The ODYSSEY MONO trial studied 103 patients with a 10-year risk of cardiovascular death of 1–5%. They were not taking statins. At the start of the trial the concentration of LDL cholesterol was approximately 3.6 mmol/L in both groups. After 24 weeks this was reduced by 47% with alirocumab and by 16% with ezetimibe.8
The ODYSSEY COMBO II trial enrolled patients with a high cardiovascular risk who had hypercholesterolaemia that was not controlled by maximally tolerated doses of statins. They continued this treatment, but 479 added alirocumab and 241 added ezetimibe. After 24 weeks the concentrations of LDL cholesterol had fallen from 2.8 mmol/L to 1.3 mmol/L with alirocumab and from 2.7 mmol/L to 2.1 mmol/L with ezetimibe. At 52 weeks LDL cholesterol was 1.4 mmol/L in the alirocumab group and 2.2 mmol/L in the ezetimibe group.9
The ODYSSEY OPTIONS I trial compared alirocumab with ezetimibe and increased statin treatment. It involved 355 patients with a 10-year risk of cardiovascular death of at least 5%. These patients started a daily baseline regimen of atorvastatin 20 mg or 40 mg. They then added alirocumab or ezetimibe or doubled their statin dose. Patients taking atorvastatin 40 mg daily could also be randomised to switch to rosuvastatin 40 mg daily. After 24 weeks, the LDL-cholesterol concentration had fallen by 44.1% in patients taking alirocumab with atorvastatin 20 mg and by 54% in those taking it with atorvastatin 40 mg. The corresponding figures for added ezetimibe were 20.5% and 22.6%. Doubling the atorvastatin dose only reduced LDL cholesterol by about 5%, but it fell by 21.4% in patients switched to rosuvastatin 40 mg.10
To compare treatment options for patients with statin intolerance, the ODYSSEY ALTERNATIVE trial randomised 126 patients to take alirocumab, 125 to take ezetimibe and 63 to take atorvastatin 20 mg in a rechallenge group. Their mean baseline LDL cholesterol was approximately 5 mmol/L. After 24 weeks this had reduced by 45% with alirocumab and by 14.6% with ezetimibe.11