Alirocumab and Statins Highly Effective in People with Diabetes with Acute Coronary Syndrome

ORLANDO, Fla., June 24, 2018 /PRNewswire-USNewswire/ -- People with diabetes who have experienced recent acute coronary syndrome (ACS) and take a combination of alirocumab and statins may reduce their risk of future cardiac events by more than double that of people on the same medication regimen who have similar cardiac histories, but have prediabetes or normal blood glucose levels, according to the study, "Alirocumab and Cardiovascular Outcomes in Patients with Acute Coronary Syndrome (ACS) and Diabetes?Prespecified Analyses of ODYSSEY OUTCOMES," presented today at the American Diabetes Association's^® (ADA's) 78th Scientific Sessions^® at the Orange County Convention Center.

People who have experienced recent ACS are at an increased risk of future heart attacks and strokes, compared to people who have never experienced ACS. If a person has experienced recent ACS and has diabetes, then the risk of future cardiovascular events is even higher.

The results of the ODYSSEY OUTCOMES trial, first presented in March 2018, showed that among patients who experienced recent ACS, an injection of alirocumab (a PCSK9 inhibitor) once every two weeks plus maximum-tolerated statin medication significantly reduced future major adverse cardiac events (MACE)?coronary heart disease death, nonfatal myocardial infarction (MI), fatal and nonfatal ischemic stroke or hospitalization for unstable angina, compared to a placebo. The 18,924 study participants had baseline LDL cholesterol levels above 70mg/dL and had experienced ACS within one to 12 months prior to the beginning of the study. In addition to maximum-tolerated statin therapy, participants were administered alirocumab subcutaneously, with the dose titrated between 75 and 150 mg every 2 weeks to achieve an LDL cholesterol level of 25-50mg/dL. The primary endpoint was the length of time to the first MACE.

The current analysis of the study evaluated the participants' absolute risk reduction (ARR), grouping results by whether the participants had diabetes, prediabetes or normoglycemia (normal levels of glucose in the blood).

Of the ODYSSEY OUTCOMES trial participants, 5,444 (28.8 percent) had diabetes, 8,246 (43.6 percent) had prediabetes, and 5,234 (27.7 percent) had normal glucose levels. The data indicates the patients with diabetes who were in the alirocumab group had the greatest ARR. Researchers concluded the medication regimen may almost double the ARR (2.3 percent%) in people with diabetes who have experienced recent ACS, compared to people with recent ACS and prediabetes (ARR = 1.2 percent) or people with normal glucose levels (ARR = 1.2 percent).

"The analyses show adding alirocumab to maximally tolerated statins reduced the overall incidence of MACE, and the absolute risk reduction was highest among those with diabetes when compared to people with prediabetes or people without diabetes," said Kausik Ray, MD, ChB, professor of public health, department of public health and primary care at the School of Public Health of Imperial College in London. "One reason for the success of the medication combination in this group is that their absolute risk was so high; the other groups that took the alirocumab also derived benefit, but the benefit was slightly less because their risk was lower. Additionally, some genetic studies have suggested that lowering bad cholesterol with this type of therapy (a PCSK9 inhibitor) might push people with prediabetes to diabetes. We found no evidence of new onset diabetes for the people in the study who took alirocumab. These results suggest intensive cholesterol-lowering using the combination of statins and alirocumab offers us a means to significantly reduce heart disease risk in this patient population."

To speak with Dr. Ray please contact the ADA Press Office on-site at the Orlando Convention Center on June 22 - 26, by phone at 407-685-4010 or by email at [email protected].

The American Diabetes Association's 78th Scientific Sessions, to be held June 22-26, 2018, at the Orange County Convention Center in Orlando, is the world's largest scientific meeting focused on diabetes research, prevention and care. During the five-day meeting, more than 16,000 health care professionals from around the world will have exclusive access to more than 3,000 original diabetes research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight theme areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Felicia Hill-Briggs, PhD, ABPP, President of Health Care and Education, will deliver her address, "The American Diabetes Association in the Era of Health Care Transformation," on Saturday, June 23, and Jane E.B. Reusch, MD, President of Medicine and Science, will present her address, "24/7/365 ? Lifetime with Diabetes," on Sunday, June 24. In total, the 2018 Scientific Sessions includes 375 oral presentations; 2,117 poster presentations, including 47 moderated poster discussions; and 297 published-only abstracts. Join the Scientific Sessions conversation on social media using #2018ADA.

About the American Diabetes Association

Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation's leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn). 

