinical data on side effects were examined and interpreted. The aim was to evaluate the general safety of these new drugs compared with older NSAIDs. RESULTS: The incidence of side effects is addressed in two large published studies comparing COX-2 inhibitors with other NSAIDs. Only rofecoxib showed an unequivocal lower incidence of complicated upper gastrointestinal ulcers. However, the incidence of serious side effects was significantly higher in the rofecoxib group. In the other study there was a trend towards more serious side effects in the celecoxib group. INTERPRETATION: The available clinical data do not suggest that COX-2 inhibitors are safer drugs than other NSAIDs.
PubMed ID
11961974 View in PubMed
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[A reply: Not without costs to prevent hundreds of NSAID-related fatal cases]

https://arctichealth.org/en/permalink/ahliterature54029
Source
Lakartidningen. 2000 Jul 26;97(30-31):3415
Publication Type
Article
Date
Jul-26-2000

Changes in rates of upper gastrointestinal hemorrhage after the introduction of cyclooxygenase-2 inhibitors in British Columbia and Ontario.

https://arctichealth.org/en/permalink/ahliterature166254
Source
CMAJ. 2006 Dec 5;175(12):1535-8
Publication Type
Article
Date
Dec-5-2006
Author
Muhammad Mamdani
Leanne Warren
Alex Kopp
J Michael Paterson
Andreas Laupacis
Ken Bassett
Geoffrey M Anderson
Author Affiliation
Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
Source
CMAJ. 2006 Dec 5;175(12):1535-8
Date
Dec-5-2006
Language
English
Publication Type
Article
Keywords
Aged
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
British Columbia - epidemiology
Cross-Sectional Studies
Cyclooxygenase Inhibitors - adverse effects - therapeutic use
Female
Gastrointestinal Hemorrhage - chemically induced - epidemiology
Health Policy
Hospitalization - statistics & numerical data
Humans
Male
Ontario - epidemiology
Prevalence
Retrospective Studies
Abstract
Population rates of upper gastrointestinal (GI) hemorrhage have been observed to increase with the introduction and rapid uptake of selective cyclooxygenase-2 (COX-2) inhibitors. Changes in COX-2 inhibitor use and upper GI bleeding rates in regions with relatively restrictive drug policies (e.g., British Columbia) have not been compared with changes in regions with relatively less restrictive drug policies (e.g., Ontario).
We collected administrative data for about 1.4 million people aged 66 years and older in British Columbia and Ontario for the period January 1996 to November 2002. We examined temporal changes in the prevalence of NSAID use and admissions to hospital because of upper GI hemorrhage in both provinces using cross-sectional time series analysis.
During the period studied, the prevalence of NSAID use in British Columbia's population of older people increased by 25% (from 8.7% to 10.9%; p
Notes
Cites: N Engl J Med. 2000 Nov 23;343(21):1520-8, 2 p following 152811087881
Cites: BMJ. 2002 Sep 21;325(7365):62412242172
Cites: Epidemiology. 1996 Jan;7(1):101-48664388
Cites: Pharmacoepidemiol Drug Saf. 2004 Mar;13(3):153-715072114
Cites: BMJ. 2004 Jun 12;328(7453):1415-615138157
Cites: CMAJ. 2002 Nov 12;167(10):1125-612427703
PubMed ID
17146090 View in PubMed
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The cost effectiveness of rofecoxib and celecoxib in patients with osteoarthritis or rheumatoid arthritis.

