Comparison of published studies.
| MUCOSA30 | CLASS6 | SUCCESS-I33 | VIGOR31 | MEDAL34 | TARGET32 | |
|---|---|---|---|---|---|---|
| Study duration | 6 mo | 12 mo | 12 wks | 12 mos | 18 mo (average from pooled analysis) | 52 wks |
| Study population | RA subjects at moderate GI risk, age ≥ 52 yrs | OA or RA subjects, age ≥ 18 yrs | OA subjects, age ≥ 18 yrs | RA subjects at moderate GI risk Age ≥ 50 yrs (or ≥ 40 yrs and requiring longterm glucocorticoid therapy) | OA or RA subjects, age ≥ 50 yrs | OA subjects at moderate GI risk, age ≥ 50 yrs |
| Population size | 8,843 | 8,059 | 13,274 | 8,076 | 34,701 | 18,325 |
| Treatment arms | Misoprostol 200 μg or placebo qid | Celecoxib 400 mg bid Ibuprofen 800 mg tid Diclofenac 75 mg bid | Celecoxib 100/200 mg bid Diclofenac 50 mg bid or naproxen 500 mg bid | Rofecoxib 50 mg qd Naproxen 500 mg bid | Etoricoxib 60 mg or 90 mg qd Diclofenac 150 mg qd | Lumiracoxib 400 mg qd Naproxen 500 mg bid Ibuprofen 800 mg tid |
| GI endpoint definition | Confirmed serious upper GI events (perforation, obstruction, bleeding) | Confirmed upper GI ulcer complications (GD perforation, obstruction, upper GI bleeding) | Confirmed serious upper GI events (GD perforation, obstruction, upper GI bleeding) | Confirmed upper GI events [GD perforation, obstruction, upper GI bleeding, symptomatic GD ulcers, bleeding (≥ 2 g/dl drop in hemoglobin with visible upper GI lesion)] | Confirmed upper GI events [GD perforation, obstruction, upper GI bleeding, symptomatic GD ulcers, bleeding (≥ 2 g/dl drop in hemoglobin with visible upper GI lesion)] | Difference in time-to-event distribution of definite or probable upper GI ulcer complications[clinically significant bleeding, perforation, obstruction, bleeding (≥ 2 g/dl drop in hemoglobin and ≥ 6 point fall in hematocrit with visible lesion)] |
| ASA usage | Yes (7 %) | Yes (21%) | Yes (7%) | Excluded | Yes (35%) | Yes (24%) |
| PPI usage | Excluded | Excluded | Excluded | Yes (9 %) | Yes (40%) | Excluded |
RA: rheumatoid arthritis; OA: osteoarthritis; GI: gastrointestinal; qid: 4 times a day; bid: twice a day; tid: 3 times a day; qd: once a day; GD: gastroduodenal; ASA: aspirin; PPI: proton-pump inhibitor.