Significant reductions in non-high density lipoprotein cholesterol (non-HDL-C) were achieved in patients with type 2 diabetes and mixed dyslipidemia with alirocumab compared with usual care, according to results from the international ODYSSEY DM-Dyslipidemia study.
In this randomized, open-label, parallel group study, researchers assessed the efficacy and safety of alirocumab versus standard care (either no additional lipid lowering therapy or ezetimibe, fenofibrates, omega-3 fatty acids, nicotinic acid) in patients with type 2 diabetes and mixed dyslipidemia who were at high cardiovascular risk (established atherosclerotic CVD [ASCVD]) or at least one other cardiovascular risk factor, with non-HDL-C not adequately controlled with the maximum tolerated dosage of statin therapy.
They defined mixed dyslipidemia as elevations in non-HDL cholesterol and triglyceride levels often accompanied by low levels of HDL cholesterol.
In all, 413 people with type 2 diabetes from 110 centers from the United States, Europe, South America, the Middle East, Australia, and the UK were enrolled for the 24-week trial, followed by an 8-week safety follow-up.
Patients were randomized 2:1 to either alirocumab (75 mg administered via an auto-injector every 2 weeks for 24 weeks); or standard care. Those in the alirocumab group who did not achieve adequate reduction in non-HDL-cholesterol at 12 weeks follow-up had their alirocumab dosage increased to 150 mg in blinded fashion. The primary endpoint of the trial was the difference between treatment arms in percentage change of non-HDL-C from baseline to week 24.
After 24 weeks of treatment, alirocumab significantly reduced non-HDL-C by 32.5% compared with usual care. Other lipid parameters improved as well in the alirocumab group compared with standard care. The number of adverse events was generally similar between the two treatment arms. Finally, alirocumab was generally well tolerated and did not affect glucose control.
“Cardiovascular disease is a significant cause of morbidity and mortality in people with type 2 diabetes,” said lead investigator Robert R. Henry, MD, professor of medicine in the division of endocrinology and metabolism at the University of California, San Diego, and chief of the endocrinology, metabolism and diabetes section and the Center for Metabolic Research at the VA Medical Center in San Diego.
“Mixed dyslipidemia is commonly present in these patients and further increases their cardiovascular risk. The ODYSSEY-DM-DYSLIPIDEMA study is the first trial that directly compares a PCSK9 inhibitor with usual care in patients with T2DM diabetes who have lipid disturbances. The results of our study will assist clinicians in the management of mixed dyslipidemia, which is a persistent challenge in clinical practice, for patients with type 2 diabetes,” concluded Dr. Henry.