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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 MATERIAL AND METHODS: Published and unpublished clinical data on side effects were examined and interpreted.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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Adoption of celecoxib and rofecoxib: a nationwide database study.

https://arctichealth.org/en/permalink/ahliterature175412
Source
J Clin Pharm Ther. 2005 Apr;30(2):145-52
Publication Type
Article
Date
Apr-2005
Author
A. Helin-Salmivaara
R. Huupponen
A. Virtanen
T. Klaukka
Author Affiliation
Centre for Pharmacotherapy Development, Helsinki, Finland. arja.helin-salmivaara@rohto.fi
Source
J Clin Pharm Ther. 2005 Apr;30(2):145-52
Date
Apr-2005
Language
English
Publication Type
Article
Keywords
Age Factors
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Child
Databases, Factual - statistics & numerical data - trends
Drug Utilization Review - methods
Finland - epidemiology
Humans
Insurance, Pharmaceutical Services - trends - utilization
Lactones - therapeutic use
Medicine - statistics & numerical data
Physician's Practice Patterns - statistics & numerical data - trends
Product Surveillance, Postmarketing - economics - methods
Pyrazoles - therapeutic use
Retrospective Studies
Sex Factors
Specialization
Sulfonamides - therapeutic use
Sulfones - therapeutic use
Time Factors
Abstract
Cyclooxygenase 2-selective non-steroidal anti-inflammatory drugs (NSAIDs, coxibs) are recommended primarily for patients at high risk of gastrointestinal bleeding, most of them being elderly. Our objective was to describe and analyse patient- and physician-related factors affecting the adoption of celecoxib and rofecoxib 2 years after their launch in Finland.
Retrospective analysis of the nationwide Prescription Register. Physicians who had issued at least 200 reimbursed prescriptions in 2002 (n = 12 033, 80% of working-age Finnish physicians) were involved in the analysis.
Excluding patients with rheumatoid arthritis (RA), almost one-fifth (18%) of NSAIDs prescriptions were for coxibs. In patients with RA the share was 25%. The share of coxib prescriptions of all NSAIDs increased with age of the patient. Over one half (58%) of coxib prescriptions were issued for patients under 65 years of age. Specialists in physical and rehabilitation medicine were the fastest adopters of coxibs: one-third of their NSAID prescriptions in 2002 were for coxibs. Primary care physicians were the most conservative both in adopting and favouring coxibs.
Coxibs have gained the status of standard prescription NSAIDs within a few years. Their use should be restricted to patients who could benefit most from the use. Routine prescribing of expensive new drugs increases the drug bill without additional health gain.
PubMed ID
15811167 View in PubMed
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Anti-inflammatory properties and inhibition of leukotriene C4 biosynthesis in vitro by flavonoid baicalein from Scutellaria baicalensis georgy roots.

https://arctichealth.org/en/permalink/ahliterature14416
Source
Agents Actions. 1993;39 Spec No:C49-51
Publication Type
Article
Date
1993
Author
I G Butenko
S V Gladtchenko
S V Galushko
Author Affiliation
State Scientific Center of Drugs, Kharkov, Ukraine.
Source
Agents Actions. 1993;39 Spec No:C49-51
Date
1993
Language
English
Publication Type
Article
Keywords
4,5-Dihydro-1-(3-(trifluoromethyl)phenyl)-1H-pyrazol-3-amine - pharmacology - therapeutic use
Animals
Arachidonate 5-Lipoxygenase - antagonists & inhibitors
Arachidonic Acids - pharmacology
Arthritis, Experimental - drug therapy
Carrageenan - toxicity
Comparative Study
Diclofenac - pharmacology
Edema - chemically induced - drug therapy
Flavanones
Flavonoids - pharmacology - therapeutic use
Hydroxamic Acids - pharmacology
Inflammation - drug therapy
Leukotriene C4 - antagonists & inhibitors
Macrophages, Peritoneal - drug effects - metabolism
Male
Rats
Rats, Wistar
Abstract
Anti-inflammatory activity of baicalein (5,6,7-trioxyflavone-7-O-beta-D-glucuronide) was greater in the chronic inflammation model (rat adjuvant arthritis, ED50 = 120.6 mg/kg) than observed in the rat carrageenan-induced paw edema, ED50 > or = 200.0 mg/kg. A comparative study of the 5-lipoxygenase (5-LO) inhibitory activity of baicalein, BW 755 C, and hydroxamic acid arachidonate on leukotriene C4 (LTC4) biosynthesis by rat resident peritoneal macrophages stimulated with calcium ionophore (A 23186) showed that these drugs significantly inhibited LTC4 production, IC50: 9.5, 41.8, and 2.8 microM, respectively. This finding suggests that inhibition of the 5-LO pathway of arachidonic acid metabolism may be one of the mechanisms of baicalein's anti-inflammatory activity.
PubMed ID
8273583 View in PubMed
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Antiobesity drugs in early pregnancy and congenital malformations in the offspring.

