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0 0.5 1 1.5 2+ Death/ICU -23% Improvement Relative Risk Antiandrogens  Lazzeri et al.  Prophylaxis Is prophylaxis with antiandrogens beneficial for COVID-19? Retrospective study in Italy Higher death/ICU with antiandrogens (not stat. sig., p=0.33) c19early.org Lazzeri et al., medRxiv, September 2020 Favors various Favors control

Impact of anti-androgen therapies on COVID-19 susceptibility: a case-control study in male population from two COVID-19 regional centers of Lombardy (Italy)

Lazzeri et al., medRxiv, doi:10.1101/2020.04.20.20068056
Sep 2020  
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7th treatment shown to reduce risk in September 2020
 
*, now known with p = 0.000000056 from 49 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments. c19early.org
Retrospective case-control study in Italy with 943 male COVID-19 patients, 45 on chronic 5ARI treatment (finasteride/dutasteride). There was significantly fewer COVID-19 patients >55 on 5ARI treatment compared to age-matched controls (5.57 vs. 8.14%, p=0.0083). The difference was greater for men aged >65 (7.14 vs. 12.31%, p=0.0001). There was no significant difference for ICU admission or death.
risk of death/ICU, 23.0% higher, OR 1.23, p = 0.33, multivariable, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lazzeri et al., 21 Sep 2020, retrospective, Italy, preprint, 11 authors.
This PaperAntiandrogensAll
Impact of anti-androgen therapies on COVID-19 susceptibility: a case-control study in male population from two COVID-19 regional centers of Lombardy (Italy)
MD-PhD Massimo Lazzeri, PhD Stefano Duga, MD Elena Azzolini, MD Vittorio Fasulo, MD Nicolò Buffi, MD Alberto Saita, MD Rodolfo Hurle, MD Alessandro Nobili, MD-PhD Maurizio Cecconi, MD Paolo Casale, PhD Rosanna Asselta
doi:10.1101/2020.04.20.20068056
May treatment of benign prostatic hyperplasia with 5-alpha reductase inhibitors (5ARIs) impact on COVID-19-related hospitalization risk? Findings: In this case-control study, which compared 943 adult males hospitalized for COVID-19 with age-matched men from Lombardy (all beneficiaries of the Regional Health Service), the proportion of patients aged >55 years, who were exposed to 5ARIs (dutasteride, finasteride), was significantly lower (5.57%) than that of the general male population (8.14%) (p=0.0083, 95%CI=0.75-3.97%). Meaning: The use of 5ARIs was associated with a potential reduced risk of hospitalization for COVID-19 in men older than >55 years. This suggests the opportunity to test whether antiandrogen therapies can prevent the transition from paucisymptomatic SARS-CoV-2 infection to overt pulmonary disease.
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{ 'DOI': '10.1101/2020.04.20.20068056', 'URL': 'http://dx.doi.org/10.1101/2020.04.20.20068056', 'abstract': '<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Importance</jats:title><jats:p>There ' 'are gender differences in vulnerability to the Coronavirus disease 2019 (COVID-19), with men ' 'experiencing more severe disease at any age. The use of anti-androgen drugs, like 5-alpha ' 'reductase inhibitors (5ARIs), could protect from severe pulmonary ' 'disease.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine ' 'whether men who received 5ARIs for benign prostatic hyperplasia (BPH) have a lower risk of ' 'hospitalization for ' 'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>This is a ' 'case-control study on patients hospitalized for COVID-19 (cases), matched to beneficiaries of ' 'the Lombardy Regional Health Service ' '(controls).</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Data were ' 'collected by two high-volume COVID-19 regional centres of Lombardy (Italy) from ' '1<jats:sup>st</jats:sup> March to 24<jats:sup>th</jats:sup> April ' '2020.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Consecutive ' 'patients positive for SARS-CoV-2 virus according to the WHO guidance, who required ' 'hospitalization.</jats:p></jats:sec><jats:sec><jats:title>Exposure</jats:title><jats:p>BPH ' 'treatment with 5ARIs (finasteride/dutasteride) in the last six ' 'months.</jats:p></jats:sec><jats:sec><jats:title>Main Outcome(s) and ' 'Measure(s)</jats:title><jats:p>The primary outcome was to compare the prevalence of male ' 'patients chronically exposed to 5ARIs, who required hospitalization for COVID-19, with the ' 'one of age-matched males in ' 'Lombardy.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Overall, 1,432 ' 'COVID-19 patients were included. Among the 943 males, 45 (4.77%) patients were exposed to ' 'chronic 5ARI therapy. COVID-19 patients aged &gt;55 years under 5ARI treatment were ' 'significantly less than expected on the basis of the prevalence of 5ARI treatment among ' 'age-matched controls (5.57 vs. 8.14%; p=0.0083, 95%CI=0.75-3.97%). This disproportion was ' 'even higher for men aged &gt;65 (7.14 vs. 12.31%; p=0.0001, ' '95%CI=2.83-6.97%).</jats:p><jats:p>Eighteen 5ARIs-patients died; the mean age of men who died ' 'was higher than those who did not: 75.98±9.29 vs. 64.78±13.57 (p&lt;0.001). Cox regression ' 'and multivariable models did not show any correlation between the exposure to 5ARIs and ' 'protection against ICU admission or death: HR=0.79 (95%CI=0.54-1.15; p=0.22) and OR=1.23 ' '(95%CI=0.81-1.87; p=0.33), respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusions ' 'and Relevance</jats:title><jats:p>In this case-control study the use of 5ARIs was less ' 'frequent among patients hospitalized for COVID-19 than among controls, suggesting that men ' 'exposed to 5ARIs might be less vulnerable to severe COVID-19. This observation further ' 'supports the idea to test in randomized clinical trials whether anti-androgen therapies can ' 'prevent the transition from paucisymptomatic SARS-CoV-2 infection to overt pulmonary ' 'disease.