Ezetimibe-Simvastatin Evaluation Study
Ezetimibe-Simvastatin Evaluation Study
The study purpose is to assess the efficacy of the fixed combination of ezetimibe-simvastatin
 in patients with hypercholesterolemia not responding to statin monotherapy in achieving the
 blood plasma LDL-C target as defined by the ESC / EAS Guideline, of 2016.
The additional study objectives are:

 1. To evaluate the efficacy of a fixed combination of ezetimibe-simvastatin in patients
 with hypercholesterolemia to improve the lipid profile (HDL-C ↑, T-CHOL, Triglycerides
 ↓).

 2. Evaluation of the response of patients with hypercholesterolemia who received a fixed
 combination of ezetimibe-simvastatin to achieve a target according to the category of
 total cardiovascular risk to which they belong.

 3. To evaluate the efficacy of a stable combination of ezetimibe and simvastatin in
 patients with hypercholesterolemia in improving non-HDL-cholesterol (non-HDL-C) levels.

 4. Safety assessment through the recording of Adverse Events during the study.
Inclusion Criteria:

 -  Patients diagnosed with primary (heterozygous familial and non-familial)
 hypercholesterolemia, homozygous familial hypercholesterolemia or mixed
 hyperlipidemia.

 -  Patients not properly responded with a statin only.

 -  Patients who have not achieved LDL-C with previous treatment.

 -  Adult patients who will sign their consent form to participate in the study.

 Exclusion Criteria:

 -  Patients who have not fully understood the study procedures and have not signed the
 consent form.

 -  Hypersensitivity to the active substances or to any of the excipients of study drug.

 -  Pregnancy and breastfeeding.

 -  Active liver disease or unexplained persistent increases in serum transaminases.

 -  Concomitant administration of potent inhibitors of the CYP3A4 system (agents that
 increase the AUC approximately 5 times or more) (eg, itraconazole, ketoconazole,
 posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease
 inhibitors (eg nelfinavir ), boceprevir, telaprevir, nefazodone and combesistate
 containing medicines.

 -  Concomitant administration of gemfibrozil, cyclosporine or danazol.

 -  Patients with homozygous familial hypercholesterolaemia (HoFH), concurrent
 administration of lopithipid with doses of study drug> 10 mg / 40 mg.