PMID- 20666691
OWN - NLM
STAT- MEDLINE
DCOM- 20101206
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 9
DP  - 2010 Sep
TI  - Varenicline treatment for smoking cessation in Asian populations: a pooled 
      analysis of placebo-controlled trials conducted in six Asian countries.
PG  - 2165-73
LID - 10.1185/03007995.2010.505130 [doi]
AB  - OBJECTIVE: A pooled analysis to evaluate the efficacy and safety of varenicline 
      versus placebo for smoking cessation in Asian populations. A secondary objective 
      was to compare the data to pooled trials among predominantly Western populations. 
      RESEARCH DESIGN AND METHODS: Smokers (n = 893) in three randomized, double-blind, 
      placebo-controlled, multicenter, phase IIb or III trials conducted in six Asian 
      countries (Japan, Taiwan, Korea, China, Singapore, and Thailand), received 
      varenicline (1 mg twice daily; n = 447) or placebo (n = 446) for 12 weeks. 
      Non-treatment follow-up lasted 12 weeks (40 weeks in Japan). Primary endpoint was 
      the carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9-12 
      (last 4 weeks of treatment). Secondary endpoint was CAR for weeks 9-24. RESULTS: 
      CAR was higher for varenicline than placebo during weeks 9-12 (58.6 vs. 34.3%; 
      odds ratio [OR]: 2.74; 95% confidence interval [CI]: 2.08-3.60; p < 0.0001), and 
      through 12 weeks of follow-up (CAR weeks 9-24; 41.4 vs. 25.3%; OR: 2.08; 95% CI: 
      1.56-2.77; p < 0.0001). The most frequent adverse events (AEs) in the varenicline 
      group (greater incidence than the placebo group) were: nausea (31.5%), headache 
      (8.5%), dizziness (7.8%), insomnia (7.4%), and upper abdominal pain (5.4%). 
      Serious AEs occurred in four varenicline and five placebo participants. 
      Discontinuations due to AEs occurred in 3.6% of varenicline and 1.6% of placebo 
      participants. Compared with the Western studies, abstinence rates for both 
      varenicline and placebo were numerically higher in the Asian studies, although 
      treatment effects were similar between the two populations. AEs reported in the 
      Asian trials were largely similar to those in the Western populations. 
      CONCLUSIONS: Varenicline significantly improved smoking abstinence in Asian 
      populations from six countries. AEs were predominantly of mild or moderate 
      intensity. These data were largely the same as those seen in Western populations, 
      but the studies were not designed to explore racial or cultural differences.
FAU - Fagerstrom, Karl
AU  - Fagerstrom K
AD  - Smokers Information Centre, Fagerstrom Consulting AB, Helsingborg, Sweden. 
      karl.fagerstrom@swipnet.se
FAU - Nakamura, Masakazu
AU  - Nakamura M
FAU - Cho, Hong-Jun
AU  - Cho HJ
FAU - Tsai, Shih-Tzu
AU  - Tsai ST
FAU - Wang, Chen
AU  - Wang C
FAU - Davies, Simon
AU  - Davies S
FAU - Ma, Wendy
AU  - Ma W
FAU - Lee, Theodore C
AU  - Lee TC
FAU - Russ, Cristina
AU  - Russ C
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
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 (Nicotinic Agonists)
RN  - 0 (Placebos)
RN  - 0 (Quinoxalines)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asia
MH  - *Asian People/statistics & numerical data
MH  - Benzazepines/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Nicotinic Agonists/adverse effects/therapeutic use
MH  - Placebos
MH  - Population
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Smoking Cessation/*methods
MH  - Treatment Outcome
MH  - Varenicline
EDAT- 2010/07/30 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/07/30 06:00
PHST- 2010/07/30 06:00 [entrez]
PHST- 2010/07/30 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - 10.1185/03007995.2010.505130 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 Sep;26(9):2165-73. doi: 10.1185/03007995.2010.505130.