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document
Efficacy of rofecoxib , celecoxib , and acetaminophen in patients with osteoarthritis of the knee . A combined analysis of the VACT studies . OBJECTIVE To compare efficacy among 1578 patients with osteoarthritis randomized to take acetaminophen 4000 mg ( n=269 ) , celecoxib 200 mg ( n=523 ) , rofecoxib 12.5 mg ( n=259 ) , or rofecoxib 25 mg ( n=527 ) in a double blind trial [ Vioxx , Acetaminophen , Celecoxib Trial ( VACT2 ) ] . Results were also pooled with the similarly designed VACT1 trial . METHODS Patients evaluated over Days 1 to 6 and 6 weeks with Patient Global Assessment of Response to Therapy ( PGART ) and Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index . RESULTS For VACT2 , median time to good or excellent PGART response was 6 , 5 , 4 , and 3 days for acetaminophen , celecoxib , rofecoxib 12.5 mg , and rofecoxib 25 mg ( COX-2 inhibitors vs acetaminophen , p < or=0.035 ; rofecoxib 25 mg vs celecoxib , p=0.01 ) . WOMAC response over the first 6 days was greater ( p < 0.05 ) with both rofecoxib doses than acetaminophen and celecoxib . At Week 6 , all COX-2 inhibitors provided significantly greater efficacy than acetaminophen . Good or excellent PGART was numerically , but not significantly , greater with rofecoxib 25 mg ( 55.4 % ) than celecoxib ( 50.6 % ) at Week 6 ; a significant difference was seen at Weeks 2 ( 6.9 , p=0.022 ) and 4 ( 6.7 , p=0.027 ) and over 6 weeks with analysis of all 5 PGART categories of response ( p=0.035 ) . Rofecoxib 25 mg provided greater response ( p < 0.05 ) than celecoxib on WOMAC subscales . Pooled analysis of VACT1/VACT2 demonstrated greater PGART ( p=0.023 ) with rofecoxib 25 mg ( 56.1 % ) than celecoxib ( 49.8 % ) at 6 weeks and greater response to all other PGART and WOMAC endpoints , and confirmed superiority of COX-2 inhibitors to acetaminophen . Overall , tolerability of the study medications was generally good and similar . There was no significant difference between treatment groups in the percentage of patients who experienced a clinical adverse experience ( AE ) . The incidence of discontinuations due to an AE was significantly lower with celecoxib ( 2.5 % ) compared to rofecoxib 25 mg ( 6.3 % , p=0.004 ) or acetaminophen ( 7.8 % , p < 0.001 ) , and did not differ significantly from rofecoxib 12.5 mg ( 4.6 % ) . Discontinuation rates due to edema and hypertension related AE were similar among all COX-2 inhibitors . CONCLUSION Rofecoxib and celecoxib provided superior efficacy to acetaminophen . There was a more rapid and greater response with rofecoxib 25 mg than celecoxib 200 mg. Rofecoxib 12.5 mg demonstrated greater efficacy than celecoxib 200 mg over the first 6 days , and was similar over 6 weeks . All study medications were generally well tolerated .
22139
Intervention_Pharmacological
rofecoxib
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Intervention_Pharmacological
celecoxib
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Intervention_Pharmacological
acetaminophen
22142
Intervention_Pharmacological
acetaminophen
22143
Intervention_Pharmacological
celecoxib
22144
Intervention_Pharmacological
rofecoxib
22145
Intervention_Pharmacological
rofecoxib
22146
Intervention_Pharmacological
Vioxx
22147
Intervention_Pharmacological
Acetaminophen
22148
Intervention_Pharmacological
Celecoxib
22149
Intervention_Pharmacological
acetaminophen
22150
Intervention_Pharmacological
celecoxib
22151
Intervention_Pharmacological
rofecoxib
22152
Intervention_Pharmacological
rofecoxib
22153
Intervention_Pharmacological
acetaminophen
22154
Intervention_Pharmacological
rofecoxib
22155
Intervention_Pharmacological
celecoxib
22156
Intervention_Pharmacological
rofecoxib
22157
Intervention_Pharmacological
rofecoxib
22158
Intervention_Pharmacological
celecoxib
22159
Intervention_Pharmacological
Rofecoxib
22160
Intervention_Pharmacological
celecoxib
22161
Intervention_Pharmacological
rofecoxib
22162
Intervention_Pharmacological
celecoxib
22163
Intervention_Pharmacological
acetaminophen
22164
Intervention_Pharmacological
celecoxib
22165
Intervention_Pharmacological
rofecoxib
22166
Intervention_Pharmacological
acetaminophen
22167
Intervention_Pharmacological
Rofecoxib
22168
Intervention_Pharmacological
celecoxib
22169
Intervention_Pharmacological
acetaminophen
22170
Intervention_Pharmacological
celecoxib
22171
Intervention_Pharmacological
Rofecoxib
22172
Intervention_Pharmacological
celecoxib
22173
Outcome_Other
Patient Global Assessment of Response to Therapy ( PGART )
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Outcome_Other
Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index
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Outcome_Physical
median time to good or excellent PGART response
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Outcome_Physical
WOMAC response
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Outcome_Other
greater efficacy
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Outcome_Other
PGART
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Outcome_Other
PGART
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Outcome_Physical
WOMAC subscales
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Outcome_Physical
greater PGART
22182
Outcome_Physical
greater response to all other PGART
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Outcome_Physical
WOMAC endpoints
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Outcome_Physical
tolerability
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Outcome_Other
good and similar
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Outcome_Adverse-effects
clinical adverse experience ( AE )
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Outcome_Adverse-effects
discontinuations due to an AE
22188
Outcome_Physical
Discontinuation rates
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Outcome_Adverse-effects
edema and hypertension related AE
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Outcome_Other
efficacy
22191
Outcome_Other
response
22192
Outcome_Other
efficacy
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Outcome_Other
tolerated
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Participant_Condition
patients with osteoarthritis of the knee .