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The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol.

Abstract

STUDY OBJECTIVE

To compare the safety of salmeterol xinafoate or placebo added to usual asthma care.

DESIGN

A 28-week, randomized, double-blind, placebo-controlled, observational study.

SETTING

Study subjects were seen once in the study physician's office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks.

PARTICIPANTS

Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting beta2-agonist use were excluded.

INTERVENTIONS

Salmeterol, 42 mug bid via metered-dose inhaler (MDI), and placebo bid via MDI.

MEASUREMENTS AND RESULTS

Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo.

CONCLUSIONS

For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    National Jewish Medical and Research Center, Denver, CO, USA.

    , , , ,

    Source

    Chest 129:1 2006 Jan pg 15-26

    MeSH

    Administration, Inhalation
    Adolescent
    Adrenergic beta-Agonists
    Adult
    Aged
    Aged, 80 and over
    Albuterol
    Asthma
    Child
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Follow-Up Studies
    Glucocorticoids
    Humans
    Male
    Middle Aged
    Retrospective Studies
    Risk Factors
    Salmeterol Xinafoate
    Survival Rate
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16424409

    Citation

    Nelson, Harold S., et al. "The Salmeterol Multicenter Asthma Research Trial: a Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol." Chest, vol. 129, no. 1, 2006, pp. 15-26.
    Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26.
    Nelson, H. S., Weiss, S. T., Bleecker, E. R., Yancey, S. W., & Dorinsky, P. M. (2006). The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest, 129(1), pp. 15-26.
    Nelson HS, et al. The Salmeterol Multicenter Asthma Research Trial: a Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol. Chest. 2006;129(1):15-26. PubMed PMID: 16424409.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. AU - Nelson,Harold S, AU - Weiss,Scott T, AU - Bleecker,Eugene R, AU - Yancey,Steven W, AU - Dorinsky,Paul M, AU - ,, PY - 2006/1/21/pubmed PY - 2006/2/17/medline PY - 2006/1/21/entrez SP - 15 EP - 26 JF - Chest JO - Chest VL - 129 IS - 1 N2 - STUDY OBJECTIVE: To compare the safety of salmeterol xinafoate or placebo added to usual asthma care. DESIGN: A 28-week, randomized, double-blind, placebo-controlled, observational study. SETTING: Study subjects were seen once in the study physician's office for screening and were provided all blinded study medication for the entire study period. Follow-up by telephone was scheduled every 4 weeks. PARTICIPANTS: Subjects (> 12 years old) with asthma as judged by the study physician were eligible. Individuals with a history of long-acting beta2-agonist use were excluded. INTERVENTIONS: Salmeterol, 42 mug bid via metered-dose inhaler (MDI), and placebo bid via MDI. MEASUREMENTS AND RESULTS: Following an interim analysis in 26,355 subjects, the study was terminated due to findings in African Americans and difficulties in enrollment. The occurrence of the primary outcome, respiratory-related deaths, or life-threatening experiences was low and not significantly different for salmeterol vs placebo (50 vs 36; relative risk [RR] = 1.40; 95% confidence interval [CI], 0.91 to 2.14). There was a small, significant increase in respiratory-related deaths (24 vs 11; RR, 2.16; 95% CI, 1.06 to 4.41) and asthma-related deaths (13 vs 3; RR, 4.37; 95% CI, 1.25 to 15.34), and in combined asthma-related deaths or life-threatening experiences (37 vs 22; RR, 1.71; 95% CI, 1.01 to 2.89) in subjects receiving salmeterol vs placebo. The imbalance occurred largely in the African-American subpopulation: respiratory-related deaths or life-threatening experiences (20 vs 5; RR, 4.10; 95% CI, 1.54 to 10.90) and combined asthma-related deaths or life-threatening experiences (19 vs 4; RR, 4.92; 95% CI, 1.68 to 14.45) in subjects receiving salmeterol vs placebo. CONCLUSIONS: For the primary end point in the total population, there were no significant differences between treatments. There were small, but statistically significant increases in respiratory-related and asthma-related deaths and combined asthma-related deaths or life-threatening experiences in the total population receiving salmeterol. Subgroup analyses suggest the risk may be greater in African Americans compared with Caucasian subjects. Whether this risk is due to factors including but not limited to a physiologic treatment effect, genetic factors, or patient behaviors leading to poor outcomes remains unknown. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/16424409/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)31518-X DB - PRIME DP - Unbound Medicine ER -