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 language | English |
|---|---|
| Pages (from-to) | 2365-2373 |
| Number of pages | 9 |
| Journal | Clinical Therapeutics |
| Volume | 29 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - 2007 Nov 1 |
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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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=37349123865&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=37349123865&partnerID=8YFLogxK
U2 - 10.1016/j.clinthera.2007.11.002
DO - 10.1016/j.clinthera.2007.11.002
M3 - Article
C2 - 18158077
AN - SCOPUS:37349123865
VL - 29
SP - 2365
EP - 2373
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 11
ER -