Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study
| Autor: | Geraldine Macdonell, Dieter Lütjohann, Thomas Musliner, Waheeda Sirah, J. Lin, Amish P. Shah, Amy O. Johnson-Levonas, Aditi Sapre, K. von Bergmann |
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| Rok vydání: | 2008 |
| Předmět: |
medicine.medical_specialty
Apolipoprotein B biology business.industry Lathosterol General Medicine Placebo Gastroenterology Sterol chemistry.chemical_compound Endocrinology chemistry Ezetimibe Tolerability Internal medicine Toxicity medicine biology.protein lipids (amino acids peptides and proteins) business Lipoprotein medicine.drug |
| Zdroj: | International Journal of Clinical Practice. 62:1499-1510 |
| ISSN: | 1368-5031 |
| DOI: | 10.1111/j.1742-1241.2008.01841.x |
| Popis: | Summary Objective: To assess the long-term efficacy and safety profile of ezetimibe 10 mg/day in patients with homozygous sitosterolemia. Methods: This was an extension of a multi-centre, randomised, double-blind, placebo-controlled base study in which patients with homozygous sitosterolemia and plasma sitosterol concentrations > 5 mg/dl were randomised 4 : 1 to ezetimibe 10 mg/day (n = 30) or placebo (n = 7) for 8 weeks. Patients who successfully completed the base study with > 80% compliance to study medication were eligible to enter two, successive, 1-year extension studies in which ezetimibe 10 mg/day was administered in an open-label manner. Patients remained on their current treatment regimen (e.g. bile salt-binding resins, statins and low-sterol diet) during the base and extension studies. Patients had to be off ezetimibe therapy for ≥ 4 weeks prior to entering the first extension. Efficacy and safety/tolerability parameters were evaluated every 12 and 26 weeks in the first and second years respectively. The primary efficacy end-point was mean percentage change in plasma sitosterol from baseline to study end for the cohort of patients (n = 21) who successfully completed the second extension study. Results: Treatment with ezetimibe 10 mg/day led to significant mean percentage reductions from baseline in plasma concentrations of sitosterol (−43.9%; p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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