Safety of formoterol in patients with asthma: Combined analysis of data from double- blind, randomized controlled trials Harold Nelson, MD, Catherine.

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Presentation transcript:

Safety of formoterol in patients with asthma: Combined analysis of data from double- blind, randomized controlled trials Harold Nelson, MD, Catherine Bonuccelli, MD, Finn Radner, PhD, Anders Ottosson, MD, PhD, Kevin J. Carroll, MSc, BSc, Tomas L.G. Andersson, MD, PhD, Craig LaForce, MD Journal of Allergy and Clinical Immunology Volume 125, Issue 2, Pages 390-396.e8 (February 2010) DOI: 10.1016/j.jaci.2009.11.036 Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Flow chart of patients with asthma involved in AstraZeneca trials with formoterol. Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Risk of asthma-related hospitalization with formoterol-containing versus non-LABA therapy: data from 42 individual studies (squares) and combined across studies (triangle; N=23,510). ∗A subset of data from only 4 (n=1270) of 42 (n=23,510) studies was included in the exploratory analysis conducted by the US Food and Drug Administration Office of Safety and Epidemiology.20,21 Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Kaplan-Meier probability curve for the time to first asthma-related hospitalization with formoterol-containing treatment versus non-LABA therapy (combined data from all studies; N=23,510). Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Risk of asthma-related hospitalization with formoterol (≥18 μg/d)+ICS compared with ICS: data from 17 individual studies (squares) and combined across studies (triangle; N=7213). Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Risk of asthma-related hospitalization with formoterol+ICS (free and/or fixed-combination) compared with ICS: combined data. (∗The individual analyses are not mutually exclusive.) BUD/FORMcomb, Budesonide and formoterol administered together in 1 inhaler (Symbicort Inhalation Aerosol or Symbicort Turbuhaler); ICSbackground, ICS as concomitant therapy (nonrandomized); ICSrandomized, ICS as randomized therapy; ICS+FORMfree, ICS and formoterol administered together in separate inhalers as a free combination; ICS+FORMfree or comb, ICS and formoterol administered together in a free or fixed combination. Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Risk of asthma-related hospitalization with formoterol-containing treatment versus non-LABA therapy in patients aged 4 to 11 years: data presented from 12 individual studies (squares) and combined across studies (triangle; n=3417). ∗The numerical imbalance in RR against the formoterol-containing treatment in the combined analysis was contributed to by a high number of patients (n=7) with asthma-related hospitalizations who were receiving a subtherapeutic dose of budesonide/formoterol (80/4.5 μg once daily) in 1 study. E26 Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Risk of asthma-related hospitalization with formoterol-containing treatment versus non-LABA therapy in patients age 12 to 17 years: data presented from 21 individual studies (squares) and combined across studies (triangle; n=2670). Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E3 Risk of asthma-related hospitalization with formoterol-containing treatment versus non-LABA therapy in patients 18 years or older: data presented from 33 individual studies (squares) and combined across studies (triangle; n=17,417). Journal of Allergy and Clinical Immunology 2010 125, 390-396.e8DOI: (10.1016/j.jaci.2009.11.036) Copyright © 2010 American Academy of Allergy, Asthma & Immunology Terms and Conditions