Sanofi and Regeneron have unveiled new data further backing the safety and efficacy of PCSK9 inhibitor Praluent in lowering cholesterol in patients with diabetes.
Data from two Phase IIIb/IV ODYSSEY-DM trials showed that when Praluent (alirocumab) was added to statin therapy in patients with diabetes, levels of low-density lipoprotein cholesterol (LDL-C) were significantly reduced.
In one trial, Praluent in combination with a maximally tolerated dose of statins reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo, while in another the drug was superior to usual care in lowering non-HDL cholesterol (37.3 percent versus 4.7 percent).
Around 80 percent of patients reached their LDL-C goals with Praluent 75mg every two weeks in the ODYSSEY DM-INSULIN trial, while in ODYSSEY DM-DYSLIPIDEMIA, 64 percent of patients hit lipid targets with the same dose of the drug.
The majority of patients with diabetes will develop atherosclerotic cardiovascular disease (ASCVD) and, despite the current standard of care, nearly 70 percent of those aged over 65 die from some form of heart disease and 16 percent of stroke.
"The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group,” noted Lawrence Leiter, chair of the ODYSSEY DM Steering Committee and director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael's Hospital, University of Toronto, Canada.
The data show that, “in a real-world setting, Praluent, on top of maximally tolerated doses of statins, significantly reduced non-HDL-C, another measure of bad cholesterol, and was superior to usual care,” added Robert Henry, member of the ODYSSEY DM Steering Committee and Director of the Center for Metabolic Research at the VA San Diego Healthcare System.
“Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles.”
Overall, Praluent was generally well tolerated in the trials, with treatment emergent adverse events (TEAEs) similar between the two groups and no emerging safety findings were identified from the study. The most frequent TEAEs included nasopharyngitis, myalgia, arthralgia and cough, while using the drug alongside insulin was also deemed safe.
Praluent was launched in the UK in October 2015 for the treatment of patients unable to reach their LDL or ‘bad’ cholesterol treatment goals, despite a healthy diet and taking a maximum tolerated dose of a statin and/or other lipid-lowering therapies.
Patients now eligible for treatment include those with high levels of LDL cholesterol, heterozygous familial hypercholesterolaemia, and those who can’t take statins.