Alirocumab effective, well tolerated in Taiwanese patients, ODYSSEY KT-TW study shows
Alirocumab has a positive effect on low-density lipoprotein cholesterol (LDL-C) levels and appears to be well tolerated in patients with hypercholesterolemia and high cardiovascular risk, according to a sub-analysis of Taiwanese patients enrolled in the ODYSSEY KT* clinical trial.
“Alirocumab treatment provided a favourable effect on LDL-C levels and other lipid parameters, and was generally well tolerated in patients from Taiwan,” said Dr Chao Ting-Hsing from the National Cheng Kung University in Taiwan who presented the results at the 21st Asian Pacific Society of Cardiology Congress (APSC 2017) held in Singapore.
In the ODYSSEY KT trial, 199 individuals from South Korea and Taiwan with hypercholesterolemia and coronary heart disease (or risk equivalent) inadequately controlled with a maximum tolerated daily dose of statin (atorvastatin, rosuvastatin, or simvastatin) were randomized to receive subcutaneous alirocumab (75 mg Q2W with the option of increase to 150 mg Q2W at week 12 if LDL-C at week 8 was >70 mg/dL) or placebo for 24 weeks.
These results detail the findings from the 116 patients randomized at 10 sites in Taiwan (KT-TW analysis), of whom 57 received alirocumab (mean age 61.5 years, 89.5 percent male, baseline LDL-C 101.5 mg/dL) and 59 placebo (mean age 60 years, 78 percent male, baseline LDL-C 102.4 mg/dL). More than 80 percent of patients in both groups were on high-intensity statin therapy and 10.9 percent of patients on alirocumab received an up-titration at week 12.
At week 24, mean LDL-C was lower in patients on alirocumab compared with placebo (49.5 vs 102.2 mg/dL, mean difference vs placebo, -53.5 percent; p<0.0001). [APSC 2017, Late Breaking Trial 4]
Alirocumab also reduced the levels of apolipoprotein B, non-high-density lipoprotein cholesterol (non-HDL-C), lipoprotein (a) cholesterol, and total cholesterol (difference vs placebo, -38.7, -43.6, -30.8, and -30.2 percent; all p<0.0001), and increased HDL-C levels (difference vs placebo, 6.2 percent; p=0.05).
More patients on alirocumab achieved target LDL-C (<70 mg/dL) at week 24 compared with placebo (81.3 percent vs 15.4 percent; p<0.0001).
The incidence of treatment emergent adverse events (TEAEs) was similar between patients on alirocumab and placebo (68.4 percent vs 69.5 percent) as was treatment discontinuation due to TEAEs (two and one patient in each group). The most common TEAEs among patients on alirocumab were diarrhoea (n=5), dizziness (n=5), and nasopharyngitis (n=3).
“The results of the current analysis were consistent with both the overall KT study and the ODYSSEY programme,” said Chao.