Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Longitudinal Numbers-Needed-To-Treat (NNT) for Achieving Various Levels of Analgesic Response and Improvement with Etoricoxib, Naproxen, and Placebo in Ankylosing Spondylitis MRI and clinical findings in patients with ankylosing spondylitis eligible for anti-tumour necrosis factor therapy after a short course of etoricoxib Etoricoxib in ankylosing spondylitis: is there a role for active patients refractory to traditional NSAIDs? Efficacy of cyclo-oxygenase-2 inhibition by etoricoxib and naproxen on the axial manifestations of ankylosing spondylitis in the presence of peripheral arthritis Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: a randomized controlled trial. Efficacy of Etoricoxib, Celecoxib, Lumiracoxib, Non-Selective NSAIDs, and Acetaminophen in Osteoarthritis: A Mixed Treatment Comparison Gastrointestinal tolerability of etoricoxib in rheumatoid arthritis patients: results of the etoricoxib vs diclofenac sodium gastrointestinal tolerability and effectiveness trial (EDGE-II). Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4‐week, multinational, randomized, double-blind study Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273] The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events Efficacy and Tolerability Profile of Etoricoxib in Patients with Osteoarthritis: A Randomized, Double-blind, Placebo and Active-comparator Controlled 12-Week Efficacy Trial Analgesic Efficacy of Etoricoxib in Primary Dysmenorrhea: Results of a Randomized, Controlled Trial Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia. The efficacy of etoricoxib vs mefenamic acid in the treatment of primary dysmenorrhoea: A randomised comparative trial Evaluation of the Dose Range of Etoricoxib in an Acute Pain Setting Using the Postoperative Dental Pain Model Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison Increased Risk for Complications After Colorectal Surgery With Selective Cyclo-oxygenase 2 Inhibitor Etoricoxib The Analgesic Efficacy of Etoricoxib Compared with Oxycodone/Acetaminophen in an Acute Postoperative Pain Model: A Randomized, Double-Blind Clinical Trial
OBJECTIVE To assess the efficacy , safety , and tolerability of etoricoxib , a cyclooxygenase 2 ( COX-2 ) selective inhibitor , administered continuously over 52 weeks for the treatment of ankylosing spondylitis ( AS ) . METHODS This 2-part , multicenter , double-blind , parallel-group , 52-week study evaluated 2 doses of etoricoxib ( 90 and 120 mg ) compared with naproxen at 1,000 mg . A 6-week , active-comparator- and placebo-controlled period ( part I ) was followed by a 46-week active-comparator-controlled period ( part II ) . The primary outcome measures ( on 100-mm visual analog scales ) were patient 's assessment of spine pain , patient 's global assessment of disease activity , and the Bath Ankylosing Spondylitis Functional Index . RESULTS Of the 387 patients r and omized to receive treatment , 301 ( 77.8 % ) completed part I and 284 ( 75.9 % ) completed part II . Compared with placebo over 6 weeks , those receiving 90 mg etoricoxib , 120 mg etoricoxib , and naproxen demonstrated significantly ( P < 0.001 ) greater improvement in all primary end points ; treatment effects ( expressed as the difference in least squares mean change versus placebo ) were 21 - 29 mm for spine pain , 18 - 25 mm for disease activity , and 11 - 15 mm for function . Compared with patients receiving naproxen , significantly greater improvement in all primary end points was demonstrated in the combined group receiving either 90 mg etoricoxib or 120 mg etoricoxib over 6 weeks , in each individual etoricoxib treatment group over 6 weeks , and in the combined etoricoxib group over 1 year ( all P < 0.05 ) ; results for secondary and exploratory end points were generally consistent with those from the primary analysis . Among all groups , there were no significant differences in the incidence of overall clinical , drug-related , or serious adverse experiences ( AEs ) and discontinuations due to AEs . Safety observations during part II were generally consistent with those in part I. CONCLUSION Etoricoxib at doses of 90 mg and 120 mg demonstrated superior efficacy compared with placebo over 6 weeks , and compared with naproxen over 1 year . These study results demonstrate that etoricoxib is generally safe , well-tolerated , and efficacious for the treatment of AS Background Clinical analgesic trials typically report response as group mean results . However , research has shown that few patients are average and most have responses at the extremes . Moreover , group mean results do not convey response levels and thus have limited value in representing the benefit-risk at an individual level . Responder analyses and numbers-needed-to-treat ( NNT ) are considered more relevant for evaluating treatment response . We evaluated levels of analgesic response and Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score improvement and the associated NNTs . Methods This was a post-hoc analysis of a 6-week , r and omized , double-blind study ( N = 387 ) comparing etoricoxib 90 mg , etoricoxib 120 mg , naproxen 1000 mg , and placebo in AS . Spine pain and BASDAI were measured on a 100-mm visual analog scale . The number and percentage of patients achieving ≥30 % and ≥50 % improvement in both BASDAI and spine pain were calculated and used to determine the corresponding NNTs . Patients who discontinued from the study for any reason were assigned zero improvement beyond 7 days of the