Observational studyDrug safety2014
Experiences with the use of varenicline in daily practice in the Netherlands: a prospective, observational cohort study.
Observational study in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- The value of patient reporting to the pharmacovigilance system: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.Pharmacoepidemiology and drug safety · 2019Article
- Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?Drug safety · 2016Article
- Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.European journal of clinical pharmacology · 2016Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough a concise overview of adverse drug reactions (ADRs) to varenicline is available, little is known about the use of varenicline in daily practice and time-related information about ADRs.
objectiveThe aim of this study was to gain insight in the safety and use of varenicline in daily practice.
methodsA prospective, observational, non-interventional cohort study was performed. The study population was defined as first-time users recruited through participating pharmacies between 1 December 2008 and 31 March 2012. Patients could sign up for the study on a dedicated website. Web-based questionnaires were sent after 1, 2 and 6 weeks, 3 months and 4 months after patients started to use varenicline. Questions were asked about drug use and ADRs. Information about the ADR, its seriousness and the action taken when experiencing an ADR was gathered.
resultsA total of 1,418 patients signed up for the study. The response rates for the various questionnaires varied from 31.3 to 62.5 %. At least one ADR was reported by 58.8 % of the patients. The most frequently reported ADRs were nausea (30.8 %), abdominal pain (11.2 %) and abnormal dreaming (10.4 %). Most patients did not stop taking varenicline when they experienced these ADRs. The median latency times for ADRs reported more than 50 times were 3-7 days, with an exception for depressed mood, which had a latency time of 10 days.
conclusionThis prospective cohort study has given insight into latency time and action taken with varenicline when ADRs occur during treatment with varenicline in daily practice. It confirms the ADR pattern detected prior to marketing of the drug.
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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.