Junya Ako1, Kiyoshi Hibi2, Kenichi Tsujita3, Takafumi Hiro4, Yoshihiro Morino5, Ken Kozuma6, Toshiro Shinke7, Hiromasa Otake8, Kiyoko Uno9, Michael J Louie10, Yoshiharu Takagi11, Katsumi Miyauchi12. 1. Department of Cardiovascular Medicine, Kitasato University School of Medicine. 2. Division of Cardiology, Yokohama City University Medical Center. 3. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University. 4. Division of Cardiology, Department of Medicine, Nihon University School of Medicine. 5. Division of Cardiology, Department of Internal Medicine, Iwate Medical University. 6. Division of Cardiology, Teikyo University Hospital. 7. Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University School of Medicine. 8. Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine. 9. Cardiovascular Medical, Sanofi. 10. Regeneron Pharmaceuticals, Inc. 11. Clinical Sciences and Operations, Sanofi. 12. Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.
Abstract
BACKGROUND: In patients with acute coronary syndrome (ACS), alirocumab reduced the risk of recurring ischemic events. ODYSSEY J-IVUS assessed the effect of alirocumab on coronary atheroma volume in Japanese patients recently hospitalized with ACS and hypercholesterolemia, using intravascular ultrasound imaging analysis.Methods and Results: Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation, were randomized (1:1) to alirocumab (75 mg every 2 weeks [Q2 W]/up to 150 mg Q2 W), or standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin ≥5 mg/day) for 36 weeks. The primary efficacy endpoint (week [W] 36 mean [standard error] percent change in normalized total atheroma volume [TAV] from baseline) was -3.1 (1.0)% with SoC vs. -4.8 (1.0)% with alirocumab (between-group difference: -1.6 [1.4]; P=0.23). W36 absolute change from baseline in percent atheroma volume was -1.3 (0.4)% (SoC) and -1.4 (0.4)% (alirocumab; nominal P=0.79). At W36, LDL-C was reduced from baseline by 13.4% (SoC) vs. 63.9% (alirocumab; nominal P<0.0001). In total, 61.8% (SoC) and 75.7% (alirocumab) of patients reported treatment-emergency adverse events. CONCLUSIONS: In Japanese patients with ACS and hypercholesterolemia inadequately controlled despite statin therapy, from baseline to W36, a numerically greater percent reduction in normalized TAV was observed with alirocumab vs. SoC, which did not reach statistical significance.
RCT Entities:
BACKGROUND: In patients with acute coronary syndrome (ACS), alirocumab reduced the risk of recurring ischemic events. ODYSSEY J-IVUS assessed the effect of alirocumab on coronary atheroma volume in Japanese patients recently hospitalized with ACS and hypercholesterolemia, using intravascular ultrasound imaging analysis.Methods and Results:Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation, were randomized (1:1) to alirocumab (75 mg every 2 weeks [Q2 W]/up to 150 mg Q2 W), or standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin ≥5 mg/day) for 36 weeks. The primary efficacy endpoint (week [W] 36 mean [standard error] percent change in normalized total atheroma volume [TAV] from baseline) was -3.1 (1.0)% with SoC vs. -4.8 (1.0)% with alirocumab (between-group difference: -1.6 [1.4]; P=0.23). W36 absolute change from baseline in percent atheroma volume was -1.3 (0.4)% (SoC) and -1.4 (0.4)% (alirocumab; nominal P=0.79). At W36, LDL-C was reduced from baseline by 13.4% (SoC) vs. 63.9% (alirocumab; nominal P<0.0001). In total, 61.8% (SoC) and 75.7% (alirocumab) of patients reported treatment-emergency adverse events. CONCLUSIONS: In Japanese patients with ACS and hypercholesterolemia inadequately controlled despite statin therapy, from baseline to W36, a numerically greater percent reduction in normalized TAV was observed with alirocumab vs. SoC, which did not reach statistical significance.
Authors: Walter Masson; Martin Lobo; Daniel Siniawski; Graciela Molinero; Gerardo Masson; Melina Huerín; Juan Patricio Nogueira Journal: Lipids Health Dis Date: 2020-05-27 Impact factor: 3.876
Authors: Thomas Metzner; Deborah R Leitner; Gudrun Dimsity; Felix Gunzer; Peter Opriessnig; Karin Mellitzer; Andrea Beck; Harald Sourij; Tatjana Stojakovic; Hannes Deutschmann; Winfried März; Ulf Landmesser; Marianne Brodmann; Gernot Reishofer; Hubert Scharnagl; Hermann Toplak; Günther Silbernagel Journal: Biomedicines Date: 2022-01-11