Patient burden of weight gain and blood pressure increase among RA patients using celecoxib, rofecoxib, and non-specific NSAIDs

Abstract

Nonspecfic NSAIDs (NS NSAIDs) and COX-2 specific inhibitors are used by 66% of RA patients; the use of these drugs may be accompanied by potential, clinically important, renal side effects. Recently, a number of reports have suggested that rofecoxib may have more renal-related side effects than celecoxib and NS NSAIDs. In this report, we compared the difference in renal-related side effects among celecoxib, rofecoxib, and NS NSAIDs and investigated the burden of these side-effects to RA patients. In 2002, 2,595 patients who participated in a long-term outcomes study of RA and consequently used COX-2 specific inhibitors or NS NSAIDs were surveyed and grouped by their current NSAID: celecoxib (N=822), rofecoxib (N=448), naproxen (N=276), ibuprofen (N=226), aspirin (N=176) and others (N=647). Patients were assessed with a specially designed questionnaire to measure weight gain, swelling, and blood pressure increases. The questionnaire inquired about side effects and symptoms that were ‘due to’ NS NSAID or COX-2 specific inhibitor use. Questions were rated on 6-point categorical scales ranging from ‘did not experience’ to ‘extremely bothered.’ Ordered logistic regression and binary logistic regression, adjusting for 13 confounders, was used to distinguish the burden of side effects by treatment group. After adjusting for possible confounding factors, patients on rofecoxib were significantly more likely to report a problem regarding weight gain (P<0.05) and blood pressure increase (p<0.001). In addition, rofecoxib users were 28% more likely to be in a more severe category for being bothered by unintentional weight gain (OR = 1.28, p < 0.05) and 53% more likely to be in a more severe category for blood pressure increase (OR = 1.53, p < 0.000), compared to patients receiving celecoxib. The differences of weight gain, swelling, and blood pressure increases between celecoxib users and NS NSAID users were not statistically significant. Weight gain and blood pressure increase was also increased by coexisting cardiovascular disease. Rofecoxib patients were 77% more likely to be moderately, quite, or extremely bothered by blood pressure increase (OR=1.77, p=0.002), compared to patients using celecoxib. Compared to celecoxib and NS NSAID use, patients using rofecoxib reported more weight gain, blood pressure increase, as well as with more bothersomeness associated with these symptoms.