78th Scientific Sessions
News Briefing: Diabetes & Cardiovascular Disease, Sunday, June 24, 9:00 a.m., ET

Session Title: Evolving Concepts in Clinical Management Strategies
Session Type: Moderated Poster Discussion
Location: Exhibit Hall (ePoster Theater A)
Session Time: Sunday, June 24, 2018, 12:00pm ? 1:00pm

Authors: KAUISK K. RAY, HELEN COLHOUN, MICHAEL SZAREK, MARIE BACCARA-DINET, DEEPAK L. BHATT, VERA BITTNER, ANDRZEJ J. BUDAJ, RAFAEL DIAZ, SR., SHAUN G. GOODMAN, CORINNE G. HANOTIN, J. WOUTER JUKEMA, VIRGINIE LOIZEAU, RENATO D. LOPES, ANGELE MORYUSEF, ROBERT PORDY, ARSEN D. RISTIC, MATTHEW ROE, JOSÉ TUÑÓN, HARVEY D. WHITE, GREGORY G. SCHWARTZ, PHILIPPE G. STEG, ODYSSEY OUTCOMES INVESTIGATORS, London, United Kingdom, Edinburgh, United Kingdom, Brooklyn, NY, Montpellier, France, Boston, MA, Birmingham, AL, Warsaw, Poland, Rosario, Argentina, Toronto, ON, Canada, Paris, France, Leiden, Netherlands, Clamart, France, Durham, NC, Bridgewater, NJ, Tarrytown, NY, Belgrade, Serbia, Madrid, Spain, Auckland, New Zealand, Denver, CO

Background: Diabetics who have suffered recently with Acute Coronary Syndrome (ACS) are at higher risk for ischemic cardiovascular events and derive greater benefit from intensive-lipid lowering therapy than those populations who are not diabetics. The effects of PCSK9 inhibition in patients with recent ACS and diabetes is unknown.

Aim: This analysis assessed the benefit of a new therapy, alirocumab, in combination with powerful doses of statins in patients who have recently suffered with ACS. Patients analyzed had LDL-C levels above 70mg/dL, which is higher than the recommended guidelines from the American Association of Clinical Endocrinologists for people with cardiovascular disease.

Methods: The sample analyzed came from the original ODYSSEY outcomes, presented in 2017. Nearly 19,000 participants with recent ACS and LDL-C levels of higher than 70mg/dL on a maximum-tolerated dose of atorvastatin or rosuvastatin were randomly assigned to an ALI 75mg group or a placebo SC. ALI blindly increased to 150mg or decreased to placebo to achieve an LDL-C of 25-50mg/dL. The primary efficacy endpoint was length of time to first major cardiac event (MACE): coronary heart disease death, nonfatal myocardial infarction (MI), ischemic stroke, or hospitalization for unstable angina. This prespecified analysis reports on the efficacy and safety by baseline glucometabolic status, including new-onset diabetes.

Results: The table below reports on incident of MACE by assigned treatment and baseline glucometabolic status. The overall results show reduced MACE, without evidence of effect modification by baseline glucometabolic status. The greatest absolute risk reduction (ARR) was observed with ALI in those with diabetes. NOD did not increase with use of ALI.

Conclusion: Patients with recent Acute Coronary Syndrome and diabetes derived the greatest benefit from using ALI in combination with maximum-tolerated statin doses. No increase in NOD with ALI was noted.