time of discontinuation . Results For etoricoxib 90 mg , etoricoxib 120 mg and naproxen 1000 mg , the NNTs at 6 weeks compared with placebo were 2.0 , 2.0 , and 2.7 respectively for BASDAI ≥30 % improvement , and 3.2 , 2.8 , and 4.1 for ≥50 % improvement . For spine pain , the NNTs were 1.9 , 2.0 , and 3.2 , respectively , for ≥30 % improvement , and 2.7 , 2.5 , and 3.7 for ≥50 % improvement . The differences between etoricoxib and naproxen exceeded the limit of ±0.5 units described as a clinical ly meaningful difference for pain . Response rates and NNTs were generally similar and stable over 2 , 4 , and 6 weeks . Conclusions For every 2 patients treated with etoricoxib , 1 achieved a clinical ly meaningful ( ≥30 % ) improvement in spine pain and BASDAI beyond that expected from placebo , whereas the corresponding values were approximately 1 in every 3 patients treated with naproxen . Use of NNTs and responder analyses provide additional , complementary information beyond population mean responses when assessing efficacy compared to placebo and amongst active therapies Objective : To describe and assess the response to short-term etoricoxib as shown by MRI and clinical variables in patients with ankylosing spondylitis ( AS ) selected for eligibility for anti-tumour necrosis factor therapy .  Methods : In a 6-week open-label study , 22 patients with AS and eligible for biological therapy were treated with 90 mg of etoricoxib daily . Clinical and laboratory parameters were obtained and MRI of the sacroiliac joints and the lower thoracic and lumbar spine performed at baseline and at week 6 . The primary end point was the proportion of patients fulfilling the SpondyloArthritis international Society ( ASAS ) response criteria for biological therapies ( ASASBIO ) while secondary end points included the change in MRI-determined bone lesions . Results : Eight of 20 completers improved enough to meet the ASASBIO response criteria and most clinical variables improved significantly . Fifteen patients had a total of 63 MRI-detectable lesions ; overall , 13/60 lesions with paired scans either resolved completely or improved , while five lesions worsened or appeared during treatment . Conclusion : Etoricoxib is an effective symptomatic treatment for patients with AS ; however , its effect on MRI-detected lesions is small . Further studies are needed to determine the effect of etoricoxib on MRI-determined bone oedema OBJECTIVES To evaluate the efficacy of etoricoxib in patients with axial ankylosing spondyloarthritis ( AS ) refractory to traditional NSAIDs . METHODS This was an open label , multicentric , r and omised , prospect i ve ( 4 weeks with and open extension to 6 months ) , non-controlled study . Consecutive patients with axial AS refractory to traditional NSAID eligible for anti-TNF-α therapy were selected . The primary outcomes were the rate of patients with good clinical response ( not eligible for anti-TNF-α therapy after etoricoxib ) and the Assessment of Spondyloarthritis International Society response criteria for biologic therapies ( ASASBIO ) response at 4 weeks . Secondary outcomes included : ASAS20 and 40 responses , ASDAS-CRP response , BASDAI , BASFI , back and night back pain , global patient and physician assessment of the disease , and biologic parameters like C-reactive protein ( CRP ) at 2 , 4 weeks and 6 months . RESULTS A total of 57 axial AS patients were recruited , 46 men , with mean age of 43 years . After 4 weeks of treatment , 26 patients ( 46 % ) achieved a good clinical response and 11 ( 20 % ) an ASASBIO response . These results at 24 weeks were 19 ( 33 % ) and 13 ( 23 % ) respectively . All individual clinical variables improved significantly after 4 weeks of treatment . CRP serum levels decreased after 4 weeks but reached no statistical significance , although 30 % of patients showed a normalisation of CRP . CONCLUSIONS Etoricoxib provided a clear clinical improvement in around a third of patients with axial AS refractory to traditional NSAIDs . Special care should be required when deciding to start anti-TNF-α therapy ; it seems reasonable to keep in mind these results of etoricoxib treatment Objective : The combined efficacy of selective and non-selective cyclo-oxygenase-2 ( COX-2 ) inhibition on the axial manifestations of ankylosing spondylitis ( AS ) in the presence or absence of chronic peripheral arthritis was evaluated . Methods : In a post hoc subgroup analysis of a 6 week , r and omised , double blind , placebo controlled trial , 387 patients with active axial AS were r and omised to receive etoricoxib 90 mg or 120 mg once a day , naproxen 500 mg twice daily , or placebo . R and omisation was stratified by the presence or absence of chronic peripheral arthritis . The primary outcome measure was the time weighted average change from baseline of spine pain intensity . Efficacy data from the three groups receiving active treatment ( the NSAID/COX-2 inhibitor group ) were combined to improve precision . An analysis of covariance model was used to evaluate the effect of peripheral disease on treatment response . Results : 93 patients were allocated to receive placebo and 294 to active treatment ( naproxen or etoricoxib ) . The combined NSAID/COX-2 inhibitor group had a significant treatment response compared with the placebo group for all efficacy measures , both in patients with and without peripheral arthritis . A significantly greater difference in mean patient assessment of spine pain was found between active and placebo treatments in