Abstract
Objective
To evaluate and compare the risk of erectile dysfunction (ED) associated with the use of allopurinol and febuxostat in adult male gout patients.
Methods
We conducted a cohort study using TriNetX (Cambridge, MA, USA), a global federated health research network that provides real-time electronic medical record datasets. We analyzed and compared the associated risk of ED in gout patients who started taking allopurinol or febuxostat within 12 months. Propensity score matching was performed to adjust for demographic variables, comorbidities, and medication use. Kaplan–Meier analysis was used to estimate the probability of the outcome of interest. The hazard ratio (HR) and associated confidence intervals were calculated along with the proportionality test using R's Survival Package v3.2-3.
Results
We identified 679,862 patients with gout among 107,517,445 patients in the database. Of these patients, 24,000 were treated with febuxostat and 299,726 with allopurinol. After propensity matching, 9075 patients receiving febuxostat without allopurinol (febuxostat group) and 9075 corresponding patients receiving allopurinol without febuxostat (allopurinol group) were analyzed for comparison. Among all male patients over 19 years of age, febuxostat was associated with a significantly higher risk of ED versus allopurinol (HR 1.354; 95% confidence interval (CI) 1.003–1.829; log rank test, p = 0.047). After subgroup analysis, in gout patients aged 19–64 years, a significantly higher incidence of ED was observed in the febuxostat group than in the allopurinol group (HR 2.002, 95% CI 1.282–3.126). The risk of ED did not differ significantly between the allopurinol and febuxostat groups in gout patients older than 65 years.
Conclusions
Febuxostat may be associated with a higher risk of ED than allopurinol in adult male patients with gout. Future large-scale prospective studies are warranted to confirm our results.
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Data availability statement
Data availability statement has been introduced in the section “Availability of data and materials (data sharing statement)”.
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DR SMD and Dr CCW had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design: Dr SMD. Acquisition, analysis, or interpretation of data: All authors. Drafting the manuscript: Dr QT. Editing the manuscript: Dr SMD. Statistical analysis: Dr SIW and Dr QT.
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This article was supported by funding from NSFC 81900795.
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The authors declare that there are no competing interests.
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The TriNetX platform is compliant with the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR). The Western Institutional Review Board (WIRB) has granted a waiver to TriNetX because it contains only aggregated counts and statistical summaries of anonymized information. The use of TriNetX for the present study was approved by the Institutional Review Board of Chung Shan Medical University Hospital (CSMUH No: CS2-21176).
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All data relevant to the study are included in the article.
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https://live.trinetx.com/tnx/study/111600/analytics/632a78c05745ce4a5743338a/outcomes/results.
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Tong, Q., Du, Y., Cui, R. et al. Risk of Erectile Dysfunction in Male Patients with Gout Treated with Febuxostat or Allopurinol: A Propensity Score-Matched Cohort Study. Drugs 82, 1717–1726 (2022). https://doi.org/10.1007/s40265-022-01816-x
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DOI: https://doi.org/10.1007/s40265-022-01816-x