Updated indications for bempedoic acid and combination of bempedoic acid and ezetimibe in Europe
The European Commission (EC) has approved label updates for bempedoic acid and the fixed dose combination of bempedoic acid and ezetimibe as treatment for hypercholesterolemia and to reduce the risk of adverse cardiovascular events.
The labels for bempedoic acid and the combination tablet of bempedoic acid and ezetimibe have been updated by the EC. The updated indications include:
- Bempedoic acid and the fixed dosed combination of bempedoic acid and ezetimibe are indicated to reduce CV risk in adults with established or at high risk of CVD who are unable to take recommended statin therapy;
- Bempedoic acid, alone or in combination with other LDL-c lowering therapies, are indicated to reduce LDL-c levels in adults with primary hyperlipidemia, as an adjunct to diet;
- The combination tablet of bempedoic acid and ezetimibe are indicated in combination with LDL-c lowering therapies, or alone when concomitant LDL-c lowering therapy is not possible, to reduce LDL-c levels in adults with primary hyperlipidemia, as an adjunct to diet.
The decision by the EC is based on the results of the CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial.
The phase 3 CLEAR Outcomes trial was a double-blind, randomized, placebo-controlled trial which was conducted at 1250 sites in 32 countries, including 485 sites across Europe. A total of 13,970 patients with or at high risk of CVD were enrolled and followed for a median duration of 3.4 years. The primary end point of 4-component MACE (defined as CV death, nonfatal stroke, nonfatal MI or coronary revascularization) was reduced by 13% in the patients who received bempedoic acid compared to those who received placebo.