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Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma.
Ann Allergy Asthma Immunol 2007; 99(6):540-8AA

Abstract

BACKGROUND

Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol.

OBJECTIVE

To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma.

METHODS

Patients with mild to moderate asthma (mean forced expiratory volume in 1 second [FEVI], 68.3% of predicted) 12 years or older participated in a multicenter, parallel-group, open-label study. Patients were randomized to levalbuterol HFA MDI (90 microg; 2 actuations of 45 microg; n = 496) or racemic albuterol HFA MDI (180 microg; 2 actuations of 90 microg; n = 250) for 52 weeks of 4 times daily dosing. The primary end point was the incidence of postrandomization adverse events. Asthma exacerbations and pulmonary parameters were also assessed.

RESULTS

The overall incidence of adverse events was similar for levalbuterol (72.0%) and racemic albuterol (76.8%). Rates of beta-mediated adverse events, serious adverse events, and discontinuations because of adverse events were low (<15%) and were comparable between groups. Rates of asthma adverse events for levalbuterol and racemic albuterol were 18.3% and 19.6%, respectively. Mean percentage of predicted FEV1 improved after dosing and was stable for both groups.

CONCLUSION

In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.

Authors+Show Affiliations

Massachusetts General Hospital, Boston, Massachusetts, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18219836

Citation

Hamilos, Daniel L., et al. "Long-term Safety Study of Levalbuterol Administered Via Metered-dose Inhaler in Patients With Asthma." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 99, no. 6, 2007, pp. 540-8.
Hamilos DL, D'Urzo A, Levy RJ, et al. Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. Ann Allergy Asthma Immunol. 2007;99(6):540-8.
Hamilos, D. L., D'Urzo, A., Levy, R. J., Marcus, M., Tripp, K., Parsey, M., ... McVicar, W. K. (2007). Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 99(6), pp. 540-8. doi:10.1016/S1081-1206(10)60384-5.
Hamilos DL, et al. Long-term Safety Study of Levalbuterol Administered Via Metered-dose Inhaler in Patients With Asthma. Ann Allergy Asthma Immunol. 2007;99(6):540-8. PubMed PMID: 18219836.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma. AU - Hamilos,Daniel L, AU - D'Urzo,Anthony, AU - Levy,Robin J, AU - Marcus,Michael, AU - Tripp,Kenneth, AU - Parsey,Merdad, AU - Baumgartner,Rudolf A, AU - McVicar,William K, PY - 2008/1/29/pubmed PY - 2008/2/20/medline PY - 2008/1/29/entrez SP - 540 EP - 8 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 99 IS - 6 N2 - BACKGROUND: Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol. OBJECTIVE: To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma. METHODS: Patients with mild to moderate asthma (mean forced expiratory volume in 1 second [FEVI], 68.3% of predicted) 12 years or older participated in a multicenter, parallel-group, open-label study. Patients were randomized to levalbuterol HFA MDI (90 microg; 2 actuations of 45 microg; n = 496) or racemic albuterol HFA MDI (180 microg; 2 actuations of 90 microg; n = 250) for 52 weeks of 4 times daily dosing. The primary end point was the incidence of postrandomization adverse events. Asthma exacerbations and pulmonary parameters were also assessed. RESULTS: The overall incidence of adverse events was similar for levalbuterol (72.0%) and racemic albuterol (76.8%). Rates of beta-mediated adverse events, serious adverse events, and discontinuations because of adverse events were low (<15%) and were comparable between groups. Rates of asthma adverse events for levalbuterol and racemic albuterol were 18.3% and 19.6%, respectively. Mean percentage of predicted FEV1 improved after dosing and was stable for both groups. CONCLUSION: In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/18219836/Long_term_safety_study_of_levalbuterol_administered_via_metered_dose_inhaler_in_patients_with_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)60384-5 DB - PRIME DP - Unbound Medicine ER -