Abstract
This pharmacoepidemiologic study was conducted to determine whether risk factors for upper gastrointestinal bleeding influenced the prescription of cyclo-oxygenase (COX)-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) at the time when COX-2 inhibitors were first included in the formulary of reimbursed medications. A population-based case–control study was conducted in which the prevalence of risk factors and the medical histories of patients prescribed COX-2 inhibitors and traditional nonselective NSAIDs were compared. The study population consisted of a random sample of members of the Quebec drug plan (age 18 years or older) who received at least one dispensation of celecoxib (n = 42,422; cases), rofecoxib (n = 25,674; cases), or traditional nonselective NSAIDs (n = 12,418; controls) during the year 2000. All study data were obtained from the Quebec health care databases. Adjusting for income level, Chronic Disease Score, prior use of low-dose acetylsalicylic acid, acetaminophen, antidepressants, benzodiazepines, prescriber specialty, and time period, the following factors were significantly associated with the prescription of COX-2 inhibitors: age 75 years or older (odds ratio [OR] 4.22, 95% confidence interval [CI] 3.95–4.51), age 55–74 years (OR 3.23, 95% CI 3.06–3.40), female sex (OR 1.52, 95% CI 1.45–1.58), prior diagnosis of gastropathy (OR 1.21, 95% CI 1.08–1.36) and prior dispensation of gastroprotective agents (OR 1.57, 95% CI 1.47–1.67). Patients who received a traditional nonselective NSAID recently were more likely to switch to a coxib, especially first-time users (OR 2.17, 95% CI 1.93–2.43). Associations were significantly greater for celecoxib than rofecoxib for age, chronic NSAID use, and last NSAID use between 1 and 3 months before the index date. At the time of introduction of COX-2 inhibitors into the formulary, prescription channeling could confound risk comparisons across products.
Highlights
Randomized clinical trials have confirmed the advantage of cyclo-oxygenase (COX)-2 inhibitors over traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with respect to gastrotoxicity [1,2,3,4,5,6,7,8], a large number of spontaneous reports have incriminated COX-2 inhibitors [9]
After applying the selection criteria, 42,422 celecoxib, 25,674 rofecoxib and 12,418 traditional non-selective NSAID users were identified for the study
Patients treated with celecoxib were on average slightly older than those treated with rofecoxib or traditional nonselective NSAIDs, and a larger proportion of women were treated with COX-2 inhibitors as opposed to traditional nonselective NSAIDs
Summary
Randomized clinical trials have confirmed the advantage of cyclo-oxygenase (COX)-2 inhibitors over traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with respect to gastrotoxicity [1,2,3,4,5,6,7,8], a large number of spontaneous reports have incriminated COX-2 inhibitors [9]. The randomized clinical trial is the design best suited to determine drug efficacy, but it is inadequate for the evaluation of effectiveness, which applies to heterogeneous patient populations and patterns of drug use observed in a real life setting. In addition to pharmacological differences across products, the dosages used for the various indications [18] and past experience with the drug (through the 'depletion of susceptibles' effect) [19] account for ASA = acetylsalicylic acid; CDS = chronic disease score; COX = cyclo-oxygenase; NSAIDs = nonsteroidal anti-inflammatory drugs. In the absence of randomization, it is of utmost importance, when comparing the risks associated with individual drug classes, to determine whether the patient populations are comparable
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