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• W1977103686 abstract "Niacin (nicotinic acid), the most effective available pharmacotherapy for increasing high-density lipoprotein cholesterol, also lowers triglycerides and hence may be useful, alone or in combination with hydroxymethylglutaryl coenzyme A reductase inhibitors (statins), to offset residual cardiovascular risk in patients with mixed or diabetic dyslipidemia. We conducted a review of published consensus guidelines since 2000 and an English-language PubMed search of prospective, randomized controlled trials and open-label studies from January 1, 1990, through December 31, 2007, concerning the effects of niacin, alone or in combination with statins, on glycemic regulation in dyslipidemic patients (with or without diabetes mellitus). For search terms, we used the title words niacin or nicotinic acid and key words including diabetes, diabetic, dyslipidemia, glucose, glycemic, HbA1c, hemoglobin, hyperglycemia, human, insulin, postprandial, and safety. Retrospective and observational studies, case reports, and case studies were excluded. On the basis of our analysis, the effects of niacin (≤2.5 g/d), alone or in combination with statins, on fasting glucose (an increase of 4%-5%) and hemoglobin A1c levels (an increase of ≤0.3%) are modest, transient or reversible, and typically amenable to adjustments in oral hypoglycemic regimens without discontinuing niacin. Niacin therapy was infrequently associated with incident diabetes or the need for new insulin prescriptions. Studies showed important clinical benefits of niacin or niacin-statin regimens despite modest effects on glucose control. On a population basis, significant reductions in incidences of cardiovascular events and the degree of atherosclerotic progression associated with long-term niacin (or niacin-statin) therapy in patients with diabetic dyslipidemia outweigh the typically mild effects of this therapy on glycemic regulation. Consensus guidelines recommend monitoring glycemic control after initiating niacin treatment or increasing its dosage. Niacin (nicotinic acid), the most effective available pharmacotherapy for increasing high-density lipoprotein cholesterol, also lowers triglycerides and hence may be useful, alone or in combination with hydroxymethylglutaryl coenzyme A reductase inhibitors (statins), to offset residual cardiovascular risk in patients with mixed or diabetic dyslipidemia. We conducted a review of published consensus guidelines since 2000 and an English-language PubMed search of prospective, randomized controlled trials and open-label studies from January 1, 1990, through December 31, 2007, concerning the effects of niacin, alone or in combination with statins, on glycemic regulation in dyslipidemic patients (with or without diabetes mellitus). For search terms, we used the title words niacin or nicotinic acid and key words including diabetes, diabetic, dyslipidemia, glucose, glycemic, HbA1c, hemoglobin, hyperglycemia, human, insulin, postprandial, and safety. Retrospective and observational studies, case reports, and case studies were excluded. On the basis of our analysis, the effects of niacin (≤2.5 g/d), alone or in combination with statins, on fasting glucose (an increase of 4%-5%) and hemoglobin A1c levels (an increase of ≤0.3%) are modest, transient or reversible, and typically amenable to adjustments in oral hypoglycemic regimens without discontinuing niacin. Niacin therapy was infrequently associated with incident diabetes or the need for new insulin prescriptions. Studies showed important clinical benefits of niacin or niacin-statin regimens despite modest effects on glucose control. On a population basis, significant reductions in incidences of cardiovascular events and the degree of atherosclerotic progression associated with long-term niacin (or niacin-statin) therapy in patients with diabetic dyslipidemia outweigh the typically mild effects of this therapy on glycemic regulation. Consensus guidelines recommend monitoring glycemic control after initiating niacin treatment or increasing its dosage. Niacin (nicotinic acid), the serum cholesterol-lowering effects of which have been well documented for more than 50 years,1Altschul R Hoffer A Stephen JD Influence of nicotinic acid on serum cholesterol in man.Arch Biochem. 