Gout Musculoskeletal Diseases Gout
Conditions
Interventions
1. All consented and screened patients potentially eligible for the study will receive allopurinol treatment prior to randomisation (allopurinol lead-in phase) according to the European League Against
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 60 years or older with at least one additional cardiovascular risk factor: 1.1. Age =70 years (male) or =75 years (female) 1.2. Smoking (current or within the last 2 years) 1.3. Diabetes mellitus 1.4. Impaired glucose tolerance 1.5. Hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) or receiving treatment to lower blood pressure 1.6. Dyslipidaemia (investigator assessment) 1.7. Chronic kidney disease (CKD) Stage 1-3 1.8. Microalbuminuria or proteinuria 1.9 Family history of coronary heart disease or stroke in first degree relative at age 30 kg/m2 2. Patients who, in the opinion of the recruiting physician, require treatment for chronic hyperuricaemia where urate deposition has already occurred (including a history or presence of tophus and/or gouty arthritis) fulfilling the recommendation for treatment with urate lowering therapy 3. Patients who have received more than or equal to 60 days treatment with allopurinol, or more than or equal to two allopurinol prescriptions, within the previous 6 months 4. Patients, who in the opinion of the recruiting physician or study site coordinator, are eligible for treatment (with reference to the summary of product characteristics) with either allopurinol or febuxostat 5. Patients who are willing to give permission for their paper and electronic medical records, hospitalisation data, prescribing data, and (in the event of their death) their death certification data to be accessed and abstracted by trial investigators 6. Patients who are willing to be contacted and interviewed by trial investigators or delegates (suitably trained research nurses), should the need arise (e.g., for adverse event [AE] assessment and to determine whether an episode of acute gout has occurred)
Exclusion criteria
Exclusion criteria: 1. Patients who have any contraindication to febuxostat or allopurinol (with reference to the summary of product characteristics) or any of the components of their formulations 2. Patients receiving urate lowering therapy (ULT) other than allopurinol 3. Patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 3x reference value, ascites, lower limb oedema, icterus or increased prothrombin time > 2x reference value). 5. Patients with a life-threatening co-morbidity or with a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol 6. Patients with a diagnosis of, or receiving treatment for malignancy (excluding minor skin cancer) in the previous 5 years 7. Patients who have experienced either a myocardial infarction or stroke within the 6 months prior to the screening visit 8. Patients with congestive heart failure, New York Heart Association (NYHA) Class III or IV 9. Patients whose behaviour or lifestyle would render them less likely to comply with study medication (i.e., abuse of alcohol, substance misuse, debilitating psychiatric conditions or inability to provide informed consent) 10. Patients with a current acute gout flare or who are within 14 days of the resolution of a gout flare 11. Patients currently participating in another clinical trial or who have participated in a clinical trial in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary analysis will be the time from randomisation to first occurrence of any event included in the APTC composite endpoint of: 1. Hospitalisation for non-fatal MI 2. Hospitalisation for non-fatal stroke 3. Death due to a cardiovascular event | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints (in rank order of importance) will be evaluated using a time to event analysis: 1. Hospitalisation for non-fatal MI 2. Hospitalisation for non-fatal stroke 3. Cardiovascular death 4. All cause mortality 5. Hospitalisation for heart failure 6. Hospitalisation for unstable, new or worsening angina 7. Hospitalisation for coronary revascularisation 8. Hospitalisation for cerebral revascularisation 9. Hospitalisation for transient ischeamic attack (TIA) 10. Hospitalisation for non-fatal cardiac arrest 11. Hospitalisation for venous and peripheral arterial vascular thrombotic event 12. Hospitalisation for arrhythmia with no evidence of ischaemia | — |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed