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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>
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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“Lower doses of nicotinic acid lessen this risk.”
From Diagnosis and Management of the Metabolic Syndrome: An American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement (2005) · cites this paper as [169]
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“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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Metadata
- 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)
- 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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