1955; 54: 558-559Crossref PubMed Scopus (428) Google Scholar is also considered the most effective available agent for increasing high-density lipoprotein cholesterol (HDL-C) and has other potentially beneficial effects on surrogate end points (eg, lipoprotein[a]). However, issues have been raised about the potentially adverse effects of niacin on glycemic regulation, including reduced peripheral insulin sensitivity, which may be secondary to a rebound increase in circulating fatty acids and/or to increased hepatic glucose output or glycogenolysis.2Stern RH Spence JD Freeman DJ Parbtani A Tolerance to nicotinic acid flushing.Clin Pharmacol Ther. 1991; 50: 66-70Crossref PubMed Scopus (69) Google Scholar, 3Guyton JR Bays HE Safety considerations with niacin therapy.Am J Cardiol. 2007 Mar 19; 99 (Epub 2006 Nov 28.): 22C-31CAbstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar, 4Wang W Basinger A Neese RA Christiansen M Hellerstein MK Effects of nicotinic acid on fatty acid kinetics, fuel selection, and pathways of glucose production in women.Am J Physiol Endocrinol Metab. 2000; 279: E50-E59PubMed Google Scholar, 5Wahlberg G Walldius G Efendic S Effects of nicotinic acid on glucose tolerance and glucose incorporation into adipose tissue in hypertriglyceridaemia.Scand J Clin Lab Invest. 1992; 52: 537-545Crossref PubMed Scopus (11) Google Scholar This review surveys current consensus guidelines concerning the use of niacin in patients with type 2 diabetes mellitus (DM) and/or diabetic dyslipidemia and reviews safety data from multicenter, randomized controlled trials (RCTs) and other studies involving niacin treatment in these and other patients, including any changes in fasting glucose (FG) levels, hemoglobin A1c (HbA1c), and antidiabetic medication use. To our knowledge, no studies of niacin as an antidyslipidemic agent in patients with type 1 DM have been published. We identified consensus guidelines including information on niacin in the management of diabetic dyslipidemia published since 2000.3Guyton JR Bays HE Safety considerations with niacin therapy.Am J Cardiol. 2007 Mar 19; 99 (Epub 2006 Nov 28.): 22C-31CAbstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar, 6Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report.Circulation. 2002; 106: 3143-3421PubMed Google Scholar, 7Buse JB Ginsberg HN Bakris GL et al.Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association.Circulation. 2007 Jan 2; 115 (Epub 2006 Dec 27.): 114-126Crossref PubMed Scopus (605) Google Scholar, 8Ryden L Standl E Bartnik M et al.Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary: the Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD).Eur Heart J. 2007; 28: 88-136PubMed Google Scholar, 9American Diabetes Association Standards of medical care in diabetes—2007.Diabetes Care. 2007; 30: S4-S41Crossref PubMed Scopus (1525) Google Scholar, 10Ginsberg HN. Dyslipidemia and diabetes mellitus: pathophysiology and treatment. National Diabetes Education Initiative (ndei.org) Web site. Treatment guidelines: management of patients with type 2 diabetes. http://www.ndei.org/v2/website/MiscContent/index.cfm?MiscContent_id=18. Published 2007. Accessed February 19, 2008.Google Scholar, 11Shepherd J Betteridge J Van Gaal L European Consensus Panel Nicotinic acid in the management of dyslipidaemia associated with diabetes and metabolic syndrome: a position paper developed by a European Consensus Panel.Curr Med Res Opin. 2005; 21: 665-682Crossref PubMed Scopus (105) Google Scholar, 12International Diabetes Federation, Clinical Guidelines Task Force Global guideline for type 2 diabetes. International Diabetes Federation Web site.http://www.idf.org/home/index.cfm?node=1457Date: 2005Google Scholar, 13Snow V Aronson MD Hornbake ER Clinical Efficacy Assessment Subcommittee of the American College of Physicians et al.Lipid control in the management of type 2 diabetes mellitus: a clinical practice guideline from the American College of Physicians.Ann Intern Med. 2004; 140: 644-649Crossref PubMed Scopus (133) Google Scholar, 14Grundy SM Cleeman JI Merz CN Coordinating Committee of the National Cholesterol Education Program et al.Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines.J Am Coll Cardiol. 