A RETROSPECTIVE, REAL-LIFE EVALUATION OF THE CARDIOVASCULAR DISEASE RISK ASSOCIATED WITH EXPOSURE TO PHARMACOLOGICAL SMOKING CESSATION INTERVENTIONS IN A REPRESENTATIVE UK PRIMARY CARE PATIENT POPULATION

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28219
• EU PAS number:
  EUPAS4238
• Study ID:
  28219
• Official title and acronym:
  A RETROSPECTIVE, REAL-LIFE EVALUATION OF THE CARDIOVASCULAR DISEASE RISK ASSOCIATED WITH EXPOSURE TO PHARMACOLOGICAL SMOKING CESSATION INTERVENTIONS IN A REPRESENTATIVE UK PRIMARY CARE PATIENT POPULATION
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Preliminary study data have indicated a possible increased cardiovascular disease (CVD) risk in patients exposed to nicotine replacement therapy (NRT) compared with controls (i.e. non-NRT exposed patients) of a magnitude that could not reasonably be accounted for by differences in the cardiovascular (CV) risk profile of the two patient groups. Further in-depth studies in this area are warranted.This retrospective study will compare the CVD event risk in a group of smokers undertaking unaided smoking cessation attempts with the event rate in a group of smokers attempting smoking cessation assisted by pharmacological interventions (any of NRT, bupropion or varenicline) in a representative UK primary care population. There will be a baseline and outcome period designed to assess CVD risk. The baseline period will be a minimum of one year prior to an index date (IPD) – the date of first recorded smoking cessation intervention, either pharmacological or non-pharmacological – for confounder definition. Of primary interest will be the CV event rate over a 4-week outcome period (secondary outcomes periods of 12, 26 and 56 weeks may also be investigated). Also of interest will be all-cause mortality and survival analysis.
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 30/11/2009

Actual: 18/12/2009

Study start date

Planned: 01/01/2000

Actual: 31/12/2009

Date of final study report

Planned: 01/08/2013

Actual: 06/02/2015

Sources of funding

Other

More details on funding

MEDICAL RESEARCH COUNCIL, Research in Real Life Ltd, Respiratory Effectiveness Group

Study protocol

Initial protocol

ISAC application_study protocol _final_update_26_07_11_clean

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable