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Cytisinicline for smoking cessation in smokers with multiple comorbidities: Real-world outcomes from an extended-dose strategy
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Unit of Pulmonology and Respiratory Failure, First Intensive Care Clinic, Medical School of the National and Kapodistrian University of Athens, “Evangelismos” General Hospital, Athens, Greece
Tob. Prev. Cessation 2026;12(Supplement 1):A39
ABSTRACT
BACKGROUND-AIM:
In everyday clinical practice, many smokers attempting to quit live with chronic comorbidities and high nicotine dependence-characteristics that are not adequately represented in existing cytisinicline trials. These individuals often face repeated treatment failures and present with complex clinical needs that challenge standard cessation approaches. Evaluating cytisinicline extended dose strategy within this real-world, multimorbid population is therefore essential for informing and optimizing treatment strategies tailored to those who struggle the most to quit. Our aim was to evaluate three-month smoking abstinence outcomes following an extended 9 mg cytisinicline regimen in smokers with multiple comorbidities, high nicotine dependence, or previous failed pharmacological quit attempts.
METHODS:
We analyzed data from 105 consecutive smokers attending the Outpatient Smoking Cessation Clinic of the First Intensive Care Unit and Pulmonary Department of “Evangelismos” Hospital (September 2024–March 2025). Cytisinicline 9 mg/day was administered until abstinence was achieved and for one additional week; dosing was then gradually tapered over a total treatment duration of approximately two months. Participants received five structured behavioral support sessions. Collected data included demographics, comorbidities, Fagerström Test for Nicotine Dependence, smoking history, and spirometry.
RESULTS:
The cohort had a mean age of 53.1 ± 10.8 years, and 45.7% were male. Comorbidities were common: 22.5% had COPD, 11.1% asthma, 24.7% hypertension, 18.8% depression, and 13.8% anxiety disorders. More than half (56%) were highly nicotine-dependent (Fagerström >7), and 46.9% had previously failed with other cessation medications. Overall, 68% achieved biochemically unverified self-reported abstinence at three months. Quit rates did not differ significantly between highly dependent smokers and those with lower dependence (57% vs. 62%, p=0.7). Among heavy smokers (>30 pack-years), abstinence typically occurred between days 14 and 21. No major adverse events were reported, and spirometric parameters did not differ between quitters and non-quitters.
CONCLUSIONS:
An extended 9 mg cytisinicline regimen appears safe and effective for smokers with substantial comorbidity burden and previous unsuccessful cessation attempts. These findings highlight the need for future clinical trials to include high-risk, multimorbid smokers and support individualized cytisinicline dosing strategies to improve cessation outcomes in this population.