PMID- 32440111
OWN - NLM
STAT- MEDLINE
DCOM- 20210625
LR  - 20231103
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 15
DP  - 2020
TI  - Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with 
      COPD Receiving Nebulized Glycopyrrolate.
PG  - 995-1004
LID - 10.2147/COPD.S240303 [doi]
AB  - PURPOSE: The clinical manifestation of COPD can differ by gender, with women 
      experiencing worse lung function and health-related quality of life than men. 
      Additionally, women tend to report more symptoms given the same disease severity. 
      Accordingly, the impact of gender on efficacy and safety in patients with 
      moderate-to-very-severe COPD was examined following 12 weeks of nebulized 
      glycopyrrolate (GLY) 25 microg twice daily (BID) or placebo. PATIENTS AND METHODS: 
      GLY and placebo pooled data from the replicate 12-week GOLDEN 3 and 4 studies 
      (n=861) were grouped by gender. Endpoints reported were change from baseline in 
      trough forced expiratory volume in 1 second (FEV(1)), St George's Respiratory 
      Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms 
      (EXACT-RS) total scores. Safety was evaluated by reviewing the incidence of 
      adverse events (AEs) and serious AEs. RESULTS: Men (placebo: 54.7%; GLY: 56.1%) 
      were generally older with a greater proportion of high cardiovascular risk and 
      use of background long-acting beta(2)-agonists or inhaled corticosteroids. GLY 
      treatment resulted in significant, clinically important improvements in trough 
      FEV(1), regardless of gender. Patients treated with GLY reported significant 
      improvements in SGRQ total score, irrespective of gender; however, the 
      improvement was numerically higher in women. Although EXACT-RS improved in both 
      genders, only women experienced a significant improvement. Overall, GLY was well 
      tolerated with a numerically lower incidence of AEs in men than women. 
      CONCLUSION: Treatment with nebulized GLY resulted in lung function, SGRQ total 
      score, and EXACT-RS total score improvements regardless of gender. However, only 
      EXACT-RS showed significantly greater improvements in women compared with men. 
      Treatment with GLY was generally well tolerated across genders. These data 
      support the efficacy and safety of GLY 25 microg BID in patients with 
      moderate-to-very-severe COPD, independent of gender. Gender similarities in 
      airflow improvement and differences in symptom-reporting augment the evidence 
      supporting the consideration of individualized treatment plans for COPD patients.
CI  - (c) 2020 Ohar et al.
FAU - Ohar, Jill A
AU  - Ohar JA
AUID- ORCID: 0000-0002-2757-6806
AD  - Department of Internal Medicine, Wake Forest University, Winston-Salem, NC, USA.
FAU - Ozol-Godfrey, Ayca
AU  - Ozol-Godfrey A
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
FAU - Goodin, Thomas
AU  - Goodin T
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
FAU - Sanjar, Shahin
AU  - Sanjar S
AUID- ORCID: 0000-0003-1462-436X
AD  - Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20200506
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Muscarinic Antagonists)
RN  - V92SO9WP2I (Glycopyrrolate)
SB  - IM
EIN - Int J Chron Obstruct Pulmon Dis. 2021 May 14;16:1347-1348. PMID: 34017171
MH  - Administration, Inhalation
MH  - Bronchodilator Agents/therapeutic use
MH  - Female
MH  - Forced Expiratory Volume
MH  - *Glycopyrrolate/therapeutic use
MH  - Humans
MH  - Lung
MH  - Male
MH  - Muscarinic Antagonists/therapeutic use
MH  - Nebulizers and Vaporizers
MH  - Patient Reported Outcome Measures
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC7212992
OTO - NOTNLM
OT  - COPD
OT  - LAMA
OT  - gender
OT  - nebulized glycopyrrolate
COIS- JO has participated in advisory boards for Sunovion Pharmaceuticals Inc., 
      AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Mylan, and 
      Theravance and has received grant funding from Sunovion Pharmaceuticals Inc and 
      Boehringer Ingelheim. AOG, TG, and SS are employees of Sunovion Pharmaceuticals 
      Inc. The authors report no other conflicts of interest in this work.
EDAT- 2020/05/23 06:00
MHDA- 2021/06/29 06:00
PMCR- 2020/05/06
CRDT- 2020/05/23 06:00
PHST- 2019/11/28 00:00 [received]
PHST- 2020/04/21 00:00 [accepted]
PHST- 2020/05/23 06:00 [entrez]
PHST- 2020/05/23 06:00 [pubmed]
PHST- 2021/06/29 06:00 [medline]
PHST- 2020/05/06 00:00 [pmc-release]
AID - 240303 [pii]
AID - 10.2147/COPD.S240303 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2020 May 6;15:995-1004. doi: 
      10.2147/COPD.S240303. eCollection 2020.