https://arctichealth.org/en/permalink/ahliterature267409
Source
Obes Res Clin Pract. 2014 Nov-Dec;8(6):e571-6
Publication Type
Article
Author
Bengt A J Källén
Source
Obes Res Clin Pract. 2014 Nov-Dec;8(6):e571-6
Language
English
Publication Type
Article
Keywords
Abnormalities, Drug-Induced - epidemiology
Adult
Anti-Obesity Agents - adverse effects
Cyclobutanes - adverse effects
Female
Heart Defects, Congenital - chemically induced - epidemiology
Humans
Infant, Newborn
Lactones - adverse effects
Obesity - drug therapy
Piperidines - adverse effects
Pregnancy
Pyrazoles - adverse effects
Registries
Sweden - epidemiology
Young Adult
Abstract
Little information exists on the possible teratogenic effect of modern antiobesity drugs. The present study refers to orlistat, sibutramine, and rimonabant. Data in the Swedish Medical Birth Register were utilised. During the years 1998-2011, among 392,126 infants born, 509 had been exposed to antiobesity drugs in early pregnancy: 248 to orlistat, 242 to sibutramine, 12 to rimonabant, 13 to unspecified antiobesity drugs. Simultaneous use of orlistat and sibutramine occurred in six cases. No increase in major malformation risk was seen after orlistat (relative risk=0.42, 95% confidence interval 0.11-1.07) but a significantly high risk was seen after sibutramine (relative risk=1.81, 95% confidence interval 1.02-2.99). The latter effect, which seemed to be mainly due to an increased risk for a cardiovascular defects, may be related to the capacity of the drug to prolong QT-time. Sibutramine has been withdrawn in Europe but is still available on the Internet and is a component in some slimming preparations. Among the 12 infants exposed to rimonabant, two which were in a twin pair were malformed.
PubMed ID
25434912 View in PubMed
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Association between nonnaproxen NSAIDs, COX-2 inhibitors and hospitalization for acute myocardial infarction among the elderly: a retrospective cohort study.

https://arctichealth.org/en/permalink/ahliterature166723
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):493-503
Publication Type
Article
Date
May-2007
Author
Elham Rahme
Douglas J Watson
Sheldon X Kong
Youssef Toubouti
Jacques LeLorier
Author Affiliation
Department of Medicine McGill University, and Research Institute, McGill University Health Center, Montreal, Canada. elham.rahme@mcgill.ca
Source
Pharmacoepidemiol Drug Saf. 2007 May;16(5):493-503
Date
May-2007
Language
English
Publication Type
Article
Keywords
Age Factors
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
Cohort Studies
Cyclooxygenase 2 Inhibitors - adverse effects - therapeutic use
Diclofenac - adverse effects - therapeutic use
Drug Prescriptions - statistics & numerical data
Drug Utilization - statistics & numerical data
Female
Hospitalization - statistics & numerical data
Humans
Ibuprofen - adverse effects - therapeutic use
Lactones - adverse effects - therapeutic use
Male
Myocardial Infarction - chemically induced - epidemiology
Product Surveillance, Postmarketing - methods - statistics & numerical data
Proportional Hazards Models
Pyrazoles - adverse effects - therapeutic use
Quebec - epidemiology
Retrospective Studies
Sex Factors
Sulfonamides - adverse effects - therapeutic use
Sulfones - adverse effects - therapeutic use
Abstract
To evaluate the association between rofecoxib, celecoxib, diclofenac, and ibuprofen and the risk of hospitalization for acute myocardial infarction (AMI) in an elderly population.
We conducted a retrospective cohort study, using data from the government of Quebec health insurance agency databases, among patients 65-80 years of age who filled a prescription for any of the study drugs during 1999-2002. Cox regression models with time-dependent exposure were used to compare the incidence rates of hospitalization for AMI adjusting for patients' baseline characteristics. Analyses stratified by dose and number of supplied days were also conducted.
At the index date, a total of 91 062 patients were taking rofecoxib, 127 928 celecoxib, 49 193 diclofenac, and 15 601 ibuprofen. The adjusted hazard ratio (HR) (95%CI) of hospitalization for AMI were: celecoxib versus rofecoxib: 0.90 (0.79, 1.01); ibuprofen versus rofecoxib: 0.95 (0.65, 1.37); diclofenac versus rofecoxib: 1.01 (0.84, 1.22). In secondary analyses based on intended duration of use, neither COX-2 selective inhibitor was associated with a higher risk than ibuprofen or diclofenac. The unadjusted risk of AMI for all NSAIDs increased with dose. In the direct two way adjusted comparison of each NSAID stratified by dose, the only statistically significant difference was with rofecoxib >25 mg/day versus celecoxib >200 mg/day.
In this study there was no difference between AMI occurrence in elderly patients taking rofecoxib or celecoxib at recommended doses for chronic indications versus those taking ibuprofen/diclofenac. However, the risk of AMI was higher among patients using higher doses of rofecoxib (>25 mg/day) compared to patients using higher doses of celecoxib (>200 mg/day).
PubMed ID
17086567 View in PubMed
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A Canadian study of the cost-effectiveness of apixaban compared with enoxaparin for post-surgical venous thromboembolism prevention.

