Effect of 1PC111, a Fixed-dose Combination of Pitavastatin and Ezetimibe, Versus Pitavastatin or Ezetimibe Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase III Study.

Autor: Chou MT; Cardiovascular Division, Chi-Mei Medical Center, Taiwan (R.O.C.)., McGirr A; Northern Beaches Clinical Research, Brookvale, New South Wales, Australia., Jong GP; Cardiovascular Division, Chung Shan Medical University Hospital, Taiwan (R.O.C)., Chao TH; Division of Cardiology, National Cheng Kung University Hospital, Taiwan (R.O.C)., Lee IT; Division of Endocrinology and Metabolism, Taichung Veterans General Hospital, Taiwan (R.O.C)., Huang CY; Division of Cardiology and Cardiovascular Research Center, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan (R.O.C); Division of Cardiology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan (R.O.C)., Chen CP; Division of Cardiology, Changhua Christian Hospital, Changhua, Taiwan (R.O.C)., Hsieh CH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan (R.O.C)., Lu CH; Division of Endocrinology and Metabolism, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Taiwan (R.O.C)., Sheu WH; Taipei Veterans General Hospital, Taipei, Taiwan (R.O.C). Electronic address: whhsheu@vghtpe.gov.tw.
Jazyk: angličtina
Zdroj: Clinical therapeutics [Clin Ther] 2022 Oct; Vol. 44 (10), pp. 1272-1281. Date of Electronic Publication: 2022 Aug 25.
DOI: 10.1016/j.clinthera.2022.08.006
Abstrakt: Purpose: This study aimed to show that the efficacy of 1PC111 is superior to that of either ezetimibe or pitavastatin alone (monotherapy) for the treatment of hypercholesterolemia.
Methods: This was a multicenter, randomized, double-blind, Phase III study. Patients with hypercholesterolemia or mixed dyslipidemia were randomized to receive 1PC111 (which was a fixed-dose combination of pitavastatin 2 mg and ezetimibe 10 mg), pitavastatin 2 mg, or ezetimibe 10 mg daily for 12 weeks. The primary end point was the difference in the percent change in LDL-C from baseline to week 12 between the 1PC111 and each monotherapy group. The secondary end points were the percent change in other lipid profiles from baseline to each visit. All patients were assessed for adverse events until end of study.
Findings: A total of 388 patients were randomly assigned to the 1PC111 (n = 128), pitavastatin (n = 132), or ezetimibe (n = 128) group. Generally, baseline characteristics were similar among the 3 groups. A statistically significant decrease in the LDL-C level at week 12 was observed in the 1PC111 group (-50.50% [14.9%]) compared with either the pitavastatin (-36.11% [11.4%]; P < 0.001) or ezetimibe (-19.85% [12.4%]; P < 0.001) group. Also, there was a statistically significant difference between 1PC111 and each monotherapy group in the reduction in total cholesterol, non-HDL-C, and apolipoprotein B levels. Moreover, there was a trend toward more efficient lowering of LDL-C levels in elderly patients (age ≥65 years) than in younger patients (age <65 years) by 1PC111 treatment. In patients given a class I recommendation for atherosclerotic cardiovascular disease prevention, the percentage of patients achieving the LDL-C target of <100 mg/dL at week 12 was significantly higher in the 1PC111 group than in both monotherapy groups (P < 0.001). Overall, the incidence of adverse events was similar among 3 groups.
Implications: 1PC111 was more effective in improving lipid profiles and achieving the LDL-C goal than pitavastatin or ezetimibe alone for hypercholesterolemia treatment. Furthermore, 1PC111 may provide more benefit in treating elderly patients.
Clinicaltrials: gov identifier: NCT04643093.
Competing Interests: Declarations of Interest Dr Jong has received honoraria for lectures from Orient EuroPharma, Novartis, Pfizer, and Merck. Dr Chao has received honoraria for lectures from Orient EuroPharma. The other authors have indicated that they have no conflicts of interest of grants, honoraria, consultancies, speakers bureau or advisory board positions, or significant stock holdings received from industry or organizations, regarding the content of this article. The study sponsor had a role in the study design: the collection, analysis, and interpretation of data. The decision to submit the manuscript for publication was made by the authors.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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