You are on page 1of 12

TUGAS CRITICAL APPRAISAL

COMPARISON OF UPPER GASTROINTESTINAL TOXICITY OF
ROFECOXIB AND NAPROXEN IN PATIENTS WITH
RHEUMATOID ARTHRITIS

KELOMPOK B- KELAS A

.

RESEARCH QUESTION How do Rofecoxib (a selective inhibitor of cyclooxygenase-2) compare with Naproxen (the nonselective NSAID) will respect to upper gastrointestinal toxicity ? .

TYPE OF ARTICLE AND DESIGN Randomized. double blind. .

CRITICAL APPRAISAL OF STUDY  Validity Assessing risk of bias  Importance Magnitude of result and its precision  Applicability External validity / generazibility .

Assessing risk of bias GATE (Graphic Approach To Epidemiology):  Participant: Elderly patients with Rheumatoid arthritis  Exposure : Receive 50 mg/day of Rofecoxib  Comparison : Receive 500 mg twice daily of Naproxen  Outcome : lower incidence of clinical upper gastrointestinal toxicity event  Time : 12 months .

investigators and the examiner. Compliance was assessed by pill count at clinic visit and by questioning of patient. Patients were contacted by phone at 10th week and every four months and there after. 29. the discontinuation between groups were similar. 28.RAMBOMAN  Recruitment : consecutive sampling with eligible criteria well described  Allocation : randomize. Cox proportional hazard analysis was used to compare the effect of treatment. Subgroup analyses were conducted with use of Cox regression analysis .3% in the Refecoxib group. between the groups.5% in the Naproxen group.  Analysis: intention to treat ( data was not shown ) was used to analyse the discontinued group.  Blinding or Objective Measured: triple blind. study design was survival analysis. with similar base line characteristic between groups  Maintenance: EG and CG were followed up for 9 months.

PARTICIPANT 301 centers in 22 countries 9539 patient 8076 patient 4047 patient  4029 patient  ROFECOXIB naproxen 178 patient  event 314 patient  event .

IMPORTANCE OF EVIDENCE  Design study: prognostic study. to measure the incidence of clinical upper gastrointestinal events  RR and 95% CI .

.

SURVIVAL RATE .

The two drugs had similar rates of clinical effectiveness. a nonselective inhibitor . treatment with rofecoxib. is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen. .APPLICABILITY  It can be applicated to patient. because this study proof that In patients with rheumatoid arthritis.clooxygenase-2. a selective inhibitor of cy.