SynthesisBMC clinical pharmacology2011
Gastrointestinal adverse effects of varenicline at maintenance dose: a meta-analysis.
Synthesis in BMC clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis 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.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016Pooled it
- Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD.International journal of chronic obstructive pulmonary disease · 2018Trial
- Trial
- Article
- Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review.BMC public health · 2024Review
- Residential treatment exclusively for smoking cessation in patients with Crohn's disease: Results from a pilot study.Tobacco induced diseases · 2022Article
- Enantiopure Cyclopropane-Bearing Pyridyldiazabicyclo[3.3.0]octanes as Selective α4β2-nAChR Ligands.ACS medicinal chemistry letters · 2014Article
- Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice.British journal of clinical pharmacology · 2014Review
- Preclinical evidence that activation of mesolimbic alpha 6 subunit containing nicotinic acetylcholine receptors supports nicotine addiction phenotype.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012Review
- Insights into the structural determinants required for high-affinity binding of chiral cyclopropane-containing ligands to α4β2-nicotinic acetylcholine receptors: an integrated approach to behaviorally active nicotinic ligands.Journal of medicinal chemistry · 2012Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTobacco smoking remains the leading modifiable health hazard and varenicline is amongst the most popular pharmacological options for smoking cessation. The purpose of this study is to critically evaluate the extent of gastrointestinal adverse effects of varenicline when used at maintenance dose (1 mg twice a day) for smoking cessation.
methodsWe conducted a meta-analysis of randomised controlled trials published in PUBMED and EMBASE according to the PRISMA guidelines. Selected studies satisfied the following criteria: (i) duration of at least 6 weeks, (ii) titrated dose of varenicline for 7 days then a maintenance dose of 1 mg twice-per-day, (iii) randomized placebo-controlled design, (iv) extractable data on adverse event - nausea, constipation or flatulence. Data was synthesized into pooled odd ratios (OR) basing on random effects model. Quality of studies was also rated as per Cochrane risk-of-bias assessment. Number need to harm (NNH) was calculated for each adverse effect.
results98 potentially relevant studies were identified, 12 of which met the final inclusion criteria (n = 5114). All 12 studies reported adverse events on nausea, which led to an OR of 4.45 (95% CI = 3.79-5.23, p < 0.001; I(2) = 0.06%, CI = 0%-58.34%) and a NNH of 5. Eight studies (n = 3539) contain data on constipation pooled into an OR of 2.45 (95% CI = 1.61-3.72, p < 0.001; I(2) = 34.09%, CI = 0%-70.81%) with a NNH of 24. Finally, five studies (n = 2516) reported adverse events of flatulence, which pooled an OR of 1.74 (95% CI = 1.23-2.48, p = 0.002; I(2) = 0%, CI = 0%- 79.2%) with a NNH of 35.
conclusionsUse of varenicline at maintenance dose of 1 mg twice a day for longer than 6 weeks is associated with adverse gastrointestinal effects. In realistic terms, for every 5 treated subjects, there will be an event of nausea, and for every 24 and 35 treated subjects, we will expect an event of constipation and flatulence respectively. Family physicians should counsel patients of such risks accordingly during their maintenance therapy with varenicline.
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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.