2004; 44: 720-732Abstract Full Text Full Text PDF PubMed Scopus (1165) Google Scholar, 15Haffner SM American Diabetes Association Dyslipidemia management in adults with diabetes.Diabetes Care. 2004; 27: S68-S71PubMed Google Scholar, 16De Backer G Ambrosioni E Borch-Johnsen K et al.European guidelines on cardiovascular disease prevention in clinical practice: Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice.Eur Heart J. 2003; 24: 1601-1610Crossref PubMed Scopus (1683) Google Scholar We then conducted an English-language PubMed search of RCTs from January 1, 1990, through December 31, 2007, using the title words niacin or nicotinic acid and key words including diabetes, diabetic, dyslipidemia, glucose, glycemic, HbA1c, hemoglobin, hyperglycemia, human, insulin, postprandial, and safety. We then searched again, removing the restriction to RCTs. This resulted in additional articles (including reviews). The bibliographies of selected non-RCT articles and the consensus guidelines were further reviewed to identify relevant citations to RCTs, including data on niacin treatment and glycemic regulation. The analysis of the effects of niacin on indices of glycemic regulation included prospective RCTs and open-label studies, as well as analyses originating from or related to such trials. Retrospective and observational studies, case reports, and case studies were excluded. Consensus clinical panels including the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III), American Diabetes Association, and American Heart Association have issued guidelines concerning safe use of niacin to manage dyslipidemia.6Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report.Circulation. 2002; 106: 3143-3421PubMed Google Scholar, 7Buse JB Ginsberg HN Bakris GL et al.Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association.Circulation. 2007 Jan 2; 115 (Epub 2006 Dec 27.): 114-126Crossref PubMed Scopus (605) Google Scholar, 9American Diabetes Association Standards of medical care in diabetes—2007.Diabetes Care. 2007; 30: S4-S41Crossref PubMed Scopus (1525) Google Scholar The most detailed guidance concerning the safety of niacin was provided recently by the National Lipid Association,3Guyton JR Bays HE Safety considerations with niacin therapy.Am J Cardiol. 2007 Mar 19; 99 (Epub 2006 Nov 28.): 22C-31CAbstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar which stated that glucose increases are typically clinically modest (4%-5%) and that niacin treatment is not contraindicated in patients with DM or impaired FG. Furthermore, any increased risk associated with hyperglycemia is outweighed by the coronary artery disease (CAD) risk-reducing effects of niacin, including its salutary effects on HDL-C, triglyceride, lipoprotein(a), and low-density lipoprotein cholesterol levels as well as on low-density lipoprotein particle size. Additional recommendations and guidelines from the National Lipid Association and other panels concerning niacin administration and monitoring are detailed in Table 1.3Guyton JR Bays HE Safety considerations with niacin therapy.Am J Cardiol. 2007 Mar 19; 99 (Epub 2006 Nov 28.): 22C-31CAbstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar, 6Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report.Circulation. 2002; 106: 3143-3421PubMed Google Scholar, 7Buse JB Ginsberg HN Bakris GL et al.Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association.Circulation. 2007 Jan 2; 115 (Epub 2006 Dec 27.): 114-126Crossref PubMed Scopus (605) Google Scholar, 9American Diabetes Association Standards of medical care in diabetes—2007.Diabetes Care. 2007; 30: S4-S41Crossref PubMed Scopus (1525) Google Scholar, 10Ginsberg HN. Dyslipidemia and diabetes mellitus: pathophysiology and treatment. National Diabetes Education Initiative (ndei.org) Web site. Treatment guidelines: management of patients with type 2 diabetes. http://www.ndei.org/v2/website/MiscContent/index.cfm?MiscContent_id=18. Published 2007. Accessed February 19, 2008.Google Scholar, 11Shepherd J Betteridge J Van Gaal L European Consensus Panel Nicotinic acid in the management of dyslipidaemia associated with diabetes and metabolic syndrome: a position paper developed by a European Consensus Panel.Curr Med Res Opin. 2005; 21: 665-682Crossref PubMed Scopus (105) Google Scholar, 17Rodbard HW Blonde L Braithwaite SS AACE Diabetes Mellitus Clinical Practice Guidelines Task Force et al.American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus.Endocrine Pract. 