|
||
|
|
||
More recently data were published in The Lancet in May 2012,[44] looking at the effects of one of the new monoclonal antibodies to PCSK9, Regeneron 727, for reducing LDL-C in patients with heterozygous FH. These patients were on stable statin doses with or without ezetimibe therapy. This was a phase II randomized controlled trial.
The Figure shows the summary data from this trial showing calculated changes in LDL-C at 2-week intervals out to week 12. The top line in red is placebo, showing no change in LDL-C levels. The purple line is Regeneron 727 every 4 weeks in 3 doses, followed by 150 mg dose every 2 weeks. The result is a sawtooth-like response to the every 4-week dosing, whereas at the 2-week dosing interval results in a significant drop initially and then a persistence in achieved LDL-C reductions throughout the remainder of the dosing cycle. Thus on average the 4-week dosing LDL-C levels attained were not as low as those with the 2-week dosing schedule, and so the question remains whether the 2-week or 4-week dosing schedules will have similar long term compliance and cardiovascular outcomes.
[44] www.thelancet.com. Published online May 26, 2012 DOI:10.1016/S0140-6736(12)60771-5.