Evidence map›Paper›PMID 34035088›Full record

ArticleBMJ open2021

Neuropsychiatric safety of varenicline in the general and COPD population with and without psychiatric disorders: a retrospective cohort study in a real-world setting.

Yuanyuan Wang, Jens H Bos, Catharina C M Schuiling-Veninga, H Marike Boezen, Job F M van Boven, Bob Wilffert, Eelko Hak

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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

7 authors at 2 institutions in 1 country.

Yuanyuan WangDepartment of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands yuanyuanwang.research@gmail.com.ORCID 0000-0002-5066-1654
Jens H BosDepartment of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.
Catharina C M Schuiling-VeningaDepartment of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.
H Marike BoezenDepartment of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Job F M van BovenGroningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.ORCID 0000-0003-2368-2262
Bob WilffertDepartment of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.
Eelko HakDepartment of PharmacoTherapy, -Epidemiology & -Economics, Groningen Research Institutte of Pharmacy, University of Groningen, Groningen, The Netherlands.
University Medical Center Groningen · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the real-world association between varenicline and neuropsychiatric adverse events (NPAEs) in general and chronic obstructive pulmonary disease (COPD) population with and without psychiatric disorders compared with nicotine replacement therapy (NRT) to strengthen the knowledge of varenicline safety.

designA retrospective cohort study.

settingPrescription database IADB.nl, the Netherlands.

participantsNew users of varenicline or NRT among general (≥18 years) and COPD (≥40 years) population. Psychiatric subcohort was defined as people prescribed psychotropic medications (≥2) within 6 months before the index date. OUTCOME MEASURES: The incidence of NPAEs including depression, anxiety and insomnia, defined by new or naive prescriptions of related medications in IADB.nl within 24 weeks after the first treatment initiation of varenicline or NRT.

resultsFor the general population in non-psychiatric cohort, the incidence of total NPAEs in varenicline (4480) and NRT (1970) groups was 10.5% and 12.6%, respectively (adjusted OR (aOR) 0.85, 95% CI 0.72 to 1.00). For the general population in psychiatric cohort, the incidence of total NPAEs was much higher, 75.3% and 78.5% for varenicline (1427) and NRT (1200) groups, respectively (aOR 0.82, 95% CI 0.68 to 0.99). For the COPD population (1598), there were no differences in the incidence of NPAEs between comparison groups in both the psychiatric cohort (aOR 0.97, 95% CI 0.66 to 1.44) and non-psychiatric cohort (aOR 0.81, 95% CI 0.54 to 1.20). Results from subgroup or sensitivity analyses also did not reveal increased risks of NPAEs but showed decreased risk of some subgroup NPAEs associated with varenicline.

conclusionsIn contrast to the concerns of a possible increased risk of NPAEs among varenicline users, we found a relative decreased risk of total NPAEs in varenicline users of the general population in psychiatric or non-psychiatric cohorts compared with NRT and no difference for NPAEs between varenicline and NRT users in smaller population with COPD.

Indexed as

Pulmonary Disease, Chronic ObstructiveSmoking CessationBenzazepinesBupropionCohort StudiesHumansNetherlandsNicotinic AgonistsQuinoxalinesRetrospective StudiesTobacco Use Cessation DevicesVareniclineBenzazepinesBupropionNicotinic AgonistsQuinoxalinesVareniclineanxiety disordersdepression & mood disordersepidemiology

Identifiers

PMID34035088
PMCPMC8154988
OpenAlexW3164800325

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.