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Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review.
Pulm Pharmacol Ther 2009; 22(1):9-19PP

Abstract

BACKGROUND

Safety of long-acting beta agonists (LABA) has been questioned and recent evidence suggested a detrimental effect on asthma control as well as an increased risk of death.

OBJECTIVE

To evaluate the safety of regular use of LABA compared with placebo or LABA added to inhaled corticosteroids (ICS) compared with ICS in persistent asthma.

METHODS

Randomized studies from MEDLINE, EMBASE, and Cochrane Controlled Trials Register were identified. Additionally, AstraZeneca, GlaxoSmithKline, Novartis and FDA clinical trials databases were searched. Primary outcomes were asthma exacerbations (AE) requiring systemic corticosteroids or hospitalization, life-threatening exacerbations and asthma-related deaths.

RESULTS

We identified 92 randomized clinical trials with 74,092 subjects. LABA (as monotherapy) reduced exacerbations requiring corticosteroids (Relative Risk [RR]=0.80; 95% CI, 0.73-0.88), without detrimental effects on hospitalizations or life-threatening episodes. Contrarily, LABA showed a significant increase in asthma-related deaths (Relative Risk=3.83; 95% CI, 1.21-12.14). Subgroup analysis suggests that children, patients receiving salmeterol, and a duration of treatment>12 weeks are associated with a higher risk of serious adverse effects; also there was a protective effect of concomitant use of ICS. On the other hand, combination of LABA/ICS reduced exacerbations (RR=0.73; 95% CI, 0.67-0.79), and hospitalizations (RR=0.58, 95% CI, 0.45-0.74). Combined therapy was also equivalent to ICS in terms of life-threatening episodes and asthma-related deaths. Again, children and use of salmeterol were associated with an increased risk of some severe outcomes as compared with adults and formoterol users, respectively.

CONCLUSIONS

This review reinforced the international recommendations in terms of the use of LABA remains the preferred add-on therapy to ICS for patients whose disease cannot adequately controlled with ICS, and that LABA cannot be prescribed as a monotherapy. Nevertheless, in spite of the protective effect of the ICS, children and salmeterol use still show an increased risk of non-fatal serious adverse events.

Authors+Show Affiliations

Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Av. 8 de Octubre 3020, Montevideo 11600, Uruguay. gurodrig@adinet.com.uyNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

19026757

Citation

Rodrigo, Gustavo J., et al. "Safety of Regular Use of Long-acting Beta Agonists as Monotherapy or Added to Inhaled Corticosteroids in Asthma. a Systematic Review." Pulmonary Pharmacology & Therapeutics, vol. 22, no. 1, 2009, pp. 9-19.
Rodrigo GJ, Moral VP, Marcos LG, et al. Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. Pulm Pharmacol Ther. 2009;22(1):9-19.
Rodrigo, G. J., Moral, V. P., Marcos, L. G., & Castro-Rodriguez, J. A. (2009). Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. Pulmonary Pharmacology & Therapeutics, 22(1), pp. 9-19. doi:10.1016/j.pupt.2008.10.008.
Rodrigo GJ, et al. Safety of Regular Use of Long-acting Beta Agonists as Monotherapy or Added to Inhaled Corticosteroids in Asthma. a Systematic Review. Pulm Pharmacol Ther. 2009;22(1):9-19. PubMed PMID: 19026757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. AU - Rodrigo,Gustavo J, AU - Moral,Vicente Plaza, AU - Marcos,Luis García, AU - Castro-Rodriguez,José A, Y1 - 2008/11/05/ PY - 2008/07/24/received PY - 2008/09/21/revised PY - 2008/10/11/accepted PY - 2008/11/26/pubmed PY - 2009/5/1/medline PY - 2008/11/26/entrez SP - 9 EP - 19 JF - Pulmonary pharmacology & therapeutics JO - Pulm Pharmacol Ther VL - 22 IS - 1 N2 - BACKGROUND: Safety of long-acting beta agonists (LABA) has been questioned and recent evidence suggested a detrimental effect on asthma control as well as an increased risk of death. OBJECTIVE: To evaluate the safety of regular use of LABA compared with placebo or LABA added to inhaled corticosteroids (ICS) compared with ICS in persistent asthma. METHODS: Randomized studies from MEDLINE, EMBASE, and Cochrane Controlled Trials Register were identified. Additionally, AstraZeneca, GlaxoSmithKline, Novartis and FDA clinical trials databases were searched. Primary outcomes were asthma exacerbations (AE) requiring systemic corticosteroids or hospitalization, life-threatening exacerbations and asthma-related deaths. RESULTS: We identified 92 randomized clinical trials with 74,092 subjects. LABA (as monotherapy) reduced exacerbations requiring corticosteroids (Relative Risk [RR]=0.80; 95% CI, 0.73-0.88), without detrimental effects on hospitalizations or life-threatening episodes. Contrarily, LABA showed a significant increase in asthma-related deaths (Relative Risk=3.83; 95% CI, 1.21-12.14). Subgroup analysis suggests that children, patients receiving salmeterol, and a duration of treatment>12 weeks are associated with a higher risk of serious adverse effects; also there was a protective effect of concomitant use of ICS. On the other hand, combination of LABA/ICS reduced exacerbations (RR=0.73; 95% CI, 0.67-0.79), and hospitalizations (RR=0.58, 95% CI, 0.45-0.74). Combined therapy was also equivalent to ICS in terms of life-threatening episodes and asthma-related deaths. Again, children and use of salmeterol were associated with an increased risk of some severe outcomes as compared with adults and formoterol users, respectively. CONCLUSIONS: This review reinforced the international recommendations in terms of the use of LABA remains the preferred add-on therapy to ICS for patients whose disease cannot adequately controlled with ICS, and that LABA cannot be prescribed as a monotherapy. Nevertheless, in spite of the protective effect of the ICS, children and salmeterol use still show an increased risk of non-fatal serious adverse events. SN - 1094-5539 UR - https://www.unboundmedicine.com/medline/citation/19026757/Safety_of_regular_use_of_long_acting_beta_agonists_as_monotherapy_or_added_to_inhaled_corticosteroids_in_asthma__A_systematic_review_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1094-5539(08)00100-4 DB - PRIME DP - Unbound Medicine ER -