PMID- 31150963
OWN - NLM
STAT- MEDLINE
DCOM- 20200721
LR  - 20200721
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 153
DP  - 2019 Jul
TI  - Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for 
      nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in 
      moderate to very severe chronic obstructive pulmonary disease.
PG  - 38-43
LID - S0954-6111(19)30162-3 [pii]
LID - 10.1016/j.rmed.2019.05.010 [doi]
AB  - BACKGROUND: Prior replicate 12-week phase 3 trials demonstrated that once-daily 
      doses of revefenacin inhalation solution at 88 mug and 175 mug produced significant 
      bronchodilation over 24 h post dose in patients with moderate to very severe 
      chronic obstructive pulmonary disease (COPD). The objective was to characterize 
      the safety profile of revefenacin 88 mug and 175 mug over 52 weeks of treatment. 
      METHODS: In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 
      participants with moderate to very severe COPD received revefenacin 88 mug or 
      175 mug in a double-blind manner, or open-label active control tiotropium. 
      RESULTS: Treatment-emergent adverse events (AEs) were comparable across all 
      treatment groups (n [%] patients; revefenacin 88 mug, 272 [74.7%]; 175 mug, 242 
      [72.2%]; tiotropium, 275 [77.2%]). Numerically fewer COPD exacerbations (n [%] 
      patients) were observed with revefenacin 175 mug (73 [21.8%]) than with 88 mug (107 
      [29.4%]) or tiotropium (100 [28.1%]). Serious AEs were comparable with 
      revefenacin 88 mug (58 [15.9%] and tiotropium (58 [16.3%]), but were lower with 
      revefenacin 175 mug (43 [12.8%]), and mortality was low. In patients using 
      revefenacin 88 mug or tiotropium with a concurrent long-acting beta-agonist (LABA) 
      product, the incidence of AEs was slightly higher than without concurrent LABA. 
      LABA did not affect the incidence of AEs for patients who received revefenacin 
      175 mug. CONCLUSIONS: Revefenacin was generally well tolerated over 52 weeks of 
      treatment, and had a safety profile that supports its use as a long-term 
      once-daily bronchodilator for the nebulized treatment of COPD.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Donohue, James F
AU  - Donohue JF
AD  - Pulmonary Medicine, UNC School of Medicine, Chapel Hill, NC, USA.
FAU - Kerwin, Edward
AU  - Kerwin E
AD  - Clinical Research Institute of Southern Oregon, PC, Medford, OR, USA.
FAU - Sethi, Sanjay
AU  - Sethi S
AD  - University at Buffalo, State University of New York, Buffalo, NY, USA.
FAU - Haumann, Brett
AU  - Haumann B
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA.
FAU - Pendyala, Srikanth
AU  - Pendyala S
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA.
FAU - Dean, Lorna
AU  - Dean L
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA.
FAU - Barnes, Chris N
AU  - Barnes CN
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA.
FAU - Moran, Edmund J
AU  - Moran EJ
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA.
FAU - Crater, Glenn
AU  - Crater G
AD  - Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA, 
      94080, USA. Electronic address: gcrater@theravance.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02518139
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190523
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Benzamides)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Carbamates)
RN  - 0 (Cholinergic Antagonists)
RN  - 0 (Muscarinic Antagonists)
RN  - G2AE2VE07O (revefenacin)
RN  - XX112XZP0J (Tiotropium Bromide)
SB  - IM
MH  - Administration, Inhalation
MH  - Adrenergic beta-2 Receptor Agonists/*therapeutic use
MH  - Aged
MH  - Benzamides/administration & dosage/adverse effects/*therapeutic use
MH  - Bronchodilator Agents/therapeutic use
MH  - Carbamates/administration & dosage/adverse effects/*therapeutic use
MH  - Case-Control Studies
MH  - Cholinergic Antagonists/therapeutic use
MH  - Disease Progression
MH  - Drug Therapy, Combination
MH  - Drug Tolerance
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Nebulizers and Vaporizers/*standards
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Safety
MH  - Severity of Illness Index
MH  - Tiotropium Bromide/therapeutic use
MH  - Vital Capacity/drug effects
OTO - NOTNLM
OT  - COPD
OT  - Long-acting muscarinic antagonist
OT  - Nebulized therapy
OT  - Once daily
OT  - Revefenacin
OT  - Safety
EDAT- 2019/06/01 06:00
MHDA- 2020/07/22 06:00
CRDT- 2019/06/01 06:00
PHST- 2018/12/28 00:00 [received]
PHST- 2019/03/26 00:00 [revised]
PHST- 2019/05/18 00:00 [accepted]
PHST- 2019/06/01 06:00 [pubmed]
PHST- 2020/07/22 06:00 [medline]
PHST- 2019/06/01 06:00 [entrez]
AID - S0954-6111(19)30162-3 [pii]
AID - 10.1016/j.rmed.2019.05.010 [doi]
PST - ppublish
SO  - Respir Med. 2019 Jul;153:38-43. doi: 10.1016/j.rmed.2019.05.010. Epub 2019 May 
      23.