2007; 13 (Accessed February 21, 2008.): 3-68www.aace.com/pub/pdf/guidelines/DMGuidelines2007.pdfGoogle ScholarTABLE 1Consensus Guidelines on Management of Diabetic Dyslipidemia With Niacin Therapya,AACE = American Association of Clinical Endocrinologists; ADA = American Diabetes Association; AHA = American Heart Association; ATP III = Adult Treatment Panel III; CAD = coronary artery disease; CV = cardiovascular; DM = diabetes mellitus; FG = fasting glucose; HDL-C = high-density lipoprotein cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; LDL-C = low-density lipoprotein cholesterol; NCEP = National Cholesterol Education Program; NDEI = National Diabetes Education Initiative; OAD = oral antidiabetic drug; PPG = postprandial glucose.bSI conversion factors: To convert LDL-C value to mmol/L, multiply by 0.0259; to convert glucose values to mmol/L, multiply by 0.0555.Consensus panelRecommendations/statementsNational Lipid Association,3Guyton JR Bays HE Safety considerations with niacin therapy.Am J Cardiol. 2007 Mar 19; 99 (Epub 2006 Nov 28.): 22C-31CAbstract Full Text Full Text PDF PubMed Scopus (221) Google Scholar 2007Minor (4%-5%) increases in glucose result from niacin-induced insulin resistance, but these increases are often clinically insignificant or readily treatedGlycemic control should be monitored after niacin initiation or dosage increaseIn some patients with IGT or IFG (eg, FG, 110-125 mg/dL), the possibility of inducing diabetes may outweigh the CV benefits of niacin. In such patients, niacin therapy may either be deferred to attempt improvements in glycemic regulation through lifestyle and dietary interventions or administered with careful monitoring as lifestyle and dietary initiatives are undertakenConsider withdrawing niacin or reducing dosage in patients with new-onset type 2 DM (FG >125 mg/dL or PPG >200 mg/dL). Niacin-associated insulin resistance is reversible. In some cases (eg, patients with very low HDL-C responding well to niacin or with progressive atherosclerotic disease), CV benefits might outweigh the role of niacin in inducing/perpetuating diabetic state If DM persists and requires OADs/insulin, consider reinitiating niacin, which will likely require no, or only minor, changes in antidiabetic therapyAHA/ADA,7Buse JB Ginsberg HN Bakris GL et al.Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association.Circulation. 2007 Jan 2; 115 (Epub 2006 Dec 27.): 114-126Crossref PubMed Scopus (605) Google Scholar 2007Both recognize niacin as the most effective available drug for raising HDL-C and state that clinical trials suggest CV risk reduction with niacin, although no trials of niacin in patients with DM have been performed. At higher doses, niacin can worsen hyperglycemiaADA,9American Diabetes Association Standards of medical care in diabetes—2007.Diabetes Care. 2007; 30: S4-S41Crossref PubMed Scopus (1525) Google Scholar 2007Niacin can significantly elevate blood glucose at high doses. However, at modest doses (750 mg/d to 2 g/d), significant lipid/lipoprotein benefits are accompanied by only modest alterations in glucose that are typically amenable to adjustment of antidiabetes regimensAACE,17Rodbard HW Blonde L Braithwaite SS AACE Diabetes Mellitus Clinical Practice Guidelines Task Force et al.American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus.Endocrine Pract. 2007; 13 (Accessed February 21, 2008.): 3-68www.aace.com/pub/pdf/guidelines/DMGuidelines2007.pdfGoogle Scholar 2007“Adverse effects of niacin therapy include flushing, mild hyperglycemia, hyperuricemia, upper-gastrointestinal distress, and hepatotoxicity. Although use of niacin in patients with diabetes mellitus has been limited because of associated increased hyperglycemia, niacin therapy is safe and effective in this patient population.”NDEI,10Ginsberg HN. Dyslipidemia and diabetes mellitus: pathophysiology and treatment. National Diabetes Education Initiative (ndei.org) Web site. Treatment guidelines: management of patients with type 2 diabetes. http://www.ndei.org/v2/website/MiscContent/index.cfm?MiscContent_id=18. Published 2007. Accessed February 19, 2008.Google Scholar 2007Niacin (or a fibrate [eg, fenofibrate]) may be effective in increasing HDL-C in patients with DM and an LDL-C of 100-129 mg/dLImproving glucose control can lower triglyceride levelsEuropean Consensus Panel,11Shepherd J Betteridge J Van Gaal L European Consensus Panel Nicotinic acid in the management of dyslipidaemia associated with diabetes and metabolic syndrome: a position paper developed by a European Consensus Panel.Curr Med Res Opin. 2005; 21: 665-682Crossref PubMed Scopus (105) Google Scholar 2005Niacin at clinically recommended doses (≤2 g/d) is an acceptable therapeutic alternative for patients with type 2 DM, as well as people with metabolic syndrome, at elevated risk of CADNCEP ATP III,6Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report.Circulation. 