ArticleDrug safety2012
Cardiovascular events in patients taking varenicline: a case series from intensive postmarketing surveillance in New Zealand.
Article in Drug safety, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 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.
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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.
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Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016Pooled it
- Pharmacological interventions for smoking cessation: an overview and network meta-analysis.The Cochrane database of systematic reviews · 2013Pooled it
- Expression of α3β2β4 nicotinic acetylcholine receptors by rat adrenal chromaffin cells determined using novel conopeptide antagonists.Journal of neurochemistry · 2020Article
- Evaluation of varenicline usage on ventricular repolarization after smoking cessation.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2019Article
- Therapeutic concentrations of varenicline in the presence of nicotine increase action potential firing in human adrenal chromaffin cells.Journal of neurochemistry · 2017Article
- New Pharmacological Agents to Aid Smoking Cessation and Tobacco Harm Reduction: What Has Been Investigated, and What Is in the Pipeline?CNS drugs · 2016Review
- Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study.The Lancet. Respiratory medicine · 2015Article
- Cardiovascular adverse events associated with smoking-cessation pharmacotherapies.Current cardiology reports · 2015Review
- Observational
- Article
- Memory impairment associated with varenicline: a case series from the New Zealand Intensive Medicines Monitoring Programme.European journal of clinical pharmacology · 2013Article
- Current and emerging pharmacotherapeutic options for smoking cessation.Substance abuse : research and treatment · 2013Article
- Use of varenicline for smoking cessation and risk of serious cardiovascular events: nationwide cohort study.BMJ (Clinical research ed.) · 2012Article
- Drug safety assessment in clinical trials: methodological challenges and opportunities.Trials · 2012Review
- Optimizing Clinical Trial Enrollment Methods Through "Goal Programming"Applied clinical trialsArticle
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe smoking cessation medicine varenicline has been associated with an increased risk of cardiovascular adverse events compared with placebo in clinical trials. Cases of cardiovascular events, including myocardial infarction (MI) and cardiac dysrhythmias, have been noted from spontaneous reporting systems.
objectiveThe aim of this study was to summarize and describe cardiovascular adverse reactions identified in a general population during intensive postmarketing surveillance of varenicline in New Zealand.
methodsObservational prospective cohort study using prescription event monitoring methods. The patient cohort was established from pharmacy dispensing data sent directly to the Intensive Medicines Monitoring Programme (IMMP) for all New Zealand patients prescribed varenicline. Adverse cardiovascular events were identified from follow-up questionnaires completed by doctors, spontaneous reports and by record linkage to national datasets. Cardiovascular events were organized into clinical groupings for further clinical assessment, and key cases were identified.
resultsAll New Zealand patients dispensed a prescription for varenicline from 1 April 2007 to 30 November 2010 were included in this study. At 31 January 2011, the IMMP varenicline events dataset included a total of 172 adverse events in the IMMP circulatory System Organ Class. There were 48 reports of myocardial ischaemia, including 12 reports of MI and 8 reports of angina. Two key cases of myocardial ischaemia suggested that this may have been induced by coronary artery spasm secondary to varenicline treatment. There were 50 reports of hypotensive events, with two key cases having documented hypotension associated with chest pain/tightness, and a further 27 reports of dysrhythmia events, including two unexplained sudden deaths.
conclusionsThis paper presents a series of cases of cardiovascular events in patients taking varenicline. Whilst there were multiple confounding factors in some patients, key cases were identified that suggested a possible mechanism of dysregulation of blood pressure leading to vasospasm or hypotension.
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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.