patients without compared with those with peripheral arthritis ( p = 0.005 ; −32.5 mm v −17.0 mm , respectively ) . Similar differences , although not statistically significant , were seen for other end points . Conclusion : NSAIDs and COX-2 inhibitors have a clinical ly relevant symptomatic effect on axial AS irrespective of the presence of peripheral arthritis . In this exploratory analysis spinal improvement appeared to be greater in patients without peripheral disease OBJECTIVES To evaluate the clinical efficacy and tolerability of etoricoxib in the treatment of osteoarthritis ( OA ) of the knee and define the clinical ly active dose range for further clinical trials . METHODS This two-part , r and omized , double-blind , placebo- and active comparator-controlled trial was conducted in 617 adults with knee OA . In Part 1 ( 6 weeks ) , patients received placebo , etoricoxib 5 , 10 , 30 , 60 or 90 mg q.d . In Part 2 ( 8 weeks ) , patients received etoricoxib 30 , 60 or 90 mg q.d . or diclofenac 50 mg t.i.d . , predetermined at Part 1 allocation . Efficacy and safety were evaluated . Primary efficacy end-points were the Western Ontario and McMaster 's University Osteoarthritis Index ( WOMAC ) Pain subscale , Patient Global Assessment of Response to Therapy , and Investigator Global Assessment of Disease Status . RESULTS At 6 weeks , etoricoxib 5 , 10 , 30 , 60 and 90 mg each demonstrated clinical efficacy superior to placebo .  Maximal efficacy was seen with 60 mg . In Part 2 , etoricoxib 30 , 60 and 90 mg were generally similar to diclofenac . Patients receiving etoricoxib 30 , 60 or 90 mg in Parts I and II had sustained effects over 14 weeks . All treatments were well tolerated . CONCLUSIONS Etoricoxib 60 mg once daily showed maximal efficacy in treating OA in this study . Etoricoxib 5 - 90 mg once daily was generally well tolerated in OA patients for up to 14 weeks OBJECTIVE To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout . METHODS A r and omized , double-blind , active-comparator study was conducted at 42 sites . A total of 189 men and women ( > or = 18 years of age ) who were experiencing an acute attack ( < or = 48 hours ) of clinical ly diagnosed gout were treated for 8 days with etoricoxib , 120 mg/day ( n = 103 ) , or indomethacin , 50 mg 3 times a day ( n = 86 ) . The primary efficacy end point was the patient 's assessment of pain in the study joint ( 0 - 4-point Likert scale ) over days 2 - 5 . Safety was assessed by adverse experiences ( AEs ) occurring during the trial . RESULTS Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient 's assessment of pain in the study joint . The difference in the mean change from baseline over days 2 - 5 was -0.08 ( 95 % confidence interval -0.29 , 0.13 ) ( P = 0.46 ) , which fell within the prespecified comparability bounds of -0.5 to 0.5 . Secondary end points over the 8-day study , including the onset of efficacy , reduction in signs of inflammation , and patient 's and investigator 's global assessment s of response to therapy , confirmed the comparable efficacy of the two treatments . The etoricoxib-treated patients had a numerically lower incidence of AEs ( 43.7 % ) than did the indomethacin-treated patients ( 57.0 % ) and a significantly lower incidence of drug-related AEs ( 16.5 % versus 37.2 % ; P < 0.05 ) . CONCLUSION Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout . Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily , and it was generally safe and well tolerated Objective : To compare the efficacy of etoricoxib , lumiracoxib , celecoxib , non-selective ( ns ) NSAIDs and acetaminophen in the treatment of osteoarthritis ( OA ) Methods : R and omized placebo controlled trials investigating the effects of acetaminophen 4000 mg , diclofenac 150 mg , naproxen 1000 mg , ibuprofen 2400 mg , celecoxib 100 - 400 mg , lumiracoxib 100 - 400 mg , and etoricoxib 30 - 60 mg with treatment duration of at least two weeks were identified with a systematic literature search . The endpoints of interest were pain , physical function and patient global assessment of disease status ( PGADS ) . Pain and physical function reported on different scales ( VAS or LIKERT ) were translated into effect sizes ( ES ) . An ES 0.2 - 0.5 was defined as a “ small ” treatment effect , whereas ES of 0.5 – 0.8 and > 0.8 were defined as “ moderate ” and “ large ” , respectively . A negative effect indicated superior effects of the treatment group compared to the control group . Results of all trials were analyzed simultaneously with a Bayesian mixed treatment comparison . Results : There is a > 95 % probability that etoricoxib ( 30 or 60 mg ) shows the greatest improvement in pain and physical function of all interventions compared . ESs of etoricoxib 30 mg relative to placebo , celecoxib 200 mg , ibuprofen 2400 mg , and diclofenac 150 mg were -0.66 ( 95 % Credible Interval -0.83 ; -0.49 ) , -0.32 ( -0.50 ; -0.14 ) , -0.25 ( -0.53 ; 0.03 ) , and -0.17 ( -0.41 ; 0.08 ) , respectively . Regarding physical functioning , ESs of etoricoxib 30 mg relative to placebo , celecoxib 200 mg , ibuprofen 2400 mg , and diclofenac 150 mg were -0.61 ( -0.76 ; -0.46 ) , -0.27 ( -0.43 ; -0.10 ) , -0.20 ( -0.47 ; 0.07 ) , and -0.09 ( - 0.33 ; 0.14 ) respectively . The greatest improvements in PGADS were expected with either etoricoxib or diclofenac . Conclusion : The current study estimated the efficacy of acetaminophen , nsNSAIDs , and COX-2 selective NSAIDs in OA and found that etoricoxib 30 mg is likely to result in the greatest improvements