PMID- 20864613
OWN - NLM
STAT- MEDLINE
DCOM- 20110421
LR  - 20220309
IS  - 1931-3543 (Electronic)
IS  - 0012-3692 (Linking)
VI  - 139
IP  - 3
DP  - 2011 Mar
TI  - Effects of varenicline on smoking cessation in patients with mild to moderate 
      COPD: a randomized controlled trial.
PG  - 591-599
LID - S0012-3692(11)60127-X [pii]
LID - 10.1378/chest.10-0865 [doi]
AB  - BACKGROUND: Smoking is the most important risk factor for COPD and accelerates 
      its progression. Despite the health implications, a large proportion of patients 
      with COPD continue to smoke, so finding effective smoking cessation interventions 
      for this population is paramount. To our knowledge, this is the first randomized 
      clinical trial to compare the efficacy and safety of varenicline tartrate vs 
      placebo in smokers with mild to moderate COPD. METHODS: In a 27-center, 
      double-blind, multinational study, 504 patients with mild to moderate COPD 
      (postbronchodilator FEV1/FVC, <70%; FEV1 percent predicted normal value, >/=50%) 
      and without known psychiatric disturbances were randomized to receive varenicline 
      (n=250) or placebo (n=254) for 12 weeks, with a 40-week nontreatment follow-up. 
      The primary end point was carbon monoxide-confirmed continuous abstinence rate 
      (CAR) for weeks 9 to 12. A secondary end point was CAR for weeks 9 to 52. 
      RESULTS: CAR for weeks 9 to 12 was significantly higher for patients in the 
      varenicline group (42.3%) than for those in the placebo group (8.8%) (OR, 8.40; 
      95% CI, 4.99-14.14; P<.0001). CAR in the patients treated with varenicline 
      remained significantly higher than in those treated with placebo through weeks 9 
      to 52 (18.6% vs 5.6%) (OR, 4.04; 95% CI, 2.13-7.67; P<.0001). Nausea, abnormal 
      dreams, upper-respiratory tract infection, and insomnia were the most commonly 
      reported adverse events (AEs) for patients in the varenicline group. Serious AEs 
      were infrequent in both treatment groups. Two patients in the varenicline group 
      and one patient in the placebo group died during the study. Reports of 
      psychiatric AEs were similar for both treatment groups. CONCLUSIONS: Varenicline 
      was more efficacious than placebo for smoking cessation in patients with mild to 
      moderate COPD and demonstrated a safety profile consistent with that observed in 
      previous trials. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00285012; URL: 
      www.clinicaltrials.gov.
FAU - Tashkin, Donald P
AU  - Tashkin DP
AD  - David Geffen School of Medicine at the University of California, Los Angeles, Los 
      Angeles, CA. Electronic address: dtashkin@mednet.ucla.edu.
FAU - Rennard, Stephen
AU  - Rennard S
AD  - University of Nebraska Medical Center, Omaha, NE.
FAU - Hays, J Taylor
AU  - Hays JT
AD  - Mayo Clinic Nicotine Dependence Center, Rochester, MN.
FAU - Ma, Wendy
AU  - Ma W
AD  - Pfizer Inc, Shanghai, China.
FAU - Lawrence, David
AU  - Lawrence D
AD  - Pfizer Inc, New York, NY.
FAU - Lee, Theodore C
AU  - Lee TC
AD  - Pfizer Inc, New York, NY.
LA  - eng
SI  - ClinicalTrials.gov/NCT00285012
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20100923
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Benzazepines)
RN  - 0 (Nicotinic Agonists)
RN  - 0 (Quinoxalines)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
CIN - Chest. 2011 Apr;139(4):968-9; author reply 969. PMID: 21467069
CIN - Expert Opin Pharmacother. 2011 Nov;12(16):2595-7. PMID: 21819275
MH  - Aged
MH  - Benzazepines/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - France
MH  - Humans
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Nicotinic Agonists/adverse effects/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*etiology/*physiopathology
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Respiratory Function Tests
MH  - Severity of Illness Index
MH  - Smoking/*adverse effects
MH  - Smoking Cessation/*methods
MH  - Spain
MH  - Spirometry
MH  - Treatment Outcome
MH  - United States
MH  - Varenicline
EDAT- 2010/09/25 06:00
MHDA- 2011/04/22 06:00
CRDT- 2010/09/25 06:00
PHST- 2010/09/25 06:00 [entrez]
PHST- 2010/09/25 06:00 [pubmed]
PHST- 2011/04/22 06:00 [medline]
AID - S0012-3692(11)60127-X [pii]
AID - 10.1378/chest.10-0865 [doi]
PST - ppublish
SO  - Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.