PMID- 20889908
OWN - NLM
STAT- MEDLINE
DCOM- 20110616
LR  - 20220330
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Linking)
VI  - 183
IP  - 5
DP  - 2011 Mar 1
TI  - Risks of pneumonia in patients with asthma taking inhaled corticosteroids.
PG  - 589-95
LID - 10.1164/rccm.201005-0694OC [doi]
AB  - RATIONALE: Inhaled corticosteroids (ICS) are the mainstay of asthma treatment. 
      Studies in chronic obstructive pulmonary disease reported increased rates of 
      pneumonia with ICS. Concerns exist about an increased pneumonia risk in patients 
      with asthma taking ICS. OBJECTIVES: To evaluate the risks of pneumonia in 
      patients with asthma taking ICS. METHODS: A retrospective analysis evaluated 
      studies of the ICS budesonide in asthma. The primary data set were all 
      double-blind, placebo-controlled trials lasting at least 3 months, involving 
      budesonide (26 trials, n = 9,067 for budesonide; n = 5,926 for the comparator) 
      sponsored by AstraZeneca. A secondary data set evaluated all double-blind trials 
      lasting at least 3 months but without placebo control (60 trials, n = 33,496 for 
      budesonide, n = 2,773 for fluticasone propionate). Cox proportional hazards 
      regression modeling was used to estimate the relative effect of ICS on pneumonia 
      adverse events (AEs) or serious adverse events (SAEs). MEASUREMENTS AND MAIN 
      RESULTS: In the primary data set, the occurrence of pneumonia AEs was 0.5% (rate 
      10.0 events/1,000 patient-years [TPY]) for budesonide and 1.2% (19.3 per TPY) for 
      placebo (hazard ratio, 0.52; 95% confidence interval, 0.36-0.76; P < 0.001); the 
      occurrence of pneumonia SAEs was 0.15% (2.9 per TPY) for budesonide and 0.13% 
      (2.1 per TPY) for placebo (hazard ratio, 1.29; 95% confidence interval, 
      0.53-3.12; P = 0.58). In the secondary data set, the percentage of patients 
      reporting pneumonia AEs was 0.70% (12.7 per TPY), whereas the percentage of 
      patients reporting pneumonia SAEs was 0.17% (3.1 per TPY). There was no increased 
      risk with higher budesonide doses or any difference between budesonide and 
      fluticasone. CONCLUSIONS: There is no increased risk of pneumonia in patients 
      with asthma, identified as an AE or SAE, in clinical trials using budesonide.
FAU - O'Byrne, Paul M
AU  - O'Byrne PM
AD  - Firestone Institute for Respiratory Health, Michael G. DeGroote School of 
      Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, 
      Canada. obyrnep@mcmaster.ca
FAU - Pedersen, Soren
AU  - Pedersen S
FAU - Carlsson, Lars-Goran
AU  - Carlsson LG
FAU - Radner, Finn
AU  - Radner F
FAU - Thoren, Anders
AU  - Thoren A
FAU - Peterson, Stefan
AU  - Peterson S
FAU - Ernst, Pierre
AU  - Ernst P
FAU - Suissa, Samy
AU  - Suissa S
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20101001
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Androstadienes)
RN  - 0 (Bronchodilator Agents)
RN  - 51333-22-3 (Budesonide)
RN  - CUT2W21N7U (Fluticasone)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adrenal Cortex Hormones/*administration & dosage/*adverse effects
MH  - Adult
MH  - Aged
MH  - Androstadienes/administration & dosage/adverse effects/therapeutic use
MH  - Asthma/*drug therapy/*epidemiology
MH  - Bronchodilator Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Budesonide/administration & dosage/adverse effects/therapeutic use
MH  - Causality
MH  - Child
MH  - Child, Preschool
MH  - Comorbidity
MH  - Double-Blind Method
MH  - Female
MH  - Fluticasone
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Pneumonia/*chemically induced/*epidemiology
MH  - Proportional Hazards Models
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Young Adult
EDAT- 2010/10/05 06:00
MHDA- 2011/06/17 06:00
CRDT- 2010/10/05 06:00
PHST- 2010/10/05 06:00 [entrez]
PHST- 2010/10/05 06:00 [pubmed]
PHST- 2011/06/17 06:00 [medline]
AID - 201005-0694OC [pii]
AID - 10.1164/rccm.201005-0694OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2011 Mar 1;183(5):589-95. doi: 
      10.1164/rccm.201005-0694OC. Epub 2010 Oct 1.