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Vol. 59. Issue 4.
Pages 270-272 (April 2023)
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Vol. 59. Issue 4.
Pages 270-272 (April 2023)
Scientific Letter
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The DESTINA Study: An Observational Cross-sectional Study to Evaluate Patient Satisfaction and Tolerability of Cytisine for Smoking Cessation in Spain
Carlos A. Jiménez-Ruiza,
Corresponding author

Corresponding author.
, Juan Antonio Riesco Mirandab, Angela Martínez Picóc, Raúl de Simón Gutiérrezd,e, Jaime Signes-Costa Miñanaf, José Luis Díaz Maroto Muñozg, Jacobo Sellarés Torresh
a Unidad Especializada en Tabaquismo, Hospital Clínico San Carlos, Madrid, Spain
b Unidad de Tabaquismo, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital Universitario San Pedro Alcántara, Cáceres, Spain
c Coordinadora Unitat Tabaquisme SAP Vallès Oriental, Institut Català de la Salut, Granollers, Spain
d Médico de Familia, Centro de Salud Luis Vives, Alcalá de Henares, Madrid, Spain
e Coordinador Nacional del grupo de Tabaquismo de SEMERGEN, Spain
f Servicio de Neumología, Hospital Clínico, INCLIVA, Valencia, Spain
g Médico rural Pozo de Guadalajara, Miembro del grupo de Tabaquismo de SEMERGEN, Spain
h Unidad de Alta Complejidad de Tabaquismo, Servicio de Neumología, Hospital Clínic, Barcelona, Spain
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Tables (2)
Table 1. Study patient's characteristics.
Table 2. Results of the study for the total population.
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To the Director,

Tobacco contributes to more than 8 million deaths each year worldwide. Quitting smoking reduces significantly the risk of death, particularly before the age of 40.1 The combination of psychological counseling with pharmacological treatment is key for a successful smoking cessation process; for years, the first-line drugs in Western Europe were nicotine replacement therapy (NRT), varenicline and bupropion,2 but currently, also cytisine should be considered as advisable pharmacological smoking cessation aid.

Here, we present the first study ever done in Spain to evaluate the role of cytisine (Todacitan®) for smoking cessation which, at the recommended doses of 1.5–9mg per day for 25 days, has been shown to be more effective than placebo and NRT in several clinical trials,3–6 and to be non-inferior and present less adverse events (AE) than varenicline.7

The present study was an observational, multicenter, multidisciplinary, cross-sectional study conducted in 7 Spanish centers, including primary care centers and hospitals. It was based on the review of real-life data from medical records and a patient's interview at the routine visit after the end of cytisine treatment (post-treatment visit). The information was collected using an electronic case report form, from March to July 2022.

The main objective was to evaluate, in routine clinical practice, the satisfaction of patients who had received cytisine for smoking cessation in the last 3 months before study initiation. The study also evaluated the tolerability and safety, the adherence and the effectiveness of cytisine for smoking cessation.

A total of 105 patients were included in the study. This sample size was lower than the initially estimated in the protocol (140), but enough to achieve the pre-defined aimed precision for the primary endpoint (±0.2 units with a SD of 1 unit).

The mean age of patients was 56.9 (SD: 10.2) years; 52.4% were women. Patients were, in average, 15.9 years (SD: 4.3) old when they started smoking and, at the initial visit, they were smoking 22 (SD: 8.4) cigarettes per day and 40.8 (SD: 21.7) pack-year. A 81.9% of patients had previously tried to quit smoking; the last attempt was with pharmacological treatment in 59.2% of patients. Among the treatments used, varenicline was the most common (68.9%). 70.5% of patients had a high or very high degree of dependence to tobacco (Table 1).

Table 1.

Study patient's characteristics.

