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Clinical Conference Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis. 2002
Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, Reicin A. · University of Southern California School of Medicine, Los Angeles, California 90033, USA. · Gastroenterology. · Pubmed #12360461 No free full text.
Abstract: BACKGROUND & AIMS: Epidemiologic data indicate that the risk of nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) clinical events varies based on patients' clinical characteristics. The authors determined risk factors for NSAID-related clinical upper GI events and the event rates, absolute risk reductions, and numbers needed to treat for individual risk factors for a nonselective NSAID and a selective cyclooxygenase 2 inhibitor in a double-blind outcomes trial. METHODS: Eight thousand seventy-six rheumatoid arthritis patients aged >or=50 years (or >or=40 on corticosteroid therapy) were randomly assigned to rofecoxib 50 mg daily or naproxen 500 mg twice daily for a median of 9 months. The development of clinical upper GI events (bleeding, perforation, obstruction, and symptomatic ulcer identified on clinically indicated work-up) was assessed. RESULTS: Significant risk factors included prior upper GI events, age >or=65, and severe rheumatoid arthritis (RR, 2.3-3.9). Patients administered naproxen who had prior upper GI complications or who were aged >or=75 years had 18.84 or 14.46 events per 100 patient-years, and the risk of events remained constant over time. The reduction in events with rofecoxib was similar in high- and low-risk subgroups (RR, 0.31-0.68). The number needed to treat with rofecoxib instead of naproxen to avert 1 GI event was 10-12 in highest risk patients (prior event, age >or=75 years, or severe rheumatoid arthritis), 17-33 in patients with other risk factors, and 42-106 in low-risk patients. CONCLUSIONS: NSAID-related GI events increase dramatically with risk factors such as prior events or older age. Ten to twelve high-risk patients need to be treated with a protective strategy such as the selective cyclooxygenase 2 inhibitor, rofecoxib, to avert a clinical GI event.
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Clinical Conference Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. free! 2000
Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, Anonymous00004. · Institute for Work and Health, Mount Sinai Hospital, and the University Health Network, Toronto, ON, Canada. · N Engl J Med. · Pubmed #11087881 links to free full text
Abstract: BACKGROUND: Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis. METHODS: We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers). RESULTS: Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P<0.001). The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.005). The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups. CONCLUSIONS: In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.
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Article 'It's quite hard to grasp the enormity of it': perceived needs of people upon diagnosis of rheumatoid arthritis. 2008
Radford S, Carr M, Hehir M, Davis B, Robertson L, Cockshott Z, Tipler S, Hewlett S. · Clinical Psychology Department, University of Plymouth, UK. · Musculoskeletal Care. · Pubmed #18649347 No free full text.
Abstract: OBJECTIVES: The diagnosis of rheumatoid arthritis (RA) brings rapid pharmacological and multidisciplinary team interventions to address inflammatory processes and symptom management. However, people may also need support on the journey to self-management. The aim of this study was to explore what professional support patients feel they receive upon diagnosis, and what support they feel would be most helpful. METHODS: Two focus groups comprised patients with at least five years'; disease duration (n = 7), and patients more recently diagnosed (5-18 months, n = 5). The latter had attended at least two appointments in a rheumatology nurse specialist clinic during the previous year, aimed at providing support upon diagnosis. Transcripts were subjected to thematic analysis to identify common issues regarding support needs, which were then grouped into themes. Interviewing and analysis was performed by researchers not involved in clinical care. RESULTS: Four overarching themes emerged. 'Information' was needed about the symptoms of RA, its management and personal outcome, while 'Support' related to emotional needs ('It's quite hard to grasp the enormity of it'). Information and Support overlapped, in that patients wanted someone to talk to, and to be listened to. These two themes were underpinned by issues of service delivery: 'Choice' (patient or professional to talk to, groups, one-to-one) and 'Involvement' (holistic care, partnership), which overlapped in terms of the opportunity to decide when and which interventions to access. CONCLUSIONS: People with RA report not only informational, but also emotional support needs at diagnosis. The potential for delivering emotional support to patients around the time of diagnosis warrants further exploration.
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Article Nursing support at the onset of rheumatoid arthritis: Time and space for emotions, practicalities and self-management. 2008
Hehir M, Carr M, Davis B, Radford S, Robertson L, Tipler S, Hewlett S. · University of the West of England, Bristol, UK. · Musculoskeletal Care. · Pubmed #17922490 No free full text.
Abstract: BACKGROUND: Following a diagnosis of rheumatoid arthritis (RA), patients have to adapt to lifelong, unpredictable but repeated episodes of pain and disability, potentially leading to permanent loss of function and its consequences on their lives. We established nurse clinics with the aim of supporting newly diagnosed RA patients in adapting to and managing their long-term condition. The aim of this study was to explore the content of clinic discussions in this new clinical service, in order to ascertain patients' needs upon diagnosis. METHODS: All clinic letters from the nurse to the family doctor were analysed. Every topic mentioned was systematically coded independently by a researcher and a patient research partner, who compared and agreed codes. Codes were organized into categories, and, finally, into overarching themes. RESULTS: Twenty-four patients had 74 appointment letters. A total of 79 codes were identified, from which ten categories emerged, and, finally, three overarching themes. The first theme related to 'Emotional support', which underpinned the other two themes and was discussed in almost all appointments. Issues included discussions about the emotional consequences of RA, needing time to adjust, frustration and fears for the future. The second theme 'Practicalities of the treatment of RA', included subordinate themes relating to the nature of RA, such as identity, cause, timeline, consequences and treatment. Medication issues were discussed and referrals to the multidisciplinary team were made. The final theme related to the 'Self-management of RA', and included discussions on physical symptoms and their management. CONCLUSIONS: The offer to attend a nurse clinic soon after diagnosis allowed RA patients to discuss a wide range of practical and self-management issues. However, most patients also took the opportunity and time to discuss emotional reactions and adaptations to diagnosis. The data suggest an unmet need for emotional support that a nurse clinic might be able to provide.
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Minor Response to expression of concern regarding VIGOR study. 2006
Bombardier C, Laine L, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, Weaver A. · No affiliation provided · N Engl J Med. · Pubmed #16495387 No free full text.
This publication has no abstract.
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