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Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial.

Abstract

CONTEXT

Long-acting beta(2)-agonists are prescribed for patients with persistent asthma and are sometimes used without inhaled corticosteroids (ICSs). No evidence exists, however, to support their use as monotherapy in adults with persistent asthma.

OBJECTIVE

To examine the effectiveness of salmeterol xinafoate, a long-acting beta(2)-agonist, as replacement therapy in patients whose asthma is well controlled by low-dose triamcinolone acetonide, an ICS.

DESIGN AND SETTING

A 28-week, randomized, blinded, placebo-controlled, parallel group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 to January 1999.

PARTICIPANTS

One hundred sixty-four patients aged 12 through 65 years with persistent asthma that was well controlled during a 6-week run-in period of treatment with inhaled triamcinolone (400 microg twice per day).

INTERVENTIONS

Patients were randomly assigned to continue triamcinolone therapy (400 microg twice per day; n = 54) or switch to salmeterol (42 microg twice per day; n = 54) or to placebo (n = 56) for 16 weeks, after which all patients received placebo for an additional 6-week run-out period.

MAIN OUTCOME MEASURES

Change in morning and evening peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV(1)), self-assessed asthma symptom scores, rescue albuterol use, asthma-specific quality-of-life scores, treatment failure, asthma exacerbation, bronchial reactivity, and markers of airway inflammation, compared among the 3 treatment groups.

RESULTS

During the 16-week randomized treatment period, no significant differences between the salmeterol and triamcinolone groups were observed for conventional outcomes of clinical studies of asthma therapy-morning PEF, evening PEF, asthma symptom scores, rescue albuterol sulfate use, or quality of life. Both active treatments were superior to placebo. However, the salmeterol group had more treatment failures than the triamcinolone group (13/54 [24%] vs 3/54 [6%]; P =.004), as well as more asthma exacerbations (11/54 [20%] vs 4/54 [7%]; P =.04), greater increases in median (interquartile range) sputum eosinophils (2.4% [0.0% to 10.6%] vs -0.1% [-0.7% to 0.3%]; P<.001), eosinophil cationic protein (71 [-2 to 430] U/L vs -4 [-31 to 56] U/L; P =.005), and tryptase (3.1 [2.1 to 7.6] ng/mL vs 0.0 [0.0 to 0.7] ng/mL; P<.001). The duration of benefit when patients were switched from active treatment to placebo after 22 weeks of randomized treatment was not significantly longer in the triamcinolone group than in the salmeterol group.

CONCLUSIONS

Patients with persistent asthma well controlled by low doses of triamcinolone cannot be switched to salmeterol monotherapy without risk of clinically significant loss of asthma control.

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  • Authors+Show Affiliations

    ,

    University of California, San Francisco, 505 Parnassus Ave, San Francisco, CA 94143-0111, USA. lazma@itsa.ucsf.edu

    , , , , , , , , , , , , , , , , ,

    Source

    JAMA 285:20 pg 2583-93

    MeSH

    Administration, Inhalation
    Adolescent
    Adrenergic beta-Agonists
    Adult
    Albuterol
    Anti-Inflammatory Agents
    Asthma
    Female
    Humans
    Male
    Middle Aged
    Respiratory Function Tests
    Salmeterol Xinafoate
    Single-Blind Method
    Treatment Failure
    Triamcinolone Acetonide