Variable  Valid N  Mean (SD)  n (%) 
Age (years)  105  56.9 (10.2)   
Sex  105     
Male      50 (47.6%) 
Female      55 (52.4%) 
Age at starting smoking (years)  105  15.9 (4.3)   
Number of cigarettes per day  105  22.0 (8.4)   
Number of pack-year  100  40.8 (21.7)   
Number of previous quit attempts without treatment  105     
0      19 (18.1%) 
1      32 (30.5%) 
2      21 (20.0%) 
3      24 (22.9%) 
>3      9 (8.6%) 
Number of previous quit attempts with treatment  104     
0      40 (38.5%) 
1      40 (38.5%) 
2      19 (18.3%) 
3      4 (3.8%) 
>3      1 (1.0%) 
Time since last attempt (months)  74  53.3 (77.3)   
Did you use treatment in the last quit attempt?  103     
No      42 (40.8%) 
Yes      61 (59.2%) 
Nicotine replacement therapy (gum)      3 (4.9%) 
Nicotine replacement therapy (mouth spray)      0 (0.0%) 
Nicotine replacement therapy (tablets)      1 (1.6%) 
Nicotine replacement therapy (patches)      5 (8.2%) 
Varenicline      42 (68.9%) 
Bupropion      7 (11.5%) 
Other      4 (6.6%) 
Patients motivated to quit smoking before the start of treatment       
EVA scale  96  8.1 (1.5)   
Qualitative scale  58     
Yes      58 (100.0%) 
No      0 (0%) 
Levels of CO in inspired air (ppm)  66    23.4 (11.5) 
Fagerström Questionnaire Score  105     
Very low (0–1)      0 (0.0%) 
Low (2–3)      2 (1.9%) 
Moderate (4–5)      29 (27.6%) 
High (6–7)      50 (47.6%) 
Very high (8–10)      24 (22.9%) 
Reinforcement Questionnaire  97     
Negative reinforcement      56 (57.7%) 
Positive reinforcement      41 (42.3%) 
Glover-Nilsson test  96     
Mild dependency      11 (11.5%) 
Moderate dependency      58 (60.4%) 
High dependency      27 (28.1%) 
Time from start of cytisine treatment to date of visit (months)  104  1.2 (0.9)   

Patients were satisfied (38.1%) or very satisfied (39.0%) with the treatment. These results were independent of sex, previous treatment attempts, degree of dependence and reinforcement pattern. At the post-treatment visit, 76% of patients were abstinent. Using a Likert scale, adherence to treatment was reported as very good (62.1%) or good (20.4%). On average, patients consumed a total of 90.3 (SD: 21.1) pills over 23.2 (SD: 5.8) days of treatment (Table 2).

Table 2.

Results of the study for the total population.

Variable  Valid N  Mean (SD)  n (%) 
Patient satisfaction with treatment  105     
Very satisfied      41 (39.0%) 
Satisfied      40 (38.1%) 
Neutral      13 (12.4%) 
Unsatisfied      7 (6.7%) 
Very unsatisfied      4 (3.8%) 
Percentage of self-reported days of complete abstinence (cigarettes=0) between the start of treatment and the study visit  104  64.9% (35.7)   
Number of patients that reported being abstinent all days (completely or partially) between the start of treatment and the study visit  104    45 (43.3%) 
Abstinent patients at the study visit  104    79 (76.0%) 
Self-reported treatment adherence  105     
Very good      64 (62.1%) 
Good      21 (20.4%) 
Average      8 (7.8%) 
Low      4 (3.9%) 
Very low      4 (3.9%) 

The study shows that cytisine is a treatment with a manageable AE profile: 37.1% of patients experienced an AE of any degree. Sleeping disorders, usually related to smoking cessation itself, were the most common AE. Other AE included nauseas (12.4%) and vomits (3.8%). Most AE were mild (36.4%) or moderate (54.5%).

Cytisine has been shown to be more effective than placebo and NRT in several clinical trials, and to be non-inferior to varenicline and associated with fewer adverse effects.3,4,6–9 At one month, different continuous abstinence rates have been reported, including 40%6 and 59.3%9 in two independent studies conducted in New Zealand, and 57.2% in a study conducted in Italy.10 Similarly, the adverse events reported in the previous studies also include gastrointestinal events and sleeping disorders as the most prevalent ones.3,8,9

Some study limitations include the lack of concurrent control group, missing values for some variables and limited time between treatment initiation and post-treatment visit. Future studies are necessary to test the effectiveness of long-term treatment with cytisine.

In summary, the study shows that most patients (77.1%) are satisfied with the treatment with cytisine for smoking cessation and are abstinent (76%) at the post-treatment visit.


The DESTINA study and the medical writing of the scientific letter was funded by Aflofarm.

Conflict of Interests

CAJR reports grants and personal fees from Aflofarm, Gebro, GSK, Johnson&Johnson, Pfizer and Menarini. JARM reports grants and personal fees from Aflofarm, GSK, Pfizer, Novartis AG, Menarini, Boehringer Ingelheim, Astra-Zeneca, Gebro, and Laboratorios Rovi. JSCM has received honoraria as medical advisor, for presentations and publications from Aflofarm, AstraZeneca, Boerhinger, Ferrer, GSK, Menarini, Novartis, Pfizer and Rovi. JST declares to have received honoraria from Aflofarm as a clinical advisor. AMP, RSM and JLDM declare no conflicts of interest.


We thank the Adelphi Team (Maite Artés and Raquel Sales) for the management of the project and medical writing contributions.

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