Cardiovascular adverse events in the drug-development program of bupropion for smoking cessation: A systematic retrospective adjudication effort.

ABSTRACT:

Background

In 2011, the US Food and Drug Administration requested that GlaxoSmithKline perform retrospective adjudication of cardiovascular (CV) events reported in the bupropion drug-development trials for smoking cessation.

Hypothesis

Retrospective adjudication of clinical trial data will not increase the identification of adverse events.

Methods

We performed a comprehensive retrospective analysis of adverse events in 19 previously completed controlled US clinical trials of bupropion marketed for the treatment of smoking cessation, yielding 9479 subjects (5290 bupropion, 2927 placebo, 1018 active control [ACT], and 244 treated concurrently with bupropion and ACT). All adverse events were sent to the Duke Clinical Research Institute for adjudication by Clinical Events

SUBMITTER: Kittle J 

PROVIDER: S-EPMC6490529 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature