RESUMO
OBJECTIVE: To develop guidelines for the appropriate use of NSAIDs in rheumatology. METHODS: We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a tworound Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of five recommendations in which the agreement was low or was divided were also carried out. RESULTS: Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. CONCLUSIONS: The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile.
RESUMO
OBJECTIVE: To assess the costs of standard care in patients with active rheumatoid arthritis (RA) seen in a tertiary care center in México City in the context of a clinical trial. To analyze the relationship between costs and utility units obtained by the patients in this scenario. PATIENTS AND METHODS: This economic evaluation was performed during a clinical trial with a 48-week followup in a tertiary care center in México City. The trial compared the efficacy of omega-3 fatty acids versus placebo in patients with active RA who also received standard rheumatology care. The costs of medical consultations, complementary tests and drugs were assessed. Other direct costs were also measured. Hypothetical scenarios with fewer medical consultations and complementary tests than those in the clinical trial were also analyzed. Utilities were assessed by the Health Utility Index. A cost-utility ratio was calculated using the baseline utilities score as comparator. A descriptive statistical analysis was performed. RESULTS: Ninety RA patients (83 women [92%], age [X ± SD] 43.2 ± 14.2 years with disease duration of 3.3 ± 4.6 years) were included. Data from 88 patients were analyzed. The total direct costs were 152,704.11 US$ 2005 divided into medical attention (78,386.43 US$ 2005, 51.33%), drugs (39,339.5 US$ 2005, 25.76%) and other direct costs (34,978.18 US$ 2005. 22.91%). In scenarios with fewer medical consultations and complementary tests than those in the clinical trial, the total direct costs ranged from 39,507.4 to 103,880.6 US$ 2005. Patients improved by a mean of 0.18 utility units on a 0-1 scale equivalent to 0.18 quality adjusted lifeyears (QALYs). The cost-utility ratios ranged from 2,494.1 to 9,640.38 US$ 2005 per QALY in the scenarios analyzed. CONCLUSIONS: The direct costs of the standard care of RA in the scenarios analyzed are substantial in the social and economic context of Mexico. The cost per gained QALY is high.
RESUMO
OBJECTIVE: To perform a systematic analysis and case-control study of our patients with systemic lupus erythematosus (SLE) to determine the prevalence of acute pancreatitis (AP). METHODS: All episodes of AP in SLE patients were identified (July 1984-July 2001). Prevalence was calculated. Etiology for each AP event was classified into mechanical, toxic-metabolic, or idiopathic. AP severity was defined based on Atlanta criteria. SLE disease activity was scored using Mex-SLEDAI index. A control group of non-SLE patients with AP was designed to establish the risk of developing severe or fatal idiopathic AP in patients with SLE. RESULTS: Forty-nine AP episodes were identified in 35 SLE patients (30 +/- 14 yrs old, 94% female). Prevalence was 3.5%. A single episode was present in 26 patients. Identified AP causes were mechanical in 14 and toxic-metabolic in 10. Seventeen episodes were considered idiopathic. At least one drug related to AP was administered in 13 episodes. Corticosteroids were in use in 32 episodes, and as the only drug in 16. Mex-SLEDAI scores were significantly higher in idiopathic events. In the case-control analysis, idiopathic AP was more frequent in SLE cases (46% vs 14%). The strength of association of AP severity and related mortality was higher in SLE patients (OR 8.6 and 7.5, respectively). CONCLUSION: AP is not a highly prevalent manifestation of SLE. Idiopathic cases predominate and show increased SLE activity. Drug consumption does not seem to participate in AP development. SLE episodes are more severe and frequently fatal.