https://arctichealth.org/en/permalink/ahliterature108119
Source
Postgrad Med. 2013 Jul;125(4):141-53
Publication Type
Article
Date
Jul-2013
Author
Nikhil Revankar
John Patterson
Ananth Kadambi
Vincent Raymond
Wissam El-Hadi
Author Affiliation
Modeling and Simulation, Evidera, Hammersmith, London, United Kingdom. nikhil.revankar@unitedbiosource.com
Source
Postgrad Med. 2013 Jul;125(4):141-53
Date
Jul-2013
Language
English
Publication Type
Article
Keywords
Aged
Anticoagulants - economics - therapeutic use
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Canada
Cost-Benefit Analysis
Decision Trees
Drug Administration Schedule
Enoxaparin - economics - therapeutic use
Female
Health Care Costs
Humans
Male
Markov Chains
Models, Economic
Postoperative Complications - economics - prevention & control
Pyrazoles - economics - therapeutic use
Pyridones - economics - therapeutic use
Quality-Adjusted Life Years
Venous Thromboembolism - economics - etiology - prevention & control
Abstract
Occurrence of a venous thromboembolism (VTE) in patients undergoing major orthopedic surgery who are not given thromboprophylactic therapy presents considerable danger to patient medical outcomes and a significant economic burden to the health care system at large. Apixaban is a direct factor Xa inhibitor that has been shown in clinical trial use to safely reduce the composite of VTE and mortality rates in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA); however, the cost-effectiveness of apixaban treatment in Canadian settings has not been studied. Our study evaluated the cost-effectiveness of apixaban compared with enoxaparin as VTE preventive therapy in patients undergoing elective THA or TKA in Canada.
An economic model, including both a decision-tree component and a Markov model, was created. The decision tree considered VTE, bleeding, and mortality incidence that occurred in patients within 90 days post-surgery using data from the Apixaban Versus Enoxaparin for Thromboprophylaxis After Knee or Hip Replacement (ADVANCE) trials, which compared apixaban therapy with 30-mg twice daily and 40-mg daily enoxaparin treatment. The Markov model provided the option to simulate events that may occur over the long term, such as recurrent VTE and post-thrombotic syndrome. Outcomes during the short-term phase directly impact the risk of events occurring during the long-term phase (5 years post-surgery).
The results of our analysis indicated that apixaban is dominant (ie, more effective and less expensive) than enoxaparin in treating patients undergoing THA and TKA. There were fewer occurrences of VTEs, bleeding events, recurrent VTEs, and post-thrombotic syndrome events in the TKA population with apixaban therapy. Similar results were seen in patients undergoing THA, with the exception of bleeding events, which were more common with apixaban treatment. Savings of $180 to $270 per patient are expected with apixaban treatment compared with enoxaparin treatment, and health outcomes in general are better with apixaban use. Sensitivity analyses yielded consistent results across the THA and TKA populations.
: This is the first economic evaluation of apixaban use for VTE thromboprophylaxis in the Canadian setting, and our study results show apixaban to be a cost-effective treatment alternative to preventive treatment with enoxaparin.
PubMed ID
23933902 View in PubMed
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CB(1) blockade-induced weight loss over 48 weeks decreases liver fat in proportion to weight loss in humans.

