Adverse Events Associated with High‐Dose Ribavirin: Evidence from the Toronto Outbreak of Severe Acute Respiratory Syndrome
Identifieur interne : 003A68 ( Main/Exploration ); précédent : 003A67; suivant : 003A69Adverse Events Associated with High‐Dose Ribavirin: Evidence from the Toronto Outbreak of Severe Acute Respiratory Syndrome
Auteurs : Matthew P. Muller [Canada] ; Linda Dresser ; Janet Raboud ; Allison Mcgeer ; Elizabeth Rea ; Susan E. Richardson [Canada] ; Tony Mazzulli ; Mark Loeb [Canada] ; Marie Louie [Canada]Source :
- Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy [ 0277-0008 ] ; 2007-04.
English descriptors
- Teeft :
- Absolute neutrophil count, Adverse event, Adverse events, Anemia, Attributable risk, Baseline, Bonferroni correction, Bradycardia, Chronic hepatitis, Clinical trial, Cohort, Corticosteroid, Data collection, First phase, Frcpc, Hemoglobin level, Hemolysis, Hemorrhagic, Hepatitis, Hong kong, Hyperamylasemia, Hypocalcemia, Hypomagnesemia, Infectious diseases, Intravenous ribavirin, Lactate dehydrogenase level, Lassa fever, Median time, Nontreated, Nontreated patients, Odds ratio, Oral ribavirin, Outbreak, Parenteral, Parenteral ribavirin, Pharmacotherapy volume, Primary analysis, Probable sars, Prognostic, Prognostic factors, Progressive anemia, Respiratory syndrome, Ribavirin, Ribavirin muller, Ribavirin therapy, Ribavirintreated patients, Sars, Selection bias, Syndrome, Tetany, Toronto outbreak, Toronto sars outbreak, Transaminitis, Viral.
Abstract
Study Objectives. To distinguish adverse events related to ribavirin therapy from those attributable to severe acute respiratory syndrome (SARS), and to determine the rate of potential ribavirin‐related adverse events. Design. Retrospective cohort study. Setting. Hospitals in Toronto, Ontario, Canada. Patients. A cohort of 306 patients with confirmed or probable SARS, 183 of whom received ribavirin and 123 of whom did not, between February 23, 2003, and July 1, 2003. Of the 183 treated patients, 155 (85%) received very high‐dose ribavirin; the other 28 treated patients received lower‐dose regimens. Measurements and Main Results. Data on all patients with SARS admitted to hospitals in Toronto were abstracted from charts and electronic databases onto a standardized form by trained research nurses. Logistic regression was used to evaluate the association between ribavirin use and each adverse event (progressive anemia, hypomagnesemia, hypocalcemia, bradycardia, transaminitis, and hyperamylasemia) after adjusting for SARS‐related prognostic factors and corticosteroid use. In the primary logistic regression analysis, ribavirin use was strongly associated with anemia (odds ratio [OR] 3.0, 99% confidence interval [CI] 1.5–6.1, p<0.0001), hypomagnesemia (OR 21, 99% CI 5.8–73, p<0.0001), and bradycardia (OR 2.3, 99% CI 1.0–5.1, p=0.007). Hypocalcemia, transaminitis, and hyperamylasemia were not associated with ribavirin use. The risk of anemia, hypomagnesemia, and bradycardia attributable to ribavirin use was 27%, 45%, and 17%, respectively. Conclusions. High‐dose ribavirin is associated with a high rate of adverse events. The use of high‐dose ribavirin is appropriate only for the treatment of infectious diseases for which ribavirin has proven clinical efficacy, or in the context of a clinical trial. Ribavirin should not be used empirically for the treatment of viral syndromes of unknown origin.
