ESC 2016: Praluent reduces the required frequency of apheresis treatment in HeFH patients.
By Louisa Joseph, Analyst
10 September 2016
Regeneron Pharmaceuticals and Sanofi presented full data from the multicentre ODYSSEY ESCAPE trial at the 2016 European Society of Cardiology (ESC) congress. The Phase III trial met its primary endpoint by demonstrating that the addition of bi-weekly Praluent (alirocumab: Sanofi/Regeneron) to standard therapy can reduce or eliminate the need for lipoprotein apheresis treatment in patients with heterozygous familial hypercholesterolemia (HeFH). Praluent treatment was shown to significantly reduce the required frequency of apheresis therapy in HeFH patients by 75% (P < 0.0001) compared to placebo. Furthermore, Praluent treatment was shown to entirely eliminate the requirement of apheresis in 63.4% of patients after six-weeks of Praluent treatment. Whilst Praluent was shown to reduce the need for apheresis therapy, there may be differences in criteria for skipping or stopping apheresis sessions in clinical practice. In the Phase III trial, there were markedly different baseline and treatment characteristics in patients from the two countries involved, US and Germany. Based on these differences, it was decided that apheresis treatment would be stopped if there was at least a 30% reduction in baseline (pre-apheresis) LDL-C levels. The investigators acknowledged that, as a result, some apheresis sessions were stopped despite the fact that the patients had not achieved their specified LDL-C goals (e.g. <1.8 mmol/L [70 mg/dL]). In practice, it is likely that patients would continue to receive lipoprotein apheresis until pre-defined LDL-C goals were attained and so the percentage reduction in required frequency of apheresis treatment observed in this study may be artificially high.
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