Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Systematic review and meta-analysis
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BUPROPION

Medical condition to be studied

Cardiovascular insufficiency
Population studied

Short description of the study population

Subjects from GSK sponsored randomized controlled trials who took at least one dose of the Bupropion marketed as Zyban (ZYB) for smoking cessation.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

10640
Study design details

Main study objective

The objective of this investigation is to compare the incidence of adverse cardiovascular events in Zyban treated groups versus control groups in previously completed randomized clinical trials of smoking cessation treatment.

Outcomes

The primary endpoint is the time to an on-treatment MACE event, Incidence of MACE, incidence of components of MACE event, Incidence of MACE+ event, Incidence of components of MACE+ event, Incidence of other events of interest,Time to MACE+

Data analysis plan

The time-to-MACE will be analyzed using log-rank test. The survival distribution of the time to first on-treatment MACE will be compared between treatment groups via a stratified log-rank test with Study as a stratification variable.