hyperuricemia
Conditions
Interventions
Febuxostat treatment group: Febuxostat will be taken orally for 36 months after enrollment (approximately 3 years). Febuxostat will be taken once daily after breakfast (generally within 30 minutes af
= 2.0 mg/dL during febuxostat up-titration, the dose will not be increased. (2) If the serum uric acid level falls to <
= 2.0 mg/dL during treatment with febuxostat, the dose will be decreased one level (20 mg).
Non-febuxostat treatment group: The administration of allopurinol 100 mg will be investigated as a response
Sponsors
FREED Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients 65 years of age or older at enrollment who are able to visit (2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment (3) Patients at risk for any of the cerebral or cardiorenovascular diseases in 1) through 4) below 1) Previous or current history of hypertension 2) Previous or current history of type 2 diabetes mellitus 3) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) 4) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure) (4) Patients who personally give written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: (1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment (2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol (3) Patients with malignant tumors (4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2, etc. (5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage) (6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment (7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment (8) Patients with AST or ALT 2 or more times the upper limit of normal within 3 months prior to enrollment (9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine (10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat (11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics (12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products) (13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded) (14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of cerebral and cardiorenovascular events and all deaths The occurrence of cerebral and cardiorenovascular events and all deaths during the study period (enrollment to study completion or withdrawal from the study) will be assessed. (1)Death due to cerebral or cardiorenovascular disease (2)New or recurrent cerebrovascular disease (stroke [cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, stroke of unknown type], transient ischemic attack (3)New or recurrent non-fatal coronary artery disease (myocardial infarction and unstable angina pectoris) (4)Cardiac failure requiring hospitalization (5)Arteriosclerotic disease requiring hospitalization (aortic aneurysm, aortic dissection, and arteriosclerosis obliterans) (6)Renal impairment (development of microalbuminuria, progression to overt proteinuria, or overt proteinuria [ >= 300 mg/gCr],confirmed by two consecutive laboratory tests performed after the initiation of study treatments; doubling of serum creatinine level;and progression to ESRD) (7)New atrial fibrillation (including paroxysmal atrial fibrillation) (8) Deaths that are not caused by cerebral or cardiorenovascular disease | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Occurrence of cerebral and cardiorenovascular events by event, by serum uric acid level, and by previous history of cerebral and cardiorenovascular disease 1) Occurrence of each cerebral and cardiorenovascular event during the study period 2) Occurrence of all cerebral and cardiorenovascular events and each cerebral and cardiorenovascular event during the study period by serum uric acid level (baseline, level reached, and change) 3) Occurrence of all cerebral and cardiorenovascular events and each cerebral and cardiorenovascular event during the study period by previous history of cerebral and cardiorenovascular disease 4) Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat dose 5) Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinol (2) Serum uric acid level 1) Levels of, and change in, serum uric acid level from baseline to Month 36 (or withdrawal from the study) 2) Percent achieving a serum uric acid level of 6.0 mg/dL during the study period (3) eGFR Levels of, and change in, eGFR from baseline to Month 36 (or withdrawal from the study) (4) Urinary microalbumin/creatinine ratio Levels of, and change in, urinary microalbumin/creatinine ratio from baseline to Month 36 (or withdrawal from the study) (5) Quantification of urinary protein Levels of, and change in, quantified urinary protein from baseline to Month 36 (or withdrawal from the study) (6) Blood pressure Levels of, and change in, blood pressure (systolic and diastolic) from baseline to Month 36 (or withdrawal from the study) (7) Adverse events | — |
Countries
Japan
Contacts
Public ContactFREED Study Support Center
FREED Study Support Center FREED Study Support Center
Outcome results
None listed