Nicotine Replacement Therapy and Cardiovascular Disease

NCT02195739 | Unknown

• 1 other identifier: E02311
• Study Type: observational
• Target: 61,050
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the cardiovascular disease event rate in smokers undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with the event rate in smokers attempting smoking cessation assisted by pharmacological interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray, transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation aids (e.g. bupropion \[Zyban®\] and varenicline \[Champix®\]) - in a representative UK primary care population.

Conditions

Smoking Cessation

Keywords

smoking; smoking cessation; cardiovascular disease; pharmacological intervention; UK primary care population; nicotine replacement therapy

Outcome Measures

Primary Outcomes (2)

• Time to first coronary heart disease diagnosis

  Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior coronary heart disease.

  4 weeks

• Time to first cerebrovascular disease diagnosis.

  Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior cerebrovascular disease.

  4 weeks

Secondary Outcomes (6)

• Time to first coronary heart disease diagnosis

  52 weeks

• Time to first cerebrovascular disease diagnosis

  52 weeks

• Odds of recording one or more consultations for coronary heart disease or cerebrovascular disease

  52 weeks

• Survival time for coronary heart disease-related death.

  52 weeks

• Survival time for cerebrovascular disease-related death.

  52 weeks

Other Outcomes (3)

• Survival time for coronary heart disease-related death

  Any time after index smoking cessation attempt

• Survival time for cerebrovascular disease-related death

  Any time after index smoking cessation attempt

• Survival time for all-cause mortality

  Any time after index smoking cessation attempt

Study Arms (3)

Nicotine replacement therapy cohort

Cohort defined as patients in whom nicotine replacement therapy (in any preparation) was initiated at the index smoking cessation attempt as the first recorded smoking cessation intervention.

Other smoking cessation therapy

Cohort defined as patients in whom other (non-nicotine replacement therapy) smoking cessation pharmacotherapy's were initiated at the index smoking cessation attempt (e.g. bupropion, varenicline) as the first recorded smoking cessation intervention

Smoking cessation advice cohort

Cohort (control patients) defined as patients whose first recorded smoking cessation intervention involved smoking cessation advice leading to a quit attempt unassisted by pharmacological smoking cessation aids, at the index smoking cessation attempt.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt was assisted by one of the following pharmacological interventions: (i) nicotine replacement therapy as any, or a combination, of transdermal patches, nasal spray, gum and tablets, inhaler. (ii) Other (e.g. bupropion, varenicline). NON-EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt involved receipt of smoking cessation advice that resulted in a quit attempt unaided by pharmacological therapies.

You may qualify if:

• The analysis will include an exposure group comprising smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose first recorded smoking cessation intervention was a cessation attempt assisted by either nicotine replacement therapy (using any of, or a combination of products) or another pharmacological smoking cessation intervention (e.g. bupropion, varenicline) at the index date.
• Aged: 18-75 years.
• Have at least one year of up-to-standard baseline data as defined by Clinical Practice Research Datalink (prior to the index smoking cessation attempt) and at least one year of up-to-standard outcome data (following the index smoking cessation attempt) or up-to-standard data up to the time of death if death occurred within the outcome period.

You may not qualify if:

• Patients will be excluded from the analysis if they:
• Have had exposure to any nicotine replacement therapy or other pharmacological smoking cessation interventions in the baseline period (year prior to the index smoking cessation attempt), and/or
• Switched between types of smoking cessation interventions (i.e. nicotine replacement therapy to other pharmacological smoking cessation interventions or vice versa) during the outcome period(s). Switching between different nicotine replacement therapy products, or use of multiple nicotine replacement therapy products, will be permissible and analysis may involve a comparison of outcomes relative to nicotine exposure over the various outcome periods.

Sponsors & Collaborators

• Research in Real-Life Ltd: lead

Study Sites (1)

Research in Real Life Ltd

Cambridge, CB24 3BA, United Kingdom

Location

Related Publications (6)

• Fiore MC, Bailey WC, Cohen SJ, et al. Treating tobacco use and dependence. Clinical practice guideline. Rockville (MD): US Department of Health and Human Services, Public Health Service, 2000

  BACKGROUND

• West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Health Education Authority. Thorax. 2000 Dec;55(12):987-99. doi: 10.1136/thorax.55.12.987.

  PMID: 11083883 BACKGROUND

• Le Foll B, George TP. Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. 2007 Nov 20;177(11):1373-80. doi: 10.1503/cmaj.070627.

  PMID: 18025429 BACKGROUND

• Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.

  PMID: 18253970 BACKGROUND

• Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD006103. doi: 10.1002/14651858.CD006103.pub2.

  PMID: 17253581 BACKGROUND

• British Medical Association and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Version 56. London; BNF Group; 2008.

  BACKGROUND

Related Links

• World Health Organization (WHO). 2007. The European tobacco control report 2007 \[online\]
• eto R, Lopez AD, Boreham J, et al. 2006. Mortality from smoking in developed countries 1950 - 2000 (2nd ed.) \[online\]

MeSH Terms

Conditions

Smoking Cessation; Smoking; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• David Price, Prof, MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: July 21, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

GB (1)