Reporting of Cardiovascular Events in Clinical Trials Supporting FDA Approval of Contemporary Cancer Therapies.

ABSTRACT:

Background

Cardiovascular disease (CVD) has become an increasingly common limitation to effective anticancer therapy. Yet, whether CVD events were consistently reported in pivotal trials supporting contemporary anticancer drugs is unknown.

Objectives

The authors sought to evaluate the incidence, consistency, and nature of CVD event reporting in cancer drug trials.

Methods

From the Drugs@FDA, clinicaltrials.gov, MEDLINE, and publicly available U.S. Food and Drug Administration (FDA) drug reviews, all reported CVD events across latter-phase (II and III) trials supporting FDA approval of anticancer drugs from 1998 to 2018 were evaluated. The primary outcome was the report of major adverse cardiovascular events (MACE), defined as incident myocardial infarction, stroke, he

SUBMITTER: Bonsu JM 

PROVIDER: S-EPMC7860639 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature