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Is There Any Advantage to Using Levalbuterol in the Treatment of Asthma?

Weinberger, Miles MD

Clinical Pulmonary Medicine: May 2004 - Volume 11 - Issue 3 - p 129-134
doi: 10.1097/01.cpm.0000127196.53489.f1
Obstrutive Airways Disease
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Albuterol has become the most commonly used bronchodilator for relieving symptoms of acute asthma since its introduction in the 1970s. Albuterol is a racemic mixture of R- and S-enantiomers. All bronchodilating activity has been recognized as coming from the R-enantiomer also known as levalbuterol. Levalbuterol has been marketed by Sepracor as the mono-isomer since 1999 under the brand name of Xopenex. Although receiving US Food and Drug Administration approval only as an alternative to racemic albuterol, it has been advertised as a “purified” albuterol, and the company has supported and extensively distributed publications purporting therapeutic advantage to levalbuterol over racemic albuterol. However, critical examination of that literature suggests the methodology used in those studies was inappropriate to examine relative potency of levalbuterol to the racemate for bronchodilator and systemic effect. Published studies of clinical efficacy in emergency rooms and hospital are very limited, and the claims of therapeutic advantage in these settings remain inconclusive. No appropriate studies of use in ambulatory patients were found. Since the cost of levalbuterol is substantially higher than racemic albuterol, there is no compelling justification for routine use of levalbuterol as an alternative to any preservative-free formulation of albuterol. Administration of albuterol by metered dose inhaler is the least expensive formulation and is as effective as by nebulizer, using a valved holding chamber for infants, toddlers, and others where coordination and cooperation are a problem for delivery. Further appropriate study is needed to determine if there is therapeutic advantage of levalbuterol in higher-than-usual doses as might be used in emergency or hospital treatment.

Levalbuterol has been marketed as a “purified” albuterol with purported therapeutic advantage over racemic albuterol based on preclinical animal and in vitro data. However, the studies supported and extensively distributed by the company marketing levalbuterol under the brand name Xopenex have not been appropriately designed to test relative potency. In fact, appropriately designed independent studies have indicated no difference when equivalent doses are given. Given the substantially greater cost of Xopenex than generic albuterol preparations, there currently appears no justification for its routine use.

From the Pediatric Allergy and Pulmonary Division, University of Iowa College of Medicine, Iowa City, IA.

Address correspondence to: Miles Weinberger MD, Pediatric Department, University of Iowa Hospital, Iowa City, IA 52242. Email: miles-weinberger@uiowa.edu.

© 2004 Lippincott Williams & Wilkins, Inc.