Table 4.

Risk of adverse events according to celecoxib treatment, stratified by hsCRP levela

PlaceboCelecoxib, 200 mg bidCelecoxib, 400 mg bid
Risk of cardiovascular disordersb
All patients
 No. with event/no. at risk23/56334/55843/559
 Cumulative incidence, 3 y, % ± SE6 ± 18 ± 19 ± 1
 RR (95% CI)1 (ref)1.19 (0.69–2.03)1.50 (0.90–2.50)
P0.530.12
Patients with hsCRP <3
 No. with event/no. at risk19/40122/38728/378
 Cumulative incidence, 3 y, % ± SE6 ± 27 ± 28 ± 2
 RR (95% CI)1 (ref)0.99 (0.53–1.83)1.11 (0.61–2.02)
P0.960.74
Patients with hsCRP ≥3
 No. with event/no. at risk4/16212/17115/181
 Cumulative incidence, 3 y, % ± SE5 ± 28 ± 211 ± 3
 RR (95% CI)1 (ref)2.27 (0.72–7.14)3.28 (1.09–9.91)
P0.160.03
Pinteraction0.290.11
Risk of renal and hypertensive disordersc
All patients
 No. with event/no. at risk95/563125/558100/559
 Cumulative incidence, 3 y, % ± SE6 ± 18 ± 19 ± 1
 RR (95% CI)1 (ref)1.24 (0.94–1.62)0.87 (0.66–1.16)
P0.120.35
Patients with hsCRP <3
 No. with event/no. at risk63/40182/38760/378
 Cumulative incidence, 3 y, % ± SE6 ± 27 ± 28 ± 2
 RR (95% CI)1 (ref)1.26 (0.90–1.75)0.78 (0.55–1.12)
P0.180.18
Patients with hsCRP ≥3
 No. with event/no. at risk32/16243/17140/181
 Cumulative incidence, 3 y, % ± SE5 ± 28 ± 211 ± 3
 RR (95% CI)1 (ref)1.13 (0.71–1.80)1.02 (0.63–1.63)
P0.600.95
Pinteraction0.680.46
Gastrointestinal ulceration/hemorrhaged
All patients
 No. with event/no. at risk57/56358/55854/559
 Cumulative incidence, 3 y, % ± SE6 ± 18 ± 19 ± 1
 RR (95% CI)1 (ref)0.87 (0.60–1.25)0.82 (0.56–1.19)
P0.450.29
Patients with hsCRP <3
 No. with event/no. at risk36/40144/38736/378
 Cumulative incidence, 3 y, % ± SE6 ± 27 ± 28 ± 2
 RR (95% CI)1 (ref)1.06 (0.68–1.65)0.79 (0.50–1.27)
P0.800.33
Patients with hsCRP ≥3
 No. with event/no. at risk21/16214/17118/181
 Cumulative incidence, 3 y, % ± SE5 ± 28 ± 211 ± 3
 RR (95% CI)1 (ref)0.52 (0.26–1.04)0.80 (0.42–1.52)
P0.060.49
Pinteraction0.070.83
  • aNo. at risk includes patients randomized regardless of whether they had a follow-up colonoscopy. All RRs are multivariate-adjusted as described in the methods. P values for interaction were assessed by using cross-product terms for each celecoxib treatment group and each hsCRP strata.

  • bIncludes investigator-reported cardiovascular disorders, which was a prespecified category encompassing cardiovascular death or circulatory collapse, stroke, myocardial infarction or angina, congestive heart failure, venous thrombosis or thromboembolism, cardiovascular therapeutic procedures, vascular therapeutic procedures, cerebrovascular disease, and vascular disease.

  • cIncludes investigator-reported renal and hypertensive disorders, which was a prespecified category encompassing elevated creatinine, fluid retention or edema, hypertension, proteinuria, and renal failure.

  • dIncludes investigator-reported gastrointestinal ulceration and hemorrhage, which was a prespecified category encompassing anemia, gastrointestinal bleeding, gastritis/duodenitis, upper or lower gastrointestinal ulceration, and other hemorrhage.