in pain and physical function . Differences in PGADS between interventions were smaller OBJECTIVE A r and omised , double-blind study to compare the gastrointestinal ( GI ) tolerability , safety and efficacy of etoricoxib and diclofenac in patients with rheumatoid arthritis ( RA ) . PATIENTS AND METHODS A total of 4086 patients ( mean age 60.8 years ) diagnosed with RA were enrolled and received etoricoxib 90 mg daily ( n = 2032 ) or diclofenac 75 mg twice daily ( n = 2054 ) . Use of gastroprotective agents and low-dose aspirin was allowed . The prespecified primary end point consisted of the cumulative rate of patient discontinuations due to clinical and laboratory GI adverse experiences ( AEs ) . General safety was also assessed , including adjudicated thrombotic cardiovascular event data . Efficacy was evaluated using the Patient Global Assessment of Disease Status ( PGADS ; 0 - 4 point scale ) . RESULTS Mean ( SD ; maximum ) duration of treatment was 19.3 ( 10.3 ; 32.9 ) and 19.1 ( 10.4 ; 33.1 ) months in the etoricoxib and diclofenac groups , respectively . The cumulative discontinuation rate due to GI AEs was significantly lower with etoricoxib than diclofenac ( 5.2 vs 8.5 events per 100 patient-years , respectively ; hazard ratio 0.62 ( 95 % CI : 0.47 , 0.81 ; p < or=0.001 ) ) . The incidence of discontinuations for hypertension-related and oedema-related AEs were significantly higher with etoricoxib ( 2.5 % and 1.1 % respectively ) compared with diclofenac ( 1.5 % and 0.4 % respectively ; p<0.001 for hypertension and p<0.01 for oedema ) . Etoricoxib and diclofenac treatment result ed in similar efficacy ( PGADS mean changes from baseline -0.62 vs -0.58 , respectively ) . CONCLUSIONS Etoricoxib 90 mg demonstrated a significantly lower risk for discontinuing treatment due to GI AEs compared with diclofenac 150 mg . Discontinuations from renovascular AEs , although less common than discontinuations from GI AEs , were significantly higher with etoricoxib OBJECTIVE To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib , 200 mg , in the treatment of osteoarthritis ( OA ) in two identically design ed studies . METHODS Two multi-centre , 26-week , double-blind , placebo-controlled , non-inferiority studies were conducted , enrolling patients who were prior non-steroidal anti-inflammatory drug ( NSAID ) or acetaminophen users . There were 599 patients in study 1 and 608 patients in study 2 r and omized 4:4:1:1 to etoricoxib 30 mg qd , celecoxib 200 mg qd or one of two placebo groups for 12 weeks . After 12 weeks , placebo patients were evenly distributed to etoricoxib or celecoxib based on their initial enrollment r and omization schedule . The primary hypothesis was that etoricoxib 30 mg would be at least as effective as celecoxib 200 mg for the time-weighted average change from baseline over 12 weeks for Western Ontario and McMaster ( WOMAC ) Pain Subscale , WOMAC Physical Function Subscale and Patient Global Assessment of Disease Status . Active treatments were also assessed over the full 26 weeks . Adverse experiences were collected for safety assessment . RESULTS In both studies , etoricoxib was non-inferior to celecoxib for all three efficacy outcomes over 12 and 26 weeks ; both were superior to placebo ( P < 0.001 ) for all three outcomes in each study over 12 weeks . The safety and tolerability of etoricoxib 30 mg qd and celecoxib 200 mg qd were similar over 12 and 26 weeks . CONCLUSIONS Etoricoxib 30 mg qd was at least as effective as celecoxib 200 mg qd and had similar safety in the treatment of knee and hip OA ; both were superior to placebo . Clinical Trials.gov Identifiers : NCT00092768 ; NCT00092791 ABSTRACT Background and methods : The efficacy and safety of etoricoxib 60 mg/day in patients with established chronic low back pain ( CLBP ) were compared with those of diclofenac 150 mg/day in a 4‐week , multicentre , r and omized , double-blind , parallel-group trial . Four hundred and forty-six adult patients with CLBP ( Quebec Task Force on Spinal Disorders Class 1 or 2 ) and with worsening pain upon discontinuation of pre- study analgesic medication were enrolled in the study . The study primary efficacy endpoint was change from baseline in Low Back Pain Intensity Scale ( LBP‐IS ) score over the 4‐week treatment period . Secondary and other efficacy endpoints included : changes in Rol and and Morris Disability Question naire ( RMDQ ) , Patient Global Assessment of Response to Therapy ( PGART ) and Low Back Pain Bothersomeness Scale ( LBP-BS ) scores . Early efficacy was assessed using PGART and LBP‐IS scores 4 h after the first dose on the mornings of Days 1 , 2 and 3 . The overall safety and tolerability  of etoricoxib 60 mg/day during 4 weeks of treatment were also assessed . Results : The least-squares mean time-weighted change from baseline LBP‐IS score over 4 weeks was –32.94 mm ( 95 % CI –36.25 , –29.63 ) for etoricoxib , indicating substantial efficacy in relief of pain . The treatment difference for the primary outcome was 2.51 mm ( 95 % CI –1.50 , 6.51 ) , fulfilling the prespecified equivalence criterion of 95 % confidence interval wholly within ± 10 mm . Etoricoxib improved all secondary and other efficacy outcomes . There were no statistically significant between-group differences in the proportion of patients with one or more clinical adverse events ( AEs )  ( etoricoxib 35 % , diclofenac 39 % ) , or the proportion of patients who discontinued due to AEs ( etoricoxib 7 % , diclofenac 5 % ) . Conclusions : The results of this study confirm