Impact of Oxypurinol in Patients With Symptomatic Heart Failure
Key result
Oxypurinol fails to improve clinical outcomes over placebo in moderate-to-severe heart failure.
- n=405
Why the study?
Increased xanthine oxidase activity may contribute to heart failure pathophysiology, but the clinical benefits of oxypurinol in symptomatic systolic heart failure patients were unclear.
Does oxypurinol improve a composite of heart failure morbidity, mortality, and quality of life in patients with NYHA class III-IV heart failure due to systolic dysfunction?
Population
405 patients with NYHA class III to IV systolic heart failure receiving optimal medical therapy
Comparison
Oxypurinol 600 mg/day vs placebo
Design
Randomized controlled trial
Follow-up
24 weeks
Authors
Discussion
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Member takes
Implication
Oxypurinol did not improve clinical outcomes in unselected patients with moderate-to-severe heart failure, though post-hoc analysis suggests potential benefit in those with elevated serum uric acid.
Key Points
- To determine whether the xanthine oxidase inhibitor oxypurinol produces clinical benefits in patients with NYHA class III to IV heart failure due to systolic dysfunction receiving optimal medical therapy.
- Randomized, double-blind, placebo-controlled clinical trial (NCT00063687) enrolling 405 patients with symptomatic systolic heart failure.
- Participants received oxypurinol (600 mg/day) or placebo for 24 weeks.
- Assessed clinical efficacy via a composite endpoint of morbidity, mortality, and quality of life, alongside changes in serum uric acid (SUA).
- The percentage of patients categorized as improved, unchanged, or worsened did not differ significantly between oxypurinol and placebo groups.
- Oxypurinol significantly reduced serum uric acid by approximately 2 mg/dl compared to placebo (p < 0.001).
- Patients with baseline serum uric acid >9.5 mg/dl (n = 108) experienced clinical benefit from oxypurinol (p = 0.02 for interaction), with responders exhibiting greater uric acid reductions than non-responders (-2.3 ± 2.1 vs. -1.0 ± 1.9 mg/dl, p = 0.0006).
Study Design
Type
RCT (n=405)
Randomization
randomized
Structured PICO
Does oxypurinol improve a composite of heart failure morbidity, mortality, and quality of life in patients with NYHA class III-IV heart failure due to systolic dysfunction?
P
Population
405 patients with NYHA class III to IV heart failure due to systolic dysfunction receiving optimal medical therapy, evaluated at 24 weeks.
I
Intervention
Oxypurinol 600 mg/day
C
Comparator
Placebo
O
Outcome
Composite end point comprising heart failure morbidity, mortality, and quality of life at 24 weekscomposite
Oxypurinol did not improve clinical outcomes in unselected patients with moderate-to-severe heart failure, though post-hoc analysis suggests potential benefit in those with elevated serum uric acid.
Limitations
- Post-hoc analysis for the subgroup with elevated serum uric acid
Cite This Study
Hare et al. (2008) conducted an RCT in New York Heart Association functional class III to IV heart failure due to systolic dysfunction (n=405). Oxypurinol vs. placebo was evaluated on composite end point comprising heart failure morbidity, mortality, and quality of life. Oxypurinol did not improve the composite of heart failure morbidity, mortality, and quality of life compared with placebo in unselected patients with moderate-to-severe heart failure.