A recent study demonstrates the safety and effectiveness of cytisine.
According to a recent study published in the Journal of Thoracic Oncology, cytisine may be a safe and effective smoking cessation treatment in lung cancer screening volunteers.
Since the 1960s, Cytisine, a plant-based alkaloid derived from Cytisus laburnum, has been approved for use in Europe as a smoking cessation aid. It is a selective partial agonist of nicotinic acetylcholine receptors. The current FDA-approved smoking cessation drugs in the United States are varenicline and bupropion. In order to evaluate the effectiveness of cytisine, a study was authorized in the United States by the Food and Drug Administration in 2018.
To determine whether cytisine is a safe and effective smoking cessation therapy during low-dose computed tomography (LDCT) screening, researchers led by Dr. Ugo Pastorino, Fondazione IRCCS Istituto Nazionale dei Tumori, in Milan, Italy, established the single-center, randomized controlled trial called Screening and Multiple Intervention on Lung Epidemics (SMILE) study.
Pastorino and colleagues randomized 869 current smokers–470 (54%) were assigned to the intervention arm including cytisine, and 399 (46%) were assigned to the control arm. The primary outcome was continuous smoking abstinence at 12 months, biochemically verified through carbon monoxide measurement.
At the 12-month follow-up, the quit rate was 32.1% (151 participants) in the intervention arm and 7.3% (29 participants) in the control arm. The adjusted odds ratio (OR) of continuous abstinence was 7.2 (95% confidence interval, 4.6 to 11.2). Self-reported adverse events occurred more frequently in the intervention arm (399 events among 196 participants) than in the control arm.
“The efficacy and safety observed in the SMILE RCT indicate that cytisine, a very low-cost medication, is a useful treatment option for smoking cessation and a feasible strategy to improve LDCT screening outcomes with a potential benefit for all-cause mortality,” said Dr. Pastorino.
Reference: “Cytisine Therapy Improved Smoking Cessation in the Randomized Screening and Multiple Intervention on Lung Epidemics Lung Cancer Screening Trial” by Ugo Pastorino, MD, Vito Ladisa, PharmD, Sara Trussardo, PharmD, Federica Sabia, MSc, Luigi Rolli, MD, Camilla Valsecchi, MSc, Roberta E. Ledda, MD, Gianluca Milanese, MD, Ph.D., Paola Suatoni, MSc, Mattia Boeri, Ph.D., Gabriella Sozzi, Ph.D., Alfonso Marchianò, MD, Elena Munarini, PsyD, Roberto Boffi, MD, Silvano Gallus, Ph.D. and Giovanni Apolone, MD, 28 July 2022, Journal of Thoracic Oncology.