that , for adult patients with CLBP  , etoricoxib 60 mg once daily over 4 weeks is effective for relief of pain and improvement of physical function and comparable to high-dose diclofenac 150 mg daily OBJECTIVE To directly compare the efficacy and safety of etoricoxib , 30 mg once daily , ibuprofen , 800 mg 3 times daily , and placebo for treatment of osteoarthritis ( OA ) of the hip and knee . PATIENTS AND METHODS A r and omized , double-blind ,  placebo-controlled trial of patients with OA of the knee or hip was performed between February 2003 and November 2003 in 61 medical centers in the United States . Qualified patients aged 40 to 89 years were r and omized to receive placebo , etoricoxib , 30 mg once daily , or ibuprofen , 800 mg 3 times daily , for 12 weeks . Primary efficacy end points Included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales and Patient Global Assessment of Disease Status . Response to treatment was assessed by the time-weighted average change from baseline over 12 weeks . RESULTS In 528 patients ,  baseline values  for the 3 primary end points ranged from 67.78 to 72.60 mm ( 0 - 100 mm visual analog scale ) . Near-maximal efficacy was achieved by week 2 with both active treatments and sustained over the course of the trial . During the 12-week period , least squares mean changes in the primary end points ( Western Ontario and McMaster Universities Osteoarthritis Index and Patient Global Assessment of Disease Status subscales ) ranged from -16.53 to -13.55 mm , -27.89 to -23.68 mm , and -26.53 to -22.97 mm in the placebo , etoricoxib , and Ibuprofen groups , respectively . Both etoricoxib and ibuprofen were more effective ( P<.001 ) than placebo for all primary end points . Etoricoxib and ibuprofen treatment responses for the primary end points were determined to be comparable with use of prespecified comparability criteria . Results for all other efficacy end points were consistent with responses observed for the primary end points . Etoricoxib and ibuprofen generally were well tolerated . CONCLUSION For patients with OA , treatment with etoricoxib , 30 mg/d , is well tolerated and provides sustained clinical effectiveness that is superior to placebo and comparable to ibuprofen , 2400 mg/d Background Etoricoxib is a highly selective COX-2 inhibitor which was evaluated for the treatment of rheumatoid arthritis ( RA ) . Methods Double-blind , r and omized , placebo and active comparator-controlled , 12-week study conducted at 67 sites in 28 countries . Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of pre study NSAIDs . Patients received either placebo , etoricoxib 90 mg once daily , or naproxen 500 mg twice daily ( 2:2:1 allocation ratio ) . Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints , and patient and investigator global assessment s of disease activity . Key secondary measures included the Stanford Health Assessment Question naire , patient global assessment of pain , and the percentage of patients who achieved ACR20 responder criteria response ( a composite of pain , inflammation , function , and global assessment s ) . Tolerability was assessed by adverse events and routine laboratory evaluations . Results 1171 patients were screened , 891 patients were r and omized ( N = 357 for placebo , N = 353 for etoricoxib , and N = 181 for naproxen ) , and 687 completed 12 weeks of treatment ( N = 242 for placebo , N = 294 for etoricoxib , and N = 151 for naproxen ) . Compared with patients receiving placebo , patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints ( p<0.05 ) . Treatment responses were similar between the etoricoxib and naproxen groups for all endpoints . The percentage of patients who achieved ACR20 responder criteria response was 41 % in the placebo group , 59 % in the etoricoxib group , and 58 % in the naproxen group . Etoricoxib and naproxen were both generally well tolerated . Conclusions In this study , etoricoxib 90 mg once daily was more effective than placebo and similar in efficacy to naproxen 500 mg twice daily for treating patients with RA over 12 weeks . Etoricoxib 90 mg was generally well tolerated in RA patients OBJECTIVE : Etoricoxib is a selective cyclooxygenase inhibitor that in clinical studies has improved the signs and symptoms of osteoarthritis and rheumatoid arthritis and reduced the potential for GI injury . The incidence of endoscopically detected ulcers and of clinical ly important upper GI events ( perforations , ulcers , and bleeding episodes ) was compared in patients taking etoricoxib or nonselective nonsteroidal anti-inflammatory drugs ( NSAIDs ) .  METHODS : Upper GI endoscopy was performed at intervals over 12 wk in 680 patients taking etoricoxib 120 mg once daily , ibuprofen 800 mg three times daily , or placebo in a r and omized , parallel-group , double-blind study .  