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

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

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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Crossref · 10.1001/archinte.162.14.1568

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  • Lower doses of nicotinic acid reduce the risk of worsening hyperglycemia.

    “Lower doses of nicotinic acid lessen this risk.”
  • At modest doses (750-2,000 mg/day), niacin significantly improves LDL cholesterol, HDL cholesterol, and triglyceride levels with only modest changes in glucose generally amenable to adjustment of diabetes therapy.

    “It can significantly increase blood glucose at high doses, but recent studies demonstrate that at modest doses (750–2,000 mg/day), significant improvements in LDL cholesterol, HDL cholesterol, and triglyceride levels are accompanied by only modest changes in glucose that are generally amenable to adjustment of diabetes therapy (205,206).”

    From Standards of Medical Care in Diabetes—2009 (2009) · cites this paper as [206]

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Authors
Grundy, S. M.
Affiliations
The University of Texas at Austin (US)
Corresponding author
Grundy, Scott M.
Venue
Archives of Internal Medicine
Published
2002-07-22
Volume
162
Issue
14
Pages
1568
ISSN
0003-9926 (ISSN-L)
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 › Surgery › 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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