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. 2020 Oct 14;2020(10):CD010216. doi: 10.1002/14651858.CD010216.pub4

Ioakeimidis 2018.

Study characteristics
Methods Design: Randomized controlled trial
Recruitment: Not specified
Setting: Hospital, Greece.
Study start date/Study end date: Not specified
Participants Total N: 54
N per arm: Arm 1: 27; Arm 2: 27
Inclusion criteria:
  • ≥10 cpd

  • Motivation to quit

  • Hospitalized with acute coronary syndrome (ACS)

  • 18 or older


Exclusion criteria:
  • Prior EC use

  • History of neuropsychiatric disorders

  • Prior varenicline use or use of SC pharmacotherapy at time of ACS

  • Cardiogencic shock or renal impairment

  • Hepatic impairment prior to ACS

  • Excessive alcohol use or current use of marijuana or non‐cigarette tobacco products


Inclusion based on specific population characteristic: People who have experienced acute coronary syndrome
65% women; mean age 52; mean cpd 21; mean FTND 5.6
Motivated to quit: Yes
E‐cigarette use at baseline: No prior EC use
Interventions EC: information on whether cig‐a‐like or refillable not provided
Both arms given "low intensity counselling"
Intervention 1: 12‐week use of EC 12 mg/ml nicotine
Intervention 2: 12‐week varenicline
Outcomes Weeks: 4, 12, 24
Cessation: 7‐day PP at 24 weeks, self‐report
Adverse events and biomarkers: Unclear how these were reported. Abstract says no SAEs, poster implies this may have just been CV or neuropsychiatric SAEs. Abstract says nothing about AEs but nausea and sleeping disorders given in table in poster. Implies (S)AEs collected during treatment period only
Other outcomes measured: Not specified
Study funding Not reported
Author declarations Not reported
Notes New for 2020 update. Abstract and poster only; limited data available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Not specified but equal amounts of contact and support between arms so performance bias judged unlikely
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐report only but equal amounts of contact between arms, no reason to suspect differential misreport
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not specified
Selective reporting (reporting bias) Unclear risk Abstract/poster only so not able to judge
Other bias High risk Abstract and poster only. Two different figures presented for quit rate in EC arm (no difference in those presented in varenicline arm) between abstract and poster. Poster percentage aligns with figure, so using that (16.5%) as opposed to abstract figure (32.5%). Contacted authors but no reply. Calculated n quit based on percentages but unclear what denominators were; EC calculates back to whole number for EC but not for varenicline