Pattern of use and safety of non-steroidal anti-inflammatory drugs in rheumatoid arthritis patients. A prospective analysis from clinical practice.

OBJECTIVE The aim of this study was to determine the prescription pattern and the safety profile of non-steroidal anti-inflammatory drugs (NSAID), including cyclooxygenase-2 inhibitors (COXIB) in patients with rheumatoid arthritis (RA) under a real life clinical setting. PATIENTS AND METHODS Data was obtained from the EMECAR study, a prospective cohort of randomly selected RA patients (n=789) followed up from 1999 to 2004 in Spain. RESULTS Upon entry into the cohort, 613 (78%) patients included took or had taken NSAID because of RA. Patients treated with NSAID, compared to those who did not take these compounds, were younger (60 versus 66 years of age) and have had both less cardiovascular (11 versus 20%; p<0.001) and gastric ulcer (11 versus 23%; p<0.001) complications. In the group of patients that used NSAID, RA had been diagnosed earlier (age at onset 47 versus 53; p<0.001) and was more active (DAS28: 4.4 versus 3.7; p<0.001). During follow-up, the percentage of RA patients using NSAID decreased from 78% in year 2000 to 66% in 2004. The use of antiulcer agents increased from 11% in 2000 to 60% in 2004, independently of both the use of classic NSAID or COXIB and the presence of risk factors for NSAID-induced gastropathy. Severe gastric complications and cardiovascular events were infrequent and the incidence was not different between patient who took NSAID and those who did not, as well as between patients treated with classic NSAID or with COXIB. CONCLUSIONS NSAID are commonly used in the management of RA. These compounds are well tolerated and the frequency of severe adverse events attributed to them is relatively low under daily practice conditions in these patients.