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EZETROL (ezetimibe), cholesterol-lowering agent

CARDIOLOGY - Paediatrics
Opinions on drugs - Posted on May 04 2016

Reason for request

Extension of Inclusion

Therapeutic benefit in children aged over 6 years comparable to that of adults.

  • As in adults, EZETROL is indicated in children aged over 6 years, in:

-     primary (heterozygous familial and non-familial) hypercholesterolaemia, in combination with a statin, for patients not controlled by a statin alone or in monotherapy for patients with a statin contraindication or a statin intolerance,

-      homozygous familial hypercholesterolaemia (HoFH),

-      homozygous sitosterolaemia.

  • The efficacy of ezetimibe in combination with simvastatin has been demonstrated in terms of reduction of LDL-C levels in children aged 10 - 17 years with heterozygous familial hypercholesterolaemia and in monotherapy in children aged 6 to 10 years with primary hypercholesterolaemia, mostly familial. In the absence of a specific study in patients with HoFH or sitosterolaemia, the efficacy of ezetimibe cannot be clearly established for children with these two diseases.
  • There is, to date, no long-term efficacy data justifying a decrease in morbidity and mortality at adult age in patients treated during childhood.
  • The safety of use of EZETROL, in combination with simvastatin, was evaluated in particular in patients aged 10 to 17 years with heterozygous familial hypercholesterolaemia. In this study, no adverse effect on growth or sexual maturity of boys or girls adolescents, or on the length of the menstrual cycle of girls, was detected.

Clinical Benefit

Substantial

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Clinical Added Value

Comments without ASMR value

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Therapeutic use

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