CITOSP

14 evidence topics · 2 sources

Objective

Clinical safety objective

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

Location and study date

Hospital setting

“Verona University Hospital” (opens the source at this quote in a new tab)

Enrollment years

Characteristic	Quoted value
First year	“2021”
Last year	“2023”

Study design

Observational design

“observational prospective study” (opens the source at this quote in a new tab)

Eligibility criteria

Cardiology population

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

Treatment

Cytisine administration

Characteristic	Quoted value
Oral cytisine unit dose	“1.5 mg”
Treatment duration	“25 days”

Study outcomes

Rationale for using adverse drug reactions as the primary safety endpoint

Primary outcome

“The primary endpoint was CYT safety” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Enrolled participants

Characteristic	Quoted value
Cohort size	“36”

Description of analysis sets

Minimum exposure for analysis

“at least one capsule” (opens the source at this quote in a new tab)

Results

Participant disposition

Study completion

Characteristic	Quoted value
Participants completing the study	“22 (61.1%)”

Baseline characteristics

Baseline sex

Characteristic	Quoted value
Male participants	“83.3%”

Efficacy results

Self-reported seven-day point-prevalence abstinence

Characteristic	Quoted value
At 3 months	“50%”
At 6 months	“47%”
At 12 months	“36%”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Primary safety findings

“The primary endpoint was CYT safety, with 11 mild-moderate Adverse Drug Reactions (ADRs) reported by 9 (25%) participants.” (opens the source at this quote in a new tab)

Study limitations

Summary

The evidence comes from a prospective observational cohort of 36 hospitalized smokers with cardiovascular disease. Its small size and lack of randomized comparison limit causal interpretation and assessment of uncommon cardiovascular harms. The reported longitudinal cessation percentages are self-reported outcomes.