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Comparative Safety of Gout Treatment Strategies on Cardiovascular Outcomes Using Observational Data:
Kazuki Yoshida1,2,3, Jun Liu4, Rishi J Desai2,4
1From the Division of Rheumatology, Inflammation, and Immunity, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Insights
Intensive gout treatment strategies targeting serum urate levels did not increase major adverse cardiovascular events. This study provides reassurance for the cardiovascular safety of these recommended gout management approaches.
Area of Science:
- Cardiology
- Rheumatology
- Health Services Research
Background:
- Gout management guidelines recommend intensive treat-to-target serum urate strategies.
- The cardiovascular safety of these intensive strategies requires examination.
Purpose of the Study:
- To examine the cardiovascular safety of intensive treat-to-target serum urate strategies for gout.
- To compare major adverse cardiovascular events (MACE) rates across different urate-lowering therapy strategies.
Main Methods:
- Retrospective analysis of Medicare claims linked to EHR laboratory data.
- Emulation of a hypothetical trial using the "clone-censor-weight" method.
- Comparison of seven urate-lowering strategies based on continuation, monitoring, and modification of therapy.
Main Results:
- 4402 gout patients initiating urate-lowering therapy were analyzed.
- No increased risk of major adverse cardiovascular events was found with intensive strategies.
- Rate ratios suggested potential reductions in MACE compared to usual care, though confidence intervals were imprecise.
Conclusions:
- Intensive treat-to-target serum urate strategies for gout appear safe from a cardiovascular perspective.
- Findings may reassure clinicians and patients about the cardiovascular safety of recommended gout management protocols.
Background:
We sought to examine the cardiovascular safety of intensive treat-to-target serum urate strategies for gout using Medicare claims data linked to electronic health record laboratory data.
Methods:
We selected patients with gout who initiated urate-lowering therapy. We emulated a hypothetical trial comparing the rate of major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) among seven different strategies over 24 months. Three aspects were considered in defining increasingly intensive strategies: (1) continuation of urate-lowering therapy, (2) serum urate monitoring, and (3) modification of urate-lowering therapy when serum urate >6 mg/dl. We applied the "clone-censor-weight" method to account for baseline and time-varying confounding.
Results:
We identified 4402 patients with gout who initiated urate-lowering therapy (mean age 77; male 60%). During a total of 6611 person-years (PY) of follow-up under usual care, the rate of major cardiovascular events (first and recurrent) was 4.5/100 PY (95% CI = 4.0, 5.1). The rate ratios (RRs) suggested reductions (RR point estimates 0.88-0.84) compared with usual care. All 95% CIs were imprecise, but their upper bounds excluded substantial increase in RRs. RRs were closer to 1.0 for the analysis focusing on the first major adverse cardiovascular event during follow-up and on comparison to the strategy requiring continuation of urate-lowering therapy (but not necessarily titration).
Conclusions:
Our treatment strategy trial emulation did not find increased risk of major adverse cardiovascular events with intensive urate-lowering strategies. Results may provide reassurance of the cardiovascular safety of intensive treat-to-target serum urate strategies recommended by rheumatology societies.
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