18373
document
Oxaprozin versus diclofenac in NSAID-refractory periarthritis pain of the shoulder . OBJECTIVE To evaluate the efficacy and safety of oxaprozin in comparison with diclofenac in patients with periarthritis pain of the shoulder previously unsuccessfully treated with nonsteroidal anti-inflammatory drugs other than diclofenac and oxaprozin . METHODS In this open , multicentre , randomised , controlled study , eligible patients with periarthritis of the shoulder were randomised to receive either oxaprozin 1200 mg once daily ( n = 49 ) or diclofenac 50 mg three times daily ( n = 47 ) . The treatment period was 15 +/- 1 days . The study was planned on a hypothesis of equivalence between the two study drugs . The primary study endpoint was the change from baseline at day 15 in the patient-assessed shoulder pain score . Secondary efficacy variables included investigator-assessed shoulder function , patient-assessed quality of life on the Short-Form-36 ( SF-36 ) Acute Health Survey and both patients ' and investigators ' overall assessment of efficacy . RESULTS At day 15 , the mean changes in shoulder pain score from baseline in the oxaprozin and diclofenac groups were -5.85 +/- SD 4.62 and -5.54 +/- SD 4.41 , respectively . The difference between the two groups was not statistically significant , confirming the hypothesis of the study that oxaprozin is as effective as diclofenac . Investigator-assessed shoulder function improved in both groups but more so in the oxaprozin group ( p = 0.028 at day 15 ) . Quality of life as measured by SF-36 total score was also improved in both treatment groups , with a trend toward greater improvement in the oxaprozin group . Furthermore , a significantly more favourable effect on the SF-36 'mental health ' item was observed in oxaprozin compared with diclofenac-treated patients at day 15 ( p = 0.0202 ) . As assessed by investigators , the overall efficacy of oxaprozin was superior to that for diclofenac at visit 3 ( 8 +/- 1 days ) ( p = 0.0067 ) . Patients also assessed the overall efficacy of oxaprozin as superior to that of diclofenac at visits 3 ( 8 +/- 1 days ) ( p = 0.0235 ) and 4 ( 15 +/- 1 days ) ( p = 0.0272 ) . Only six adverse events , all of which were mild or moderate in intensity and occurred in four diclofenac recipients , were observed in the study . CONCLUSIONS As expected , once-daily oxaprozin proved to be as effective as diclofenac three times daily in reducing the primary efficacy variable of patient-assessed shoulder pain score in patients with periarthritis of the shoulder refractory to previous treatments with other NSAIDs . Oxaprozin was shown to be superior to diclofenac in improving shoulder function and was considered by investigators and patients to have greater overall efficacy than diclofenac . In addition , oxaprozin showed a trend toward superior results in improving patients ' quality of life compared with diclofenac . A trend towards better tolerability results for oxaprozin compared with diclofenac was also noted .
18374
Intervention_Pharmacological
Oxaprozin
18375
Intervention_Pharmacological
diclofenac
18376
Intervention_Pharmacological
oxaprozin
18377
Intervention_Pharmacological
diclofenac
18378
Intervention_Pharmacological
oxaprozin
18379
Intervention_Pharmacological
diclofenac
18380
Intervention_Pharmacological
oxaprozin
18381
Intervention_Pharmacological
diclofenac
18382
Intervention_Pharmacological
oxaprozin
18383
Intervention_Pharmacological
oxaprozin
18384
Intervention_Pharmacological
diclofenac
18385
Intervention_Pharmacological
oxaprozin
18386
Intervention_Pharmacological
diclofenac
18387
Intervention_Pharmacological
diclofenac
18388
Intervention_Pharmacological
oxaprozin
18389
Intervention_Pharmacological
diclofenac
18390
Intervention_Pharmacological
Oxaprozin
18391
Intervention_Pharmacological
diclofenac
18392
Intervention_Pharmacological
diclofenac
18393
Intervention_Pharmacological
oxaprozin
18394
Intervention_Pharmacological
diclofenac
18395
Intervention_Pharmacological
oxaprozin
18396
Intervention_Pharmacological
diclofenac
18397
Outcome_Pain
change from baseline at day 15 in the patient-assessed shoulder pain score
18398
Outcome_Other
efficacy
18399
Outcome_Pain
shoulder pain score
18400
Outcome_Other
difference
18401
Outcome_Physical
Investigator-assessed shoulder function
18402
Outcome_Physical
Quality of life as measured by SF-36 total score
18403
Outcome_Other
effect
18404
Outcome_Physical
SF-36 'mental health ' item
18405
Outcome_Other
efficacy
18406
Outcome_Adverse-effects
adverse events
18407
Outcome_Pain
patient-assessed shoulder pain score
18408
Outcome_Physical
shoulder function
18409
Outcome_Physical
quality of life
18410
Outcome_Other
tolerability results
18411
Participant_Condition
periarthritis
18412
Participant_Condition
eligible patients with periarthritis of the shoulder
18413
Participant_Condition
shoulder pain
18414
Participant_Sample-size
Short-Form-36
18415
Participant_Sample-size
SF-36
18416
Participant_Condition
periarthritis