Effect of 0.5 mg versus 1 mg varenicline for smoking cessation: a randomized controlled trial

Fouz-Rosón, Natalia; Montemayor-Rubio, Teodoro; Pacheco, Virginia Almadana; Montserrat-García, Soledad; Gómez-Bastero, Ana; Romero-Muñoz, Concepción; Polo-Padillo, Juan

doi:10.1111/add.13855

Cited by 9 publications

(13 citation statements)

References 40 publications

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“…Most of the studies included in this review consisted of RCTs ( n = 38) [ 32 – 69 ], followed by cohort ( n = 17) [ 70 – 86 ], cross-sectional ( n = 3) [ 87 – 89 ], quasi-experimental ( n = 3) [ 90 – 92 ], and qualitative ( n = 1) [ 93 ] studies, and one study ( n = 1) [ 53 ] was a mediation analysis that examined an observational study and RCT. The majority of studies had a low to moderate risk of bias [27 studies were of low risk of bias [ 37 – 39 , 42 , 44 , 47 – 56 , 61 , 65 , 71 – 73 , 75 , 83 , 84 , 86 , 88 , 92 , 93 ]; 28 studies were of moderate risk [ 32 , 33 , 35 , 40 , 41 , 43 , 45 , 46 , 59 , 60 , 62 – 64 , 66 – 70 , 77 – 82 , 85 , 87 , 89 , 90 ]; and six studies were of high risk of bias [ 36 , 57 , 58 , 74 , 76 , 91 ]]. Studies were conducted in a multitude of countries across all continents except Antarctica.…”

Section: Resultsmentioning

confidence: 99%

“…Most studies included in this review reported barriers as opposed to facilitators. Of the 61 studies, 51 studies [ 32 , 33 , 36 – 40 , 42 – 57 , 59 – 65 , 67 – 69 , 71 , 73 – 78 , 80 – 83 , 86 – 92 ] only mentioned barriers, while four studies [ 41 , 58 , 66 , 85 ] only mentioned facilitators, and six studies mentioned both barriers and facilitators [ 35 , 37 , 70 , 79 , 84 , 93 ]. Definitions of the theoretical domains according to Atkins, et al [ 94 ] can be found in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

“…Providing ongoing support through education and information about the course of treatment and treatment expectations [ 36 ]. Providing knowledge about varenicline and information about the positive effects of not smoking and medication adherence through counselling [ 40 ]. Low willpower caused regular clinic patients to discontinue varenicline use compared to volunteer participants, and thus, clinic patients may need better support systems to improve varenicline adherence [ 78 ] Behavioural regulation “Anything aimed at managing or changing objectively observed or measured actions” [ 94 ] Barrier ( n = 3) Facilitator ( n = 1) Harrison-Woolrych et al 2010, [ 74 ]; Jung et al 2010, [ 79 ]; Park et al 2011, [ 81 ] Gordon et al 2017, [ 93 ] Barrier Self-monitoring: participants who prematurely discontinued varenicline did so due to poor compliance [ 73 , 80 ], and low will power [ 78 ] Facilitator Self-monitoring: having an accessible and easy to use app that reminded participants to take their medication [ 92 ] …”

Section: Resultsmentioning

confidence: 99%

“…Knowledge about varenicline and providing information about the benefits of quitting smoking and medication adherence [ 57 , 40 ]…”

Section: Resultsmentioning

confidence: 99%

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Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review

