Bempedoinsäure (1) – Nilemdo®

a) or mixed dyslipidaemia, where pharmacological and dietary options for lowering lipid levels have not been fully utilised

• The additional benefit is not proven.
• In summary, the stable background therapy administered in the studies particularly given the high cardiovascular risk among the included patients with inadequately controlled LCL-C levels, does not appear appropriate for a fair comparison of bempedoic acid against the appropriate comparator therapy.
• mortality
  • Further endpoints in both studies included mortality, cardiovascular events and, in the CLEAR WISDOM AE study,
• morbidity
  • In the CLEAR WISDOM trial, the primary endpoint was the change in LDL-C levels at week 12.
  • Additional endpoints in both studies included mortality, cardiovascular events and, in the CLEAR WISDOM study, AE.
• Side effects
  • In the CLEAR HARMONY study, safety endpoints were assessed as the primary endpoint, including, for example, adverse events (AEs) and clinical safety laboratory parameters, amongst others.

b) or mixed dyslipidaemia, in which pharmacological (excluding evolocumab) and dietary options for lipid-lowering have been exhausted

• The additional benefit is not proven.
• No data were presented for the assessment of the additional benefit of bempedoic acid for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.