Evidence map›Paper›PMID 27036394›Full record

Trial reportThe American journal of medicine2016

Effects of Extended-Release Niacin Added to Simvastatin/Ezetimibe on Glucose and Insulin Values in AIM-HIGH.

Ronald B Goldberg, Vera A Bittner, Richard L Dunbar, Jerome L Fleg, George Grunberger, John R Guyton, Lawrence A Leiter, Ruth McBride, Jennifer G Robinson, Debra L Simmons and 3 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 5% 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.

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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Niacin for primary and secondary prevention of cardiovascular events.The Cochrane database of systematic reviews · 2017 · on this map
    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 at 12 institutions in 2 countries.

Ronald B GoldbergDivision of Endocrinology, Metabolism and Diabetes, University of Miami Miller School of Medicine, Fla.
Vera A BittnerDivision of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham School of Medicine.
Richard L DunbarDivision of Translational Medicine and Human Genetics, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Jerome L FlegDivision of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, Md.
George GrunbergerGrunberger Diabetes Institute, Bloomfield Hills, Mich.
John R GuytonDuke University Medical Center, Durham, NC.
Lawrence A LeiterDivision of Endocrinology and Metabolism, Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michaels Hospital, Toronto, Ont, Canada.
Ruth McBrideAxio Research, LLC, Seattle, Wash. Electronic address: ruthm@axioresearch.com.
Jennifer G RobinsonCollege of Public Health & Carver College of Medicine, University of Iowa, Iowa City.
Debra L SimmonsDivision of Endocrinology, Department of Internal Medicine, University of Utah, Salt Lake City.
Carol WyshamRockwood Diabetes and Endocrinology, Spokane, Wash.
Ping XuPPD, Wilmington, NC.
William E BodenDepartment of Medicine, Albany VA Medical Center, NY.
Albany Stratton VA Medical Center Albany · USAptevo Therapeutics (United states) · USDuke Medical Center · USGrunberger Diabetes Institute · USNational Heart Lung and Blood Institute · USRockwood Clinic · USSt. Michael's Hospital · CAUniversity of Alabama at Birmingham · USUniversity of Iowa · USUniversity of Miami · USUniversity of Pennsylvania · USUniversity of Utah · US

Funding

University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Kirk Michael Habegger · 2013 to 2026
$19.5M
AIM-HIGHU01HL081649 · NHLBI · AXIO RESEARCH, LLC · PI MCBRIDE, RUTH M · 2005 to 2010
$15.1M
AIM HIGH: Niacin Plus Statin to Prevent Vascular EventsU01HL081616 · NHLBI · UNIVERSITY OF WASHINGTON · PI PROBSTFIELD, JEFFREY LYNN · 2005 to 2010
$6.0M
Biomarkers and Outcomes in the Diabetes Prevention ProgramR01DK078907 · NIDDK · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI GOLDBERG, RONALD B · 2008 to 2010
$1.5M
NHLBI NIH HHS U01 HL081616NHLBI NIH HHS U01 HL081649NIDDK NIH HHS P30 DK079626NIDDK NIH HHS R01 DK078907
6 · The paper itself

Abstract

backgroundNiacin is an antidyslipidemic agent that may cause blood sugar elevation in patients with diabetes, but its effects on glucose and insulin values in nondiabetic statin-treated subjects with cardiovascular disease and at high risk for diabetes are less well known.

methodsThis was a prespecified, intent-to-treat analysis of the Atherothrombosis Intervention in Metabolic syndrome with low high-density lipoprotein/high triglycerides: Impact on Global Health outcomes trial which randomized 3,414 participants at 92 centers in the US and Canada to extended-release niacin (ERN) plus simvastatin/ezetimibe (ERN) or simvastatin/ezetimibe plus placebo (Placebo). Baseline and annual fasting glucose and insulin values were measured. Those experiencing an adverse event indicative of diabetes or starting medications for diabetes were considered to have confirmed diabetes. In addition, nondiabetic subjects with 2 annual follow-up glucose measurements were categorized into normal, impaired fasting glucose or newly diagnosed diabetes (presumed or confirmed) states.

resultsCompared with placebo, ERN increased annual fasting glucose from baseline to 1 year in both those with normal (7.9 ± 15.8 vs 4.3 ± 10.3 mg/dL; P < .001) and impaired fasting glucose (4.1 ± 18.7 vs 1.4 ± 14.9; P < .02) and increased insulin levels. Both effects waned over the next 2 years. There were less consistent effects in those with baseline diabetes. There was an increased risk of progressing from normal to presumed or confirmed impaired fasting glucose (ERN 197/336) cases (58.6%) vs placebo 135/325 cases (41.5%; P < .001) over time, but no difference in diabetes development in the 2 treatment groups except in those with normal fasting glucose at baseline.

conclusionsThe addition of ERN to simvastatin/ezetimibe had marginal effects on glycemia in those with diabetes at baseline, and there was a trend toward increased development of new-onset diabetes. In addition, ERN increased the risk of developing impaired fasting glucose, which may have deleterious consequences over time and warrants further study.

Indexed as

AgedBlood GlucoseDelayed-Action PreparationsDiabetes MellitusDrug Therapy, CombinationEzetimibe, Simvastatin Drug CombinationFemaleGlucose IntoleranceHumansHypolipidemic AgentsInsulinIntention to Treat AnalysisMaleMiddle AgedNiacinBlood GlucoseDelayed-Action PreparationsEzetimibe, Simvastatin Drug CombinationHypolipidemic AgentsInsulinNiacinClinical trialDiabetesExtended release niacinGlucose and insulinHeart diseaseImpaired fasting glucoses

Identifiers

PMID27036394
PMCPMC4914402
OpenAlexW2324454784

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.