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Safety of salmeterol in the maintenance treatment of asthma.

Abstract

BACKGROUND

Salmeterol is the first long-acting inhaled beta 2-agonist available in the US for the maintenance treatment of asthma.

OBJECTIVE

To compare the safety of salmeterol with that of the short-acting beta 2-agonist albuterol.

METHODS

Two identically designed, prospective, randomized, double-blind, parallel studies were conducted comparing salmeterol 42 micrograms twice daily, albuterol 180 micrograms four times daily, and placebo over 12 weeks in 556 patients (12 to 73 years old) with mild-to-moderate chronic asthma. Patients in each treatment group could use albuterol as needed to control acute symptoms.

RESULTS

The incidence of potentially drug-related adverse events was similar among the treatment groups (range: 22% to 23%), with headache being the most commonly reported (range: 9% to 10%). No deaths occurred during the studies. Concomitant use of > 4 puffs of supplemental albuterol per day in the salmeterol group produced no increase in the incidence of adverse events either in general or of a cardiovascular nature. There were no statistically significant differences among treatment groups or clinically significant changes from pretreatment values in mean pulse rate, systolic/diastolic blood pressure, or clinical laboratory values after 12 weeks. There were no clinically significant differences among groups in heart rates nor were there differences in the frequency of supraventricular or ventricular ectopic beats during 24-hr Holter monitoring. The frequency of asthma exacerbations was lowest among patients receiving salmeterol (and highest among those who received placebo), and this rate did not increase over the 12 weeks. Asthma exacerbations were treated successfully with nebulized albuterol (2.5 mg), with no evidence of any increased risk of cardiovascular events.

CONCLUSIONS

Salmeterol 42 micrograms twice daily is well-tolerated in patients with asthma, having a similar safety profile as that of albuterol 180 micrograms inhaled four times daily or placebo (plus as-needed albuterol). Concomitant use of albuterol, either by MDI or nebulization, did not affect the safety of salmeterol. Extensive cardiovascular monitoring revealed no significant cardiovascular adverse effects or arrhythmogenic effects associated with salmeterol over 12 weeks.

Authors+Show Affiliations

,

Asthma and Allergy Associates, Colorado Springs, Colorado, USA.

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Source

MeSH

Adolescent
Adrenergic beta-Agonists
Adult
Aged
Albuterol
Asthma
Child
Chronic Disease
Double-Blind Method
Female
Heart
Hemodynamics
Humans
Male
Middle Aged
Nebulizers and Vaporizers
Prospective Studies
Salmeterol Xinafoate

Pub Type(s)

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

Language

eng

PubMed ID

7552926

Citation

Nathan, R A., et al. "Safety of Salmeterol in the Maintenance Treatment of Asthma." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 75, no. 3, 1995, pp. 243-8.
Nathan RA, Seltzer JM, Kemp JP, et al. Safety of salmeterol in the maintenance treatment of asthma. Ann Allergy Asthma Immunol. 1995;75(3):243-8.
Nathan, R. A., Seltzer, J. M., Kemp, J. P., Chervinsky, P., Alexander, W. J., Liddle, R., & Mills, R. (1995). Safety of salmeterol in the maintenance treatment of asthma. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 75(3), pp. 243-8.
Nathan RA, et al. Safety of Salmeterol in the Maintenance Treatment of Asthma. Ann Allergy Asthma Immunol. 1995;75(3):243-8. PubMed PMID: 7552926.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of salmeterol in the maintenance treatment of asthma. AU - Nathan,R A, AU - Seltzer,J M, AU - Kemp,J P, AU - Chervinsky,P, AU - Alexander,W J, AU - Liddle,R, AU - Mills,R, PY - 1995/9/1/pubmed PY - 1995/9/1/medline PY - 1995/9/1/entrez SP - 243 EP - 8 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 75 IS - 3 N2 - BACKGROUND: Salmeterol is the first long-acting inhaled beta 2-agonist available in the US for the maintenance treatment of asthma. OBJECTIVE: To compare the safety of salmeterol with that of the short-acting beta 2-agonist albuterol. METHODS: Two identically designed, prospective, randomized, double-blind, parallel studies were conducted comparing salmeterol 42 micrograms twice daily, albuterol 180 micrograms four times daily, and placebo over 12 weeks in 556 patients (12 to 73 years old) with mild-to-moderate chronic asthma. Patients in each treatment group could use albuterol as needed to control acute symptoms. RESULTS: The incidence of potentially drug-related adverse events was similar among the treatment groups (range: 22% to 23%), with headache being the most commonly reported (range: 9% to 10%). No deaths occurred during the studies. Concomitant use of > 4 puffs of supplemental albuterol per day in the salmeterol group produced no increase in the incidence of adverse events either in general or of a cardiovascular nature. There were no statistically significant differences among treatment groups or clinically significant changes from pretreatment values in mean pulse rate, systolic/diastolic blood pressure, or clinical laboratory values after 12 weeks. There were no clinically significant differences among groups in heart rates nor were there differences in the frequency of supraventricular or ventricular ectopic beats during 24-hr Holter monitoring. The frequency of asthma exacerbations was lowest among patients receiving salmeterol (and highest among those who received placebo), and this rate did not increase over the 12 weeks. Asthma exacerbations were treated successfully with nebulized albuterol (2.5 mg), with no evidence of any increased risk of cardiovascular events. CONCLUSIONS: Salmeterol 42 micrograms twice daily is well-tolerated in patients with asthma, having a similar safety profile as that of albuterol 180 micrograms inhaled four times daily or placebo (plus as-needed albuterol). Concomitant use of albuterol, either by MDI or nebulization, did not affect the safety of salmeterol. Extensive cardiovascular monitoring revealed no significant cardiovascular adverse effects or arrhythmogenic effects associated with salmeterol over 12 weeks. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/7552926/Safety_of_salmeterol_in_the_maintenance_treatment_of_asthma_ L2 - http://www.diseaseinfosearch.org/result/633 DB - PRIME DP - Unbound Medicine ER -