Survival analysis was used to analyze time-to-event data for the incidence of gastric or duodenal ulcers ( ≥3 mm and ≥5 mm ) , and the log rank test was used to compare the cumulative incidence between treatment groups . A combined analysis of upper GI events in all 10 Phase II/III clinical trials of etoricoxib ( 60 , 90 , or 120 mg ) versus nonselective NSAIDs ( naproxen , ibuprofen , or diclofenac ) for osteoarthritis , rheumatoid arthritis , and chronic low back pain was conducted . Investigators reported potential events for adjudication by an external , blinded committee , using prespecified criteria to confirm events . All events that occurred during active treatment periods ( maximum 792 days ) or within 14 days of stopping treatment were included in the analysis . Time to first event was evaluated using survival analysis ; the Kaplan – Meier method was used to determine the cumulative incidence , and relative risk was estimated with the Cox proportional hazards model . RESULTS : In the endoscopy study , the cumulative incidence of ulcers ≥3 mm at 12 wk in the ibuprofen group ( 17 % ) was significantly higher than in the etoricoxib group ( 8.1 % , p < 0.001 ) ; similar results were seen for ulcers ≥5 mm . In the placebo group , the rate of ulcers ≥3 mm was 1.86 % . Of 3142 patients treated with once-daily etoricoxib and 1828 patients treated with a nonselective NSAID ( ibuprofen , naproxen , or diclofenac ) , 82 patients with investigator-reported upper GI events ( 71 confirmed ) were eligible for the combined analysis . For etoricoxib versus NSAIDs  , the rate per 100 patient-yr for confirmed events was 1.16 versus 3.05 ( relative risk = 0.44 , 95 % CI = 0.27–0.72 , p < 0.001 ) , whereas that for investigator-reported events was 1.35 versus 3.42 ( relative risk = 0.47 , 95 % CI = 0.30–0.74 , p = 0.001 ) . Results were driven primarily by studies with naproxen as the comparator . CONCLUSIONS : The incidence of endoscopically detected ulcers was significantly lower with etoricoxib 120 mg than with ibuprofen 2400 mg . Treatment with etoricoxib reduced the incidence of investigator-reported and confirmed adverse upper GI events by approximately 50 % compared with treatment with nonselective NSAIDs Summary Objective : To evaluate the efficacy of 12 weeks of treatment with etoricoxib , a selective COX-2 inhibitor , in patients with osteoarthritis ( OA ) of the knee or hip . Methods : In the 12-week placebo- and active comparator-controlled period of a r and omized , double-blind study , eligible patients were treated with etoricoxib 60 mg once daily ( n = 224 ) , naproxen 500 mg twice daily ( n = 221 ) , or placebo ( n = 56 ) . Western Ontario McMaster 's Osteoarthritis Index ( WOMAC ) pain and physical function subscales and patient 's global assessment of disease status were primary end points . Key secondary and other end points were patient 's and investigator 's global assessment of response to therapy , WOMAC stiffness subscale , investigator 's global assessment of disease status , rescue paracetamol use , proportion of patients discontinuing due to lack of efficacy , and study joint tenderness . Results : Etoricoxib 60 mg demonstrated efficacy significantly superior to placebo ( p ≤ 0.005 ) and comparable to naproxen 500 mg twice daily as assessed by the primary efficacy end points . Secondary and other end points confirmed these results . Treatment effects were evident by day 2 , maximal by week 2 , and sustained over the entire 12 weeks . Etoricoxib was well tolerated for 12 weeks . Conclusions : Etoricoxib showed rapid and durable treatment effects in patients with OA of the knee or hip . Etoricoxib was generally well tolerated Objective : To determine the efficacy of etoricoxib in the treatment of primary dysmenorrhea . Methods : Seventy-three women were r and omly assigned to receive single oral doses of etoricoxib 120 mg , placebo , or naproxen sodium 550 mg at the onset of moderate to severe pain associated with menses . During 3 consecutive menstrual cycles in this double-blind , 3-period , crossover study , pain intensity and pain relief were assessed over the 24-hour period following dosing , and global ratings of therapy were made at 8 and 24 h after dosing . Tolerability was assessed by spontaneous reports of adverse experiences . Results : Etoricoxib 120 mg provided analgesic efficacy superior to placebo for the primary endpoint , total pain relief over 8 h ( TOPAR8 , p < 0.001 ) , and for all secondary endpoints ( p < 0.050 ) . The analgesic effect of etoricoxib 120 mg over the first 8 h was similar to that of naproxen sodium 550 mg . All treatments were well tolerated . Conclusions : Etoricoxib 120 mg provided rapid and sustained analgesia that was superior to placebo and similar to that of naproxen sodium 550 mg Abstract Objective : Assess the efficacy and safety of etoricoxib 120 mg compared with ibuprofen 600 mg qid in the treatment of moderate to severe primary dysmenorrhea in Chinese women . Methods : This multicenter , double-blind , two-period , cross-over study r and omized healthy , Chinese women ≥18 years of age to etoricoxib 120 mg qd or ibuprofen up to 2400 mg ( 600 mg qid ) upon onset of moderate or severe primary dysmenorrhea symptoms during two menstrual cycles . The primary efficacy endpoint was Total Pain Relief score over the first 6 hours ( TOPAR6 ) . Secondary endpoints included Sum of Pain Intensity Difference scores over the first 6 hours ( SPID6 ) and Patient ’s Global Evaluation ( GLOBAL ) of pain at 6 and 24 hours post initial dose . The primary hypothesis was that etoricoxib would be non-inferior to ibuprofen . Adverse experiences ( AE ) were monitored and evaluated . Results : A total of 139 patients were included in this study . Difference in least squares ( LS ) mean ( 95 % CI ) TOPAR6 score for etoricoxib vs. ibuprofen was 0.89 ( 0.03 , 1.76 ) ( p = 0.043 ) . LS mean ( 95 % CI ) difference for etoricoxib vs. ibuprofen SPID6 , GLOBAL6 , and GLOBAL24 were 0.20 ( −1.16 , 1.57 ) ( p = 0.768 ) , 0.26 ( 0.07 , 0.45 ) ( p = 0.007 ) , and 0.36 ( 0.17 , 0.54 ) ( p < 0.001 ) , respectively . AEs were rare , with the following AEs determined to be drug-related : hypomenorrhea ( two patients on etoricoxib ) and allergic