Febuxostat versus allopurinol streamlined trial

Not Applicable

Completed

• Conditions: Gout; Musculoskeletal Diseases

• Registration Number: ISRCTN72443728
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25011991 2019 substudy results in: https://www.ncbi.nlm.nih.gov/pubmed/30700250 (added 01/02/2019) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33181081/ (added 13/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-28
• Study Completion: 2019-12-31
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6128

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 < 55 years
1.10. Inflammatory arthritis (investigator assessment ? including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
1.11. Chronic non-steroidal anti-inflammatory drugs (NSAID) therapy (investigator assessment)
1.12. Previous cardiovascular (CV) event [myocardial infarction (MI), cerebrovascular accident (CVA) or transient ischaemic attack (TIA)]
1.13. Peripheral vascular disease (investigator/clinical assessment)
1.14. Chronic obstructive pulmonary disease (COPD)
1.15. Body mass index > 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

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) < 30 mL/min as defined by the Cockroft-Gault formula (http://www.nephron.com/cgi-bin/CGSI.cgi) according to creatinine, age, sex and body weight]
4. Patients with moderate or severe hepatic impairment i.e. cirrhosis with clinical and/or biological decompensation (i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified