Evidence map›Paper›PMID 35210758›Full record

ArticlePatient preference and adherence2022

Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study.

Minsu Ock, Ji Soo Shin, Seung Won Ra

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Patient preference and adherence, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00483002 (Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00483002 completednot on this map

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

TypeobservationalSponsorPfizerRan2007 to 2011Enrolled3,719ConditionsSmoking CessationArmsvarenicline
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Minsu OckDepartment of Preventive Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.ORCID 0000-0001-9949-9224
Ji Soo ShinMedical Affairs, Pfizer Korea, Seoul, South Korea.
Seung Won RaDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.ORCID 0000-0002-2458-8414
Ulsan College · KRPfizer (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeVarenicline 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

methodsSmokers 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.

resultsA 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).

conclusionVarenicline in adult Korean smokers was well tolerated and effective as a smoking cessation aid in routine clinical practice.

Indexed as

adverse drug eventsAsiaproduct surveillancesmoking cessationvarenicline

Identifiers

PMID35210758
PMCPMC8858022
OpenAlexW4220866796

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.