Bempedoinsäure / Ezetimib (1) – Nustendi®

• Clinical trials
  • In the four-arm, double-blind, randomised, controlled trial 1002FDC-053, the fixed-dose combination of bempedoic acid andezetimibe was compared with the individual substances bempedoic acid and ezetimibe, as well as with placebo, over a treatment period of 12 weeks.

a) or mixed dyslipidaemia, in whom pharmacological and dietary options for lipid-lowering have not been exhausted

• The additional benefit is not proven.
• In summary, the study submitted as supplementary evidence by the pharmaceutical manufacturer is not suitable for evaluating a comparison of the fixed-dose combination of bempedoic acid and ezetimibe against the appropriate comparator therapy.
• On the one hand, the patients included do not adequately represent the authorised therapeutic indication as set out in the SmPC.
• On the other hand, the appropriate comparator therapy was not implemented and the treatment duration of 12 weeks is too short for an assessment.

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

• An additional benefit is not proven.
• No data were submitted for comparison with the appropriate comparator therapy to assess the additional benefit of the fixed-dose combination of bempedoic acid and ezetimibe for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet.

Courtesy translation only, please refer to the German original.