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."