MedicalResearch.com Interview with:
Robert R. Henry, M.D.
Professor of Medicine
Member of the ODYSSEY DM Steering Committee and
Director of the Center for Metabolic Research
VA San Diego Healthcare System
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The ODYSSEY DM-DYSLIPIDEMIA trial was a randomized, open-label, parallel-group study designed to evaluate the superiority of Praluent versus usual care in 413 patients with type 2 diabetes with mixed dyslipidemia at high cardiovascular (CV) risk, not adequately controlled with maximally tolerated dose (MTD) statins. The primary endpoint was percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to week 24.
In ODYSSEY DM-DYSLIPIDEMIA, Praluent 75 mg was added to MTD statins, with dose adjusted at week 12 to 150 mg every two weeks if their non-HDL-C was greater than or equal to 100 mg/dL at week 8. Approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose.
Results from the ODYSSEY DM-DYSLIPIDEMIA study found that Praluent added to MTD statins showed significant reduction in non-HDL-C and other lipid parameters compared to those on usual care.
Praluent was superior to usual care in lowering non-HDL-C (37.3 percent and 4.7 percent, for the usual care arm). The mean difference between the two treatment arms was -32.5 percent (p<0.0001).
Praluent in combination with MTD statins reduced LDL-C by 43 percent from baseline compared to a 0.3 percent increase for usual care (p<0.0001). Treatment with Praluent also improved the overall lipid profile.
There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Furthermore, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The ODYSSEY DM program comprises the first dedicated studies reported to date to evaluate a PCSK9 inhibitor in people with diabetes and hypercholesterolemia at high CV risk. Results from this study evaluating a PCSK9 inhibitor in this patient population provide valuable information on the efficacy and safety of Praluent in this high CV risk group, and will help guide clinical decision-making beyond statin therapy.
The ODYSSEY DM program leverages Sanofi’s strong legacy and commitment in diabetes, as well as Regeneron’s science-driven approach to bring innovative treatments to market, and reinforces the need for innovative treatments such as Praluent in patients who need better cholesterol management.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: These data are a positive addition to the overall ODYSSEY clinical trial program, including the ODYSSEY OUTCOMES studies that are continuing on track.
ODYSSEY OUTCOMES evaluates the effect of Praluent on CV events in more than 18,000 patients, who experienced a coronary event within a year before entering the trial. These very high CV risk patients have amongst the greatest unmet needs.
In the future, I would also like to see more research in special populations with diabetes, like the elderly, people with significant renal impairment, and minority populations.
Disclosures: Dr. Henry is on the advisory panel and is a speaker for AstraZeneca, Boehringer Ingelheim, Elcelyx, Intarcia, Janssen, and Johnson & Johnson. He is a consultant and speaker for Alere, AstraZeneca, Intarcia, Ionis, Janssen, Johnson & Johnson, REMD Biotherapeutics, and Sanofi. He receives research support from Eli Lilly, Hitachi, Lexicon, Novo Nordisk, ViaCyte, and AstraReal.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: Abstract presented at the 2017 ADA meeting
Alirocumab vs. Usual Care in Diabetes with Mixed Dyslipidemia—ODYSSEY DM-DYSLIPIDEMIA Study
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.