Abstract
The search for an optimum method of inhibiting proprotein convertase subtilisin kexin (PCSK9) goes on and the clinical researches into monoclonal antibodies to PCSK9 (PCSK9-inhibitors) continue to yield new information. Recently the results of the study ODYSSEY CHOICE I have been published, which tested efficiency and safety of alirocumab administered in the dose of 300 mg once a month, compared to placebo and a group of patients treated with alirocumab in the dose of 75 mg once in 14 days.
The study lasted 48 weeks. 803 patients were divided based on statin doses into the study's therapeutical branches (alirocumab 300 mg 1x a month, placebo, alirocumab 150 mg 2x a month) in the ratio of 3 : 2 : 1. Average lowering of LDL-C levels in the 24th week of the study with alirocumab doses of 300 mg administered 1x a month was -52.7 % in the patients not treated with statins (placebo -0.3 %), and -58,8 % in the users of statins (placebo -0.1 %). 14.7 % participants not using statin and 19.3 % statin users on the study had their dose changed in the 12th week from 300 mg alirocumab 1x a month to 150 mg administered 1x in 2 weeks due to insufficiently balanced therapeutic response.
Incidence of adverse effects was similar among the users of active therapy and those taking placebo (61.1-75 % in the placebo branch, 71.5-78.1 % in the alirocumab branch). Relatively higher efficiency of PCSK9 inhibition was demonstrated again in statin users, who have increased PCSK9 concentrations as the accompanying effect of their LDL-C lowering effect.
Very good efficiency of alirocumab and its safety profile have been proven again. A dose taken once in a month may bring an improvement in adherence and thereby also in long-term therapeutical results, although at the moment the data to test this hypothesis is not available.
The possibility of using a long dosing interval will contribute to further individualization of therapy.