Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV.
AIDS
HIV
Nicotine dependence
Smoking cessation
Tobacco use
Varenicline
Journal
Drug and alcohol dependence
ISSN: 1879-0046
Titre abrégé: Drug Alcohol Depend
Pays: Ireland
ID NLM: 7513587
Informations de publication
Date de publication:
01 07 2019
01 07 2019
Historique:
received:
17
12
2018
revised:
13
03
2019
accepted:
14
03
2019
pubmed:
15
5
2019
medline:
21
1
2020
entrez:
15
5
2019
Statut:
ppublish
Résumé
People living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH. This was a single-site randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT01710137). PLWH on antiretroviral therapy (ART) who were treatment-seeking daily smokers were randomized (1:1) to 12 weeks of varenicline (n = 89) or placebo (n = 90). All participants were offered six smoking cessation behavioral counseling sessions. The primary outcome was 7-day point prevalence abstinence, confirmed with breath carbon monoxide, at Weeks 12 and 24. Continuous abstinence and time to relapse were secondary outcomes. Safety measures were treatment-related side effects, adverse events, blood pressure, viral load, and ART adherence. Of the 179 smokers, 81% were African American, and 68% were male. Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001). Continuous abstinence from Week 9 to 12 was higher for varenicline vs. placebo (23.6% vs. 10%; OR = 4.65, 95% CI:1.71-12.67, P = .003); at Week 24, there was no effect of varenicline for point prevalence (14.6% vs. 10%), continuous abstinence (10.1% vs. 6.7%), or time to relapse (Ps > .05). There were no differences between varenicline and placebo on safety measures (Ps > .05). Varenicline is safe and efficacious for short-term smoking cessation among PLWH and should be used to reduce tobacco-related life-years lost in this population.
Sections du résumé
BACKGROUND
People living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH.
METHODS
This was a single-site randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT01710137). PLWH on antiretroviral therapy (ART) who were treatment-seeking daily smokers were randomized (1:1) to 12 weeks of varenicline (n = 89) or placebo (n = 90). All participants were offered six smoking cessation behavioral counseling sessions. The primary outcome was 7-day point prevalence abstinence, confirmed with breath carbon monoxide, at Weeks 12 and 24. Continuous abstinence and time to relapse were secondary outcomes. Safety measures were treatment-related side effects, adverse events, blood pressure, viral load, and ART adherence.
RESULTS
Of the 179 smokers, 81% were African American, and 68% were male. Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001). Continuous abstinence from Week 9 to 12 was higher for varenicline vs. placebo (23.6% vs. 10%; OR = 4.65, 95% CI:1.71-12.67, P = .003); at Week 24, there was no effect of varenicline for point prevalence (14.6% vs. 10%), continuous abstinence (10.1% vs. 6.7%), or time to relapse (Ps > .05). There were no differences between varenicline and placebo on safety measures (Ps > .05).
CONCLUSIONS
Varenicline is safe and efficacious for short-term smoking cessation among PLWH and should be used to reduce tobacco-related life-years lost in this population.
Identifiants
pubmed: 31082665
pii: S0376-8716(19)30140-1
doi: 10.1016/j.drugalcdep.2019.03.011
pmc: PMC6588414
mid: NIHMS1528773
pii:
doi:
Substances chimiques
Smoking Cessation Agents
0
Varenicline
W6HS99O8ZO
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
26-33Subventions
Organisme : NIAID NIH HHS
ID : P30 AI045008
Pays : United States
Organisme : NIDA NIH HHS
ID : R01 DA033681
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA016520
Pays : United States
Organisme : NIMH NIH HHS
ID : P30 MH097488
Pays : United States
Organisme : NIDA NIH HHS
ID : K24 DA045244
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.
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