Cytisine versus varenicline for smoking cessation in New Zealand indigenous Māori: A randomized controlled trial

N. Walker*, B. Smith, J. Barnes, M. Verbiest, V. Parag, S. Pokhrel, M. Wharakura, T. Lees, H. Cubillos Gutierrez, B. Jones, C. Bullen

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

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Abstract

Aim:
To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Māori or whānau (extended-family) of Māori, given the high smoking prevalence in this population.

Design:
Pragmatic, open-label, randomized, community-based non-inferiority trial.

Setting:
Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand.

Participants:
Adult daily smokers who identified as Māori or whānau of Māori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi-media advertising.

Interventions
A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low-intensity cessation behavioural support from the prescribing doctor and community stop-smoking services or a research assistant. Day 5 of treatment was the designated quit date.

Measurements:
The primary outcome was carbon monoxide-verified continuous abstinence at 6 months, analysed as intention-to-treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post-quit date included: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life.

Findings:
Verified continuous abstinence rates at 6 months post-quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = –0.22 to 8.79; relative risk 1.55; 95% CI = 0.97–2.46]. Sensitivity analyses confirmed that the findings were robust. Self-reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49–0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping.

Conclusion:
A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Māori or whānau (extended-family) of Māori, with significantly fewer adverse events.
Original languageEnglish
Pages (from-to)2847-2858
JournalAddiction
Volume116
Issue number10
DOIs
Publication statusPublished - 2021

Keywords

  • Adult
  • Alkaloids
  • Azocines
  • Humans
  • New Zealand
  • Quality of Life
  • Quinolizines
  • Smoking Cessation
  • Treatment Outcome
  • Varenicline/therapeutic use

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