These guidelines set by ESC and EAS 2019 established treatment goals for LDL-C, non-HDL-C, and Apo-B in patients at high risk for cardiovascular disease.
New data presented at the European Society of Cardiology (ESC 2020) Congress showed that evolocumab helped patients with type 2 diabetes meliitus achieve the new lipid management goals set by ESC and the European Atherosclerosis Society (EAS) last year.
These guidelines established treatment goals for low-density cholesterol (LDL-C), non-high density lipoprotein-cholesterol (non-HDL-C), and apolipoprotein B (ApoB) in high risk cardiovascular (CV) disease patients.
A team led by Alberto J. Lorenzatti, MD, Head of the Lipid Clinic and Cardiovascular Prevention, Hospital Córdoba, analyzed the results of the phase 3 BANTING and BERSON trials to determine the percentage of type 2 diabetes patients who achieved the recommended goals with evolocumab plus statin therapy.
Both trials had previously reported that evolocumab, compared with placebo, significantly reduced LDL-C, non-HDL-C, and ApoB in such patients receiving statin therapy.
Thus, Lorenzatti and team combined the data from the double-blind, randomized trials. They included all patients who had undergone randomization and received at least one dose of evolocumab or placebo.
The investigators in the BANTING study had subcutaneously administered 420 mg of evocolumab or placebo to patients monthly for up to 12 weeks. At the initiation of treatment, all patients were already receiving maximal tolerated doses of statin of at least moderate intensity.
In the BERSON study, patients began treatment with 20 mg of atorvastatin at enrollement. Then, evolocumab patients subcutaneously received 140 mg of the drug every 2 weeks or 42 mg every month for up to 12 weeks. The same was done for patients randomly assigned to placebo.
Additionally, half the patients in the BERSON study were enrolled in China, and all patients between the studies were ≥18. The median age in the overall population was 62 years, and 47% were men.
Of the 1402 participants pooled from both studies, 89.4% were considered to be at very high CV risk.
Lonenzatti’s team then used the data to assess evololcumab’s effect on ESC/EAS goal achievement at the mean of weeks 10 and 12 for LDL-C and non-HDL-C, and week 12 for ApoB. They stratified their results by monthly or bi-weekly treatment regimens.
For patients who received bi-weekly dosing, 78% in the evolocumab group (n = 312) achieved a ≥50% LCL-C reduction from baseline—compared with only 1.3% in the placebo group (n = 157).
Up to 75% of evolocumab patients achieved both ≥50% LCL-C reduction and <1.4 mmol/L—versus 0% in the placebo group.
Non-HDL-C level of <2.6 mmol/L were achieved by 89.7% evolocumab and 29.9% placebo patients. Similarly, <2.4 mmol/L was achieved by 84.6% and 13.4% of patients with evolocumab and placebo, respectively.
As for ApoB goals, 91.6% in the bi-weekly evolocumab group (n = 287) reached <80 mg/dL versus 45.3% in the placebo group. Furthermore, 84% and 16.9% reached <65 mg/dL, respectively
Similar patterns were noted for patients who received monthly dosage. Additionally, these results were consistent in the Chinese subpopulation.
“Evolocumab plus statins enabled most T2D patients at very-high/high CVD risk to achieve their lipid treatment goals,” Lorenzatti and colleagues concluded.
The study, "Achievement of ESC/EAS lipid treatment goals with evolocumab in patients with type 2 diabetes: analyses of the BANTING and BERSON trials," was presented at ESC 2020.