Selective cyclooxygenase-2 inhibition and cardiovascular effects: An observational study of a Medicaid population

Channeling and prevalence of cardiovascular contraindications in users of cyclooxygenase 2 selective nonsteroidal antiinflammatory drugs

“…Cohort studies (US and Canada) that compared cardiovascular outcomes between coxibs and nonselective NSAIDs showed that coxib users received more cardiovascular comedication and had more comorbidity, higher prior use of NSAIDs, and more prescriptions at baseline (13)(14)(15)(16)(17), which is in line with our data.…”

“…Evidence of channeling of coxibs to persons with NSAID-related GI risk factors is consistently described in all observational studies that investigate the GI and/or cardiovascular effects of coxibs as compared with nonselective NSAIDs, both in Canada and the US (13)(14)(15)(16)(17). A UK study of GI outcomes demonstrated that coxibs are prescribed to patients with a greater disease severity, more comorbid conditions, and higher prevalence of GI risk factors (18).…”

Risks versus benefits of cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs

“…These observational studies allow us to examine the use of these agents in much larger populations and in subgroups of interest that were not included in the RCTs, including those at extreme age, with various comorbidities of interest, and with concomitant medications with potentially important interactions. In summary, these data indicate that rofecoxib is associated with an increased risk of cardiovascular events in a dose-dependent fashion as compared with traditional NSAIDs and celecoxib in most studies, 15,[17][18][19][20][21][22]24,40 except in studies conducted by Mamdani et al, 41 Kimmel et al, 42 and Shaya et al 43 In these latter three studies, data from all rofecoxib dosages were combined. In contrast to the APPROVe data, which showed significantly increased cardiovascular risk after only 18 months, data from observational studies suggest that rofecoxib increases risk early in the course of usage.…”

Retrospective analysis of utilization patterns and cost implications of coxibs among seniors in Quebec, Canada: What is the potential impact of the withdrawal of rofecoxib?

“…For example, one retrospective database study found a significantly higher rate of hospitalization for upper GI hemorrhage among rofecoxib users than celecoxib users (36), but trends towards a higher rate of GI adverse events for rofecoxib than celecoxib in 2 retrospective case-control studies appeared not to be significant (37,38). Some observational studies found significantly higher rates of various serious cardiovascular events for rofecoxib compared with celecoxib (39 -44), whereas other studies indicated no significant difference (45)(46)(47). The US Food and Drug Administration recently concluded that currently available data do not allow ranking of coxibs with regard to cardiovascular risk (48).…”