Imran H Iftikhar1, Muhammad Imtiaz, Allan S Brett, David J Amrol. 1. Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, University of South Carolina, 1 Medical Park, Suite 300, Columbia, SC, 29203, USA, imran.iftikhar@uscmed.sc.edu.
Abstract
INTRODUCTION: Long-acting beta agonists and inhaled corticosteroids combination products (LABA-ICS) are widely used in the treatment of asthma. However, there appears to be little data on their cardiovascular safety. The purpose of this study was to conduct a systematic review of the available studies and trials on the cardiovascular safety of LABA-ICS in adults with asthma. METHODS: Two independent reviewers screened citations from PubMed and National Clinical Trials registry to identify studies and trials on the cardiovascular effects of LABA-ICS in patients with asthma. RESULTS: A total of 15 studies (with 17 cohorts on LABA-ICS to compare with a comparator or placebo) with 5,440 total study participants met the inclusion criteria. Two studies on budesonide-formoterol and one on fluticasone-salmeterol reported treatment emergent cardiovascular adverse events, all of which were dysrhythmias. For comparison, the pooled estimate of the Peto odds ratio (0.72; 95 % confidence interval [CI] 0.17-3; p = 0.65) and the summary risk ratio (0.77; 95 % CI 0.26-2.3; p = 0.64) indicated a nonsignificant difference between LABA-ICS and comparator/placebo groups. CONCLUSIONS: Our systematic review found that few studies and trials reported treatment emergent cardiovascular adverse events with LABA-ICS. However, the Peto odds ratio and risk ratio for these outcomes was statistically nonsignificant. This suggests that LABA-ICS products may have a safe cardiovascular profile in asthma patients.
INTRODUCTION: Long-acting beta agonists and inhaled corticosteroids combination products (LABA-ICS) are widely used in the treatment of asthma. However, there appears to be little data on their cardiovascular safety. The purpose of this study was to conduct a systematic review of the available studies and trials on the cardiovascular safety of LABA-ICS in adults with asthma. METHODS: Two independent reviewers screened citations from PubMed and National Clinical Trials registry to identify studies and trials on the cardiovascular effects of LABA-ICS in patients with asthma. RESULTS: A total of 15 studies (with 17 cohorts on LABA-ICS to compare with a comparator or placebo) with 5,440 total study participants met the inclusion criteria. Two studies on budesonide-formoterol and one on fluticasone-salmeterol reported treatment emergent cardiovascular adverse events, all of which were dysrhythmias. For comparison, the pooled estimate of the Peto odds ratio (0.72; 95 % confidence interval [CI] 0.17-3; p = 0.65) and the summary risk ratio (0.77; 95 % CI 0.26-2.3; p = 0.64) indicated a nonsignificant difference between LABA-ICS and comparator/placebo groups. CONCLUSIONS: Our systematic review found that few studies and trials reported treatment emergent cardiovascular adverse events with LABA-ICS. However, the Peto odds ratio and risk ratio for these outcomes was statistically nonsignificant. This suggests that LABA-ICS products may have a safe cardiovascular profile in asthmapatients.
Authors: Roman Jaeschke; Paul M O'Byrne; Parameswaran Nair; Filip Mejza; Wiktoria Leśniak; Jan Brozek; Lehana Thabane; Ji Cheng; Małgorzata Bała; Holger J Schünemann; Malcolm R Sears; Gordon Guyatt Journal: Pol Arch Med Wewn Date: 2008-11
Authors: E D Bateman; S S Hurd; P J Barnes; J Bousquet; J M Drazen; J M FitzGerald; P Gibson; K Ohta; P O'Byrne; S E Pedersen; E Pizzichini; S D Sullivan; S E Wenzel; H J Zar Journal: Eur Respir J Date: 2008-01 Impact factor: 16.671
Authors: Don D Sin; S F Paul Man; Darcy D Marciniuk; Gordon Ford; Mark FitzGerald; Eric Wong; Ernest York; Rajesh R Mainra; Warren Ramesh; Lyle S Melenka; Eric Wilde; Robert L Cowie; Dave Williams; Wen Q Gan; Roxanne Rousseau Journal: Am J Respir Crit Care Med Date: 2008-02-28 Impact factor: 21.405