ACTRN12616001654448

16 evidence topics · 1 source

Objective

Primary comparison

“noninferiority” (opens the source at this quote in a new tab)

Location and study date

Country

“Australia” (opens the source at this quote in a new tab)

Study design

Trial masking

“open-label” (opens the source at this quote in a new tab)

Eligibility criteria

Population

“adult daily smokers” (opens the source at this quote in a new tab)

Treatment

Treatment duration

Characteristic	Quoted value
Cytisine, days	“25”
Varenicline, days	“84”

Study outcomes

Rationale for using continuous smoking abstinence as the primary endpoint

Primary outcome

Characteristic	Quoted value
Continuous-abstinence assessment	“6 months”

Statistical analysis description

Number of participants (Planned and analyzed)

Randomized sample

Characteristic	Quoted value
Total participants	“1452”
Cytisine	“725”
Varenicline	“727”

Description of analysis sets

Noninferiority threshold

Characteristic	Quoted value
Margin	“5%”
One-sided significance level	“.025”

Results

Participant disposition

Follow-up completion

Characteristic	Quoted value
Participants completing follow-up	“1108”

Baseline characteristics

Baseline age and sex

Characteristic	Quoted value
Mean age, years	“42.9”
Female participants	“51.1%”

Efficacy results

Verified 6-month continuous abstinence

Cytisine	Varenicline
“11.7%”	“13.3%”

Primary noninferiority analysis

“This primary analysis did not confirm noninferiority of cytisine compared with varenicline at the 2.5% level of significance” (opens the source at this quote in a new tab)

Risk difference and investigator conclusion

“Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, −1.62% [1-sided 97.5% CI, −5.02% to ∞]; P = .03 for noninferiority).” (opens the source at this quote in a new tab)
“Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation.” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Reported adverse-event counts

Characteristic	Quoted value
Cytisine	“997”
Varenicline	“1206”

Self-reported adverse events: incident rate ratio against varenicline

“Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002).” (opens the source at this quote in a new tab)

Study limitations

Summary

The primary analysis did not establish noninferiority. Cytisine was administered for 25 days and varenicline for 84 days, so the comparison combines differences in medication and duration. The trial was open-label.