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Clin Epidemiol. 2017 Apr 26;9:231-243. doi: 10.2147/CLEP.S127775. eCollection 2017.

Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study.

Author information

1
Dollerup Medical Consultancy, Kongens Lyngby, Denmark.
2
Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, UK.
3
Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.
4
Family Physician Airways Group of Canada, Richmond Hill, ON, Canada.
5
National Jewish Health, Denver, CO, USA.
6
Federal University of Santa Catarina, Santa Catarina, Brazil.
7
Observational and Pragmatic Research Institute Pte Ltd, Singapore.
8
Centre for Academic Primary Care, University of Aberdeen, Aberdeen, UK.

Abstract

BACKGROUND:

Previous research suggests exposure to nicotine replacement therapy (NRT) may be associated with an increased risk of cardiovascular disease (CVD).

METHODS:

Using data from the United Kingdom's Clinical Practice Research Datalink, this study aimed to evaluate CVD events and survival among individuals who attempted smoking cessation with the support of NRT compared with those aided by smoking cessation advice only. We studied CVD outcomes over 4 and 52 weeks in 50,214 smokers attempting to quit - 33,476 supported by smoking cessation advice and 16,738 with the support of NRT prescribed by their primary care physician. Patients were matched (2 smoking cessation advice patients:1 NRT patient) on demographic and clinical characteristics during a baseline year preceding their quit attempt. Cox proportional hazard regression, conditional negative binomial regression model, and conditional logistic regression were used to analyze data.

RESULTS:

Mean (standard deviation) population age was 47 (11.2) years; 51% were females. Time to first diagnosis of ischemic heart disease (IHD) among NRT and smoking cessation advice patients was similar within the first 4 weeks, but shorter for NRT patients over 52 weeks (hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.03-1.77). A similar trend was observed for cerebrovascular disease (HR: 1.54, 95% CI: 1.08-2.19). NRT patients with a prior diagnosis of IHD or cerebrovascular disease had a higher rate of primary or secondary care consultations for IHD or cerebrovascular disease by 52 weeks (rate ratio: 1.50, 95% CI: 1.14-1.99). Patients prescribed NRT had a shorter survival time over 52 weeks, compared with those receiving advice only (HR: 1.39, 95% CI: 1.09-1.76).

CONCLUSION:

Our findings suggest that treatment with NRT over 4 weeks does not appear to have an impact on cardiovascular risks. However, a longer follow-up period of 52 weeks resulted in an increase in cardiovascular events for patients prescribed NRT, compared with those receiving smoking cessation advice only.

KEYWORDS:

cardiovascular; nicotine replacement therapy; risk; smokers; smoking cessation advice

Conflict of interest statement

Disclosure JD was formerly employed at MSD, Pfizer, and GSK, and was a contractor with Teva and Gilead. JV has received honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi pharmaceuticals, GlaxoSmithKline, and Novartis for advising and presenting, none of it related to smoking cessation products. AK is either on the advisory board or speakers bureau for Astra Zeneca, Boehringer Ingelheim, Griffols, GSK, Johnson and Johnson, Meda, Merck Frosst, Novartis, Pfizer, Purdue, and Teva. RJM was a consultant for Teva and AstraZeneca, has received travel support from REG, is on the Genentech and Boehringer Ingelheim advisory boards, and has received research grants from NHLBI and MedImmune. AB and JM were employed by Observational and Pragmatic Research Institute Pte Ltd, which receives funding from the UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, REG, Takeda, Teva Pharmaceuticals, Theravance, and Zentiva. DBP has board membership with Aerocrine, Amgen, Astra-Zeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from the UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, REG, Takeda, Teva Pharmaceuticals, Theravance, and Zentiva; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; stock/stock options from AKL Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd, UK, and 74% of Observational and Pragmatic Research Institute Pte Ltd, Singapore; received payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrollment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, and Zentiva; and peer reviewer for grant committees of the Medical Research Council, Efficacy and Mechanism Evaluation program, and Health Technology Assessment. The authors report no other conflicts of interest in this work.

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