Safety, tolerability, and outcomes of losartan use in patients hospitalized with SARS-CoV-2 infection: A feasibility study

Autor: Sandeep K. Mallipattu, Haseena Sahib, Luis A. Marcos, Farrukh M. Koraishy, O. Bolotova, Sahar Ahmad, Jeanwoo Yoo, I. Chaudhri, Hal Skopicki
Rok vydání: 2020
Předmět:
Male
RNA viruses
Viral Diseases
Coronaviruses
Blood Pressure
Pilot Projects
030204 cardiovascular system & hematology
Vascular Medicine
Biochemistry
law.invention
0302 clinical medicine
Medical Conditions
Randomized controlled trial
law
Medicine and Health Sciences
030212 general & internal medicine
Prospective Studies
Prospective cohort study
Immune Response
Pathology and laboratory medicine
Multidisciplinary
Middle Aged
Medical microbiology
C-Reactive Proteins
Losartan
Infectious Diseases
Tolerability
Research Design
Cohort
Hypertension
Viruses
Medicine
Female
Hypotension
SARS CoV 2
Pathogens
medicine.drug
Research Article
medicine.medical_specialty
Drug Research and Development
SARS coronavirus
Clinical Research Design
Science
Immunology
Research and Analysis Methods
Microbiology
03 medical and health sciences
Signs and Symptoms
Internal medicine
medicine
Humans
Clinical Trials
Adverse effect
Aged
Retrospective Studies
Inflammation
Pharmacology
business.industry
SARS-CoV-2
Organisms
Viral pathogens
COVID-19
Biology and Life Sciences
Proteins
Retrospective cohort study
Covid 19
Adverse events
Blood pressure
Oxygen
Randomized controlled trials
Randomized Controlled Trials
Discontinuation
Microbial pathogens
Adverse Events
Clinical Medicine
business
Angiotensin II Type 1 Receptor Blockers
Zdroj: PLoS ONE
PLoS ONE, Vol 15, Iss 12, p e0244708 (2020)
PLOS ONE, 15(12):e0244708
ISSN: 1932-6203
Popis: Background Retrospective studies on the use of Renin-Angiotensin-Aldosterone System blockade in patients with Coronavirus Disease 2019 (COVID-19) have been informative but conflicting, and prospective studies are required to demonstrate the safety, tolerability, and outcomes of initiating these agents in hospitalized patients with COVID-19 and hypertension. Methods and findings This is a single center feasibility study encompassing two cohorts: (1) prospective cohort (April 21, 2020 to May 29, 2020) and (2) retrospective cohort (March 7, 2020 to April 1, 2020) of hospitalized patients with real-time polymerase chain reaction (PCR) positive SARS-CoV-2 by nasopharyngeal swab. Key inclusion criteria include BP > 130/80 and a requirement of supplemental oxygen with FiO2 of 25% or higher to maintain SpO2 > 92%. Key exclusion criteria included hyperkalemia and acute kidney injury (AKI) at the time of enrollment. Prospective cohort consisted of de novo initiation of losartan and continuation for a minimum of 7 days and assessed for adverse events (AKI, hyperkalemia, transaminitis, hypotension) and clinical outcomes (change in SpO2/FiO2 and inflammatory markers, need for ICU admission and mechanical ventilation). Retrospective cohort consisted of continuation of losartan (prior-to-hospitalization) and assessment of similar outcomes. In the prospective cohort, a total of 250 hospitalized patients were screened and inclusion/exclusion criteria were met in 16/250 patients and in the retrospective cohort, a total of 317 hospitalized patients were screened and inclusion/exclusion criteria were met in 14/317 patients. Most common adverse event was hypotension, leading to discontinuation in 3/16 (19%) and 2/14 (14%) patients in the prospective and retrospective cohort. No patients developed AKI in the prospective cohort as compared to 1/14 (7%) patients in the retrospective cohort, requiring discontinuation of losartan. Hyperkalemia occurred in 1/16 (6%) and 0/14 patients in the prospective and retrospective cohorts, respectively. In the prospective cohort, 3/16 (19%) and 2/16 (13%) patients required ICU admission and mechanical ventilation. In comparison, 3/14 (21%) required ICU admission and mechanical ventilation in the retrospective cohort. A majority of patients in both cohorts (14/16 (88%) and 13/14 (93%) patients from the prospective and retrospective cohort) were discharged alive from the hospital. A total of 9/16 (prospective) and 5/14 (retrospective) patients completed a minimum 7 days of losartan. In these 9 patients in the prospective cohort, a significant improvement in SpO2/FiO2 ratio was observed from day 1 to 7. No significant changes in inflammatory markers (initiation, peak, and day 7) were observed in either cohort. Conclusion In this pilot study we demonstrate that losartan was well-tolerated among hospitalized patients with COVID-19 and hypertension. We also demonstrate the feasibility of patient recruitment and the appropriate parameters to assess the outcomes and safety of losartan initiation or continuation, which provides a framework for future randomized clinical trials.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje