NDLI: Effect of intravenous zanamivir on cardiac repolarization.

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Effect of intravenous zanamivir on cardiac repolarization.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lou, Yu Gan, Jianjun Peppercorn, Amanda Gould, Elizabeth Weller, Steve Piscitelli, Stephen C. Patel, Parul
Description	Country affiliation: United States Author Affiliation: Lou Y ( Infectious Diseases Medicines Discovery and Development, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.)
Abstract	STUDY OBJECTIVE: To assess the effect of a therapeutic and supratherapeutic intravenous dose of the neuraminidase inhibitor zanamivir on QT and rate-corrected QT intervals. DESIGN: Randomized, placebo-controlled, single-dose, four-period, balanced crossover study. SETTING: Clinical research unit. SUBJECTS: Forty healthy adults were randomized to receive intravenous zanamivir at two dose levels, oral moxifloxacin, and placebo; 38 subjects completed all four study treatments. INTERVENTION: Subjects were randomized to receive a single intravenous dose of zanamivir 600 mg (therapeutic dose) with oral moxifloxacin placebo, a single intravenous dose of zanamivir 1200 mg (supratherapeutic dose) with oral moxifloxacin placebo, oral moxifloxacin 400 mg (positive control) with intravenous zanamivir placebo, or intravenous zanamivir placebo with oral moxifloxacin placebo. Subjects crossed over to all other treatments, with each treatment separated by a 7-day washout period. MEASUREMENTS AND MAIN RESULTS: Zanamivir pharmacokinetics were dose proportional; the pharmacokinetic exposure from zanamivir 1200 mg was 2 times higher than that from 600 mg, the maximum dose under clinical evaluation. For both 600-mg and 1200-mg doses of intravenous zanamivir, the upper limit of the 90% confidence interval (CI) for the placebo-adjusted mean change from baseline of the QT interval corrected for heart rate using Fridericia's formula (ΔΔQTcF) was less than 10 msec at all time points. The sensitivity of the study to detect modest increases in QT interval was established with the positive control, moxifloxacin. The maximum ΔΔQTcF value for zanamivir 1200 mg was 1.73 msec (90% CI -0.40 to 3.87 msec), which was observed within 30 minutes after dosing, and 11.21 msec (90% CI 8.81-13.60) for moxifloxacin, observed at 4 hours after dosing. No relationship was observed between zanamivir serum concentration and ΔΔQTcF. Zanamivir was generally well tolerated, with very few adverse events; none were serious or severe. CONCLUSION: Intravenous zanamivir does not affect cardiac repolarization. Accordingly, treatment with intravenous zanamivir does not require additional cardiac monitoring beyond the standard of care.
File Format	HTM / HTML
ISSN	02770008
Issue Number	7
Volume Number	33
e-ISSN	18759114
Journal	Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2013-07-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Antiviral Agents Administration & Dosage Long Qt Syndrome Chemically Induced Zanamivir Administration, Oral Adult Adverse Effects Pharmacokinetics Aza Compounds Cross-over Studies Dose-response Relationship, Drug Double-blind Method Electrocardiography Female Fluoroquinolones Heart Rate Drug Effects Humans Infusions, Intravenous Male Quinolines Time Factors Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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