Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial
Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered. However, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol / l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration. This study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.
• Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
• Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):
‣ Either a first crisis,
⁃ Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.
• Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
• Age ≥ 18 years old,
• Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion),
• Patient having read and understood the information letter and signed the consent form,
• Affiliation to a social security scheme,
• Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after the last dose of the drug. ) and a negative urine pregnancy test on inclusion and throughout the duration of the study Where Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.