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Urate Lowering Therapy with Febuxostat in Daily Practice—A Multicentre, Open-Label, Prospective Observational Study

DOI: 10.1155/2014/123105

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Abstract:

Introduction. Febuxostat, a novel xanthine oxidase inhibitor for the treatment of symptomatic hyperuricemia, showed superiority over allopurinol in the reduction of serum uric acid levels in pivotal studies. Whether this holds true the FORTE (febuxostat in the oral urate lowering treatment: effectiveness and safety) study was conducted to evaluate treatment with febuxostat under daily practice conditions. Materials/Methods. The multicentre, open-label, and prospective observational study was conducted in 1,690 German medical practices from 9/2010 to 5/2011. Safety and efficacy data were assessed at baseline and week 4. Results. Data from 5,592 gout patients (72.6% male, mean age 63.7 years) were collected. Under urate lowering treatment with febuxostat mean serum uric acid levels decreased significantly from ?mg/dL ( ? mol/L) at baseline to ?mg/dL ( ? mol/L) at week 4. 67% which reached the mean uric acid target ( ?mg/dL [ ? mol/L]). Only 43.1% of patients received concomitant flare prophylaxis. A total of 178 adverse events (mostly gout flares) were reported in 152 patients (2.6%). Conclusion. Febuxostat lowers serum uric acid levels effectively in routine clinical practice. Overall, treatment with febuxostat in both available dosages (80?mg/120?mg) was safe and well tolerated. 1. Introduction Gout is the most common inflammatory arthritic disease. Gout incidence is increasing due to the aging population and concomitant rise in comorbidities, such as chronic renal impairment, as well as administration of drugs known to inhibit uric acid excretion (e.g., low-dose aspirin, thiazide, and loop diuretics) [1, 2]. A “modern” lifestyle (purine-rich diet, lack of physical exercise, and excessive alcohol consumption) and successively increased body mass index promote hyperuricaemia and gout [3, 4]. Persistent untreated hyperuricaemia can lead to depositions of monosodium urate in joints and soft tissues (known as tophi). The solubility of monosodium urate is strong temperature and pH dependency. The saturation threshold at 37°C is 6.8?mg/dL (~400?μmol/L). Exceeding this threshold leads to crystallization. Initially, characteristic flares occur as monoarticular arthritis, such as the classic podagra. During progression, other joints can be involved, leading to tophus formation and joint destruction. Only rarely have cases of tophus formation in interior organs, for example, valvular or pancreatic regions, been observed [5]. Other complications from gout include formation of kidney stones and deterioration of prevalent impaired renal function. Therefore gout is a

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