International cohort study indicates no association between alpha-1 blockers and susceptibility to COVID-19 in benign prostatic hyperplasia patients
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Abstract
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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SciScore for 10.1101/2021.03.18.21253778: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Strengths and limitations: This open science study comes with certain limitations, but also with unique strengths by virtue of our access to an international network of standardized databases. Below, we discuss potential limitations one by one, as well as ways through which our study addresses them to the extent practically possible. First, the study only partially addresses the question of whether alpha-1 blockers alleviate the disease …
SciScore for 10.1101/2021.03.18.21253778: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
NIH rigor criteria are not applicable to paper type.Table 2: Resources
No key resources detected.
Results from OddPub: Thank you for sharing your code.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Strengths and limitations: This open science study comes with certain limitations, but also with unique strengths by virtue of our access to an international network of standardized databases. Below, we discuss potential limitations one by one, as well as ways through which our study addresses them to the extent practically possible. First, the study only partially addresses the question of whether alpha-1 blockers alleviate the disease progression of COVID-19 as postulated by Konig et al. 2020. With COVID-19 being an emergent disease, the number of in-patient COVID-19 cases was rather small during the studied period even in the extensive network of databases we have access to. We thus determined the number to be insufficient for us to directly estimate the effectiveness against the disease progression in a scientifically meaningful manner. Instead, we attempted to investigate the question under the hypothesis that, if alpha-1 blockers were indeed protective against severe COVID-19 symptoms, we should see a negative association between the prevalent use of alpha-1 blockers and COVID-19 related outcomes such as hospitalization. Even COVID-19 diagnosis alone could be indicative of relatively severe symptoms since patients are otherwise unlikely to seek interactions with healthcare systems. Second, we used a prevalent-user cohort design since there are so few patients initiating BPH therapies during and immediately preceding the pandemic that a new-user design is infeasible. A p...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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