dermatitis ( one patient on ibuprofen ) . Limitations of the study design include a sample size that is not adequate for evaluation of rare adverse effects , an evaluation period that was limited to 24 hours , and inconsistent frequency of active treatment doses between etoricoxib ( once daily ) and ibuprofen ( up to four times daily ) . Conclusions : The primary objective of the study was met , demonstrating that etoricoxib 120 mg qd was non-inferior to ibuprofen 600 mg qid ; further , etoricoxib was statistically superior to ibuprofen 600 mg qid according to the primary endpoint ( TOPAR6 ) and patient global assessment s of study medication . Etoricoxib and ibuprofen were generally well tolerated OBJECTIVES Current therapeutic approaches to fibromyalgia syndrome ( FMS ) do not provide satisfactory pain control to a high percentage of patients . This unmet need constantly fuels the pursuit for new modalities for pain relief . This r and omised , double-blind , controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS . METHODS In this double-blind , placebo-controlled study , female patients were r and omised to receive either 90 mg etoricoxib  once daily  or placebo for 6 weeks . Several physical and mental parameters were assessed throughout the study . The primary end-point was the response to treatment , defined as ≥ 30 % reduction in the average Brief Pain Inventory score . Secondary outcomes were changes in the Fibromyalgia Impact Question naire , SF-36 Quality of Life assessment question naire and Hamilton rating scales for anxiety and depression . RESULTS Overall , 73 patients were recruited . Although many outcome measures improved throughout the study , no difference was recorded between the etoricoxib- and placebo-treated groups . The Brief Pain Inventory , Fibromyalgia Impact Question naire , The Hamilton Anxiety and Depression scores did not differ between the two groups . CONCLUSIONS This is the first r and omised , double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS . Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects Summary Dysmenorrhoea is painful menstruation that occurs in 45–72 % of all women . This was a prospect i ve r and omised study of the efficacy of etoricoxib ( Arcoxia ® ) compared with mefenamic acid ( Ponstan ® ) in treating primary dysmenorrhoea . All single , sexually inactive women with primary dysmenorrhoea were r and omised into two groups ( mefenamic acid and etoricoxib ) of pain relief and underwent a cross-over study . The success of treatment as evidence d by pain relief , the side-effects and complications were observed and analysed . Some 80 % ( 20 women ) had significantly better pain relief with etoricoxib , compared with only 20 per cent in the mefenamic acid group ( p = 0.007 ) . Etoricoxib  has significantly fewer side-effects compared with mefenamic acid ( p = 0.005 ) with significantly reduced menstrual blood loss ( p = 0.025 ) . In conclusion , etoricoxib is a better treatment for primary dysmenorrhoea with better pain relief , less menstrual blood loss and fewer side-effects compared with mefenamic acid Objective This study was conducted to evaluate the dose range of etoricoxib in acute pain using the postoperative dental pain model further . Methods This double-blind , r and omized controlled study evaluated etoricoxib ( 90 and 120 mg ) , ibuprofen ( 600 mg ) , and acetaminophen ( 600 mg/codeine ) ( 60 mg , ( A/C ) ) in patients aged ≥18 years with moderate or severe pain after surgical extraction of ≥2 third molars ( ≥1 impacted ) . The patients reported pain intensity and pain relief over 24 hours . The primary efficacy endpoint was total pain relief over 6 hours ( TOPAR6 ) . Adverse events were evaluated throughout the study . Results There were 588 patients r and omized to placebo  ( n=46 ) , etoricoxib ( 90 mg ( n=191 ) ) , etoricoxib ( 120 mg ( n=97 ) ) , ibuprofen ( 2400 mg ( n=192 ) ) , and A/C ( n=62 ) . The overall analgesic effect ( TOPAR6 ) of etoricoxib ( 90 , 120 mg ) was significantly greater than that of placebo ( P⩽0.001 ) , and not inferior to that of ibuprofen ; no discernible difference was observed between etoricoxib 90 and 120 mg . Both etoricoxib doses were superior to A/C ( P⩽0.001 ) . Etoricoxib ( 90 and 120 mg ) and ibuprofen ( 2400 mg ) were generally well tolerated and had a similar incidence of adverse events ( AEs ) . A/C was associated with significantly more AEs that led to discontinuation ( ie , nausea and vomiting ) . Conclusions Etoricoxib ( 90 and 120 mg ) showed similar efficacy in the postoperative dental pain model , which was noninferior to ibuprofen and superior to A/C. A higher number of tooth extraction s or a higher mean impaction score may have led to a greater separation in efficacy between the 2 etoricoxib doses BACKGROUND Cyclo-oxygenase-2 ( COX-2 ) selective inhibitors have been associated with an increased risk of thrombotic cardiovascular events in placebo-controlled trials , but no clinical trial has been reported with the primary aim of assessing relative cardiovascular risk of these drugs compared with traditional non-steroidal anti-inflammatory drugs ( NSAIDs ) . The MEDAL programme was design ed to provide a precise estimate of thrombotic cardiovascular events with the COX-2 selective inhibitor etoricoxib versus the traditional NSAID diclofenac . METHODS We design ed a prespecified pooled analysis of data from three trials in which patients with osteoarthritis or rheumatoid arthritis were r and omly assigned to etoricoxib ( 60 mg or 90 mg daily ) or diclofenac ( 150 mg daily ) . The primary hypothesis stated that etoricoxib is not inferior to diclofenac , defined as an upper boundary of less than 1.30 for the 95 % CI of the hazard ratio for thrombotic cardiovascular events in the per- protocol analysis . Intention-to-treat analyses were also done to assess consistency of results . These trials are registered at http://www . clinical trials.gov with the numbers NCT00092703 , NCT00092742 , and NCT00250445 . FINDINGS 34 701 patients ( 24 913 with osteoarthritis and 9 787 with rheumatoid arthritis ) were enrolled . Average treatment duration was 18 months ( SD 11.8 ) . 