PMID- 35210758
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220502
IS  - 1177-889X (Print)
IS  - 1177-889X (Electronic)
IS  - 1177-889X (Linking)
VI  - 16
DP  - 2022
TI  - Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide 
      Post-Marketing Surveillance Study.
PG  - 413-426
LID - 10.2147/PPA.S344757 [doi]
AB  - PURPOSE: Varenicline has demonstrated its safety and efficacy in Western studies 
      including <3% of Asian participants. This prospective multi-center observational 
      study investigated the safety and effectiveness of varenicline in Korean smokers. 
      PATIENTS AND METHODS: Smokers prescribed varenicline for the first time were 
      enrolled from 252 medical institutions. Investigators recorded and graded all 
      adverse events (AEs). To assess the effectiveness of varenicline, the 7-day point 
      prevalence (PP) of smoking cessation was evaluated at the four visits during the 
      12-week treatment course. Rates of AE incidence and smoking cessation were 
      analyzed using Chi-squared test or Fisher's exact test. This study is registered 
      with ClinicalTrials.gov, number NCT00483002. RESULTS: A total of 3719 and 3700 
      study subjects were included in the safety and effectiveness analyses, 
      respectively. Overall, 346 (9.3%) subjects experienced 471 AEs: 358 mild, 97 
      moderate, 9 severe, and 7 serious. The most frequent AEs were nausea (5.1%), 
      dyspepsia (0.8%), abnormal dreams (0.8%), insomnia (0.8%), and headache (0.7%). 
      Among the subjects with AEs, 73 subjects discontinued treatment, of which 68 were 
      due to AE occurrence. The 7-day PP of smoking cessation at weeks 1-2, 3-6, 7-10, 
      and >/= week 11 were 51.7% (387/749), 59.6% (1740/2922), 73.3% (1114/1520), and 
      77.0% (1116/1449), respectively (p for trend = 0.023). Comorbidities and 
      allergies were associated with a higher incidence of AEs and lower smoking 
      cessation rate (p < 0.05). Younger subjects, infrequent alcohol drinkers, and 
      lighter smokers showed a higher smoking cessation rate (p < 0.05). CONCLUSION: 
      Varenicline in adult Korean smokers was well tolerated and effective as a smoking 
      cessation aid in routine clinical practice.
CI  - (c) 2022 Ock et al.
FAU - Ock, Minsu
AU  - Ock M
AUID- ORCID: 0000-0001-9949-9224
AD  - Department of Preventive Medicine, Ulsan University Hospital, University of Ulsan 
      College of Medicine, Ulsan, South Korea.
FAU - Shin, Ji Soo
AU  - Shin JS
AD  - Medical Affairs, Pfizer Korea, Seoul, South Korea.
FAU - Ra, Seung Won
AU  - Ra SW
AUID- ORCID: 0000-0002-2458-8414
AD  - Department of Internal Medicine, Ulsan University Hospital, University of Ulsan 
      College of Medicine, Ulsan, South Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT00483002
PT  - Journal Article
DEP - 20220215
PL  - New Zealand
TA  - Patient Prefer Adherence
JT  - Patient preference and adherence
JID - 101475748
PMC - PMC8858022
OTO - NOTNLM
OT  - Asia
OT  - adverse drug events
OT  - product surveillance
OT  - smoking cessation
OT  - varenicline
COIS- Seung Won Ra is a paid consultant for Pfizer Pharmaceuticals Korea Ltd. and has 
      contributed to this study in investigation, interpretation of analysis results, 
      writing original draft manuscript, and review and editing of manuscript. Ji Soo 
      Shin is a full-time employee of, and holds stock in, Pfizer Inc. and has 
      contributed to this study in interpretation of analysis results, writing original 
      draft manuscript, review and editing of manuscript, and project administration. 
      The authors report no other conflicts of interest in this work. The abstract of 
      this paper was presented at the American Thoracic Society 2019 International 
      Conference in Dallas, Texas, USA, in May 2019. The poster's abstract was 
      published in "Poster Abstracts" as follows: 
      https://conference.thoracic.org/program/resources/2019/virtual-final-program/343/
EDAT- 2022/02/26 06:00
MHDA- 2022/02/26 06:01
PMCR- 2022/02/15
CRDT- 2022/02/25 05:36
PHST- 2021/10/16 00:00 [received]
PHST- 2022/01/20 00:00 [accepted]
PHST- 2022/02/25 05:36 [entrez]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/02/26 06:01 [medline]
PHST- 2022/02/15 00:00 [pmc-release]
AID - 344757 [pii]
AID - 10.2147/PPA.S344757 [doi]
PST - epublish
SO  - Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. 
      eCollection 2022.