Medium- and longer-term cardiovascular effects of e-cigarettes in adults making a stop-smoking attempt: a randomized controlled trial

TY - JOUR

T1 - Medium- and longer-term cardiovascular effects of e-cigarettes in adults making a stop-smoking attempt

T2 - a randomized controlled trial

AU - Klonizakis, Markos

AU - Gumber, Anil

AU - McIntosh, Emma

AU - Brose, Leonie S

N1 - Funding Information: The trial was funded by Heart Research UK under a Translational Research Grant (RG2658). The funder had no role in the study’s design, conduct, and reporting. Publisher Copyright: © 2022, The Author(s).

PY - 2022/8/16

Y1 - 2022/8/16

N2 - Background: Smoking is a major risk factor for cardiovascular disease and smoking cessation reduces excess risk. E-cigarettes are popular for smoking cessation but there is little evidence on their cardiovascular health effect. Our objective was to compare the medium- and longer-term cardiovascular effects in smokers attempting to quit smoking using e-cigarettes with or without nicotine or prescription nicotine replacement therapy (NRT). Methods: This was a single-center, pragmatic three-arm randomized (1:1:1) controlled trial, which recruited adult smokers (≥ 10 cigarettes/day), who were willing to attempt to stop smoking with support (n = 248). Participants were randomized to receive behavioral support with either (a) e-cigarettes with 18 mg/ml nicotine, (b) e-cigarettes without nicotine, and (c) NRT. Flow-mediated dilation (%FMD) and peak cutaneous vascular conductance (CVCmax) responses to acetylcholine (ACh) and sodium nitroprusside (SNP), mean arterial pressure (MAP), and other outcomes were recorded at baseline, 3, and 6 months after stopping smoking. Data were analyzed using generalized estimating equations (GEE). Results: At 3- and 6-month follow-up, %FMD showed an improvement over baseline in all three groups (e.g., p < 0.0001 at 6 months). Similarly, ACh, SNP, and MAP improved significantly over baseline in all groups both at 3 and 6 months (e.g., ACh: p = 0.004, at 6 months). Conclusions: Smokers attempting to quit experienced positive cardiovascular impact after both a 3- and 6-month period. None of the groups (i.e., nicotine-containing and nicotine-free e-cigarettes or NRT) offered superior cardiovascular benefits to the others. Trial registration: ClinicalTrials.gov NCT03061253. Registered on 17 February 2017.

AB - Background: Smoking is a major risk factor for cardiovascular disease and smoking cessation reduces excess risk. E-cigarettes are popular for smoking cessation but there is little evidence on their cardiovascular health effect. Our objective was to compare the medium- and longer-term cardiovascular effects in smokers attempting to quit smoking using e-cigarettes with or without nicotine or prescription nicotine replacement therapy (NRT). Methods: This was a single-center, pragmatic three-arm randomized (1:1:1) controlled trial, which recruited adult smokers (≥ 10 cigarettes/day), who were willing to attempt to stop smoking with support (n = 248). Participants were randomized to receive behavioral support with either (a) e-cigarettes with 18 mg/ml nicotine, (b) e-cigarettes without nicotine, and (c) NRT. Flow-mediated dilation (%FMD) and peak cutaneous vascular conductance (CVCmax) responses to acetylcholine (ACh) and sodium nitroprusside (SNP), mean arterial pressure (MAP), and other outcomes were recorded at baseline, 3, and 6 months after stopping smoking. Data were analyzed using generalized estimating equations (GEE). Results: At 3- and 6-month follow-up, %FMD showed an improvement over baseline in all three groups (e.g., p < 0.0001 at 6 months). Similarly, ACh, SNP, and MAP improved significantly over baseline in all groups both at 3 and 6 months (e.g., ACh: p = 0.004, at 6 months). Conclusions: Smokers attempting to quit experienced positive cardiovascular impact after both a 3- and 6-month period. None of the groups (i.e., nicotine-containing and nicotine-free e-cigarettes or NRT) offered superior cardiovascular benefits to the others. Trial registration: ClinicalTrials.gov NCT03061253. Registered on 17 February 2017.

KW - Adult

KW - Electronic Nicotine Delivery Systems

KW - Humans

KW - Nicotine/adverse effects

KW - Smoking/adverse effects

KW - Smoking Cessation

KW - Tobacco Smoking

KW - Tobacco Use Cessation Devices

UR - http://www.scopus.com/inward/record.url?scp=85136035418&partnerID=8YFLogxK

U2 - 10.1186/s12916-022-02451-9

DO - 10.1186/s12916-022-02451-9

M3 - Article

C2 - 35971150

SN - 1741-7015

VL - 20

SP - 276

JO - BMC Medicine

JF - BMC Medicine

IS - 1

M1 - 276

ER -