Minian,

Wong,

Hafuth

et al. 2024

BMC Public Health

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Background Adhering to varenicline has been shown to significantly improve the chances of successfully quitting smoking, with studies indicating a twofold increase in 6-month quit rates. However, despite its potential benefits, many individuals struggle with maintaining good adherence to varenicline; thus there is a need to develop scalable strategies to help people adhere. As a first step to inform the development of an intervention to improve adherence to varenicline, we conducted a rapid literature review to identify: 1) modifiable barriers and facilitators to varenicline adherence, and 2) behaviour change techniques associated with increased adherence to varenicline. Methods We searched MEDLINE, Embase, APA PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials for relevant studies published between 2006 and 2022. Search terms included “varenicline,” “smoking cessation,” and "adherence," and their respective subject headings and synonyms. We screened and included studies reporting modifiable determinants of adherence to varenicline and then assessed quality, extracted modifiable determinants and mapped them to the Theoretical Domains Framework version 2 and the Behaviour Change Technique Taxonomy version 1. Results A total of 1,221 titles were identified through the database searches; 61 met the eligibility criteria. Most of the studies were randomized controlled trials and predominantly focused on barriers to varenicline. Only nine studies explicitly mentioned behaviour change techniques used to help varenicline adherence. Eight domains were identified as barriers to varenicline adherence (behavioural regulation, memory, goals, intentions, beliefs about capabilities, beliefs about consequences, optimism/pessimism, and environmental context) and five as facilitators (knowledge, behavioural regulation, beliefs about capabilities, social influences, and environmental context). Conclusions This study identifies barriers and facilitators that should be addressed when developing a complex adherence intervention tailored to patients’ needs based on modifiable determinants of medication adherence, some of which are under- used by existing adherence interventions. The findings from this review will inform the design of a theory-based healthbot planned to improve varenicline adherence in people undergoing smoking cessation treatment. Systematic review registration This study was registered with PROSPERO (# CRD42022321838).

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Knowledge about varenicline and providing information about the benefits of quitting smoking and medication adherence [ 57 , 40 ]…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review

Minian,

Wong,

Hafuth

et al. 2024

BMC Public Health

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“…Также исключили работы с существенно измененной длительностью курса приема варениклина [23,26,33,38,39,41,52,74,78,100,106]. Исключены исследования, у которых отсутствовала контрольная группа [31]. Исключены работы, где фармакологическую терапию начинали после терапии НЗТ или использовали комбинацию препаратов [22,40,46,48,57,58,82,[87][88][89].…”

Section: Introductionunclassified

Network meta-analysis: a comparison of effectiveness and safety of partial agonists of nicotinic acetylcholine receptors varenicline and cytisine for smoking cessation

Radchenko

Владимировна²,

Sykhovskaya

et al. 2018

Rev Clin Pharm Drug Ther

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Background. Partial agonists of α4b2 nicotinic acetylcholine receptors are the most effective treatment strategy for tobacco smoking cessation. They are able to alleviate withdrawal symptoms and to reduce smoking satisfaction. The aim of this study was to review the efficacy and safety of nicotinic receptor partial agonists varenicline and cytisine, for smoking cessation. Methods. A search for randomized controlled trials was done using the terms (“cytisine”, “tabex”, “varenicline” or 'partial agonists of nicotinic receptors’) in MEDLINE, EMBASE, eLibrary in May 2018. Types of participants, the doses and duration of the treatments, efficacy and safety parameters, quality of randomization and blinding procedures were evaluated. Bayesian network meta-analysis was performed. Results. Cytisine overcame placebo in the 12, 24 and 52 weeks of therapy with the following odds ratios (ORs) for abstinence: 3.3 (95% CrI 1.8–5.8), 3.9 (2.4–6.7), 3.8 (CrI 1.3–11,9) accordingly. Varenicline in 2 mg/day dose overcame placebo in the 12, 24 and 52 weeks of therapy with the ORs: 4.0 (3.3–4.7), 3.1 (2.5–3.7), 2.9 (2.2–4.1) accor dingly. Varenicline in 1 mg/day dose overcame placebo in 12 and 52 weeks of therapy, the ORs were 3.0 (2.0–4.7) and 2.3 (1.3–4.4) accordingly. Varenicline in 0.5 mg/day dose overcame placebo in 12 weeks of therapy only with the OR 2.4 (1.3–4.4). Cytisine and varenicline 2 mg/day were associated with more gastrointestinal disturbances than placebo with the ORs 6.2 (2.1–22.8) and 2.4 (2.0–2.8) accordingly. Cytisine and varenicline 2 mg/day were associated with more psychiatric problems than placebo with ORs 5.2 (1.9–15.1) and 1.6 (1.3–1.9) accordingly. There was no difference in serious adverse events between the investigated drugs and placebo: OR for cytisine was 2.4 (0.8–6.8), varenicline 0.5 mg/day – 2.0 (0.5–6.6), varenicline 1.0 mg/day – 1.0 (0.3–2.7), varenicline 2 mg/day – 1.0 (0.7–1.4). Conclusion. Cytisine was proved to be as effective and safe aid for smoking cessation as varenicline.

