Evicenter
P&T meetings

Cytisinicline

Smoking cessation

Last updated
86 sources

Clinical evidence

ISRCTN43811467

12 evidence topics · 2 sources

Objective
Location and study date
Study design
Eligibility criteria
Treatment
Regimen
CharacteristicQuoted value
Treatment course“25 days”
Concomitant intervention“brief behavioural support”
Study outcomes
Rationale for using continuous smoking abstinence as the primary endpoint
Primary assessment
CharacteristicQuoted value
Continuous-abstinence follow-up, months“6”
Statistical analysis description
Number of participants (Planned and analyzed)
Randomized participants
CharacteristicQuoted value
Total“2472”
Cytisine“1239”
Placebo“1233”
Description of analysis sets
Results
Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results
Continuous abstinence at 6 months
CharacteristicQuoted value
Cytisine participants abstinent“401”
Placebo participants abstinent“366”
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Participants with serious adverse events
CharacteristicQuoted value
Cytisine“53”
Placebo“46”
Study limitations
Summary

The study population had pulmonary tuberculosis, and both groups received brief behavioral support. The investigators did not support adding cytisine in this setting. Results should not be treated as a direct evaluation of the ORCA regimen in the general smoking population.