Cargando…
Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial
PURPOSE: This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva(®)) and the reference formulation (Lipitor(®)) of atorvastatin, both at a dosage of 20 mg once daily. METHODS: This study was a prospective open-label, randomized controlled study. Hyperchole...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546732/ https://www.ncbi.nlm.nih.gov/pubmed/28814835 http://dx.doi.org/10.2147/DDDT.S112241 |
_version_ | 1783255604089847808 |
---|---|
author | Lee, Ju-Hee Kim, Sang-Hyun Choi, Dong-Ju Tahk, Seung-Jea Yoon, Jung-Han Choi, Si Wan Hong, Taek-Jong Kim, Hyo-Soo |
author_facet | Lee, Ju-Hee Kim, Sang-Hyun Choi, Dong-Ju Tahk, Seung-Jea Yoon, Jung-Han Choi, Si Wan Hong, Taek-Jong Kim, Hyo-Soo |
author_sort | Lee, Ju-Hee |
collection | PubMed |
description | PURPOSE: This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva(®)) and the reference formulation (Lipitor(®)) of atorvastatin, both at a dosage of 20 mg once daily. METHODS: This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. RESULTS: Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (−43.9%±15.3% in the generic group, −43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804). CONCLUSION: The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia. |
format | Online Article Text |
id | pubmed-5546732 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-55467322017-08-16 Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial Lee, Ju-Hee Kim, Sang-Hyun Choi, Dong-Ju Tahk, Seung-Jea Yoon, Jung-Han Choi, Si Wan Hong, Taek-Jong Kim, Hyo-Soo Drug Des Devel Ther Original Research PURPOSE: This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva(®)) and the reference formulation (Lipitor(®)) of atorvastatin, both at a dosage of 20 mg once daily. METHODS: This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. RESULTS: Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (−43.9%±15.3% in the generic group, −43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804). CONCLUSION: The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia. Dove Medical Press 2017-08-02 /pmc/articles/PMC5546732/ /pubmed/28814835 http://dx.doi.org/10.2147/DDDT.S112241 Text en © 2017 Lee et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Lee, Ju-Hee Kim, Sang-Hyun Choi, Dong-Ju Tahk, Seung-Jea Yoon, Jung-Han Choi, Si Wan Hong, Taek-Jong Kim, Hyo-Soo Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title | Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title_full | Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title_fullStr | Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title_full_unstemmed | Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title_short | Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
title_sort | efficacy and tolerability of two different formulations of atorvastatin in korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546732/ https://www.ncbi.nlm.nih.gov/pubmed/28814835 http://dx.doi.org/10.2147/DDDT.S112241 |
work_keys_str_mv | AT leejuhee efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT kimsanghyun efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT choidongju efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT tahkseungjea efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT yoonjunghan efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT choisiwan efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT hongtaekjong efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial AT kimhyosoo efficacyandtolerabilityoftwodifferentformulationsofatorvastatininkoreanpatientswithhypercholesterolemiaamulticenterprospectiverandomizedclinicaltrial |