PARIS and TARRYTOWN, N.Y., June 11, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced positive results from two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes. In the studies, Praluent® (alirocumab), when administered on top of maximally tolerated doses (MTD) of statins, significantly reduced low-density lipoprotein cholesterol (LDL-C), the primary endpoint of the ODYSSEY DM-INSULIN study, and was superior to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C), the primary endpoint of the ODYSSEY DM-DYSLIPIDEMIA study. Both studies also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the ODYSSEY Phase 3 program.
The results were unveiled today as part of the official symposium of the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, CA, titled, "Inhibition of PCSK9 in Dyslipidemia Patients with Diabetes." The data were also featured in the official ADA Scientific Sessions Advance program.
"Patients with long-standing diabetes, including insulin-treated patients, are at high risk of cardiovascular disease," said Lawrence Leiter, M.D., 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 positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group."
Most people with diabetes will develop atherosclerotic cardiovascular disease (ASCVD). 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.1
"Mixed dyslipidemia is common in people with type 2 diabetes and further increases CV risk, and yet it is difficult to treat with available therapies," said Robert Henry, M.D., member of the ODYSSEY DM Steering Committee and Director of the Center for Metabolic Research at the VA San Diego Healthcare System. "The results of ODYSSEY DM-DYSLIPIDEMIA showed 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. Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles."
In ODYSSEY DM-INSULIN, patients were randomized to Praluent 75 mg every two weeks or placebo in addition to MTD statins. Praluent dose was adjusted at week 12 to 150 mg every two weeks if their LDL-C was greater than or equal to 70 mg/dL at week 8. Approximately 80 percent of patients reached their LDL-C goals with Praluent 75 mg every two weeks in this study. In ODYSSEY DM-DYSLIPIDEMIA, patients were randomized to Praluent 75 mg every two weeks or usual care in addition to MTD statins. Praluent dose was 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.
ODYSSEY DM-INSULIN was a randomized, double-blind, placebo-controlled, parallel-group multicenter study that evaluated Praluent in 517 people with type 1 and type 2 diabetes on insulin with high CV risk and hypercholesterolemia who took MTD statins.2 The primary endpoint was percent change in calculated LDL-C from baseline to week 24. Results in the type 2 diabetes study population (n=441) were presented at ADA and showed:
- Praluent in combination with MTD statins reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was 49 percent (p<0.0001).
- Treatment with Praluent also improved the overall lipid profile.
- Overall, Praluent was generally well tolerated. Treatment emergent adverse events (TEAEs) were 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. There was no new safety signal with the concomitant use of Praluent and insulin.
- There was no impact on glycemic control as assessed by fasting plasma glucose (FPG), A1C and glucose lowering treatments remained stable over time in both treatment groups.
ODYSSEY DM-DYSLIPIDEMIA was a randomized, open-label, parallel-group, multicenter, multinational study designed to evaluate the superiority of Praluent versus usual care in 413 people with type 2 diabetes and mixed dyslipidemia at high CV risk, not adequately controlled with MTD statins.3 The primary endpoint was percent change in non-HDL-C from baseline to week 24. Non-HDL-C is calculated as total cholesterol minus high-density lipoprotein cholesterol, and provides a single index of all the potentially atherogenic, apolipoprotein (apo) B-containing lipoproteins, including LDL, very-low-density lipoprotein (VLDL), intermediate-density lipoprotein (IDL), and lipoprotein(a).
- Praluent was superior to usual care in lowering non-HDL cholesterol (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 reduced measured LDL-C by 43.3 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.
- Praluent was generally well-tolerated. The most frequent TEAEs included urinary tract infection, diarrhea, and nasopharyngitis.
- There was no impact on glycemic control observed as assessed by fasting plasma glucose (FPG), A1C and glucose lowering treatments remained stable over time in both treatment groups.
In the previously reported results from the ODYSSEY LONG TERM study in which all patients were treated with Praluent 150 mg on top of MTD statins, Praluent reduced LDL-C by 60 percent from baseline in patients with diabetes (n=545) at week 24.4
The recommended starting dose of Praluent is 75 mg administered subcutaneously every 2 weeks, or alternatively 300 mg every 4 weeks (monthly) for patients who prefer less frequent dosing. The majority of patients taking Praluent achieve sufficient LDL-C reduction with the 75 mg dose. If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks.
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL-C levels in the blood.
Praluent is approved in more than 50 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU). In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical ASCVD who require additional lowering of LDL-C. In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not yet been determined. ODYSSEY OUTCOMES is prospectively evaluating the effect of Praluent on the occurrence of CV events in approximately 18,000 patients who have experienced an acute coronary syndrome.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Important Safety Information for the U.S.
Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent.
Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a Praluent injection and follow the "Instructions for Use" that comes with Praluent.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for the past 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its unique VelociSuite® technologies and ambitious initiatives such as The Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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- American Heart Association Cardiovascular Disease and Diabetes. April 2017. http://www.heart.org/HEARTORG/Conditions/More/Diabetes/WhyDiabetesMatters/Cardiovascular-Disease-Diabetes_UCM_313865_Article.jsp/#.WRXYVFXyvIU. Accessed June 2017.
- Cariou B., Leiter LA, Müller‑Wieland D, et al. Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM–INSULIN trial. Diabetes Metab (2017), http://www.diabet-metabolism.com/article/S1262-3636(17)30008-3/fulltext.
- Müller‑Wieland, Leiter LA, Cariou B, et al. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol (2017);16:70, DOI 10.1186/s12933-017-0552-4.
- Colhoun HM, Ginsberg HN, Leiter LA, et al. Efficacy and safety of alirocumab in individuals with diabetes: analyses from the ODYSSEY LONG TERM study. Diabetologia (2015);58 (Suppl 1):S79-S80.
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