https://arctichealth.org/en/permalink/ahliterature185034
Source
Arthritis Rheum. 2003 Jun 15;49(3):283-92
Publication Type
Article
Date
Jun-15-2003
Author
Andreas Maetzel
Murray Krahn
Gary Naglie
Author Affiliation
University Health Network, Toronto, Ontario, Canada. maetzel@uhnres.utoronto.ca
Source
Arthritis Rheum. 2003 Jun 15;49(3):283-92
Date
Jun-15-2003
Language
English
Publication Type
Article
Keywords
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - economics - therapeutic use
Arthritis, Rheumatoid - drug therapy - physiopathology
Canada
Cost-Benefit Analysis
Cyclooxygenase Inhibitors - adverse effects - economics - therapeutic use
Drug Costs
Female
Gastrointestinal Diseases - chemically induced
Humans
Lactones - adverse effects - economics - therapeutic use
Male
Markov Chains
Middle Aged
Osteoarthritis - drug therapy - physiopathology
Pyrazoles
Quality of Life
Randomized Controlled Trials as Topic
Risk factors
Sulfonamides - adverse effects - economics - therapeutic use
Sulfones
Abstract
To evaluate the cost effectiveness of the cyclooxygenase 2 (COX-2) selective nonsteroidal antiinflammatory drug (NSAID) rofecoxib compared with naproxen and the COX-2 NSAID celecoxib compared with ibuprofen and diclofenac.
Cost-effectiveness analysis based on a 5-year Markov model. Probability estimates were derived from detailed data of 2 randomized trials and a systematic search of the medical literature. Utility estimates were obtained from 60 randomly selected members of the general public. Cost estimates were obtained from Canadian provincial databases. Incremental cost-effectiveness ratios were calculated for patients at average risk of upper gastrointestinal (UGI) events and for high-risk patients with a prior history of a UGI event. Subjects were patients with osteoarthritis or rheumatoid arthritis (RA) where a decision has been made to treat with NSAIDs but who do not require low-dose aspirin. Main outcome measures were proportion of patients with clinical or complicated UGI events, quality-adjusted life expectancy, and life expectancy.
Evaluation of rofecoxib versus naproxen in patients with RA at average risk resulted in costs per quality-adjusted life year (QALY) gained of $Can271,188. Celecoxib was dominated by diclofenac in average-risk patients. Both rofecoxib and celecoxib are cost-effective in high-risk patients. Analyses by age groups and assuming a threshold of Can$50,000 per QALY gained, suggest that rofecoxib or celecoxib would be cost-effective in patients aged over 76 and 81, respectively, without additional risk factors.
Both rofecoxib and celecoxib are economically attractive in high risk and elderly patients. They are not economically attractive in patients at average risk. Coprescription of proton-pump inhibitors with COX-2 NSAIDs is not economically attractive for patients at high risk.
PubMed ID
12794781 View in PubMed
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COX-2 inhibition and thrombotic tendency: a need for surveillance.

https://arctichealth.org/en/permalink/ahliterature14005
Source
Med J Aust. 2001 Aug 20;175(4):214-7
Publication Type
Article
Date
Aug-20-2001
Author
L G Cleland
M J James
L K Stamp
P S Penglis
Author Affiliation
Rheumatology Unit, Royal Adelaide Hospital, SA. Iceland@mail.rah.sa.gov.au
Source
Med J Aust. 2001 Aug 20;175(4):214-7
Date
Aug-20-2001
Language
English
Publication Type
Article
Keywords
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
Arthritis, Rheumatoid - drug therapy
Aspirin - adverse effects - therapeutic use
Cyclooxygenase Inhibitors - adverse effects - therapeutic use
Female
Gastrointestinal Diseases - chemically induced
Humans
Lactones - adverse effects - therapeutic use
Middle Aged
Pyrazoles
Randomized Controlled Trials
Research Support, Non-U.S. Gov't
Risk factors
Sulfonamides - adverse effects - therapeutic use
Sulfones
Venous Thrombosis - chemically induced
Abstract
Cyclooxygenase-2 (COX-2) inhibitors belong to a new class of drugs which have anti-inflammatory efficacy similar to that of traditional non-steroidal anti-inflammatory drugs (NSAIDs), but are associated with a reduced incidence of adverse upper gastrointestinal events. Biochemical evidence that COX-2 inhibitors could promote or exacerbate a tendency to thrombosis is supported by recent results from clinical trials and case reports. Two agents in this class, celecoxib and rofecoxib, have been listed on the Pharmaceutical Benefits Scheme (PBS) for very broad indications in chronic arthropathies, suggesting that they will move into widespread community use. It is important to canvass the possibility that use of these agents could be associated with thrombotic events.
Notes
Comment In: Med J Aust. 2002 Jan 21;176(2):88-9; author reply 8911936297
PubMed ID
11587283 View in PubMed
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COX-2 inhibitors in the treatment of cardiovascular disease.

https://arctichealth.org/en/permalink/ahliterature188083
Source
CMAJ. 2002 Oct 1;167(7):738-9; author reply 739-40
Publication Type
Article
Date
Oct-1-2002
Author
John C Peterson
Source
CMAJ. 2002 Oct 1;167(7):738-9; author reply 739-40
Date
Oct-1-2002
Language
English
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems
Canada
Cardiovascular Diseases - drug therapy - enzymology
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors - adverse effects
Humans
Isoenzymes - antagonists & inhibitors
Membrane Proteins
Prostaglandin-Endoperoxide Synthases
Notes
Cites: JAMA. 2000 Sep 13;284(10):1247-5510979111
Cites: N Engl J Med. 2000 Nov 23;343(21):1520-8, 2 p following 152811087881
Cites: Am J Ther. 2001 Mar-Apr;8(2):85-9511304662
Cites: JAMA. 2001 Aug 22-29;286(8):954-911509060
Cites: Am J Cardiol. 2002 Feb 15;89(4):425-3011835924
Cites: JAMA. 2001 Dec 12;286(22):2809-10; author reply 2811-211735745
Cites: JAMA. 2001 Dec 12;286(22):2810-1; author reply 2811-211735748
Cites: JAMA. 2001 Dec 12;286(22):2811-211735749
Cites: Clin Ther. 2001 Sep;23(9):1478-9111589261
PubMed ID
12389824 View in PubMed
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The economic implications of cyclooxygenase-2-specific inhibitors.

