What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation

Leaviss, J; Sullivan, William F.; Ren, Shijie; Everson-Hock, Emma; Stevenson, Matt; Stevens, John; Strong, Mark; Cantrell, Anna

doi:10.3310/hta18330

Cited by 67 publications

(56 citation statements)

References 89 publications

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“…The theoretical basis of this method is described in detail in the literature [86][87][88] and examples of its use in HTAs are also available. 89,90 In common with previous applications of this method, generalised additive models were used for non-parametric regression, 91 implemented in R (The R Foundation for Statistical Computing, Vienna, Austria) using the 'mcgv package' and a 'n = 5000' PSA sample. [92][93][94] Individual EVPPI was initially calculated for each model input separately.…”

Section: Expected Value Of Information Methodologymentioning

confidence: 99%

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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BackgroundReconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence – with regard to ‘early neurosurgery’ in this cohort – which we sought to address.MethodsPilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters). Primary outcomes: recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. ‘Open-label’ secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions.ResultsOverall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%;p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury.ConclusionsCurrent NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating ‘early neurosurgery through bypass’ and address the challenge of reliable TBI diagnosis at the scene of injury.Trial registrationCurrent Controlled Trials ISRCTN68087745.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 1. See the NIHR Journals Library website for further project information.

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Section: Expected Value Of Information Methodologymentioning

confidence: 99%

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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“…There is growing interest in getting cytisine approved as a smoking cessation agent because of its potential to be a much more affordable medication for smoking cessation than any other current pharmacotherapy available . In an economic evaluation that compared cytisine to varenicline for smoking cessation, cytisine was estimated to be more cost‐effective than varenicline . Despite its long history of use, significant gaps remain in our knowledge of cytisine.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of cytisine, an α₄β₂ nicotinic receptor partial agonist, in healthy smokers following a single dose

Jeong

Newcombe

Sheridan

et al. 2014

Drug Testing and Analysis

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Cytisine, an α4 β2 nicotinic receptor partial agonist, is a plant alkaloid that is commercially extracted for use as a smoking cessation medication. Despite its long history of use, there is very little understanding of the pharmacokinetics of cytisine. To date, no previous studies have reported cytisine concentrations in humans following its use as a smoking cessation agent. A high performance liquid chromatography-ultraviolet (HPLC-UV) method was developed and validated for analysis of Tabex® and nicotine-free oral strips, two commercial products containing cytisine. A sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed and validated for the quantification of cytisine in human plasma and for the detection of cytisine in urine. Single-dose pharmacokinetics of cytisine was studied in healthy smokers. Subjects received a single 3 mg oral dose administration of cytisine. Cytisine was detected in all plasma samples collected after administration, including 15 min post-dose and at 24 h. Cytisine was renally excreted and detected as an unchanged drug. No metabolites were detected in plasma or urine collected in the study. No adverse reactions were reported.

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“…It is available in some former Eastern European countries and over the Internet. Seven trials have been published, but only two highquality studies were included in two meta-analyses with an RR of 3.98 (95% CI 2.01-7.87) for cytisine versus placebo [59,60]. In both trials, cytisine was used for only 4 weeks and with relative little behavioural support in contrast to all studies with varenicline, where weekly visits were scheduled during the first 12 weeks.…”

Section: Cytisinementioning

confidence: 99%

Pharmacotherapy: Nicotine Replacement Therapy and Other Drugs in Smoking Cessation (Including Vaccination)

Tønnesen¹

2015

The Tobacco Epidemic

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The basic principles in quitting smoking are to set a target quit day and try to cut down to zero cigarettes in a few weeks -but best at target quit day -and then use one of the primary drugs for smoking cessation for 2-3 months. In this period, the ex-smoker has to break the psychological addiction as well as the nicotine dependence. Using one of the primary drugs reduces the withdrawal symptoms. Any support will increase quit rate and counselling should be used in combination with one of the primary drugs, i.e. varenicline, nicotine replacement treatment (NRT) and bupropion SR. Varenicline and the combination of two NRT formulations is equally effective, while varenicline is more effective than either single NRT or bupropion SR. NRTs are especially safe. All three drugs have also been shown to be especially effective in patients with chronic obstructive pulmonary disease and in patients with cardiovascular disorders; the main reason for the larger effect in this subgroup is the low quit rate among placebo-treated subjects. There is extensive and solid scientific proof that underlines the efficacy of these three primary drugs in smoking cessation as well as the very high cost-effectiveness of smoking cessation. Vaccines against nicotine have not been effective until now. © 2015 S. Karger AG, BaselThe aims of this chapter are to summarise the state of the art in smoking cessation with the three first-line drugs, i.e. nicotine replacement therapy (NRT), varenicline and bupropion SR, as well as a short review of the second-line drugs and also the present state of nicotine vaccination. Special focus will be on NRT as NRT is the most used approach for smoking cessation. After reading this chapter, the clinician should have the necessary background information to be able to use and select among the three primary drugs in smoking cessation. Benefits of Smoking CessationLong-term smoking is the main causal reason for chronic obstructive pulmonary disease (COPD) and lung cancer, and to approximately one third of cases of cardiovascular disorders. Compared to never smokers, long-term daily cigarette smoking is associated with higher early mortality from smokinginduced diseases, and ex-smokers have a longer average survival than continuing smokers [1] (see also chapters 7 and 8). Particularly convincing evidence comes from a longitudinal study of UK male doctors who were followed for more than 50 years [1,2]. It was found that the mortality of the smokers was almost double (1.8 times) that of never smokers and that COPD was approximately 13 times more prevalent and lung cancer approximately15 times more prevalent among smokers compared with never smokers. After a 50-year observation, it was concluded that smokers die 10 years younger than non-smokers. Cessation at ages 60, 50, 40 or 30 years gains about 3, 6, 9 or 10 years of life expectancy, respectively. Among UK women, two thirds of all deaths of smokers in their 50s, 60s and 70s are caused by smoking; smokers lose at least 10 years of lifespan [3]. Smoking is also a st...

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What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation

Cited by 67 publications

References 89 publications

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Pharmacokinetics of cytisine, an α₄β₂ nicotinic receptor partial agonist, in healthy smokers following a single dose

Pharmacotherapy: Nicotine Replacement Therapy and Other Drugs in Smoking Cessation (Including Vaccination)

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What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation

Cited by 67 publications

References 89 publications

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Pharmacokinetics of cytisine, an α4β2 nicotinic receptor partial agonist, in healthy smokers following a single dose

Pharmacotherapy: Nicotine Replacement Therapy and Other Drugs in Smoking Cessation (Including Vaccination)

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Pharmacokinetics of cytisine, an α₄β₂ nicotinic receptor partial agonist, in healthy smokers following a single dose