PMID- 26924197
OWN - NLM
STAT- MEDLINE
DCOM- 20171205
LR  - 20220318
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 39
IP  - 6
DP  - 2016 Jun
TI  - Safety Considerations with Dual Bronchodilator Therapy in COPD: An Update.
PG  - 501-8
LID - 10.1007/s40264-016-0402-4 [doi]
AB  - Combining a long-acting beta2-agonist (LABA) with a long-acting anti-muscarinic 
      agent (LAMA) provides synergistic benefit on airway smooth muscle relaxation, 
      which may have major implications for the use of LABA/LAMA combinations in the 
      treatment of chronic obstructive pulmonary disease (COPD). There are four 
      different approved LAMA/LABA fixed-dose combinations 
      (FDCs)-glycopyrronium/indacaterol, umeclidinium/vilanterol, 
      tiotropium/olodaterol, and aclidinium/formoterol-and another, 
      glycopyrronium/formoterol, that is still under clinical development. Many pivotal 
      trials have shown that all of these FDCs are more effective than monotherapies in 
      inducing bronchodilation and do not amplify the possible adverse events (AEs) 
      that are characteristic of LAMAs and LABAs when used as monotherapy. 
      Unfortunately, these clinical trials have included a very small and highly 
      selected fraction of the COPD patient population. Therefore, it is questionable 
      whether such data can be extrapolated to a larger, 'real-life' population of 
      patients with COPD, especially given that COPD patients with co-morbidities are 
      often excluded from clinical trials, COPD is a major risk factor for most 
      cardiovascular diseases, and both LAMAs and LABAs have a high potential to impact 
      cardiac activities. All clinical trials have been conducted under widely varying 
      conditions and, consequently, AE rates of a drug observed in a clinical trial 
      cannot be directly compared with rates in the clinical trials of another drug and 
      may not reflect the rates observed in practice. Head-to-head studies comparing 
      the different LAMA/LABA FDCs that will include the true patients that we meet in 
      our everyday practice are absolutely essential if we wish to make a therapeutic 
      choice that is not purely empirical.
FAU - Matera, Maria Gabriella
AU  - Matera MG
AD  - Department of Experimental Medicine, Second University of Naples, Naples, Italy.
FAU - Rogliani, Paola
AU  - Rogliani P
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
FAU - Calzetta, Luigino
AU  - Calzetta L
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
FAU - Cazzola, Mario
AU  - Cazzola M
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. 
      mario.cazzola@uniroma2.it.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Muscarinic Antagonists)
SB  - IM
MH  - Adrenergic beta-2 Receptor Agonists/administration & dosage/*therapeutic use
MH  - Bronchodilator Agents/administration & dosage/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Drug Combinations
MH  - Humans
MH  - Muscarinic Antagonists/administration & dosage/*therapeutic use
MH  - Patient Reported Outcome Measures
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Risk Assessment
MH  - Treatment Outcome
EDAT- 2016/03/01 06:00
MHDA- 2017/12/06 06:00
CRDT- 2016/03/01 06:00
PHST- 2016/03/01 06:00 [entrez]
PHST- 2016/03/01 06:00 [pubmed]
PHST- 2017/12/06 06:00 [medline]
AID - 10.1007/s40264-016-0402-4 [pii]
AID - 10.1007/s40264-016-0402-4 [doi]
PST - ppublish
SO  - Drug Saf. 2016 Jun;39(6):501-8. doi: 10.1007/s40264-016-0402-4.