Evidence map›Paper›PMID 25750540›Full record

Trial reportVascular health and risk management2015

Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control.

Harold E Bays, Eliot A Brinton, Joseph Triscari, Erluo Chen, Darbie Maccubbin, Alexandra A MacLean, Kendra L Gibson, Rae Ann Ruck, Amy O Johnson-Levonas, Edward A O'Neill and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vascular health and risk management, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00485758. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
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.

NCT00485758 phase3completed

A Multicenter, Randomized, Double-Blind, Placebo Controlled 36 Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant in Patients With Type 2 Diabetes

Ran2007Enrolled796Registered outcomes3Posted comparisons3ConditionsDiabetes Mellitus Type 2ArmsComparator : placebo (unspecified), ER niacin/laropiprant
Open the trial in the graph
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
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

11 authors at 3 institutions in 1 country.

Harold E BaysLouisville Metabolic & Atherosclerosis Research Center (L-MARC), Louisville, KY, USA.
Eliot A BrintonUtah Foundation for Biomedical Research, Salt Lake City, UT, USA.
Joseph TriscariMerck & Co, Inc., Whitehouse Station, NJ, USA.
Erluo ChenMerck & Co, Inc., Whitehouse Station, NJ, USA.
Darbie MaccubbinMerck & Co, Inc., Whitehouse Station, NJ, USA.
Alexandra A MacLeanMerck & Co, Inc., Whitehouse Station, NJ, USA.
Kendra L GibsonMerck & Co, Inc., Whitehouse Station, NJ, USA.
Rae Ann RuckMerck & Co, Inc., Whitehouse Station, NJ, USA.
Amy O Johnson-LevonasMerck & Co, Inc., Whitehouse Station, NJ, USA.
Edward A O'NeillMerck & Co, Inc., Whitehouse Station, NJ, USA.
Yale B MitchelMerck & Co, Inc., Whitehouse Station, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USFoundation for Biomedical Research · USLouisville Metabolic and Atherosclerosis Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe degree of glycemic control in patients with type 2 diabetes mellitus (T2DM) may alter lipid levels and may alter the efficacy of lipid-modifying agents.

objectiveEvaluate the lipid-modifying efficacy of extended-release niacin/laropiprant (ERN/LRPT) in subgroups of patients with T2DM with better or poorer glycemic control.

methodsPost hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo (n=796), examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels.

resultsAt Week 12 of treatment, ERN/LRPT significantly improved low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, triglycerides, and lipoprotein (a), compared with placebo, with equal efficacy in patients above or below median baseline glycemic control. Compared with placebo, over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication, irrespective of baseline glycemic control. Incidences of other adverse experiences were generally low in all treatment groups.

conclusionThe lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM (NCT00485758).

Indexed as

AgedBiomarkersBlood GlucoseDelayed-Action PreparationsDiabetes Mellitus, Type 2Double-Blind MethodDrug CombinationsDrug InteractionsDyslipidemiasFemaleGlycated HemoglobinHumansHypoglycemic AgentsHypolipidemic AgentsIndolesLipidsBiomarkersBlood GlucoseDelayed-Action PreparationsDrug CombinationsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsHypolipidemic AgentsIndolesLipidsMK-0524NiacinHDLhyperglycemiaLDLlipid-modifying agentstriglycerides

Identifiers

PMID25750540
PMCPMC4348131
OpenAlexW2000958077

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.