دورية أكاديمية
أعرض في EDS

Drug-drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open-label, randomized, 6-sequence, 3-period crossover studies.

التفاصيل البيبلوغرافية
العنوان: Drug-drug interactions between pemafibrate and statins on pharmacokinetics in healthy male volunteers: Open-label, randomized, 6-sequence, 3-period crossover studies.
المؤلفون: Kamimura T; Medical Affairs Department I, Kowa Company, Ltd., Tokyo, Japan., Hounslow N; Kowa Pharmaceutical Europe Co., Ltd., Wokingham, UK., Suganami H; Global Data Science Center, Kowa Company, Ltd., Tokyo, Japan., Tanigawa R; Global Clinical Development Department, Kowa Company, Ltd., Tokyo, Japan.
المصدر: Clinical and translational science [Clin Transl Sci] 2024 Aug; Vol. 17 (8), pp. e13900.
نوع المنشور: Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Malden, MA : WileyBlackwell Pub., 2008-
مواضيع طبية MeSH: Drug Interactions* , Hydroxymethylglutaryl-CoA Reductase Inhibitors*/pharmacokinetics , Hydroxymethylglutaryl-CoA Reductase Inhibitors*/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors*/administration & dosage , Cross-Over Studies* , Butyrates*/pharmacokinetics , Butyrates*/administration & dosage , Healthy Volunteers* , Benzoxazoles*/pharmacokinetics , Benzoxazoles*/administration & dosage , Benzoxazoles*/adverse effects , Benzoxazoles*/pharmacology, Humans ; Male ; Adult ; Young Adult ; Middle Aged ; PPAR alpha/agonists ; PPAR alpha/metabolism
مستخلص: Elevated triglyceride levels are associated with an increased risk of cardiovascular events despite guideline-based statin treatment of low-density lipoprotein cholesterol. Peroxisome proliferator-activated receptor α (PPARα) agonists exert a significant triglyceride-lowering effect. However, combination therapy of PPARα agonists with statins poses an increased risk of rhabdomyolysis, which is rare but a major concern of the combination therapy. Pharmacokinetic interaction is suspected to be a contributing factor to the risk. To examine the potential for combination therapy with the selective PPARα modulator (SPPARMα) pemafibrate and statins, drug-drug interaction studies were conducted with open-label, randomized, 6-sequence, 3-period crossover designs for the combination of pemafibrate 0.2 mg twice daily and each of 6 statins once daily: pitavastatin 4 mg/day (n = 18), atorvastatin 20 mg/day (n = 18), rosuvastatin 20 mg/day (n = 29), pravastatin 20 mg/day (n = 18), simvastatin 20 mg/day (n = 20), and fluvastatin 60 mg/day (n = 19), involving healthy male volunteers. The pharmacokinetic parameters of pemafibrate and each of the statins were similar regardless of coadministration. There was neither an effect on the systemic exposure of pemafibrate nor a clinically important increase in the systemic exposure of any of the statins on the coadministration although the systemic exposure of simvastatin was reduced by about 15% and its open acid form by about 60%. The HMG-CoA reductase inhibitory activity in plasma samples from the simvastatin and pemafibrate combination group was about 70% of that in the simvastatin alone group. In conclusion, pemafibrate did not increase the systemic exposure of statins, and vice versa, in healthy male volunteers.
(© 2024 The Author(s). Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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معلومات مُعتمدة: Kowa Company, Ltd.; Kowa Research Europe Co., Ltd.
المشرفين على المادة: 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
0 ((R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid)
0 (Butyrates)
0 (Benzoxazoles)
0 (PPAR alpha)
تواريخ الأحداث: Date Created: 20240730 Date Completed: 20240730 Latest Revision: 20240801
رمز التحديث: 20240801
مُعرف محوري في PubMed: PMC11287820
DOI: 10.1111/cts.13900
PMID: 39078149
قاعدة البيانات: MEDLINE
الوصف
تدمد:1752-8062
DOI:10.1111/cts.13900