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Nicotine receptor partial agonists for smoking cessation

Livingstone‐Banks

Fanshawe

Thomas

et al. 2023

Cochrane Database of Systematic Reviews

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Background Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). This is an update of a Cochrane Review first published in 2007. Objectives To assess the effectiveness of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. Search methods We searched the Cochrane Tobacco Addiction Group's Specialised Register in April 2022 for trials, using relevant terms in the title or abstract, or as keywords. The register is compiled from searches of CENTRAL, MEDLINE, Embase, and PsycINFO. Selection criteria We included randomised controlled trials that compared the treatment drug with placebo, another smoking cessation drug, e‐cigarettes, or no medication. We excluded trials that did not report a minimum follow‐up period of six months from baseline. Data collection and analysis We followed standard Cochrane methods. Our main outcome was abstinence from smoking at longest follow‐up using the most rigorous definition of abstinence, preferring biochemically validated rates where reported. We pooled risk ratios (RRs), using the Mantel‐Haenszel fixed‐effect model. We also reported the number of people reporting serious adverse events (SAEs). Main results We included 75 trials of 45,049 people; 45 were new for this update. We rated 22 at low risk of bias, 18 at high risk, and 35 at unclear risk. We found moderate‐certainty evidence (limited by heterogeneity) that cytisine helps more people to quit smoking than placebo (RR 1.30, 95% confidence interval (CI) 1.15 to 1.47; I 2 = 83%; 4 studies, 4623 participants), and no evidence of a difference in the number reporting SAEs (RR 1.04, 95% CI 0.78 to 1.37; I 2 = 0%; 3 studies, 3781 participants; low‐certainty evidence). SAE evidence was limited by imprecision. We found no data on neuropsychiatric or cardiac SAEs. We found high‐certainty evidence that varenicline helps more people to quit than placebo (RR 2.32, 95% CI 2.15 to 2.51; I 2 = 60%, 41 studies, 17,395 participants), and moderate‐certainty evidence that people taking varenicline are more likely to report SAEs than those not taking it (RR 1.23, 95% CI 1.01 to 1.48; I 2 = 0%; 26 studies, 14,356 participants). While point estimates suggested increased risk of cardiac SAEs (RR 1.20, 95% CI 0.79 to 1.84; I 2 = 0%; 18 studies, 7151 participants; low‐certainty evidence), and decreased risk of neuropsychiatric SAEs (RR 0.89, 95% CI 0.61 to 1.29; I 2 = 0%; 22 studies, 7846 participants; low‐certainty evidence), in both cases evidence was limited ...

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Effect of 0.5 mg versus 1 mg varenicline for smoking cessation: a randomized controlled trial

Abstract: There appears to be no difference in smoking cessation effectiveness between 1 mg and 0.5 mg varenicline, both administered twice daily for 8 weeks, with similar rates of abstinence (46.5% versus 46.4%), adherence and side effects.

Cited by 9 publications

References 40 publications

Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review

Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review

Network meta-analysis: a comparison of effectiveness and safety of partial agonists of nicotinic acetylcholine receptors varenicline and cytisine for smoking cessation

Nicotine receptor partial agonists for smoking cessation

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