PMID- 28203364
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 2042-0986 (Print)
IS  - 2042-0994 (Electronic)
IS  - 2042-0986 (Linking)
VI  - 8
IP  - 1
DP  - 2017 Jan
TI  - Tiotropium formulations and safety: a network meta-analysis.
PG  - 17-30
LID - 10.1177/2042098616667304 [doi]
AB  - Tiotropium is now delivered via two different inhaler devices: the original 
      Handihaler 18 mug once daily, which uses a powder formulation; and the newer 
      Respimat Soft Mist Inhaler (SMI) 5 mug once daily. It has been questioned whether 
      the two devices can be assumed to have the same safety profile, although the 
      TIOSPIR trial showed that tiotropium when administered via Respimat SMI 5 mug is 
      not less safe than Handihaler 18 mug. Therefore, we have carried out a safety 
      evaluation of tiotropium Handihaler 18 microg versus tiotropium Respimat SMI 5 microg and 
      2.5 microg, via systematic review and network meta-analysis of the currently 
      available clinical evidence. The results of our meta-analysis with an extremely 
      large number of patients analysed demonstrate that the safety profile of 
      tiotropium HandiHaler is generally superior to that of tiotropium Respimat SMI, 
      although no statistical difference was detected between these two devices. 
      However, the SUCRA analysis favoured tiotropium Respimat SMI with regards to 
      serious adverse events (AEs). We do not believe that using Respimat SMI rather 
      that HandiHaler exposes patients to higher risks of real AEs. Rather, we believe 
      that there may be a different cardiovascular (CV) response to muscarinic 
      receptors blockage in individual patients. Therefore, it will be essential to 
      make all possible efforts to proactively identify patients at increased risk of 
      CV AEs when treated with tiotropium or another antimuscarinic drug.
FAU - Cazzola, Mario
AU  - Cazzola M
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Via Montpellier 
      1, 00133 Rome, Italy.
FAU - Calzetta, Luigino
AU  - Calzetta L
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
FAU - Rogliani, Paola
AU  - Rogliani P
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
FAU - Matera, Maria Gabriella
AU  - Matera MG
AD  - Department of Experimental Medicine, Second University of Naples, Naples, Italy.
LA  - eng
PT  - Journal Article
DEP - 20160916
PL  - England
TA  - Ther Adv Drug Saf
JT  - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC5298465
OTO - NOTNLM
OT  - COPD
OT  - handihaler
OT  - meta-analysis
OT  - respimat SMI
OT  - safety
OT  - tiotropium
COIS- Conflict of interest statement: The author(s) declared no potential conflicts of 
      interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2017/02/17 06:00
MHDA- 2017/02/17 06:01
PMCR- 2017/01/01
CRDT- 2017/02/17 06:00
PHST- 2017/02/17 06:00 [entrez]
PHST- 2017/02/17 06:00 [pubmed]
PHST- 2017/02/17 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - 10.1177_2042098616667304 [pii]
AID - 10.1177/2042098616667304 [doi]
PST - ppublish
SO  - Ther Adv Drug Saf. 2017 Jan;8(1):17-30. doi: 10.1177/2042098616667304. Epub 2016 
      Sep 16.