Patients with diabetes who recently experienced acute coronary syndrome (ACS) had the most benefit with alirocumab in combination with the maximum-tolerated statin dose compared with individuals with a similar cardiac history but without diabetes, according to the results of the ODYSSEY OUTCOMES (ClinicalTrials.gov Identifier: NCT01663402) study presented at the American Diabetes Association’s 78th Scientific Sessions held in Orlando, Florida, June 22 – 26, 2018.
Participants (N=18,924) identified from the original ODYSSEY outcomes study who recently experienced ACS, had high low-density lipoprotein cholesterol (LDL-C) levels (>70 mg/dL), and who were taking a maximally tolerated dose of atorvastatin or rosuvastatin were randomly assigned to either alirocumab 75 mg or placebo subcutaneously. The alirocumab dose was blindly increased to 150 mg or decreased to placebo to lower LDL-C within a target range of 25 to 50 mg/dL. The primary end point was length of time until the first major adverse cardiovascular event (MACE), which included nonfatal myocardial infarction, ischemic stroke, coronary heart disease death, or hospitalization for unstable angina. The investigators collected data on the incidence of new-onset diabetes and assessed the safety and efficacy of alirocumab.
Overall, the incidence of MACE was lower in the alirocumab group (n=903) compared with placebo (n=1050; absolute risk reduction 1.6; hazard ratio 0.85; 95% CI, 0.78-0.93). In participants with a diagnosis of diabetes, prediabetes, or no diabetes, the incidence of MACE was lower for those receiving alirocumab vs placebo (14.1%, 8.0%, 7.3% vs 16.4%, 9.2%, 8.5%, respectively, P=.98 for all). The greatest absolute risk reduction was seen in participants with diabetes taking alirocumab (2.3%). The incidence of new-onset diabetes did not increase with the use of alirocumab.
Investigator Kausik Ray, MD, ChB, professor of public health in the department of public health and primary care at the School of Public Health of Imperial College in London, stated in a press release that “[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. .. 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.”
This study was supported by Sanofi and Regeneron.. Please refer to reference for a complete list of authors’ disclosures.
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Ray KK, Colhoun H, Szarek M, et al; Odyssey Outcomes Investigators. Alirocumab and cardiovascular outcomes in patients with acute coronary syndrome (ACS) and diabetes—prespecified analyses of ODYSSEY OUTCOMES. Poster presented at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Poster 6-LB.