320 patients in the etoricoxib group and 323 in the diclofenac group had thrombotic cardiovascular events , yielding event rates of 1.24 and 1.30 per 100 patient-years and a hazard ratio of 0.95 ( 95 % CI 0.81 - 1.11 ) for etoricoxib compared with diclofenac .  Rates of upper gastrointestinal clinical events ( perforation , bleeding , obstruction , ulcer ) were lower with etoricoxib than with diclofenac ( 0.67 vs 0.97 per 100 patient-years ; hazard ratio 0.69 [ 0.57 - 0.83 ] ) , but the rates of complicated upper gastrointestinal events were similar for etoricoxib ( 0.30 ) and diclofenac ( 0.32 ) . INTERPRETATION Rates of thrombotic cardiovascular events in patients with arthritis on etoricoxib are similar to those in patients on diclofenac with long-term use of these drugs BACKGROUND : Cyclo-oxygenase 2 inhibitors can be used for pain treatment after colorectal surgery . OBJECTIVE : The aim of this study was to investigate whether the use of etoricoxib has negative effects on the perioperative outcome in colorectal surgery . DESIGN : Complication data from an advanced medical data base system were sample d prospect ively , and patient records were review ed retrospectively . PATIENTS : All patients with elective colorectal surgery within an enhanced recovery after surgery protocol from 2008 to 2009 were selected . INTERVENTION : The nonr and omized use of perioperative etoricoxib treatment was compared with a control group . MAIN OUTCOME MEASURES : The primary outcome measured was the number of patients with postoperative complications according to the Dindo-Clavien classification . RESULTS : One hundred one patients received etoricoxib treatment , whereas 104 did not . The patient groups were very comparable . We observed a significant increase in the number of patients with postoperative complications with etoricoxib treatment ( 43 vs 30 patients ; 42.6 % vs 28.8 % , p = 0.041 ) due to an increase in patients with a major complication ( Dindo-Clavien complication grade III – V : 22.8 % vs 9.6 % , p = 0.01 ) . Patients with etoricoxib treatment and a complication needed a longer recovery period than patients with a complication in the control group ( 18 ( 17 ; 20 ) vs 14 ( 13 ; 15 ) days , p = 0.05 ) . We observed an increased level of postoperative serum creatinine with etoricoxib treatment ( 105 ( 98 ; 112 ) vs 82 ( 78 ; 85 ) , p = 0.003 ) , which was more pronounced in patients with a complication ( 141 ( 127 ; 155 ) vs 91 ( 83 ; 98 ) , p = 0.002 ; 25 vs 8 patients with serum creatinine > 100 & mgr;mol/L , p = 0.008 ) . In multivariate analysis , etoricoxib was identified as an independent risk factor for experiencing a major complication with a risk increase of approximately 2.5-fold ( p = 0.03 ) . LIMITATIONS : This study was limited by the nonr and omized use of perioperative etoricoxib and the retrospective nature of its review of patient records . CONCLUSIONS : Etoricoxib increased the number of patients with postoperative complications and should be considered carefully in colorectal surgery Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model . Patients experiencing moderate to severe pain after extraction of two or more third molars were r and omized to single doses of etoricoxib 120 mg ( n = 100 ) , oxycodone/acetaminophen 10/650 mg ( n = 100 ) , or placebo ( n = 25 ) . The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy ; onset , peak , and duration of effect ; and rescue opioid analgesic use . Active treatments were statistically significantly superior to placebo for all efficacy measures . Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen ( P < 0.001 ) . Patient global assessment of response to therapy at 6 and 24 h was superior for etoricoxib . Both drugs achieved rapid onset , although the time was faster for oxycodone/acetaminophen by 5 min . The peak effect was similar for both drugs . Compared with oxycodone/acetaminophen patients , etoricoxib patients experienced a longer analgesic duration , had a smaller percentage requiring rescue opioids during 6 and 24 h , and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment result ed in more frequent adverse events ( AEs ) , drug-related AEs , nausea , and vomiting compared with etoricoxib treatment . In conclusion , etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs
Results : This systematic review will provide a detailed summary of present evidence related to the efficacy and safety  of etoricoxib for patients with AS .
Conclusion : The results of this study may provide management guidance for AS treated by etoricoxib .
Background : Previous clinical trials have reported that etoricoxib has been utilized to treat ankylosing spondylitis ( AS ) effectively .
However , no study systematic ally investigated the efficacy and safety of etoricoxib for patients with AS .
In this systematic review , we will assess the efficacy and safety of etoricoxib for AS .