Response to expression of concern regarding VIGOR study.
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Arthritis, Rheumatoid↗
Biomedical subjects
Barry Davis
Publications and source records attributed to Barry Davis.
Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis.
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.
Adrenal Cortex Hormones↗
Diabetes mellitus, smoking, and the risk for asymptomatic peripheral arterial disease: whom should we screen?
OBJECTIVE: To describe coexisting medical conditions and lifestyle factors associated with asymptomatic peripheral arterial disease (PAD) in a population of white, African American, and Hispanic patients. STUDY DESIGN AND SETTING: White, African American, and Hispanic patients 50 years or older were recruited for this cross-sectional study from 4 primary care clinics in Houston, TX. Patients with an ankle-brachial index (ABI) < 0.9 and without leg symptoms typical of PAD were diagnosed with asymptomatic PAD. RESULTS: 403 patients were screened for PAD. Of these, 25 (6.2%) had asymptomatic PAD. Compared with patients without PAD, diabetes mellitus ([OR] 3.8; 95% CI 1.6, 9.0) and a history of smoking at least 1 pack of cigarettes per day ([OR] 2.5; 95% CI 1.1, 6.0) were significantly associated with asymptomatic PAD. An interaction effect existed between diabetes mellitus and smoking at least 1 pack of cigarettes per day. Diabetes mellitus combined with heavy smoking showed the highest predicted value positive (15%) and the highest specificity (92%). A lack of both demonstrated low rates for predicting asymptomatic PAD (predicted value positive, 1%). CONCLUSION: The ankle-brachial index could become routine screening among patients with diabetes mellitus and/or who smoke.
Aged↗