Efficacy and safety of pemafibrate in people with type 2 diabetes and elevated triglyceride levels: 52-week data from the PROVIDE study.

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  • Additional Information
    • Source:
      Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE
    • Publication Information:
      Original Publication: Oxford : Wiley-Blackwell, c1999-
    • Subject Terms:
      Benzoxazoles*/adverse effects ; Benzoxazoles*/therapeutic use ; Butyrates*/adverse effects ; Butyrates*/therapeutic use ; Hypertriglyceridemia*/complications ; Hypertriglyceridemia*/drug therapy ; Hypolipidemic Agents*/adverse effects ; Hypolipidemic Agents*/therapeutic use; Diabetes Mellitus, Type 2/*complications; Humans ; Triglycerides/blood
    • Abstract:
      The aim of this study was to evaluate the efficacy and safety of pemafibrate in people with type 2 diabetes and hypertriglyceridaemia over a 52-week period. Participants were randomly assigned to receive treatment with placebo or pemafibrate at a dose of 0.2 or 0.4 mg/d for 24 weeks (treatment period 1). The main results from treatment period 1 have been reported previously. The assigned treatment was continued up to week 52, except that the placebo was changed to pemafibrate 0.2 mg/d after week 24 (treatment period 2). The percentage changes in fasting serum triglyceride (TG) levels at week 52 (last observation carried forward) were -48.2%, -42.3%, and -46.4% in the placebo/pemafibrate 0.2 mg/d (n = 57), pemafibrate 0.2 mg/d (n = 54), and pemafibrate 0.4 mg/d (n = 55) groups, respectively. Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks. Pemafibrate was well tolerated throughout the study period. The present study is the first to show that pemafibrate treatment substantially ameliorated lipid abnormalities and was well tolerated for 52 weeks in people with type 2 diabetes and hypertriglyceridaemia.
      (© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
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    • Contributed Indexing:
      Keywords: clinical trial; dyslipidaemia; lipid-lowering therapy; phase III study; randomized trial; type 2 diabetes
    • Accession Number:
      0 ((R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid)
      0 (Benzoxazoles)
      0 (Butyrates)
      0 (Hypolipidemic Agents)
      0 (Triglycerides)
    • Publication Date:
      Date Created: 20190305 Date Completed: 20200710 Latest Revision: 20210109
    • Publication Date:
      20240628
    • Accession Number:
      PMC6617746
    • Accession Number:
      10.1111/dom.13686
    • Accession Number:
      30830727