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    11368732

    Citation

    Lazarus, S C., et al. "Long-acting Beta2-agonist Monotherapy Vs Continued Therapy With Inhaled Corticosteroids in Patients With Persistent Asthma: a Randomized Controlled Trial." JAMA, vol. 285, no. 20, 2001, pp. 2583-93.
    Lazarus SC, Boushey HA, Fahy JV, et al. Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. JAMA. 2001;285(20):2583-93.
    Lazarus, S. C., Boushey, H. A., Fahy, J. V., Chinchilli, V. M., Lemanske, R. F., Sorkness, C. A., ... Szefler, S. J. (2001). Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. JAMA, 285(20), pp. 2583-93.
    Lazarus SC, et al. Long-acting Beta2-agonist Monotherapy Vs Continued Therapy With Inhaled Corticosteroids in Patients With Persistent Asthma: a Randomized Controlled Trial. JAMA. 2001;285(20):2583-93. PubMed PMID: 11368732.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. AU - Lazarus,S C, AU - Boushey,H A, AU - Fahy,J V, AU - Chinchilli,V M, AU - Lemanske,R F,Jr AU - Sorkness,C A, AU - Kraft,M, AU - Fish,J E, AU - Peters,S P, AU - Craig,T, AU - Drazen,J M, AU - Ford,J G, AU - Israel,E, AU - Martin,R J, AU - Mauger,E A, AU - Nachman,S A, AU - Spahn,J D, AU - Szefler,S J, AU - ,, PY - 2001/5/23/pubmed PY - 2001/6/23/medline PY - 2001/5/23/entrez SP - 2583 EP - 93 JF - JAMA JO - JAMA VL - 285 IS - 20 N2 - CONTEXT: Long-acting beta(2)-agonists are prescribed for patients with persistent asthma and are sometimes used without inhaled corticosteroids (ICSs). No evidence exists, however, to support their use as monotherapy in adults with persistent asthma. OBJECTIVE: To examine the effectiveness of salmeterol xinafoate, a long-acting beta(2)-agonist, as replacement therapy in patients whose asthma is well controlled by low-dose triamcinolone acetonide, an ICS. DESIGN AND SETTING: A 28-week, randomized, blinded, placebo-controlled, parallel group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 to January 1999. PARTICIPANTS: One hundred sixty-four patients aged 12 through 65 years with persistent asthma that was well controlled during a 6-week run-in period of treatment with inhaled triamcinolone (400 microg twice per day). INTERVENTIONS: Patients were randomly assigned to continue triamcinolone therapy (400 microg twice per day; n = 54) or switch to salmeterol (42 microg twice per day; n = 54) or to placebo (n = 56) for 16 weeks, after which all patients received placebo for an additional 6-week run-out period. MAIN OUTCOME MEASURES: Change in morning and evening peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV(1)), self-assessed asthma symptom scores, rescue albuterol use, asthma-specific quality-of-life scores, treatment failure, asthma exacerbation, bronchial reactivity, and markers of airway inflammation, compared among the 3 treatment groups. RESULTS: During the 16-week randomized treatment period, no significant differences between the salmeterol and triamcinolone groups were observed for conventional outcomes of clinical studies of asthma therapy-morning PEF, evening PEF, asthma symptom scores, rescue albuterol sulfate use, or quality of life. Both active treatments were superior to placebo. However, the salmeterol group had more treatment failures than the triamcinolone group (13/54 [24%] vs 3/54 [6%]; P =.004), as well as more asthma exacerbations (11/54 [20%] vs 4/54 [7%]; P =.04), greater increases in median (interquartile range) sputum eosinophils (2.4% [0.0% to 10.6%] vs -0.1% [-0.7% to 0.3%]; P<.001), eosinophil cationic protein (71 [-2 to 430] U/L vs -4 [-31 to 56] U/L; P =.005), and tryptase (3.1 [2.1 to 7.6] ng/mL vs 0.0 [0.0 to 0.7] ng/mL; P<.001). The duration of benefit when patients were switched from active treatment to placebo after 22 weeks of randomized treatment was not significantly longer in the triamcinolone group than in the salmeterol group. CONCLUSIONS: Patients with persistent asthma well controlled by low doses of triamcinolone cannot be switched to salmeterol monotherapy without risk of clinically significant loss of asthma control. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/11368732/Long_acting_beta2_agonist_monotherapy_vs_continued_therapy_with_inhaled_corticosteroids_in_patients_with_persistent_asthma:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/285/pg/2583 DB - PRIME DP - Unbound Medicine ER -