Phase III Trial of Eprotirome: Discontinued for Safety Concerns
Author: Sweetlove, Mel
Source: Pharmaceutical Medicine, Volume 26, Number 3, 1 June 2012 , pp. 185-187(3)
Publisher: Adis International
Abstract:A placebo-controlled, double-blind, randomized, parallel-group, long-term phase III trial assessing the safety and efficacy of eprotirome in patients with heterozygous familial hypercholesterolaemia (HeFH) who are on optimal standard of care. This study was investigating the efficacy of eprotirome in patients with HeFH who were receiving optimal standard of care. The primary endpoint was the percent reduction in low-density lipoprotein cholesterol from baseline to 12 weeks. The development of eprotirome was discontinued in February 2012, after dog toxicology studies revealed that 12 months of exposure to the drug led to cartilage damage, leading to termination of this trial and all other trials in the phase III programme.
Document Type: Research Article
Affiliations: Adis, Auckland, New Zealand
Publication date: June 1, 2012