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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.
Clin Ther. 2007 Nov; 29(11):2365-73.CT

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.

Authors+Show Affiliations

Cardiology Division, Yonsei Cardiovascular Center, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul, Republic of Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18158077

Citation

Lee, Sang Hak, et al. "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, 2007, pp. 2365-73.
Lee SH, Chung N, Kwan J, et al. 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. Clin Ther. 2007;29(11):2365-73.
Lee, S. H., Chung, N., Kwan, J., Kim, D. I., Kim, W. H., Kim, C. J., Kim, H. S., Park, S. H., Seo, H. S., Shin, D. G., Shin, Y. W., Shim, W. J., Ahn, T. H., Ho Yun, K., Yoon, M. H., Cha, K. S., Choi, S. W., Han, S. W., & Hyon, M. S. (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, 29(11), 2365-73.
Lee SH, et al. 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. Clin Ther. 2007;29(11):2365-73. PubMed PMID: 18158077.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lee,Sang Hak, AU - Chung,Namsik, AU - Kwan,Jun, AU - Kim,Doo-Il, AU - Kim,Won Ho, AU - Kim,Chee Jeong, AU - Kim,Hyun Seung, AU - Park,Si Hoon, AU - Seo,Hong Seog, AU - Shin,Dong Gu, AU - Shin,Yung Woo, 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 - Han,Seong Wook, AU - Hyon,Min Su, PY - 2007/09/25/accepted PY - 2007/12/26/pubmed PY - 2008/2/21/medline PY - 2007/12/26/entrez SP - 2365 EP - 73 JF - Clinical therapeutics JO - Clin Ther VL - 29 IS - 11 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. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/18158077/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(07)00351-7 DB - PRIME DP - Unbound Medicine ER -