4.7 Article

International cohort study indicates no association between alpha-1 blockers and susceptibility to COVID-19 in benign prostatic hyperplasia patients

Journal

FRONTIERS IN PHARMACOLOGY
Volume 13, Issue -, Pages -

Publisher

FRONTIERS MEDIA SA
DOI: 10.3389/fphar.2022.945592

Keywords

treatment for SARS CoV-2; observational study; electronic health records; federated data model; causal inference; open science

Funding

  1. US Food and Drug Administration
  2. National Institute of Health [HHS-FDA 75F40120D00039]
  3. Clarendon Fund [R01 AG068002]
  4. Jardine Foundation
  5. European Health Data and Evidence Network (EHDEN) project
  6. Innovative Medicines Initiative 2 Joint Undertaking (JU)
  7. European Union's Horizon 2020 research and innovation programme [806968]
  8. EFPIA
  9. Health Department from the Generalitat de Catalunya
  10. VA Informatics and Computing Infrastructure (VA HSR RES)
  11. AbbVie Inc. [13-457]
  12. Alnylam Pharmaceuticals Inc.
  13. Astellas Pharma Inc.
  14. AstraZeneca Pharmaceuticals LP
  15. Biodesix, Inc.
  16. Boehringer Ingelheim International GmbH
  17. Celgene Corporation
  18. Eli Lilly and Company
  19. Genentech Inc.
  20. Gilead Sciences Inc.
  21. GlaxoSmithKline PLC
  22. Innocrin Pharmaceuticals Inc.
  23. Janssen Pharmaceuticals, Inc.
  24. Kantar Health
  25. Myriad Genetic Laboratories, Inc.
  26. Novartis International AG
  27. Parexel International Corporation through the University of Utah
  28. Wellcome Trust Clinical Research Career Development Fellowship
  29. Australian National Health and Medical Research Council [214588/Z/18/Z]
  30. EHDEN project [GNT1157506]
  31. US National Institutes of Health
  32. NIHR Senior Research Fellowship [R01 LM006910]
  33. Bill and Melinda Gates Foundation [SRF-2018-11-ST2-004]
  34. UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre [INV016201]
  35. IQVIA
  36. Wellcome Trust [214588/Z/18/Z] Funding Source: Wellcome Trust
  37. National Institutes of Health Research (NIHR) [SRF-2018-11-ST2-004] Funding Source: National Institutes of Health Research (NIHR)

Ask authors/readers for more resources

This international cohort study found no significant association between the use of alpha-1 blockers and the risks of diagnosis, hospitalization, or hospitalization requiring intensive services in COVID-19 patients.
Purpose: Alpha-1 blockers, often used to treat benign prostatic hyperplasia (BPH), have been hypothesized to prevent COVID-19 complications by minimising cytokine storm release. The proposed treatment based on this hypothesis currently lacks support from reliable real-world evidence, however. We leverage an international network of large-scale healthcare databases to generate comprehensive evidence in a transparent and reproducible manner. Methods: In this international cohort study, we deployed electronic health records from Spain (SIDIAP) and the United States (Department of Veterans Affairs, Columbia University Irving Medical Center, IQVIA OpenClaims, Optum DOD, Optum EHR). We assessed association between alpha-1 blocker use and risks of three COVID-19 outcomes-diagnosis, hospitalization, and hospitalization requiring intensive services-using a prevalent-user active-comparator design. We estimated hazard ratios using state-of-the-art techniques to minimize potential confounding, including large-scale propensity score matching/stratification and negative control calibration. We pooled database-specific estimates through random effects meta-analysis. Results: Our study overall included 2.6 and 0.46 million users of alpha-1 blockers and of alternative BPH medications. We observed no significant difference in their risks for any of the COVID-19 outcomes, with our meta-analytic HR estimates being 1.02 (95% CI: 0.92-1.13) for diagnosis, 1.00 (95% CI: 0.89-1.13) for hospitalization, and 1.15 (95% CI: 0.71-1.88) for hospitalization requiring intensive services. Conclusion: We found no evidence of the hypothesized reduction in risks of the COVID-19 outcomes from the prevalent-use of alpha-1 blockers-further research is needed to identify effective therapies for this novel disease.

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