ORCA-OL

13 evidence topics · 3 sources

Objective

Extended exposure objective

“long-term safety” (opens the source at this quote in a new tab)

Location and study date

U.S. study sites

Characteristic	Quoted value
Number of U.S. sites	“29”

Study design

Open-label exposure-safety study

“The ORCA-OL trial, an open-label, long-term, exposure safety study, enrolled 475 adults who smoke cigarettes, use e-cigarettes, or both.” (opens the source at this quote in a new tab)

Eligibility criteria

Prior-study eligibility

“ORCA-2, ORCA-3, or ORCA-V1” (opens the source at this quote in a new tab)

Treatment

Continuous treatment regimen

“cytisinicline 3 mg three times daily for up to 52 weeks of continuous exposure” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using treatment-emergent adverse events as the primary safety endpoint

Safety assessment

“Treatment-emergent adverse event (TEAE) incidence” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Treated participants

Characteristic	Quoted value
Treated sample	“475”

Description of analysis sets

Safety analysis set

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

Results

Participant disposition

Exposure duration

Characteristic	Quoted value
Participants exposed for at least 24 weeks, number and percentage	“392 (82.5)”
Participants exposed for at least 48 weeks, number and percentage	“319 (67.2)”
Participants exposed for at least 51 weeks, number and percentage	“281 (59.2)”

Baseline characteristics

Baseline age and sex

Characteristic	Quoted value
Median age, years	“55”
Female participants, number and percentage	“275 (57.9)”

Efficacy results

Not applicable.

Health-related quality of life and patient-reported outcomes

Exit-survey design

“voluntary post-trial survey” (opens the source at this quote in a new tab)

Safety results

Serious adverse events, deaths, and discontinuations

“Serious TEAEs occurred in 31 participants (6.5%)” (opens the source at this quote in a new tab)
“Two deaths (0.4%) occurred and were considered unrelated to treatment” (opens the source at this quote in a new tab)
“few participants (5.7%) discontinued due to TEAEs” (opens the source at this quote in a new tab)

Study limitations

Summary

This open-label study had no concurrent comparator. It enrolled participants previously treated in the ORCA program, rather than a newly recruited randomized population. Exposure declined from 475 treated participants to 281 with at least 51 weeks of treatment. The exit survey was voluntary.