https://arctichealth.org/en/permalink/ahliterature196017
Source
Am J Med. 2001 Feb 19;110 Suppl 3A:50S-4S
Publication Type
Article
Date
Feb-19-2001
Author
P M Peloso
J M Scheiman
Author Affiliation
Division of Rheumatology, Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Source
Am J Med. 2001 Feb 19;110 Suppl 3A:50S-4S
Date
Feb-19-2001
Language
English
Publication Type
Article
Keywords
Arthritis, Rheumatoid - drug therapy - economics - epidemiology
Canada
Cost Savings
Cost of Illness
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors - adverse effects - economics
Drug Costs - statistics & numerical data
Economics, Pharmaceutical
Gastrointestinal Diseases - chemically induced - economics
Health Care Costs - statistics & numerical data
Humans
Isoenzymes - antagonists & inhibitors
Membrane Proteins
Osteoarthritis - drug therapy - economics - epidemiology
Prevalence
Prostaglandin-Endoperoxide Synthases
Risk factors
Abstract
Rheumatoid arthritis and osteoarthritis are prevalent and costly conditions. A large proportion of the direct costs associated with these conditions relates to management of iatrogenic side effects. The cyclooxygenase (COX)-2-specific inhibitors lead to equivalent control of pain and disability compared with traditional NSAIDs. However, the COX-2-specific inhibitors have significant potential to reduce health-care costs, principally through the reduction of side effects. These cost savings are most likely to be realized through reductions in costs associated with dyspepsia and upper gastrointestinal ulcers and bleeding. Reduced indirect costs through improved disability scores and improved health-related quality of life are also predictable with the use of COX-2-specific inhibitors. This is accomplished without the attendant increase in risk to the gastrointestinal tract associated with traditional NSAIDs.
PubMed ID
11173051 View in PubMed
Less detail

Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly.

https://arctichealth.org/en/permalink/ahliterature186635
Source
Arch Intern Med. 2003 Feb 24;163(4):481-6
Publication Type
Article
Date
Feb-24-2003
Author
Muhammad Mamdani
Paula Rochon
David N Juurlink
Geoffrey M Anderson
Alex Kopp
Gary Naglie
Peter C Austin
Andreas Laupacis
Author Affiliation
Institute for Clinical Evaluative Sciences, 2075 Bayview Ave-G215, Toronto, Ontario, Canada M4N 3M5. muhammad.mamdani@ices.on.ca
Source
Arch Intern Med. 2003 Feb 24;163(4):481-6
Date
Feb-24-2003
Language
English
Publication Type
Article
Keywords
Aged
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Case-Control Studies
Cyclooxygenase Inhibitors - adverse effects
Female
Humans
Lactones - adverse effects
Male
Myocardial Infarction - chemically induced - epidemiology
Naproxen - adverse effects
Ontario - epidemiology
Proportional Hazards Models
Pyrazoles
Retrospective Studies
Risk factors
Sulfonamides - adverse effects
Sulfones
Abstract
Recent debate has emerged regarding the cardiovascular safety of selective cyclooxygenase 2 inhibitors and the possible cardioprotective effect of naproxen sodium. We compared the rates of acute myocardial infarction (AMI) among elderly patients dispensed selective cyclooxygenase 2 inhibitors, naproxen, and nonselective nonnaproxen nonsteroidal anti-inflammatory drugs (NSAIDs).
We conducted a population-based retrospective cohort study using administrative health care data from Ontario, Canada, from April 1, 1998, to March 31, 2001. We identified NSAID-naive cohorts of subjects aged 66 years and older in whom treatment was initiated with celecoxib (n = 15 271), rofecoxib (n = 12 156), naproxen (n = 5669), and nonnaproxen nonselective NSAIDs (n = 33 868), along with a randomly selected control cohort not exposed to NSAIDs (n = 100 000). Multivariate Cox proportional hazards models were used to compare AMI rates between study drug groups while controlling for potential confounders.
Relative to control subjects, the multivariate model showed no significant differences in AMI risk for new users of celecoxib (adjusted rate ratio [aRR], 0.9; 95% confidence interval [CI], 0.7-1.2), rofecoxib (aRR, 1.0; 95% CI, 0.8-1.4), naproxen (aRR, 1.0; 95% CI, 0.6-1.7), or nonnaproxen nonselective NSAIDs (aRR, 1.2; 95% CI, 0.9-1.4).
The findings of this observational study suggest no increase in the short-term risk of AMI among users of selective cyclooxygenase 2 inhibitors as commonly used in clinical practice. Furthermore, the findings do not support a short-term reduced risk of AMI with naproxen.
PubMed ID
12588209 View in PubMed
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27 records – page 1 of 3.