Cited by 551Lipoproteins and Cardiovascular HealthDiabetes, Cardiovascular Risks, and LipoproteinsLipid metabolism and disorders

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Efficacy, Safety, and Tolerability of Once-Daily Niacin for the Treatment of Dyslipidemia Associated With Type 2 Diabetes<subtitle>Results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial</subtitle>

Grundy, Scott M.·2002·Archives of Internal Medicine

DOI 10.1001/archinte.162.14.1568

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Abstract

BACKGROUND: Diabetic dyslipidemia is characterized by high triglyceride levels; low high-density lipoprotein cholesterol levels; small, dense low-density lipoprotein particles; and high free fatty acid levels. Niacin reduces concentrations of triglyceride-rich and small low-density lipoprotein particles while increasing high-density lipoprotein cholesterol levels. It also lowers levels of free fatty acids and lipoprotein(a). However, the use of niacin in patients with diabetes has been discouraged because high doses can worsen glycemic control. We evaluated the efficacy and safety of once-daily extended-release (ER) niacin in patients with diabetic dyslipidemia. METHODS: During a 16-week, double-blind, placebo-controlled trial, 148 patients were randomized to placebo (n = 49) or 1000 (n = 45) or 1500 mg/d (n = 52) of ER niacin. Sixty-nine patients (47%) were also receiving concomitant therapy with statins. RESULTS: Dose-dependent increases in high-density lipoprotein cholesterol levels (+19% to +24% [P<.05] vs placebo for both niacin dosages) and reductions in triglyceride levels (-13% to -28% [P<.05] vs placebo for the 1500-mg ER niacin) were observed. Baseline and week 16 values for glycosylated hemoglobin levels were 7.13% and 7.11%, respectively, in the placebo group; 7.28% and 7.35%, respectively, in the 1000-mg ER niacin group (P=.16 vs placebo); and 7.2% and 7.5%, respectively, in the 1500-mg ER niacin group (P=.048 vs placebo). Four patients discontinued participation because of inadequate glucose control. Rates of adverse event rates other than flushing were similar for the niacin and placebo groups. Four patients discontinued participation owing to flushing (including 1 receiving placebo). No hepatotoxic effects or myopathy were observed. CONCLUSION: Low doses of ER niacin (1000 or 1500 mg/d) are a treatment option for dyslipidemia in patients with type 2 diabetes.

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Authors: Grundy, S. M.
Affiliations: The University of Texas at Austin (US)
Corresponding author: Grundy, Scott M.
ORCID: Grundy, Scott M.
Venue: Archives of Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2002-07-22
Volume: 162
Issue: 14
Pages: 1568
ISSN: 0003-9926 (ISSN-L)
DOI: 10.1001/archinte.162.14.1568
OpenAlex: W2119065130
Cited by: 551
References: 21
Citations by year: 2026: 2 · 2025: 2 · 2024: 4 · 2023: 3 · 2022: 5 · 2021: 6 · 2020: 8 · 2019: 5 · 2018: 3 · 2017: 5 · 2016: 6 · 2015: 16 · 2014: 14 · 2013: 31 · 2012: 28
FWCI: 50.60
Type: journal article
Language: en
Open access: closed
Locations: Archives of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
Keywords: nicotinic acid, extended-release niacin, diabetic dyslipidemia, type 2 diabetes, hypertriglyceridemia, HDL cholesterol, triglycerides, glycemic control, statin combination therapy, lipoprotein(a), drug safety and tolerability, dose-response relationship, hepatotoxicity, myopathy, HbA1c, small dense LDL
MeSH terms: Adult, Aged, Hypolipidemic Agents, Blood Glucose, C-Reactive Protein, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Hyperlipidemias, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Niacin, Triglycerides, United States, Biomarkers, Body Mass Index, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Endpoint Determination

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Efficacy, Safety, and Tolerability of Once-Daily Niacin for the Treatment of Dyslipidemia Associated With Type 2 Diabetes<subtitle>Results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial</subtitle>

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