Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia

Sang Hak Lee, Namsik Chung, Jun Kwan, Doo Il Kim, Won Ho Kim, Chee Jeong Kim, Hyun Seung Kim, Si Hoon Park, Hong Seog Seo, Dong Gu Shin, Yung Woo Shin, Wan Joo Shim, Tae Hoon Ahn, Kyeong Ho Yun, Myeong Ho Yoon, Kwang Soo Cha, Si Wan Choi, Seong Wook Han, Min Su Hyon

Research output: Contribution to journalArticle

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Abstract

Background: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study. Objective: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults. Methods: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits. Results: A total of 268 patients were randomized to treatment, and 222 (82.8%) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7% [102/110] vs 92.0% [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1%) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0%) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4%) in the pitavastatin group and 7 patients (5.3%) in the atorvastatin group. There were no serious adverse drug reactions in either group. Conclusions: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.

Original languageEnglish
Pages (from-to)2365-2373
Number of pages9
JournalClinical Therapeutics
Volume29
Issue number11
DOIs
Publication statusPublished - 2007 Nov 1

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Hypercholesterolemia
LDL Cholesterol
Cholesterol
C-Reactive Protein
Triglycerides
pitavastatin
Atorvastatin Calcium
Lipids
Therapeutics
Korea
Creatine Kinase
Drug-Related Side Effects and Adverse Reactions
HDL Cholesterol
Multicenter Studies
Education
Weights and Measures

Keywords

  • atorvastatin
  • hypercholesterolemia
  • pitavastatin
  • statins

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Comparison of the efficacy and tolerability of pitavastatin and atorvastatin : An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia. / Hak Lee, Sang; Chung, Namsik; Kwan, Jun; Kim, Doo Il; Ho Kim, Won; Jeong Kim, Chee; Seung Kim, Hyun; Hoon Park, Si; Seo, Hong Seog; Gu Shin, Dong; Woo Shin, Yung; Shim, Wan Joo; Ahn, Tae Hoon; Ho Yun, Kyeong; Yoon, Myeong Ho; Cha, Kwang Soo; Choi, Si Wan; Wook Han, Seong; Su Hyon, Min.

In: Clinical Therapeutics, Vol. 29, No. 11, 01.11.2007, p. 2365-2373.

Research output: Contribution to journalArticle

Hak Lee, S, Chung, N, Kwan, J, Kim, DI, Ho Kim, W, Jeong Kim, C, Seung Kim, H, Hoon Park, S, Seo, HS, Gu Shin, D, Woo Shin, Y, Shim, WJ, Ahn, TH, Ho Yun, K, Yoon, MH, Cha, KS, Choi, SW, Wook Han, S & Su Hyon, M 2007, 'Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia', Clinical Therapeutics, vol. 29, no. 11, pp. 2365-2373. https://doi.org/10.1016/j.clinthera.2007.11.002
Hak Lee, Sang ; Chung, Namsik ; Kwan, Jun ; Kim, Doo Il ; Ho Kim, Won ; Jeong Kim, Chee ; Seung Kim, Hyun ; Hoon Park, Si ; Seo, Hong Seog ; Gu Shin, Dong ; Woo Shin, Yung ; Shim, Wan Joo ; Ahn, Tae Hoon ; Ho Yun, Kyeong ; Yoon, Myeong Ho ; Cha, Kwang Soo ; Choi, Si Wan ; Wook Han, Seong ; Su Hyon, Min. / Comparison of the efficacy and tolerability of pitavastatin and atorvastatin : An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia. In: Clinical Therapeutics. 2007 ; Vol. 29, No. 11. pp. 2365-2373.
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abstract = "Background: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study. Objective: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults. Methods: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits. Results: A total of 268 patients were randomized to treatment, and 222 (82.8{\%}) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7{\%} [102/110] vs 92.0{\%} [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1{\%}) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0{\%}) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4{\%}) in the pitavastatin group and 7 patients (5.3{\%}) in the atorvastatin group. There were no serious adverse drug reactions in either group. Conclusions: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.",
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TY - JOUR

T1 - Comparison of the efficacy and tolerability of pitavastatin and atorvastatin

T2 - An 8-week, multicenter, randomized, open-label, dose-titration study in korean patients with hypercholesterolemia

AU - Hak Lee, Sang

AU - Chung, Namsik

AU - Kwan, Jun

AU - Kim, Doo Il

AU - Ho Kim, Won

AU - Jeong Kim, Chee

AU - Seung Kim, Hyun

AU - Hoon Park, Si

AU - Seo, Hong Seog

AU - Gu Shin, Dong

AU - Woo Shin, Yung

AU - Shim, Wan Joo

AU - Ahn, Tae Hoon

AU - Ho Yun, Kyeong

AU - Yoon, Myeong Ho

AU - Cha, Kwang Soo

AU - Choi, Si Wan

AU - Wook Han, Seong

AU - Su Hyon, Min

PY - 2007/11/1

Y1 - 2007/11/1

N2 - Background: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study. Objective: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults. Methods: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits. Results: A total of 268 patients were randomized to treatment, and 222 (82.8%) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7% [102/110] vs 92.0% [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1%) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0%) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4%) in the pitavastatin group and 7 patients (5.3%) in the atorvastatin group. There were no serious adverse drug reactions in either group. Conclusions: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.

AB - Background: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study. Objective: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults. Methods: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits. Results: A total of 268 patients were randomized to treatment, and 222 (82.8%) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7% [102/110] vs 92.0% [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1%) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0%) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4%) in the pitavastatin group and 7 patients (5.3%) in the atorvastatin group. There were no serious adverse drug reactions in either group. Conclusions: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.

KW - atorvastatin

KW - hypercholesterolemia

KW - pitavastatin

KW - statins

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