Efficacy and Tolerability of Celecoxib versus Naproxen in Patients with Osteoarthritis of the Knee: A Randomized, Double-Blind, Double-Dummy Trial
OBJECTIVE: To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. METHODS: This 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg...
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| Published in: | Journal of international medical research Vol. 40; no. 4; pp. 1357 - 1370 |
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| Format: | Journal Article |
| Language: | English |
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SAGE Publications
2012
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| Abstract | OBJECTIVE: To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. METHODS: This 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg celecoxib orally once daily or 500 mg naproxen orally twice daily. The primary endpoint was defined as a 20% improvement from baseline to 6 months in Western Ontario and McMaster Universities (WOMAC) OA total score. RESULTS: A total of 586 out of 589 randomized patients received at least one dose of celecoxib (n = 294) or naproxen (n = 292). The primary endpoint (6-month response rate) was achieved by 52.7% and 49.7% of patients in the celecoxib and naproxen treatment groups, respectively. Significantly fewer discontinuations due to gastrointestinal adverse events occurred in patients receiving celecoxib than in those receiving naproxen (4.1% versus 15.1%, respectively). CONCLUSIONS: Over the 6-month study period, celecoxib provided similar improvements in OA symptoms to naproxen. In addition, celecoxib provided better upper gastrointestinal tolerability than naproxen. |
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| AbstractList | OBJECTIVETo assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee.METHODSThis 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg celecoxib orally once daily or 500 mg naproxen orally twice daily. The primary endpoint was defined as a 20% improvement from baseline to 6 months in Western Ontario and McMaster Universities (WOMAC) OA total score.RESULTSA total of 586 out of 589 randomized patients received at least one dose of celecoxib (n=294) or naproxen (n=292). The primary endpoint (6-month response rate) was achieved by 52.7% and 49.7% of patients in the celecoxib and naproxen treatment groups, respectively. Significantly fewer discontinuations due to gastrointestinal adverse events occurred in patients receiving celecoxib than in those receiving naproxen (4.1% versus 15.1%, respectively).CONCLUSIONSOver the 6month study period, celecoxib provided similar improvements in OA symptoms to naproxen. In addition, celecoxib provided better upper gastrointestinal tolerability than naproxen. To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. This 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg celecoxib orally once daily or 500 mg naproxen orally twice daily. The primary endpoint was defined as a 20% improvement from baseline to 6 months in Western Ontario and McMaster Universities (WOMAC) OA total score. A total of 586 out of 589 randomized patients received at least one dose of celecoxib (n=294) or naproxen (n=292). The primary endpoint (6-month response rate) was achieved by 52.7% and 49.7% of patients in the celecoxib and naproxen treatment groups, respectively. Significantly fewer discontinuations due to gastrointestinal adverse events occurred in patients receiving celecoxib than in those receiving naproxen (4.1% versus 15.1%, respectively). Over the 6month study period, celecoxib provided similar improvements in OA symptoms to naproxen. In addition, celecoxib provided better upper gastrointestinal tolerability than naproxen. OBJECTIVE: To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. METHODS: This 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg celecoxib orally once daily or 500 mg naproxen orally twice daily. The primary endpoint was defined as a 20% improvement from baseline to 6 months in Western Ontario and McMaster Universities (WOMAC) OA total score. RESULTS: A total of 586 out of 589 randomized patients received at least one dose of celecoxib (n = 294) or naproxen (n = 292). The primary endpoint (6-month response rate) was achieved by 52.7% and 49.7% of patients in the celecoxib and naproxen treatment groups, respectively. Significantly fewer discontinuations due to gastrointestinal adverse events occurred in patients receiving celecoxib than in those receiving naproxen (4.1% versus 15.1%, respectively). CONCLUSIONS: Over the 6-month study period, celecoxib provided similar improvements in OA symptoms to naproxen. In addition, celecoxib provided better upper gastrointestinal tolerability than naproxen. |
| Author | Sands, Gh Essex, Mn Bhadra, P |
| Author_xml | – sequence: 1 givenname: Mn surname: Essex fullname: Essex, Mn email: margaret.essex@pfizer.com organization: Pfizer Inc., New York, New York, USA – sequence: 2 givenname: P surname: Bhadra fullname: Bhadra, P organization: Pfizer Inc., New York, New York, USA – sequence: 3 givenname: Gh surname: Sands fullname: Sands, Gh organization: Pfizer Inc., New York, New York, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22971487$$D View this record in MEDLINE/PubMed |
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| Keywords | KNEE NONSTEROIDAL ANTI-INFLAMMATORY DRUGS EFFICACY NAPROXEN OSTEOARTHRITIS TOLERABILITY: WOMAC SCORE CELECOXIB |
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| Snippet | OBJECTIVE: To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. METHODS: This 6-month,... To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee. This 6-month, randomized, double-blind,... OBJECTIVETo assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee.METHODSThis 6-month, randomized,... |
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| SubjectTerms | Administration, Oral Adult Aged Aged, 80 and over Celecoxib Cyclooxygenase 2 Inhibitors - administration & dosage Cyclooxygenase 2 Inhibitors - adverse effects Double-Blind Method Drug Administration Schedule Female Gastrointestinal Diseases - chemically induced Humans Male Middle Aged Naproxen - administration & dosage Naproxen - adverse effects Osteoarthritis, Knee - drug therapy Pyrazoles - administration & dosage Pyrazoles - adverse effects Sulfonamides - administration & dosage Sulfonamides - adverse effects Treatment Outcome |
| Title | Efficacy and Tolerability of Celecoxib versus Naproxen in Patients with Osteoarthritis of the Knee: A Randomized, Double-Blind, Double-Dummy Trial |
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