2002; 106: 3143-3421PubMed Google Scholar 2002High doses of niacin (>3 g/d) generally should be avoided in people with type 2 DM, although lower doses may effectively treat diabetic dyslipidemia without significantly worsening hyperglycemiaa AACE = American Association of Clinical Endocrinologists; ADA = American Diabetes Association; AHA = American Heart Association; ATP III = Adult Treatment Panel III; CAD = coronary artery disease; CV = cardiovascular; DM = diabetes mellitus; FG = fasting glucose; HDL-C = high-density lipoprotein cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; LDL-C = low-density lipoprotein cholesterol; NCEP = National Cholesterol Education Program; NDEI = National Diabetes Education Initiative; OAD = oral antidiabetic drug; PPG = postprandial glucose.b SI conversion factors: To convert LDL-C value to mmol/L, multiply by 0.0259; to convert glucose values to mmol/L, multiply by 0.0555. Open table in a new tab Department of Veterans Affairs Study. In this, the first randomized crossover study evaluating the utility of high-dose niacin in type 2 DM, 13 men (mean age, 59 years), 12 of whom were receiving an oral antidiabetic drug (OAD) (sulfonylurea) or insulin at baseline, were enrolled; the mean glycated hemoglobin for these patients was 9.6%.18Garg A Grundy SM Nicotinic acid as therapy for dyslipidemia in noninsulin-dependent diabetes mellitus.JAMA. 1990; 264: 723-726Crossref PubMed Scopus (275) Google Scholar After a 5-day dietary stabilization phase, patients were treated with immediate-release (IR) niacin (titrated from 150 mg/d to 4.5 g/d by treatment week 4, then maintained through week 8) or placebo. Compared with the placebo phase, niacin treatment was associated with a 21% increase in glycated hemoglobin (10.5% vs 8.7%; P=.002) and a 16% increase in mean plasma glucose (164 vs 141 mg/dL; P=.068) (to convert to mmol/L, multiply by 0.0555).18Garg A Grundy SM Nicotinic acid as therapy for dyslipidemia in noninsulin-dependent diabetes mellitus.JAMA. 1990; 264: 723-726Crossref PubMed Scopus (275) Google Scholar Although the findings of the Department of Veterans Affairs study signaled a need for caution in treating patients with type 2 DM with niacin, more recent studies (discussed later) specifying lower niacin doses, less aggressive titration schedules, and a more flexible approach to modifying OADs or insulin in the event of hyperglycemiahave been associated with more modest effects of niacin on glycemic regulation. Arterial Disease Multiple Intervention Trial. Some of these methodologic limitations were addressed in the Arterial Disease Multiple Intervention Trial (ADMIT),19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar in which 468 patients with hypercholesterolemia (125 patients [27%] with stable type 2 DM) received up to 1 g/d of niacin-IR during a 12-week active run-in period. Patients were then randomized to continued niacin or placebo for a further 48 weeks. Mean daily niacin doses after an 18-week titration phase were approximately 2.55 g in the DM group and 2.63 g in the non-DM group (P=.44).19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar As shown in Figure 1, niacin treatment was associated with modest, transient increases in FG among patients with DM, particularly as niacin was up-titrated (weeks 12-18). However, these elevations tended to return to baseline (preniacin) levels at the end of follow-up. Effects of niacin on these parameters in patients without DM were also modest. The increases in FG in the niacin group were significantly different from placebo among patients with DM or without DM.19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar Niacin treatment did not significantly affect HbA1c in patients with DM; however, a slight decrease (0.3%) in HbA1c in patients with DM receiving placebo differed significantly from the 0% change (P=.05) in the group receiving niacin. In patients without DM, both niacin and placebo increased HbA1c by 0.1%; no significant intertreatment difference in these effects and no significant change in the use of OADs or insulin dose were observed.19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar Similar proportions of patients receiving niacin (6%) or placebo (3%; P=.44) discontinued treatment because of glucose intolerance. A single case of incident (ie, new-onset) diabetes occurred among the 173 patients without DM who received niacin (0.6%). Niacin doses were reduced in 18 patients because HbA1c exceeded 10%.19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar The ADMIT investigators concluded that lipid-modifying doses (<3 g/d) of niacin-IR can be used safely in patients with stable, controlled type 2 DM.19Elam MB Hunninghake DB Davis KB et al.Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial.JAMA. 2000; 284: 1263-1270Crossref PubMed Scopus (475) Google Scholar Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial. The Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial (ADVENT)20Grundy SM Vega GL McGovern ME Diabetes Multicenter Research Group et al.Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial.Arch Intern Med. 2002; 162: 1568-1576Crossref PubMed Scopus (497) Google Scholar extended the findings of ADMIT in a smaller, 3-arm, 16-week RCT of 148 patients with type 2 DM who received extended-release (ER) niacin (niacin-ER, Niaspan [Abbott, Abbott Park, IL]) at a daily dose of 1.0 g or 1.5 g (or placebo). Eligible patients had stable type 2 DM, HbA1c of less than 9%, and FG levels of less than 200 mg/dL. From treatment week 4 through 12, no significant changes from baseline in HbA1c were noted for any group. Niacin-ER (1.5 g/d) increased HbA1c modestly (<0.3%) but significantly (from 7.21% to 7.50%; P=.048). Fasting glucose levels increased transiently and modestly at niacin-ER treatment weeks 4 and 8 but returned tobaseline by week 16, with no intertreatment differences.20Grundy SM Vega GL McGovern ME Diabetes Multicenter Research Group et al.Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial.Arch Intern Med. 2002; 162: 1568-1576Crossref PubMed Scopus (497) Google Scholar Slightly higher proportions of patients who were receiving niacin-ER required a new antidiabetic medication or an increased dosage of their current medication. Glycemic control worsened (by investigator judgment) in 18% of patients who were receiving 1.0 g/d of niacin-ER, in 29% of patients who were receiving 1.5 g/d of niacin-ER, and in 12% of patients who were receiving a placebo. Hyperglycemia prompted 4 (3%) patients to discontinue treatment. In conclusion, low doses of niacin-ER (≤1.5 g/d) were well tolerated, and modest increases in FG levels were effectively managed with adjustments in antidiabetic therapies.20Grundy SM Vega GL McGovern ME Diabetes Multicenter Research Group et al.Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial.Arch Intern Med. 2002; 162: 1568-1576Crossref PubMed Scopus (497) Google Scholar High-Density Lipoprotein Atherosclerosis Treatment Study. The HDL Atherosclerosis Treatment Study (HATS),21Zhao XQ Morse JS Dowdy AA et al.Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study).Am J Cardiol. 2004; 93: 307-312Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar a clinical and angiographic study evaluating treatment with slow-release niacin (Slo-Niacin [Upsher-Smith, Maple Grove, MN]) (mean daily dose, 2.4 g) plus simvastatin (mean daily dose, 13 mg) in 160 patients with CAD, showed that alterations in glycemic regulation associated with niacin-statin treatment were modest, transient, and amenable to adjustments in antidiabetic treatment regimens.21Zhao XQ Morse JS Dowdy AA et al.Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study).Am J Cardiol. 2004; 93: 307-312Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar Patients with DM were eligible if FG values were 180 mg/dL or lower, and 25 patients with DM (16%) were randomized to 4 factorial combinations of antioxidants or their placebos and simvastatin plus niacin or their placebos. In the active-treatment (simvastatin-niacin) group, the dose of slow-release niacin was escalated linearly, from 0.5 g/d to 2 g/d during a 4-week period, and patients with suboptimalHDL-C responses at treatment month 3, 8, or 12 were switched to niacin-IR, the dosage of which could be raised to a maximum of 4 g/d to meet prespecified HDL-C goals. In the event of suboptimal glycemic control, niacin-statin treatment could" @default.
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• W1977103686 title "Effects of Niacin on Glucose Control in Patients With Dyslipidemia" @default.
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