Hydroxychloroquine in hospitalized COVID-19 patients: Real world experience assessing mortality
Annie et al.,
Hydroxychloroquine in hospitalized COVID-19 patients: Real world experience assessing mortality,
Pharmacotherapy, doi:10.1002/phar.2467
Retrospective database analysis with PSM not including COVID-19 severity, finding mortality OR 0.95 [0.62-1.46] for HCQ, and 1.24 [0.70-2.22] for HCQ+AZ.
Confounding by indication likely.
This study is excluded in the after exclusion results of meta
analysis:
confounding by indication is likely and adjustments do not consider COVID-19 severity at baseline.
risk of death, 4.3% lower, RR 0.96, p = 0.83, treatment 48 of 367 (13.1%), control 50 of 367 (13.6%), NNT 183, odds ratio converted to relative risk.
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risk of death, 20.5% higher, RR 1.21, p = 0.46, treatment 29 of 199 (14.6%), control 24 of 199 (12.1%), odds ratio converted to relative risk.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Annie et al., 12 Oct 2020, retrospective, database analysis, USA, peer-reviewed, 5 authors.
Abstract: ORIGINAL RESEARCH ARTICLES
Hydroxychloroquine in Hospitalized Patients with
COVID-19: Real-World Experience Assessing Mortality
Frank H. Annie,
Cristian Sirbu,
Keely R. Frazier, Mike Broce,
and B. Daniel Lucas Jr.
Charleston Area Medical Center Health Education and Research Institute, Charleston, West Virginia,
INTRODUCTION Hydroxychloroquine (HCQ) for coronavirus disease 2019 (COVID-19) is presently being
used off-label or within a clinical trial.
OBJECTIVES We investigated a multinational database of patients with COVID-19 with real-world data
containing outcomes and their relationship to HCQ use. The primary outcome was all-cause mortality within 30 days of follow-up.
METHODS This was a retrospective cohort study of patients receiving HCQ within 48 hours of hospital
admission. Medications, preexisting conditions, clinical measures on admission, and outcomes were
recorded.
RESULTS Among patients with a diagnosis of COVID-19 in our propensity-matched cohort, the mean
ages SD were 62.3 15.9 years (53.7% male) and 61.9 16.0 years (53.0% male) in the HCQ
and no-HCQ groups, respectively. There was no difference in overall 30-day mortality between the
HCQ and no-HCQ groups (HCQ 13.1%, n=367; no HCQ 13.6%, n=367; odds ratio 0.95, 95% confidence interval 0.62–1.46) after propensity matching. Although statistically insignificant, the HCQazithromycin (AZ) group had an overall mortality rate of 14.6% (n=199) compared with propensitymatched no-HCQ–AZ cohort’s rate of 12.1% (n=199, OR 1.24, 95% CI 0.70–2.22). Importantly,
however, there was no trend in this cohort’s overall mortality/arrhythmogenesis outcome (HCQ-AZ
17.1%, no HCQ–no AZ 17.1%; OR 1.0, 95% CI 0.6–1.7).
CONCLUSIONS We report from a large retrospective multinational database analysis of COVID-19 outcomes with HCQ and overall mortality in hospitalized patients. There was no statistically significant
increase in mortality and mortality-arrhythmia with HCQ or HCQ-AZ.
KEY WORDS Antimalarial, azithromycin, coronavirus, hydroxychloroquine, macrolide, severe acute respiratory syndrome coronavirus 2.
(Pharmacotherapy 2020;40(11):1072–1081) doi: 10.1002/phar.2467
The search for safe and effective coronavirus
disease 2019 (COVID-19) therapies has accelerated at a frenzied pace. Having advocated for
clinicaltrials.gov use in the search for alternative
approaches to the patient with COVID-19,1
searching within the database revealed 3185
COVID-19 clinical trials as of August 31, 2020.
Conflict of interest: The authors declare no conflicts of
interest.
*Address for correspondence: B. Daniel Lucas Jr., CAMC
Health Education and Research Institute, 3200 MacCorkle
Avenue, Charleston, WV 25304; e-mail: dan.lucas@camc.org.
Ó 2020 Pharmacotherapy Publications, Inc.
Of these registered COVID-19 clinical trials,
1792 appeared to be treatment trials. Repurposed hydroxychloroquine (HCQ) in prospective
randomized clinical trials accounted for 251 of
these registered trials with completion dates
ranging from February 2020 to December 2029.
Presently, HCQ for COVID-19 is being used offlabel or within one of these clinical trials.
Although understanding HCQ’s efficacy profile
in COVID-19 is an immediate concern, its safety
profile has dominated recent public conversation. Indeed, the United States Food and Drug
Administration issued additional safety guidance
for use of HCQ after the original, now
HYDROXYCHLOROQUINE IN PATIENTS WITH COVID-19 Annie et al
withdrawn, emergency use authorization,2..
Late treatment
is less effective
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