Table 1. Characteristics of randomized controlled trials included in the qualitative synthesis.
Study | Condition | Total Sample Size | Comparators | Celecoxib Doses and Frequency | Duration |
---|---|---|---|---|---|
Bingham 2007 (Trial 1) [25] | OA | 599 | Placebo | 200mg Qd | 26 weeks |
Bingham 2007 (Trial 2) [25] | OA | 608 | Placebo | 200mg Qd | 26 weeks |
Birbara 2006 (Trial 1) [26] | OA | 395 | Placebo | 200mg Qd | 6 weeks |
Birbara 2006 (Trial 2) [26] | OA | 413 | Placebo | 200mg Qd | 6 weeks |
Cannon 2008 [27] | OA | 433 | Placebo, Ibuprofen | 200mg Bid | 12 weeks |
Clegg 2006 (GAIT) [28] | OA | 1583 | Placebo | 200mg/day | 24 weeks |
Conaghan 2012 [29] | OA | 1399 | Placebo | 100mg/day | 12 weeks |
Cryer 2012 (PROBE) [30] | OA | 8067 | (1) | (2) | 6 months |
Dahlberg 2009 [31] | OA | 925 | Diclofenac | 200mg Qd | 1 year |
Essex 2012 [32] | OA | 589 | Naproxen | 200mg Qd | 6 months |
Gibofsky 2003 [33] | OA | 477 | Placebo | 200mg/day | 6 weeks |
Hawel 2003 [34] | OA | 148 | Dexiprofen | 100mg/day | 15 days |
MacDonald 2017 (SCOT) [35] | OA&RA | 7297 | Diclofenac, Ibuprofen and Naproxen | 169.8±80.6mg/day | (3) |
McKenna 2001 [36] | OA | 182 | Placebo | 200mg Qd | 6 weeks |
Nissen 2016 (PRECISION) [37] | OA&RA | 24081 | Naproxen and Ibuprofen | 209±37mg/day | 20 months (4) |
Sampalis 2012 [38] | OA | 60 | Placebo | 200mg/day | 90 days |
Sawitzke 2010 [39] | OA | 662 | Placebo | 200mg/day | 24 weeks |
Schnitzer 2011 [40] | OA | 1262 | Placebo | 200mg Qd | 13 weeks |
Simon 1999 [41] | RA | 1149 | Placebo and Naproxen | 100mg, 200mg, or 400mg Bid | 12 weeks |
Smugar 2006 (Trial 1) [42] | OA | 1521 | Placebo | 200mg Qd | 6 weeks |
Smugar 2006 (Trial 2) [42] | OA | 1082 | Placebo | 200mg Qd | 6 weeks |
White 2002 (CLASS) [43] | OA&RA | 7968 | Diclofenac and Ibuprofen | 100 mg Bid in patients with OA and up to 200 mg Bid in patients with RA | 13 weeks |
Williams 2001 [44] | OA | 718 | Placebo | 100mg Bid or 200mg Qd | 6 weeks |
Wittenberg 2006 [45] | OA | 364 | Placebo | 200mg Bid | 1 week |
(1): The nsNSAID in the comparator group was any nsNSAID of the investigator’s choice, prescribed within the dosages allowed in the United States package insert.
(2): Celecoxib dosage could be adjusted within the United States prescribing guidelines.
(3): The median intention-to-treat follow-up for the primary outcome was 3.0 years (maximum 6.3 years, total 22 600 person-years)
(4): The mean duration of treatment was 20.3±16.0 months for all patients.
OA: Osteoarthritis; RA: Rheumatoid Arthritis; Qd: once per day; Bid: twice per day; GAIT: Glucosamine/chondroitin Arthritis Intervention Trial; PROBE: Prospective, Randomized, Open-label, Blinded Endpoint; SCOT: Standard care vs. Celecoxib Outcome Trial; PRECISION: Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen; mg: milligram; nsNSAID: non-selective Non-Steroidal Anti-Inflammatory Drug.