TABLE 2.
Major trials of coxibs versus placebo
Trial | Population | Regimen | Follow-up | Serious cardiovascular events |
---|---|---|---|---|
APPROVe (6) | 2586 patients with history of colorectal adenoma | Rofecoxib (R) 25 mg/day vs placebo (Pl) | Mean R=2.4 years, Pl=2.6 years | Serious thrombotic events: R=1.50%/year, Pl=0.78%/year, HR=1.92 (P=0.008) |
APC (7) | 2035 patients with history of colorectal adenoma | Celecoxib (C) 400 mg or 800 mg/day vs Pl | Range 2.8–3.1 years | Composite of cardiovascular death, myocardial infarction, stroke or heart failure: C=0.96%/year, Pl=0.34%/year, RR=2.8 (P=0.01) |
Nussmeier et al (8) | 1671 patients immediately after CABG surgery | Parecoxib (P) IV for 3 days, then valdecoxib (V) for 7 days vs Pl IV, then V vs Pl IV, then Pl po | 30 days | Cardiovascular events: P or V=1.62% in 1 month (P=0.5), RR=2.9 (P=0.08) |
APC Adenoma Prevention with Celecoxib; APPROVe Adenomatous Polyp PRevention On Vioxx; CABG Coronary artery bypass graft; HR Hazard ratio; IV Intravenous; po By mouth