{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:03:50Z","timestamp":1790795030625,"version":"4.1.0"},"reference-count":47,"publisher":"American Diabetes Association","issue":"4","license":[{"start":{"date-parts":[[2022,3,25]],"date-time":"2022-03-25T00:00:00Z","timestamp":1648166400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/content\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,4,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>High plasma triglyceride (TG) is an independent risk factor for cardiovascular disease. Fibrates lower TG levels through peroxisome proliferator\u2013activated receptor \u03b1 (PPAR\u03b1) agonism. Currently available fibrates, however, have relatively low selectivity for PPAR\u03b1. The aim of this trial was to assess the safety, tolerability, and efficacy of K-877 (pemafibrate), a selective PPAR\u03b1 modulator, in statin-treated European patients with hypertriglyceridemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>A total of 408 statin-treated adults were recruited from 68 European sites for this phase 2, randomized, double-blind, placebo-controlled trial. They had fasting TG between 175 and 500 mg\/dL and HDL-cholesterol (HDL-C) \u226450 mg\/dL for men and \u226455 mg\/dL for women. Participants were randomly assigned to receive placebo or one of six pemafibrate regimens: 0.05 mg twice a day, 0.1 mg twice a day, 0.2 mg twice a day, 0.1 mg once daily, 0.2 mg once daily, or 0.4 mg once daily. The primary end points were TG and non\u2013HDL-C level lowering at week 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Pemafibrate reduced TG at all doses (adjusted P value &amp;lt;0.001), with the greatest placebo-corrected reduction from baseline to week 12 observed in the 0.2-mg twice a day treatment group (54.4%). Reductions in non\u2013HDL-C did not reach statistical significance. Reductions in TG were associated with improvements in other markers for TG-rich lipoprotein metabolism, including reductions in apoB48, apoCIII, and remnant cholesterol and an increase in HDL-C levels. Pemafibrate increased LDL-cholesterol levels, whereas apoB100 was unchanged. Pemafibrate was safe and well-tolerated, with only minor increases in serum creatinine and homocysteine concentrations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Pemafibrate is effective, safe, and well-tolerated for the reduction of TG in European populations with hypertriglyceridemia despite statin treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc21-1288","type":"journal-article","created":{"date-parts":[[2022,3,3]],"date-time":"2022-03-03T10:06:04Z","timestamp":1646301964000},"page":"898-908","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":39,"title":["Efficacy and Safety of K-877 (Pemafibrate), a Selective PPAR\u03b1 Modulator, in European Patients on Statin Therapy"],"prefix":"10.2337","volume":"45","author":[{"given":"Henry N.","family":"Ginsberg","sequence":"first","affiliation":[{"name":"Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9821-4941","authenticated-orcid":false,"given":"Neil J.","family":"Hounslow","sequence":"additional","affiliation":[{"name":"Kowa Research Europe, Ltd., Berkshire, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuke","family":"Senko","sequence":"additional","affiliation":[{"name":"Kowa Company, Ltd., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9130-0137","authenticated-orcid":false,"given":"Hideki","family":"Suganami","sequence":"additional","affiliation":[{"name":"Kowa Company, Ltd., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawel","family":"Bogdanski","sequence":"additional","affiliation":[{"name":"Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, Poznan, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Ceska","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Charles University and University General Hospital, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akos","family":"Kalina","sequence":"additional","affiliation":[{"name":"Hungarian Defense Forces Medical Centre, Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman A.","family":"Libis","sequence":"additional","affiliation":[{"name":"Orenburg State Medical University, Orenburg, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana V.","family":"Supryadkina","sequence":"additional","affiliation":[{"name":"First City Clinical Hospital named after E.E. 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