Evidence map›Paper›PMID 30830727›Full record

Trial reportDiabetes, obesity & metabolism2019

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

Eiichi Araki, Shizuya Yamashita, Hidenori Arai, Koutaro Yokote, Jo Satoh, Toyoshi Inoguchi, Jiro Nakamura, Hiroshi Maegawa, Narihito Yoshioka, Yukio Tanizawa and 3 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Eiichi ArakiDepartment of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.ORCID 0000-0002-4064-7525
Shizuya YamashitaDepartment of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Hidenori AraiNational Centre for Geriatrics and Gerontology, Aichi, Japan.
Koutaro YokoteDepartment of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID 0000-0003-3033-4813
Jo SatohTohoku Medical and Pharmaceutical University Wakabayashi Hospital, Miyagi, Japan.
Toyoshi InoguchiFukuoka Health Promotion Support Centre, Fukuoka, Japan.
Jiro NakamuraDivision of Diabetes, Department of Internal Medicine, Aichi Medical University, Aichi, Japan.
Hiroshi MaegawaDepartment of Medicine, Shiga University of Medical Science, Shiga, Japan.
Narihito YoshiokaDivision of Diabetes and Endocrinology, Department of Medicine, Sapporo Medical Centre, NTT East Corporation, Hokkaido, Japan.
Yukio TanizawaDivision of Endocrinology, Metabolism, Haematological Science and Therapeutics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-5961-1816
Hideki SuganamiClinical Data Science Department, Kowa Company, Ltd, Tokyo, Japan.ORCID 0000-0001-9130-0137
Shun IshibashiDivision of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University, Tochigi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

BenzoxazolesButyratesHypertriglyceridemiaHypolipidemic AgentsDiabetes Mellitus, Type 2HumansTriglyceridesBenzoxazolesButyratesHypolipidemic Agents(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidTriglyceridesclinical trialdyslipidaemialipid-lowering therapyphase III studyrandomized trialtype 2 diabetes

Identifiers

PMID30830727
PMCPMC6617746

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.