PMID- 36348141
OWN - NLM
STAT- MEDLINE
DCOM- 20230124
LR  - 20230224
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 40
IP  - 1
DP  - 2023 Jan
TI  - Safety of SABA Monotherapy in Asthma Management: a Systematic Review and 
      Meta-analysis.
PG  - 133-158
LID - 10.1007/s12325-022-02356-2 [doi]
AB  - INTRODUCTION: Short-acting beta(2)-agonist (SABA) reliever overuse is common in 
      asthma, despite availability of inhaled corticosteroid (ICS)-based maintenance 
      therapies, and may be associated with increased risk of adverse events (AEs). 
      This systematic literature review (SLR) and meta-analysis aimed to investigate 
      the safety and tolerability of SABA reliever monotherapy for adults and 
      adolescents with asthma, through analysis of randomized controlled trials (RCTs) 
      and real-world evidence. METHODS: An SLR of English-language publications between 
      January 1996 and December 2021 included RCTs and observational studies of 
      patients aged >/= 12 years treated with inhaled SABA reliever monotherapy (fixed 
      dose or as needed) for >/= 4 weeks. Studies of terbutaline and fenoterol were 
      excluded. Meta-analysis feasibility was dependent on cross-trial data 
      comparability. A random-effects model estimated rates of mortality, serious AEs 
      (SAEs), and discontinuation due to AEs (DAEs) for as-needed and fixed-dose SABA 
      treatment groups. ICS monotherapy and SABA therapy were compared using a 
      fixed-effects model. RESULTS: Forty-two studies were identified by the SLR for 
      assessment of feasibility. Final meta-analysis included 24 RCTs. Too few 
      observational studies (n = 2) were available for inclusion in the meta-analysis. 
      One death unrelated to treatment was reported in each of the ICS, ICS + LABA, and 
      fixed-dose SABA groups. No other treatment-related deaths were reported. SAE and 
      DAE rates were < 4%. DAEs were reported more frequently in the SABA treatment 
      groups than with ICS, potentially owing to worsening asthma symptoms being 
      classified as an AE. SAE risk was comparable between SABA and ICS treatments. 
      CONCLUSIONS: Meta-analysis of data from RCTs showed that deaths were rare with 
      SABA reliever monotherapy, and rates of SAEs and DAEs were comparable between 
      SABA reliever and ICS treatment groups. When used appropriately within prescribed 
      limits as reliever therapy, SABA does not contribute to excess rates of 
      mortality, SAEs, or DAEs.
CI  - (c) 2022. The Author(s).
FAU - Sriprasart, Thitiwat
AU  - Sriprasart T
AUID- ORCID: 0000-0002-4029-917X
AD  - Department of Medicine, Faculty of Medicine, Chulalongkorn University and King 
      Chulalongkorn Memorial Hospital, Thai Red Cross Society, 1873 Rama IV Road, 
      Patumwan, Bangkok, 10330, Thailand. thitiwatsr@yahoo.com.
FAU - Waterer, Grant
AU  - Waterer G
AUID- ORCID: 0000-0002-7222-8018
AD  - University of Western Australia, Royal Perth Hospital, Perth, Australia.
FAU - Garcia, Gabriel
AU  - Garcia G
AD  - Pneumology, Hospital Rossi, La Plata, Argentina.
FAU - Rubin, Adalberto
AU  - Rubin A
AUID- ORCID: 0000-0002-4591-1444
AD  - Pulmonary Department of Santa Casa Hospital, Federal University of Porto Alegre 
      (UFCSPA), Porto Alegre, Brazil.
FAU - Andrade, Marco Antonio Loustaunau
AU  - Andrade MAL
AD  - ISSSTECALI UABC, Mexicali, Baja California, Mexico.
FAU - Roguska, Agnieszka
AU  - Roguska A
AUID- ORCID: 0000-0003-1256-3591
AD  - GSK, Warsaw, Poland.
FAU - Phansalkar, Abhay
AU  - Phansalkar A
AUID- ORCID: 0000-0001-8619-8772
AD  - GSK, General Medicines, Mumbai, India.
FAU - Fulmali, Sourabh
AU  - Fulmali S
AD  - GSK, General Medicines, Mumbai, India.
FAU - Martin, Amber
AU  - Martin A
AUID- ORCID: 0000-0002-4614-5374
AD  - Evidera, Waltham, MA, USA.
FAU - Mittal, Lalith
AU  - Mittal L
AUID- ORCID: 0000-0002-8328-3653
AD  - Evidera, Bengaluru, Karnataka, India.
FAU - Aggarwal, Bhumika
AU  - Aggarwal B
AUID- ORCID: 0000-0002-8370-9319
AD  - GSK, General Medicines, Singapore, Singapore.
FAU - Levy, Gur
AU  - Levy G
AUID- ORCID: 0000-0002-5115-921X
AD  - Respiratory Medical Emerging Markets, GSK, Panama City, Panama.
LA  - eng
GR  - Study ID 218222/GSK/
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20221108
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Ethanolamines)
RN  - N8ONU3L3PG (Terbutaline)
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Anti-Asthmatic Agents)
MH  - Adult
MH  - Adolescent
MH  - Humans
MH  - Ethanolamines/adverse effects
MH  - *Asthma/drug therapy
MH  - Terbutaline/therapeutic use
MH  - Adrenal Cortex Hormones/adverse effects
MH  - Drug Therapy, Combination
MH  - Administration, Inhalation
MH  - *Anti-Asthmatic Agents/adverse effects
PMC - PMC9859883
OTO - NOTNLM
OT  - Adolescents
OT  - Adults
OT  - Adverse events
OT  - Monotherapy
OT  - Mortality
OT  - Overuse
OT  - SABA
OT  - Safety
EDAT- 2022/11/09 06:00
MHDA- 2023/01/25 06:00
PMCR- 2022/11/08
CRDT- 2022/11/08 23:42
PHST- 2022/08/22 00:00 [received]
PHST- 2022/10/11 00:00 [accepted]
PHST- 2022/11/09 06:00 [pubmed]
PHST- 2023/01/25 06:00 [medline]
PHST- 2022/11/08 23:42 [entrez]
PHST- 2022/11/08 00:00 [pmc-release]
AID - 10.1007/s12325-022-02356-2 [pii]
AID - 2356 [pii]
AID - 10.1007/s12325-022-02356-2 [doi]
PST - ppublish
SO  - Adv Ther. 2023 Jan;40(1):133-158. doi: 10.1007/s12325-022-02356-2. Epub 2022 Nov 
      8.