PMID- 17407636
OWN - NLM
STAT- MEDLINE
DCOM- 20070501
LR  - 20190911
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 4
DP  - 2007 Apr
TI  - A double-blind study evaluating the long-term safety of varenicline for smoking 
      cessation.
PG  - 793-801
AB  - OBJECTIVE: We assessed the safety of long-term varenicline administration for 
      smoking cessation. METHODS: In this randomized, double-blind, multicenter trial, 
      eligible adult smokers (18-75 years) who smoked an average of > or =10 
      cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or 
      placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then 
      every 4 weeks until week 52, with a follow-up visit at week 53. The target quit 
      date was the morning of the week 1 clinic visit. Brief counseling was provided at 
      each visit, and vital signs, adverse events (AEs), and smoking status were 
      documented. Other laboratory measures were collected at specified visits. 
      RESULTS: A total of 251 subjects were randomized to varenicline and 126 to 
      placebo. Approximately half of the subjects in each arm completed the study 
      (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% 
      of varenicline- and 82.5% of placebo-treated subjects during the study. Common 
      varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and 
      insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs 
      leading to discontinuation of varenicline treatment included nausea (7.6%), 
      insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious 
      AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point 
      prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). 
      CONCLUSIONS: Varenicline 1 mg BID can be safely administered for up to 1 year. 
      Varenicline was also a more effective smoking cessation aid than placebo 
      throughout the study, supporting both its short- (12-week) and long-term 
      (52-week) efficacy.
FAU - Williams, Kathryn E
AU  - Williams KE
AD  - Pfizer Global Research & Development, Groton, CT 06340, USA. 
      kathryn.e.williams@pfizer.com
FAU - Reeves, Karen R
AU  - Reeves KR
FAU - Billing, Clare B Jr
AU  - Billing CB Jr
FAU - Pennington, Ann M
AU  - Pennington AM
FAU - Gong, Jason
AU  - Gong J
LA  - eng
SI  - ClinicalTrials.gov/NCT00143299
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Benzazepines)
RN  - 0 (Placebos)
RN  - 0 (Quinoxalines)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
CIN - Curr Med Res Opin. 2008 Feb;24(2):577-8; author reply 578-9. PMID: 18198011
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Benzazepines/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Smoking Cessation/*methods
MH  - *Smoking Prevention
MH  - Time
MH  - Time Factors
MH  - Treatment Outcome
MH  - Varenicline
EDAT- 2007/04/05 09:00
MHDA- 2007/05/02 09:00
CRDT- 2007/04/05 09:00
PHST- 2007/04/05 09:00 [pubmed]
PHST- 2007/05/02 09:00 [medline]
PHST- 2007/04/05 09:00 [entrez]
AID - 10.1185/030079907x182185 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Apr;23(4):793-801. doi: 10.1185/030079907x182185.