What is the effectiveness of varenicline compared with nicotine replacement therapy for long term smoking cessation and clinically important outcomes such as mortality, myocardial infarction and frequency of service use? Evidence from the Clinical Practice Research Datalink

Davies NM, Taylor AE, Taylor GM, Itani T, Jones T, Martin RM, Munafò MR, Windmeijer F, Thomas KH
Record ID 32015001015
Authors' objectives: In this study we will provide important new information about the effects of the smoking cessation medication varenicline. We know from randomised trials that smokers who take a course of this drug are much more likely to successfully quit smoking in the short term. However, some recent research has suggested that patients prescribed varenicline might be more likely to have psychiatric problems or heart attacks. The evidence from randomised trials is not necessarily informative about the effects of varenicline when used in everyday clinical settings. For example, patients prescribed varenicline by GPs as part of their day-to-day care may be very different from participants recruited to a pharmaceutical trial. To address this gap in the evidence, in this study we will use data from the Clinical Practice Research Datalink, which contains information from electronic medical records of patients attending GP practices across the UK. We will investigate if patients prescribed varenicline are more likely to successfully abstain from smoking in the long term. We will also investigate whether by prescribing varenicline, and helping their patients quit smoking, GPs can help reduce the frequency that their patients attend the GP and are admitted to hospital. This is an important outcome because smoking related illnesses are a significant burden on the NHS s resources. We will also investigate if prescribing varenicline affects whether patients develop significant side-effects such as respiratory illnesses, heart attacks or depression. Finally, one of the novel features of our study is that we will employ a number of different statistical approaches to check whether our results are reliable evidence that varenicline actually causes these outcomes. This is an important issue when using non-experimental data, and our previous studies have suggested that recently developed statistical techniques may help. In a Methodological Bolt-On attached to this project, which is funded by the Medical Research Council, we will provide further evidence and guidance about when these statistical techniques may be helpful for regulators, clinicians and patients.
Project Status: Completed
Year Published: 2020
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Benzazepines
  • Therapeutic Uses
  • Smoking Cessation
  • Nicotine
  • Varenicline
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
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