Endocrinology and Metabolism

Original Articles

Clinical Study
Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study): In-Kyung Jeong, Sung-Rae Kim; Endocrinol Metab. 2020;35(4):882-891. Published online December 2, 2020; DOI: https://doi.org/10.3803/EnM.2020.723

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Background
While randomized controlled trials provide useful information about drug safety and efficacy, they do not always reflect the observed results in the real world. The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin in clinical practice in 28,343 patients.
Methods
This study was conducted in 893 facilities in Korea from April 2, 2012 to April 1, 2017. This study was designed to administer 1, 2, or 4 mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
Results
For 126 days of mean duration of administration of pitavastatin, the % change of low density lipoprotein cholesterol indicated a dose dependent reduction: –23.4%, –29.1%, and –35.2% in the 1, 2, and 4 mg groups, respectively in patients who have not been treated with lipid lowering medications prior to study. Only 1.74% (492/28,343) of pitavastatin-treated patients experienced adverse events, of which 0.43% (123/28,343) were adverse drug reactions. Less than 1% of patients experienced the grade 2 or more toxicity (Common Terminology Criteria for Adverse Events v4.03) in alanine aminotransferase, aspartate aminotransferase, serum creatinine, and serum creatine phosphokinase. Although there were no rhabdomyolysis in 28,343 patients, 0.04% of patients had been reported pitavastatin-related musculoskeletal disorders.
Conclusion
Overall, this observational study showed that pitavastatin was well tolerated and effectively modified the lipid profile, reducing cardiovascular and cerebrovascular risk in Korean patients with hypercholesterolemia in the real world.

Citations

Citations to this article as recorded by

Low-Density Lipoprotein Cholesterol Level, Statin Use and Myocardial Infarction Risk in Young Adults
Heekyoung Jeong, Kyungdo Han, Soon Jib Yoo, Mee Kyoung Kim
Journal of Lipid and Atherosclerosis.2022; 11(3): 288. CrossRef

Clinical Study
Effect of Pitavastatin Treatment on ApoB-48 and Lp-PLA₂ in Patients with Metabolic Syndrome: Substudy of PROspective Comparative Clinical Study Evaluating the Efficacy and Safety of PITavastatin in Patients with Metabolic Syndrome: Hyo-Sun Lee, Chang Hee Jung, Sung Rae Kim, Hak Chul Jang, Cheol-Young Park; Endocrinol Metab. 2016;31(1):120-126. Published online March 16, 2016; DOI: https://doi.org/10.3803/EnM.2016.31.1.120

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Background

Apolipoprotein (Apo) B-48 is an intestinally derived lipoprotein that is expected to be a marker for cardiovascular disease (CVD). Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a vascular-specific inflammatory marker and important risk predictor of CVD. The aim of this study was to explore the effect of pitavastatin treatment and life style modification (LSM) on ApoB-48 and Lp-PLA₂ levels in metabolic syndrome (MS) patients at relatively low risk for CVD, as a sub-analysis of a previous multi-center prospective study.

Methods

We enrolled 75 patients with MS from the PROPIT study and randomized them into two treatment groups: 2 mg pitavastatin daily+intensive LSM or intensive LSM only. We measured the change of lipid profiles, ApoB-48 and Lp-PLA₂ for 48 weeks.

Results

Total cholesterol, low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, and ApoB-100/A1 ratio were significantly improved in the pitavastatin+LSM group compared to the LSM only group (P≤0.001). Pitavastatin+LSM did not change the level of ApoB-48 in subjects overall, but the level of ApoB-48 was significantly lower in the higher mean baseline value group of ApoB-48. The change in Lp-PLA₂ was not significant after intervention in either group after treatment with pitavastatin for 1 year.

Conclusion

Pitavastatin treatment and LSM significantly improved lipid profiles, ApoB-100/A1 ratio, and reduced ApoB-48 levels in the higher mean baseline value group of ApoB-48, but did not significantly alter the Lp-PLA₂ levels.

Citations

Citations to this article as recorded by

A comprehensive review on the lipid and pleiotropic effects of pitavastatin
Amirhossein Sahebkar, Nasim Kiaie, Armita Mahdavi Gorabi, Massimo R. Mannarino, Vanessa Bianconi, Tannaz Jamialahmadi, Matteo Pirro, Maciej Banach
Progress in Lipid Research.2021; 84: 101127. CrossRef
Change in ALT levels after administration of HMG‐CoA reductase inhibitors to subjects with pretreatment levels three times the upper normal limit in clinical practice
Hyunah Kim, Hyeseon Lee, Tong Min Kim, So Jung Yang, Seo Yeon Baik, Seung‐Hwan Lee, Jae‐Hyoung Cho, Hyunyong Lee, Hyeon Woo Yim, In Young Choi, Kun‐Ho Yoon, Hun‐Sung Kim
Cardiovascular Therapeutics.2018;[Epub] CrossRef
Articles inEndocrinology and Metabolismin 2016
Won-Young Lee
Endocrinology and Metabolism.2017; 32(1): 62. CrossRef
Use of Moderate‐Intensity Statins for Low‐Density Lipoprotein Cholesterol Level above 190 mg/dL at Baseline in Koreans
Hun‐Sung Kim, Hyeseon Lee, Sue Hyun Lee, Yoo Jin Jeong, Tong Min Kim, So Jung Yang, Sun Jung Baik, Hyunah Kim, Seung‐Hwan Lee, Jae Hyoung Cho, In‐Young Choi, Kun‐Ho Yoon, Ju Han Kim
Basic & Clinical Pharmacology & Toxicology.2017; 121(4): 272. CrossRef
Another statin option in HIV
Philip E Tarr, Helen Kovari
The Lancet HIV.2017; 4(7): e278. CrossRef
Clinical benefits of pitavastatin: focus on patients with diabetes or at risk of developing diabetes
Vivencio Barrios, Carlos Escobar
Future Cardiology.2016; 12(4): 449. CrossRef

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