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- Title
2015 - Review: Varenicline does not differ from placebo for adverse neuropsychiatric events.
- Authors
Lancaster, Tim; Cahill, Kate
- Abstract
Review scope Included studies compared maximum-dose varenicline (1 mg twice daily) for any duration, with placebo in smokers or nonsmokers. Primary outcomes were adverse neuropsychiatric events (depression, suicidal ideation, attempted suicide, and a composite of suicide or attempted suicide). Secondary outcomes included death, anxiety, fatigue, insomnia, and sleep disorders. Review methods MEDLINE, EMBASE/Excerpta Medica, PsycINFO, Cochrane Central Register of Controlled Trials, clinicaltrials.gov (all to May 2014), and reference lists were searched for randomized controlled trials (RCTs). 44 RCTs (n = 11 146, mean age range 15 to 73 y, 32% to 100% men, treatment duration 7 d to 52 wk) met selection criteria. Study populations included smokers in the general population (18 RCTs), smokers previously treated with varenicline (1 RCT), smokeless tobacco users (2 RCTs), people dependent on opioids or cocaine (3 RCTs), smokers with psychiatric illness (8 RCTs), adolescents (1 RCT), nonsmokers (2 RCTs), and patients with other conditions (9 RCTs). Risk for bias was low for randomization (38 RCTs), allocation concealment (37 RCTs), blinding of personnel or participants (42 RCTs), and blinded outcome assessments (38 RCTs). 5 RCTs were excluded from meta-analysis due to unclear risk for bias for ≥ 4 of 6 quality assessment criteria or lack of data. Main results Varenicline did not differ from placebo for depression, suicidal ideation, attempted suicide, suicide or attempted suicide, or death; it reduced anxiety and increased fatigue, insomnia, and sleep disorders (Table). Conclusion Varenicline does not differ from placebo for depression, suicidal ideation, attempted suicide, or suicide or attempted suicide.
- Subjects
ANXIETY; CONFIDENCE intervals; MENTAL depression; FATIGUE (Physiology); INFORMATION storage &; retrieval systems; MEDICAL databases; MEDICAL information storage &; retrieval systems; PSYCHOLOGY information storage &; retrieval systems; INSOMNIA; MEDLINE; META-analysis; MORTALITY; PATIENT safety; SLEEP disorders; SMOKING cessation; SUICIDAL behavior; SYSTEMATIC reviews; RANDOMIZED controlled trials; RELATIVE medical risk; TREATMENT effectiveness; SUICIDAL ideation; NICOTINIC agonists; DESCRIPTIVE statistics; ODDS ratio
- Publication
ACP Journal Club, 2015, Vol 163, Issue 2, p5
- ISSN
1056-8751
- Publication type
Article