Table 4.
Criteria | Answer | Evidence |
---|---|---|
Is there a strong independent, consistent association between the surrogate endpoint and the clinical endpoint? | Yes | Recent IPD analysis from two allopurinol RCTs shows clear relationship between achieving urate <0.36mmol/l and reduction in flares [24] Trials of febuxostat and allopurinol and pegloticase consistently show reduction in flares [1, 25] |
Is there evidence from randomized trials in the same drug class that improvement in the surrogate end point has consistently led to improvement in the target outcome? | Yes | Trials of febuxostat and allopurinol consistently show reduction in flares [1, 25] Recent IPD analysis from two allopurinol RCTs shows clear relationship between achieving urate <0.36mmol/l and reduction in flares [24] |
Is there evidence from randomized trials in other drug classes that improvement in the surrogate end point has consistently led to improvement in the target outcome? | (Yes) | Trials of febuxostat and allopurinol and pegloticase consistently show reduction in flares [1, 25] |