AstraZeneca Toprol-XL Review Raises Retrospective Sub-Analyses Questions
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A retrospective subset analysis showing an imbalance in mortality rates for U.S. versus European heart failure patients receiving AstraZeneca’s Toprol-XL (metoprolol succinate) raises general questions about subset analyses and foreign data that "could have major implications" for study design, FDA said in review documents for Toprol XL's heart failure indication.