</jats:p></jats:sec><jats:sec><jats:title>KEY ' 'POINTS</jats:title><jats:sec><jats:title>Question</jats:title><jats:p>May treatment of benign ' 'prostatic hyperplasia with 5-alpha reductase inhibitors (5ARIs) impact on COVID-19-related ' 'hospitalization ' 'risk?</jats:p></jats:sec><jats:sec><jats:title>Findings</jats:title><jats:p>In this ' 'case-control study, which compared 943 adult males hospitalized for COVID-19 with age-matched ' 'men from Lombardy (all beneficiaries of the Regional Health Service), the proportion of ' 'patients aged &gt;55 years, who were exposed to 5ARIs (dutasteride, finasteride), was ' 'significantly lower (5.57%) than that of the general male population (8.14%) (p=0.0083, ' '95%CI=0.75-3.97%).</jats:p></jats:sec><jats:sec><jats:title>Meaning</jats:title><jats:p>The ' 'use of 5ARIs was associated with a potential reduced risk of hospitalization for COVID-19 in ' 'men older than &gt;55 years. This suggests the opportunity to test whether anti-androgen ' 'therapies can prevent the transition from paucisymptomatic SARS-CoV-2 infection to overt ' 'pulmonary disease.</jats:p></jats:sec></jats:sec>', 'accepted': {'date-parts': [[2020, 9, 21]]}, 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-4411-3715', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Lazzeri', 'given': 'Massimo', 'sequence': 'first'}, { 'ORCID': 'http://orcid.org/0000-0003-3457-1410', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Duga', 'given': 'Stefano', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Azzolini', 'given': 'Elena', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0001-6155-5964', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Fasulo', 'given': 'Vittorio', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Buffi', 'given': 'Nicolò', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0003-0000-5517', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Saita', 'given': 'Alberto', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0001-9978-8587', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Hurle', 'given': 'Rodolfo', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Nobili', 'given': 'Alessandro', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Cecconi', 'given': 'Maurizio', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Casale', 'given': 'Paolo', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0001-5351-0619', 'affiliation': [], 'authenticated-orcid': False, 'family': 'Asselta', 'given': 'Rosanna', 'sequence': 'additional'}, {'affiliation': [], 'name': 'The Humanitas COVID-19 Task Force', 'sequence': 'additional'}, { 'affiliation': [], 'name': 'The Humanitas Gavazzeni COVID-19 Task Force', 'sequence': 'additional'}], 'container-title': [], 'content-domain': {'crossmark-restriction': False, 'domain': []}, 'created': {'date-parts': [[2020, 4, 24]], 'date-time': '2020-04-24T14:25:17Z', 'timestamp': 1587738317000}, 'deposited': { 'date-parts': [[2021, 2, 17]], 'date-time': '2021-02-17T00:03:53Z', 'timestamp': 1613520233000}, 'group-title': 'Infectious Diseases (except HIV/AIDS)', 'indexed': {'date-parts': [[2022, 12, 7]], 'date-time': '2022-12-07T02:58:22Z', 'timestamp': 1670381902221}, 'institution': [{'name': 'medRxiv'}], 'is-referenced-by-count': 3, 'issued': {'date-parts': [[2020, 4, 24]]}, 'link': [ { 'URL': 'https://syndication.highwire.org/content/doi/10.1101/2020.04.20.20068056', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '246', 'original-title': [], 'posted': {'date-parts': [[2020, 4, 24]]}, 'prefix': '10.1101', 'published': {'date-parts': [[2020, 4, 24]]}, 'publisher': 'Cold Spring Harbor Laboratory', 'reference': [ { 'key': '2021021209051885000_2020.04.20.20068056v2.1', 'unstructured': 'https://coronavirus.jhu.edu/map.html'}, { 'DOI': '10.1001/jama.2020.5394', 'doi-asserted-by': 'publisher', 'key': '2021021209051885000_2020.04.20.20068056v2.2'}, { 'DOI': '10.1016/S0140-6736(20)30526-2', 'doi-asserted-by': 'publisher', 'key': '2021021209051885000_2020.04.20.20068056v2.3'}, { 'DOI': '10.1016/j.cell.2020.02.052', 'doi-asserted-by': 'publisher', 'key': '2021021209051885000_2020.04.20.20068056v2.4'}, { 'DOI': '10.1128/JVI.02232-10', 'doi-asserted-by': 'publisher', 'key': '2021021209051885000_2020.04.20.20068056v2.5'}, { 'DOI': '10.1101/gad.211011.112', 'doi-asserted-by': 'publisher', 'key': '2021021209051885000_2020.04.20.20068056v2.6'}, { 'key': '2021021209051885000_2020.04.20.20068056v2.7', 'unstructured': 'Asselta R , Paraboschi EM , Mantovani A , Duga S . 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Androgen-deprivation ' 'therapies for prostate cancer and risk of infection by SARS-CoV-2. a ' 'population-based study (n=4532). Ann Oncol 2020. doi. ' 'https.//doi.org/10.1016/j.annonc.2020.04.479'}], 'reference-count': 13, 'references-count': 13, 'relation': {}, 'resource': {'primary': {'URL': 'http://medrxiv.org/lookup/doi/10.1101/2020.04.20.20068056'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subtitle': [], 'subtype': 'preprint', 'title': 'Impact of anti-androgen therapies on COVID-19 susceptibility: a case-control study in male ' 'population from two COVID-19 regional centers of Lombardy (Italy)', 'type': 'posted-content'}
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