Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugs: a 6-week and a 1-year trial in patients with osteoarthritis. Osteoarthritis Studies Group.
Arch Fam Med
; 9(10): 1124-34, 2000.
Article
em En
| MEDLINE
| ID: mdl-11115219
ABSTRACT
INTRODUCTION:
Rofecoxib, a cyclooxygenase 2 inhibitor (sometimes known as a specific cyclooxygenase 2 inhibitor or Coxib), is used in osteoarthritis (OA). Published information indicates rofecoxib's improved gastrointestinal safety profile over nonselective nonsteroidal anti-inflammatory agents (NSAIDs).OBJECTIVE:
To evaluate the efficacy and safety of rofecoxib in treating OA in 2 studies.METHODS:
Two randomized, double-blind, parallel-group studies in patients with OA of the knee or hip were conducted using identical entry criteria and end points. A 6-week placebo-controlled trial in 736 patients compared 12.5 and 25 mg of rofecoxib once daily with 800 mg of ibuprofen 3 times daily, and a 1-year study compared 12.5 and 25 mg of rofecoxib once daily with 50 mg of diclofenac 3 times daily in 693 patients.RESULTS:
Rofecoxib, at 12.5 and 25 mg, demonstrated efficacy clinically comparable with ibuprofen, assessed by 3 primary end points according to predefined comparability criteria. Both rofecoxib doses and ibuprofen provided significantly greater efficacy than placebo on all primary end points at 6 weeks. Both rofecoxib doses and diclofenac showed similar efficacy over 1 year. All treatments were well tolerated.CONCLUSIONS:
Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year. Arch Fam Med. 2000;91124-1134
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Osteoartrite
/
Anti-Inflamatórios não Esteroides
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Inibidores Enzimáticos
/
Lactonas
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Arch Fam Med
Ano de publicação:
2000
Tipo de documento:
Article
País de afiliação:
Estados Unidos