Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase IIIb/IV DM-INSULIN and DM-DYSLIPIDEMIA clinical trials of Praluent (alirocumab) to treat patients with diabetes and hypercholesterolemia.
Praluent is designed to prevent the binding of PCSK9 to the low-density lipoprotein (LDL) receptor, resulting in an increase of the number of LDL receptors available and a subsequent decrease of LDL cholesterol (LDL-C) levels in the blood.
Upon administration of the product on top of maximally tolerated doses (MTD) of statins, a significant decrease of LDL-C in DM-INSULIN trial and greater reduction in non-high-density lipoprotein cholesterol (non-HDL-C) during DM-DYSLIPIDEMIA trial were observed when compared to standard care.
The randomised, double-blind, placebo-controlled, parallel-group, multi-centre DM-INSULIN trial evaluated 75mg of Praluent for every two weeks in 517 type 1 and type 2 diabetes patients, who were on insulin with high cardiovascular (CV) risk, hypercholesterolemia and took MTD statins.
During the trial, the dose was changed to 150mg every two weeks at week 12, in the case of patients with LDL-C greater than or equal to 70mg/dL at week eight.
In the randomised, open-label, parallel-group, multi-centre, multi-national DM-DYSLIPIDEMIA trial, the superiority of Praluent was assessed in 413 type 2 diabetes and mixed dyslipidemia patients who were at high-CV risk that is not properly controlled with MTD statins.
The dose in this trial was adjusted if the patients’ non-HDL-C was greater than or equal to 100mg/dL at week eight.
In DM-INSULIN, up to 80% of patients reached their lipid goals, while a total of 64% reached their goals in the DM-DYSLIPIDEMIA trial.
The primary endpoint of the trials was percentage change in calculated LDL-C or non-HDL-C from baseline to week 24.
Praluent was found to be well-tolerated, with an overall safety profile comparable with other trials in the ODYSSEY Phase III programme.