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ODYSSEY COMBO II - Investigational agent outshines ezetimibe for lowering cholesterol

Hot Line II: Coronary artery disease and lipids

Risk Factors and Prevention

BARCELONA, Spain – Sunday 31 August: The investigational drug alirocumab significantly improved cholesterol levels compared to ezetimibe, when added to regular statin therapy in patients with high cholesterol and elevated risk of cardiovascular disease (CVD), according to the ODYSSEY COMBO II trial, presented as a Hot Line today at ESC Congress 2014.

“The findings suggest that adding alirocumab to established statin regimens may provide an important new option to achieve needed reductions in low-density lipoprotein cholesterol (LDL-C) levels in high risk patients," said the study’s principal investigator, Christopher Cannon, MD, from the Harvard Clinical Research Institute in Boston, Massachusetts, USA.

Alirocumab is a PCSK9 (proprotein convertase subtilisin / kexin type 9) inhibitor -  a new class of drug that is believed to work synergistically with traditional cholesterol-lowering therapies, he explained.
The study included 720 patients (aged approximately 62 years) with high cholesterol or other risks of cardiovascular disease, and who were already receiving a maximally tolerated daily statin dose.
The patients were randomised to receive either alirocumab (n=479) by subcutaneous injection (75-150 mg once every 2 weeks) or ezetimibe (n=241) as a pill (10 mg daily) for a period of 104 weeks.
All subjects were also assigned to a placebo treatment, either a pill (in the active alirocumab group) or an injection (in the active ezetimibe group) in order to maintain blinding.
The study showed that, compared to ezetimibe, alirocumab lowered LDL-C levels significantly more by week 24 (50.6% vs 20.7%, P<0.0001) and by week 52 (49.5% versus 18.3% respectively at 52 weeks (P<0.001).
Similarly 77% of alirocumab-treated patients achieved LDL-C levels of 1.81 mmol/L [70 mg/dL] or lower by week 24 compared to 45.6% of ezetimibe-treated patients (P<0.0001).
Treatment-emergent adverse events (TEAEs) occurred in 71.2% of alirocumab patients and 67.2% of ezetimibe patients, leading to discontinuation in 7.5% and 5.4% respectively.

“This trial evaluated a 75 mg initial dose of alirocumab, which could be increased to 150 mg if needed,” noted Dr. Cannon. “However, more than three-quarters of patients were able to reach target LDL-C levels at the initial dose without the need to up-titrate.”

Notes to editor

SOURCES OF FUNDING: The study was funded by Sanofi and Regeneron.
DISCLOSURES: Dr. Cannon has received grants from Accumetrics, Arisaph, Astra Zeneca, Boehringer-Ingelheim, and Janssen; grants and consulting fees from GlaxoSmithKline, Merck, and Takeda; and consulting fees from BMS, CSL Behring, Essentialis, Lipimedix,  Pfizer, Regeneron and Sanofi.
About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 80 000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
About ESC Congress 2014
The ESC Congress is currently the world's largest international congress in cardiovascular medicine.  The spotlight of this year's event is “innovation and the heart”.  ESC Congress 2014 takes place from 30 August to 3 September at the Fira Gran Via in Barcelona, Spain. For more information on ESC Congress 2014 contact the ESC Press Office.
To access all the scientific resources from the sessions during the congress, visit ESC Congress 365.
This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2014. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.