Url:
DOI: 10.1592/phco.27.4.494
Affiliations:
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Richardson</name><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Microbiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Mazzulli, Tony" sort="Mazzulli, Tony" uniqKey="Mazzulli T" first="Tony" last="Mazzulli">Tony Mazzulli</name><affiliation><wicri:noCountry code="no comma">Departments of Microbiology</wicri:noCountry></affiliation></author><author><name sortKey="Loeb, Mark" sort="Loeb, Mark" uniqKey="Loeb M" first="Mark" last="Loeb">Mark Loeb</name><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Louie, Marie" sort="Louie, Marie" uniqKey="Louie M" first="Marie" last="Louie">Marie Louie</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Microbiology, Provincial Laboratory for Public Health, Calgary, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy</title><title level="j" type="alt">PHARMACOTHERAPY: THE JOURNAL OF HUMAN PHARMACOLOGY AND DRUG THERAPY</title><idno type="ISSN">0277-0008</idno><idno type="eISSN">1875-9114</idno><imprint><biblScope unit="vol">27</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="494">494</biblScope><biblScope unit="page" to="503">503</biblScope><biblScope unit="page-count">10</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2007-04">2007-04</date></imprint><idno type="ISSN">0277-0008</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0277-0008</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Absolute neutrophil count</term><term>Adverse event</term><term>Adverse events</term><term>Anemia</term><term>Attributable risk</term><term>Baseline</term><term>Bonferroni correction</term><term>Bradycardia</term><term>Chronic hepatitis</term><term>Clinical trial</term><term>Cohort</term><term>Corticosteroid</term><term>Data collection</term><term>First phase</term><term>Frcpc</term><term>Hemoglobin level</term><term>Hemolysis</term><term>Hemorrhagic</term><term>Hepatitis</term><term>Hong kong</term><term>Hyperamylasemia</term><term>Hypocalcemia</term><term>Hypomagnesemia</term><term>Infectious diseases</term><term>Intravenous ribavirin</term><term>Lactate dehydrogenase level</term><term>Lassa fever</term><term>Median time</term><term>Nontreated</term><term>Nontreated patients</term><term>Odds ratio</term><term>Oral ribavirin</term><term>Outbreak</term><term>Parenteral</term><term>Parenteral ribavirin</term><term>Pharmacotherapy volume</term><term>Primary analysis</term><term>Probable sars</term><term>Prognostic</term><term>Prognostic factors</term><term>Progressive anemia</term><term>Respiratory syndrome</term><term>Ribavirin</term><term>Ribavirin muller</term><term>Ribavirin therapy</term><term>Ribavirintreated patients</term><term>Sars</term><term>Selection bias</term><term>Syndrome</term><term>Tetany</term><term>Toronto outbreak</term><term>Toronto sars outbreak</term><term>Transaminitis</term><term>Viral</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Study Objectives. To distinguish adverse events related to ribavirin therapy from those attributable to severe acute respiratory syndrome (SARS), and to determine the rate of potential ribavirin‐related adverse events. Design. Retrospective cohort study. Setting. Hospitals in Toronto, Ontario, Canada. Patients. A cohort of 306 patients with confirmed or probable SARS, 183 of whom received ribavirin and 123 of whom did not, between February 23, 2003, and July 1, 2003. Of the 183 treated patients, 155 (85%) received very high‐dose ribavirin; the other 28 treated patients received lower‐dose regimens. Measurements and Main Results. Data on all patients with SARS admitted to hospitals in Toronto were abstracted from charts and electronic databases onto a standardized form by trained research nurses. Logistic regression was used to evaluate the association between ribavirin use and each adverse event (progressive anemia, hypomagnesemia, hypocalcemia, bradycardia, transaminitis, and hyperamylasemia) after adjusting for SARS‐related prognostic factors and corticosteroid use. In the primary logistic regression analysis, ribavirin use was strongly associated with anemia (odds ratio [OR] 3.0, 99% confidence interval [CI] 1.5–6.1, p<0.0001), hypomagnesemia (OR 21, 99% CI 5.8–73, p<0.0001), and bradycardia (OR 2.3, 99% CI 1.0–5.1, p=0.007). Hypocalcemia, transaminitis, and hyperamylasemia were not associated with ribavirin use. The risk of anemia, hypomagnesemia, and bradycardia attributable to ribavirin use was 27%, 45%, and 17%, respectively. Conclusions. High‐dose ribavirin is associated with a high rate of adverse events. The use of high‐dose ribavirin is appropriate only for the treatment of infectious diseases for which ribavirin has proven clinical efficacy, or in the context of a clinical trial. Ribavirin should not be used empirically for the treatment of viral syndromes of unknown origin.</div></front></TEI><affiliations><list><country><li>Canada</li></country><region><li>Ontario</li></region><settlement><li>Hamilton (Ontario)</li><li>Toronto</li></settlement><orgName><li>Université McMaster</li><li>Université de Toronto</li></orgName></list><tree><noCountry><name sortKey="Dresser, Linda" sort="Dresser, Linda" uniqKey="Dresser L" first="Linda" last="Dresser">Linda Dresser</name><name sortKey="Mazzulli, Tony" sort="Mazzulli, Tony" uniqKey="Mazzulli T" first="Tony" last="Mazzulli">Tony Mazzulli</name><name sortKey="Mcgeer, Allison" sort="Mcgeer, Allison" uniqKey="Mcgeer A" first="Allison" last="Mcgeer">Allison Mcgeer</name><name sortKey="Raboud, Janet" sort="Raboud, Janet" uniqKey="Raboud J" first="Janet" last="Raboud">Janet Raboud</name><name sortKey="Rea, Elizabeth" sort="Rea, Elizabeth" uniqKey="Rea E" first="Elizabeth" last="Rea">Elizabeth Rea</name></noCountry><country name="Canada"><noRegion><name sortKey="Muller, Matthew P" sort="Muller, Matthew P" uniqKey="Muller M" first="Matthew P." last="Muller">Matthew P. Muller</name></noRegion><name sortKey="Loeb, Mark" sort="Loeb, Mark" uniqKey="Loeb M" first="Mark" last="Loeb">Mark Loeb</name><name sortKey="Louie, Marie" sort="Louie, Marie" uniqKey="Louie M" first="Marie" last="Louie">Marie Louie</name><name sortKey="Richardson, Susan E" sort="Richardson, Susan E" uniqKey="Richardson S" first="Susan E." last="Richardson">Susan E. Richardson</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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