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Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma.
J Allergy Clin Immunol 1998; 102(6 Pt 1):943-52JA

Abstract

BACKGROUND

Racemic albuterol is an equal mixture of (R)-albuterol (levalbuterol), which is responsible for the bronchodilator effect, and (S)-albuterol, which provides no benefit and may be detrimental.

OBJECTIVE

We sought to compare 2 doses of a single enantiomer, levalbuterol (0.63 mg and 1.25 mg), and equivalent amounts of levalbuterol administered as racemic albuterol with placebo in patients with moderate-to-severe asthma.

METHODS

This was a randomized, double-blind, parallel-group trial. Three hundred sixty-two patients 12 years of age or older were treated with study drug administered by means of nebulization 3 times daily for 28 days. The primary endpoint was peak change in FEV1 after 4 weeks.

RESULTS

The change in peak FEV1 response to the first dose in the combined levalbuterol group was significantly greater compared with the combined racemic albuterol group (0.92 and 0.82 L, respectively; P =.03), with similar but nonsignificant results after 4 weeks (0.84 and 0.74 L, respectively). Improvement in FEV1 was similar for levalbuterol 0.63 mg and racemic albuterol 2.5 mg and greatest for levalbuterol 1.25 mg. Racemic albuterol 1.25 mg demonstrated the weakest bronchodilator effect, particularly after chronic dosing. The greatest increase in FEV1 was seen after levalbuterol 1.25 mg, especially in subjects with severe asthma. All active treatments were well tolerated, and beta-adrenergic side effects after administration of levalbuterol 0.63 mg were reduced relative to levalbuterol 1.25 mg or racemic albuterol 2.5 mg. At week 4, the predose FEV1 value was greatest in patients who received levalbuterol or placebo when compared with those who received racemic albuterol. The difference was more evident and was statistically significant in patients who were not receiving inhaled corticosteroids.

CONCLUSION

Levalbuterol appears to provide a better therapeutic index than the standard dose of racemic albuterol. These results support the concept that (S)-albuterol may have detrimental effects on pulmonary function.

Authors+Show Affiliations

National Jewish Medical and Research Center, Denver, CO, 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)

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

Language

eng

PubMed ID

9847435

Citation

Nelson, H S., et al. "Improved Bronchodilation With Levalbuterol Compared With Racemic Albuterol in Patients With Asthma." The Journal of Allergy and Clinical Immunology, vol. 102, no. 6 Pt 1, 1998, pp. 943-52.
Nelson HS, Bensch G, Pleskow WW, et al. Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma. J Allergy Clin Immunol. 1998;102(6 Pt 1):943-52.
Nelson, H. S., Bensch, G., Pleskow, W. W., DiSantostefano, R., DeGraw, S., Reasner, D. S., ... Rubin, P. D. (1998). Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma. The Journal of Allergy and Clinical Immunology, 102(6 Pt 1), pp. 943-52.
Nelson HS, et al. Improved Bronchodilation With Levalbuterol Compared With Racemic Albuterol in Patients With Asthma. J Allergy Clin Immunol. 1998;102(6 Pt 1):943-52. PubMed PMID: 9847435.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma. AU - Nelson,H S, AU - Bensch,G, AU - Pleskow,W W, AU - DiSantostefano,R, AU - DeGraw,S, AU - Reasner,D S, AU - Rollins,T E, AU - Rubin,P D, PY - 1998/12/16/pubmed PY - 1998/12/16/medline PY - 1998/12/16/entrez SP - 943 EP - 52 JF - The Journal of allergy and clinical immunology JO - J. Allergy Clin. Immunol. VL - 102 IS - 6 Pt 1 N2 - BACKGROUND: Racemic albuterol is an equal mixture of (R)-albuterol (levalbuterol), which is responsible for the bronchodilator effect, and (S)-albuterol, which provides no benefit and may be detrimental. OBJECTIVE: We sought to compare 2 doses of a single enantiomer, levalbuterol (0.63 mg and 1.25 mg), and equivalent amounts of levalbuterol administered as racemic albuterol with placebo in patients with moderate-to-severe asthma. METHODS: This was a randomized, double-blind, parallel-group trial. Three hundred sixty-two patients 12 years of age or older were treated with study drug administered by means of nebulization 3 times daily for 28 days. The primary endpoint was peak change in FEV1 after 4 weeks. RESULTS: The change in peak FEV1 response to the first dose in the combined levalbuterol group was significantly greater compared with the combined racemic albuterol group (0.92 and 0.82 L, respectively; P =.03), with similar but nonsignificant results after 4 weeks (0.84 and 0.74 L, respectively). Improvement in FEV1 was similar for levalbuterol 0.63 mg and racemic albuterol 2.5 mg and greatest for levalbuterol 1.25 mg. Racemic albuterol 1.25 mg demonstrated the weakest bronchodilator effect, particularly after chronic dosing. The greatest increase in FEV1 was seen after levalbuterol 1.25 mg, especially in subjects with severe asthma. All active treatments were well tolerated, and beta-adrenergic side effects after administration of levalbuterol 0.63 mg were reduced relative to levalbuterol 1.25 mg or racemic albuterol 2.5 mg. At week 4, the predose FEV1 value was greatest in patients who received levalbuterol or placebo when compared with those who received racemic albuterol. The difference was more evident and was statistically significant in patients who were not receiving inhaled corticosteroids. CONCLUSION: Levalbuterol appears to provide a better therapeutic index than the standard dose of racemic albuterol. These results support the concept that (S)-albuterol may have detrimental effects on pulmonary function. SN - 0091-6749 UR - https://www.unboundmedicine.com/medline/citation/9847435/Improved_bronchodilation_with_levalbuterol_compared_with_racemic_albuterol_in_patients_with_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091674998004539 DB - PRIME DP - Unbound Medicine ER -