https://arctichealth.org/en/permalink/ahliterature122323
Source
Int J Obes (Lond). 2013 May;37(5):699-703
Publication Type
Article
Date
May-2013
Author
R. Bergholm
K. Sevastianova
A. Santos
A. Kotronen
M. Urjansson
A. Hakkarainen
J. Lundbom
M. Tiikkainen
A. Rissanen
N. Lundbom
H. Yki-Järvinen
Author Affiliation
Minerva Foundation Institute for Medical Research, Helsinki, Finland.
Source
Int J Obes (Lond). 2013 May;37(5):699-703
Date
May-2013
Language
English
Publication Type
Article
Keywords
Adult
Aged
Cannabinoid Receptor Antagonists - therapeutic use
Double-Blind Method
Fatty Liver - drug therapy - epidemiology - pathology
Female
Finland - epidemiology
Humans
Liver - drug effects - pathology
Male
Metabolic Syndrome X - drug therapy - epidemiology - pathology
Middle Aged
Obesity - drug therapy - epidemiology - pathology
Piperidines - therapeutic use
Pyrazoles - therapeutic use
Retrospective Studies
Treatment Outcome
Weight Loss - drug effects
Abstract
Studies in mice have suggested that endocannabinoid blockade using the cannabinoid receptor type 1 (CB1) blocker rimonabant prevents obesity-induced hepatic steatosis.
To determine effects of rimonabant on liver fat in humans, we measured liver fat content by proton magnetic resonance spectroscopy in 37 subjects who used either a CB1 blocker rimonabant or placebo in a double-blind, randomized manner. This was retrospectively compared with a historical hypocaloric diet weight loss group (n=23).
Weight loss averaged 8.5±1.4?kg in the rimonabant, 1.7±1.0?kg in the placebo and 7.5±0.2?kg in the hypocaloric diet group (P0.0001). The decreases in liver fat were comparable between the rimonabant and the young historical hypocaloric diet groups.
We conclude that, unlike in mice, in humans rimonabant decreases liver fat in proportion to weight loss.
PubMed ID
22828945 View in PubMed
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Characterizing early prescribers of newly marketed drugs in Canada: a population-based study.

https://arctichealth.org/en/permalink/ahliterature164490
Source
Eur J Clin Pharmacol. 2007 Jun;63(6):597-604
Publication Type
Article
Date
Jun-2007
Author
Anita Kozyrskyj
Colette Raymond
Amber Racher
Author Affiliation
Faculty of Pharmacy and Medicine, Department of Community Health Sciences and Pediatrics and Child Health, Manitoba Centre for Health Policy, University of Manitoba, 210 Pharmacy Bldg, Winnipeg, MB, Canada. kozyrsk@cc.umanitoba.ca
Source
Eur J Clin Pharmacol. 2007 Jun;63(6):597-604
Date
Jun-2007
Language
English
Publication Type
Article
Keywords
2-Pyridinylmethylsulfinylbenzimidazoles - therapeutic use
Aged
Aged, 80 and over
Alendronate - therapeutic use
Attitude of Health Personnel
Data Collection
Diffusion of Innovation
Drug Prescriptions - statistics & numerical data
Drug Utilization - statistics & numerical data - trends
Family Practice - statistics & numerical data - trends
Female
Humans
Insurance, Health, Reimbursement
Male
Manitoba
Middle Aged
Physician's Practice Patterns - statistics & numerical data - trends
Pyrazoles - therapeutic use
Socioeconomic Factors
Sulfonamides - therapeutic use
Ticlopidine - analogs & derivatives - therapeutic use
Time Factors
Abstract
The diffusion of innovations model proposes that early adopters of innovation influence others. This study was undertaken to determine if early prescribers and users of newly marketed drugs had different sociodemographic and professional characteristics as compared to majority and late users and prescribers.
After market availability in Manitoba, Canada, of celecoxib, alendronate, clopiodogrel and pantoprazole, time to first prescriptions was determined. Early, majority and late adopters of the new drug were characterized by this diffusion time. The prescription, health and prescriber records were compared across adopter categories. The likelihood of being an early or late prescriber or user of the new medications according to patient demographic characteristics, physician factors (specialty and place of training) and neighborhood income was determined with polytomous logistic regression.
Celecoxib demonstrated a much more rapid uptake into routine use than the other drugs. More than 300 Manitoba physicians prescribed celecoxib within two weeks of market availability. Early prescribers of celecoxib were more likely than majority prescribers to be general practitioners (OR = 1.81, 95%CI: 1.40-2.35) and have hospital affiliations (OR = 1.35, 95%CI: 1.03-1.77). Early users of celecoxib were more likely than the majority to have arthritic conditions, have a high income and have paid out-of-pocket for their prescription. For alendronate, clopidogrel and pantoprazole, only prescription drug coverage predicted adopter category. Early prescribers of one new drug were not early prescribers of the other new drugs.
No common group of patients or physicians who were early prescribers or users of all four medications was described.
PubMed ID
17380324 View in PubMed
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82 records – page 1 of 9.