ESC Congress 2016 - 24

clINIcAl TRIAl HIgHlIgHTs ODYSSEY ESCAPE: Alirocumab Reduces Frequency of Lipoprotein Apheresis in Patients With HeFH every 2 weeks on the frequency of lipoprotein apheresis treatments in patients with heterozygous FH (HeFH) [Moriarty PM et al. Eur Heart J. 2016]. A total of 62 patients with HeFH undergoing weekly or biweekly lipoprotein apheresis at centers in the US or Germany were randomly assigned to receive alirocumab 150 mg (n = 41) or placebo (n = 21) every 2 weeks for 18 weeks. The patients were on stable background lipid-lowering therapy and had undergone consistent lipoprotein apheresis every week for ≥ 4 weeks or every 2 weeks for ≥ 8 weeks. During the first 6 weeks, the patients remained on their established fixed apheresis schedule. From Week 7 to 18, apheresis was only performed if the LDL-C was < 30% lower than the baseline LDL-C. The primary efficacy endpoint was the frequency of apheresis treatments from Week 7 to 18, normalized according to the number of planned apheresis treatments. The secondary endpoints included the effect of alirocumab on other lipids and the safety and tolerability of alirocumab. Randomization was stratified by frequency of apheresis procedure (weekly or Q2W) and normal (< 30 mg/dL) or elevated (> 30 mg/dL) lipoprotein(a) values. At baseline, the frequency of apheresis was similar in both groups. At randomization, 46.3% of patients in the alirocumab group and 61.9% in the placebo group were on any statin; 63.4% in the alirocumab group and 76.2% in the placebo group were taking lipid-lowering therapy other than statins. Written by Toni Rizzo Untreated familial hypercholesterolemia (FH) is associated with severely elevated low-density lipoprotein cholesterol (LDL-C) levels and a high risk of premature coronary heart disease (CHD) [Ito MK et al. J Clin Lipidol. 2011]. Despite lipid-lowering therapy, many patients with FH do not reach target LDL-C levels [Huijgen R et al. PLoS One. 2010] and require weekly or biweekly lipoprotein apheresis, which is costly, time-consuming, and invasive [Reiner Z et al. Eur Heart J. 2011; Bays HE et al. J Clin Lipidol. 2014]. Lipoprotein apheresis acutely reduces LDL-C levels by 50% to 75%, which approximates a 30% time-averaged reduction of LDL-C between apheresis procedures [Nordestgaard BG et al. Eur Heart J. 2013]. Alirocumab is a fully human monoclonal PCSK9 antibody that has been shown to reduce LDL-C levels by up to 62% when used as monotherapy or with a statin with or without other lipid-lowering therapy [Robinson JG et al. N Engl J Med. 2015]. The ODYSSEY ESCAPE trial, presented by Patrick M. Moriarty, MD, University of Kansas Medical Center, Kansas City, Kansas, United States, aimed to evaluate the effect of alirocumab 150 mg Figure 1. Standardized Apheresis Treatment Rates From Week 7 to 18 Primary endpoint: Standardised apheresis treatment rate in the period Weeks 7-18 Hodges-Lehmann estimate of median treatment difference (95% CI) 0.75 (0.67-0.83) P value versus placebo 100 < .0001 Alirocumab 150 mg Q2W (n = 41) Placebo (n = 21) Patients (%) 80 60 63.4 40 33.3 17.1 20 0 0 0 28.6 23.8 12.2 14.3 0 > 0 and ≤ 0.25 > 0.25 and ≤ 0.5 2.4 > 0.5 and ≤ 0.75 2.4 > 0.75 and < 1 2.4 1 Standardized Apheresis Rate From Week 7 to Week 18† † An apheresis rate of 0 indicates that the patient skipped all planned apheresis treatments and an apheresis rate of 1 indicates that the patient received all planned apheresis treatments between Week 7 and Week 18 (i.e. an apheresis rate of 0.75 means that the patient received 75% of planned apheresis treatments) Adapted from Moriarty PM et al. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur Heart J. 2016; doi:10.1093/eurheartj/ehw388. By permission of Oxford University Press on behalf of the European Society of Cardiology. 24 October 2016 www.escardio.org/ESCcongressinreview http://www.escardio.org/ESCcongressinreview

Table of Contents for the Digital Edition of ESC Congress 2016