Author Disclosures: K.K. Ray: Consultant; Self; Amgen Inc., Sanofi. Research Support; Self; Sanofi. Consultant; Self; The Medicines Company. Research Support; Self; Amgen Inc., Regeneron Pharmaceuticals, Inc. Consultant; Self; Regeneron Pharmaceuticals, Inc., Pfizer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., AstraZeneca, Esperion Therapeutics, Kowa Pharmaceuticals America, Inc. Research Support; Self; Pfizer Inc. Consultant; Self; Merck Sharp & Dohme Corp. Research Support; Self; Merck Sharp & Dohme Corp. H. Colhoun: Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH. Stock/Shareholder; Self; Bayer AG. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Other Relationship; Self; Eli Lilly and Company. Advisory Panel; Self; Novartis Pharmaceuticals Corporation. Research Support; Self; Regeneron Pharmaceuticals, Inc. Advisory Panel; Self; Regeneron Pharmaceuticals, Inc. Speaker's Bureau; Self; Regeneron Pharmaceuticals, Inc. Other Relationship; Self; Regeneron Pharmaceuticals, Inc. Research Support; Self; Pfizer Inc., Roche Pharma. Stock/Shareholder; Self; Roche Pharma. Research Support; Self; Sanofi-Aventis. Advisory Panel; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi. Other Relationship; Self; Sanofi. Research Support; Self; Novo Nordisk Inc. M. Szarek: Consultant; Self; Sanofi, Regeneron Pharmaceuticals, Inc., Baxter, Resverlogix Corp. M. Baccara-Dinet: Employee; Self; Sanofi D.L. Bhatt: Research Support; Self; Amarin Corporation, Amgen Inc., AstraZeneca, Bristol-Myers Squibb Company, Chiesi USA, Inc., Eisai Inc., Ethicon US, LLC., Forest Laboratories, Inc., Ironwood Pharmaceuticals, Inc., Ischemix, Eli Lilly and Company, Medtronic, Pfizer Inc., Roche Pharma, Sanofi-Aventis, The Medicines Company. Other Relationship; Self; American Heart Association. V. Bittner: Research Support; Self; AstraZeneca, Sanofi, Bayer AG, Esperion Therapeutics, Amgen Inc. Advisory Panel; Self; Sanofi. Research Support; Self; Dalcor. A.J. Budaj: Other Relationship; Self; Sanofi-Aventis, AstraZeneca, Pfizer Inc., GlaxoSmithKline plc. Consultant; Self; Bayer AG. Other Relationship; Self; Novartis Pharma K.K., Eisai Co., Ltd. R. Diaz: None. S.G. Goodman: Research Support; Self; Amgen Inc. Consultant; Self; Amgen Inc. Research Support; Self; AstraZeneca. Consultant; Self; AstraZeneca. Research Support; Self; Bayer AG. Consultant; Self; Bayer AG. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Research Support; Self; Bristol-Myers Squibb Company. Consultant; Self; Bristol-Myers Squibb Company. Research Support; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Research Support; Self; GlaxoSmithKline plc. Consultant; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation. Research Support; Self; Pfizer Inc. Consultant; Self; Pfizer Inc. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Research Support; Self; Regeneron Pharmaceuticals, Inc. Consultant; Self; Regeneron Pharmaceuticals, Inc. Research Support; Self; CSL Behring. C.G. Hanotin: Employee; Self; Sanofi. J. Jukema: Research Support; Self; Sanofi-Aventis, Regeneron Pharmaceuticals, Inc., Amgen Inc. V. Loizeau: Employee; Self; Sanofi. R.D. Lopes: Consultant; Self; Bayer AG, Boehringer Ingelheim GmbH. Other Relationship; Self; Bristol-Myers Squibb Company. Consultant; Self; Daiichi Sankyo Company, Limited. Other Relationship; Self; GlaxoSmithKline plc., Medtronic. Consultant; Self; Merck & Co., Inc. Other Relationship; Self; Pfizer Inc. A. Moryusef: Employee; Self; Sanofi. R. Pordy: Employee; Self; Regeneron Pharmaceuticals, Inc. A.D. Ristic: None. M. Roe: None. J. Tuñón: Speaker's Bureau; Self; Sanofi-Aventis. Advisory Panel; Self; Sanofi-Aventis. Other Relationship; Self; Sanofi-Aventis. Speaker's Bureau; Self; Amgen Inc. H.D. White: Other Relationship; Self; AstraZeneca, Eli Lilly and Company. Research Support; Self; National Institute for Health and Clinical Excellence. Other Relationship; Self; Omthera Pharmaceuticals, Inc., Pfizer Inc., Eisai Inc. Research Support; Self; DalCor Pharma UK Inc. Advisory Panel; Self; Sirtex, Actelion Pharmaceuticals US, Inc. Other Relationship; Self; Luitpold Pharmaceuticals Ltd., CSL Behring, Sanofi-Aventis. G.G. Schwartz: Research Support; Self; Roche Pharma, Sanofi, Resverlogix Corp. P.G. Steg: Consultant; Self; Amarin Corporation, AstraZeneca. Research Support; Self; Bayer AG. Consultant; Self; Bayer AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company. Advisory Panel; Self; Novartis AG. Consultant; Self; Pfizer Inc., Sanofi. Research Support; Self; Sanofi, Servier. Consultant; Self; Novo Nordisk A/S, Regeneron Pharmaceuticals

Press Office in Orlando
June 22 - 26, 2018
407-685-4010

Contact:
Michelle Kirkwood
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[email protected]

SOURCE American Diabetes Association