OBJECTIVE: To determine the risk, by age group, of serious asthma-related events with long-acting β(2)-adrenergic receptor agonists marketed in the United States for asthma. METHODS: The US Food and Drug Administration performed a meta-analysis of controlled clinical trials comparing the risk of LABA use with no LABA use for patients 4 to 11, 12 to 17, 18 to 64, and older than 64 years old. The effects of age on a composite of asthma-related deaths, intubations, and hospitalizations (asthma composite index) and the effects of concomitant inhaled corticosteroid (ICS) use were analyzed. RESULTS: One hundred ten trials with 60 954 patients were included in the meta-analysis. The composite event incidence difference for all ages was 6.3 events per 1000 patient-years (95% confidence interval [CI]: 2.2-10.3) for using LABAs compared with not using LABAs. The largest incidence difference was observed for the 4- to 11-year age group (30.4 events per 1000 patient-years [95% CI: 5.7-55.1]). Differences according to age were statistically significant (P = .020). Results for the subgroup of patients with concomitant ICS use (n = 36 210) were similar to the overall results; with assigned ICSs (n = 15 192), the incidence difference was 0.4 events per 1000 patient-years (95% CI: -3.8 to 4.6), and there was no statistically significant difference according to age group. CONCLUSIONS: The excess of serious asthma-related events attributable to LABAs was greatest among children. Additional data are needed to assess risks of LABA use for children with simultaneous ICS use.
OBJECTIVE: To determine the risk, by age group, of serious asthma-related events with long-acting β(2)-adrenergic receptor agonists marketed in the United States for asthma. METHODS: The US Food and Drug Administration performed a meta-analysis of controlled clinical trials comparing the risk of LABA use with no LABA use for patients 4 to 11, 12 to 17, 18 to 64, and older than 64 years old. The effects of age on a composite of asthma-related deaths, intubations, and hospitalizations (asthma composite index) and the effects of concomitant inhaled corticosteroid (ICS) use were analyzed. RESULTS: One hundred ten trials with 60 954 patients were included in the meta-analysis. The composite event incidence difference for all ages was 6.3 events per 1000 patient-years (95% confidence interval [CI]: 2.2-10.3) for using LABAs compared with not using LABAs. The largest incidence difference was observed for the 4- to 11-year age group (30.4 events per 1000 patient-years [95% CI: 5.7-55.1]). Differences according to age were statistically significant (P = .020). Results for the subgroup of patients with concomitant ICS use (n = 36 210) were similar to the overall results; with assigned ICSs (n = 15 192), the incidence difference was 0.4 events per 1000 patient-years (95% CI: -3.8 to 4.6), and there was no statistically significant difference according to age group. CONCLUSIONS: The excess of serious asthma-related events attributable to LABAs was greatest among children. Additional data are needed to assess risks of LABA use for children with simultaneous ICS use.
Authors: Richard Carr; Yang Du; Julie Quoyer; Reynold A Panettieri; Jay M Janz; Michel Bouvier; Brian K Kobilka; Jeffrey L Benovic Journal: J Biol Chem Date: 2014-11-13 Impact factor: 5.157
Authors: Jennifer Danielsson; Sarah Zaidi; Benjamin Kim; Hiromi Funayama; Peter D Yim; Dingbang Xu; Tilla S Worgall; George Gallos; Charles W Emala Journal: Lung Date: 2016-03-17 Impact factor: 2.584
Authors: N G Papadopoulos; H Arakawa; K-H Carlsen; A Custovic; J Gern; R Lemanske; P Le Souef; M Mäkelä; G Roberts; G Wong; H Zar; C A Akdis; L B Bacharier; E Baraldi; H P van Bever; J de Blic; A Boner; W Burks; T B Casale; J A Castro-Rodriguez; Y Z Chen; Y M El-Gamal; M L Everard; T Frischer; M Geller; J Gereda; D Y Goh; T W Guilbert; G Hedlin; P W Heymann; S J Hong; E M Hossny; J L Huang; D J Jackson; J C de Jongste; O Kalayci; N Aït-Khaled; S Kling; P Kuna; S Lau; D K Ledford; S I Lee; A H Liu; R F Lockey; K Lødrup-Carlsen; J Lötvall; A Morikawa; A Nieto; H Paramesh; R Pawankar; P Pohunek; J Pongracic; D Price; C Robertson; N Rosario; L J Rossenwasser; P D Sly; R Stein; S Stick; S Szefler; L M Taussig; E Valovirta; P Vichyanond; D Wallace; E Weinberg; G Wennergren; J Wildhaber; R S Zeiger Journal: Allergy Date: 2012-06-15 Impact factor: 13.146
Authors: Michael R Gionfriddo; John B Hagan; Christina R Hagan; Gerald W Volcheck; Ana Castaneda-Guarderas; Matthew A Rank Journal: Allergy Asthma Proc Date: 2015 Jul-Aug Impact factor: 2.587
Authors: Hengameh H Raissy; H William Kelly; Michelle Harkins; Stanley J Szefler Journal: Am J Respir Crit Care Med Date: 2013-04-15 Impact factor: 21.405
Authors: Amy Brown; Jennifer Danielsson; Elizabeth A Townsend; Yi Zhang; Jose F Perez-Zoghbi; Charles W Emala; George Gallos Journal: Am J Physiol Lung Cell Mol Physiol Date: 2016-01-15 Impact factor: 5.464