Clinical trial experience with extendedrelease niacin (niaspan): Dose- escalation study

American Journal of Cardiology

Volumn 82, Issue 12 A, 1998, Pages

  Goldberg, Anne Carol ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARTATE AMINOTRANSFERASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LACTATE DEHYDROGENASE; LIPOPROTEIN A; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NICOTINIC ACID; PLACEBO; TRIACYLGLYCEROL; URIC ACID;

ADULT; AGED; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSLIPIDEMIA; FEMALE; FLUSHING; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PRURITUS; RASH; SEX DIFFERENCE; SUSTAINED RELEASE FORMULATION;

EID: 0032542277     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9149(98)00952-7     Document Type: Conference Paper

References (18)

1. Grundy SM, Mok HY, Zech L, Berman M. Influence of nicotinic acid on metabolism of cholesterol and triglycerides in man. J Lipid Res 1981;22:24-36.
2. Martin-Jadraque R, Tato F, Mostaza JM, Vega GL, Grundy SM. Effectiveness of low-dose crystalline nicotinic acid in men with low high-density lipoprotein cholesterol levels. Arch Intern Med 1996;156:1081-1088.
3. Carlson LA, Hamsten A, Asplund A. Pronounced lowering of serum levels of lipoprotein Lp(a) in hyperlipidaemic subjects treated with nicotinic acid. J Intern Med 1989;226:271-276.
4. Seed M, O'Connor B, Perombelon N, O'Donnell M, Reaveley D, Knight BL. The effect of nicotinic acid and acipimox on lipoprotein(a) concentration and turnover. Atherosclerosis 1993;101:61-68.
5. The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975;231:360-381.
6. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W. Fifteen year mortality of Coronary Drug Project patients: long-term treatment with niacin. J Am Coll Cardiol 1986;8:1245-1255.
7. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA 1987;257:3233-3240.
8. Brown G, Albers JJ, Fisher LD, Schaefer SM, Lin J-T, Kaplan C, Zhao X-Q, Bisson BD, Fitzpatrick VF, Dodge HT. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B. N Engl J Med 1990;323:1289-1298.
9. Gibbons LW, Gonzalez V, Gordon N, Grundy S. The prevalence of side effects with regular and sustained-release nicotinic acid. Am J Med 1995;99:378-385.
10. Knopp RH, Ginsberg J, Albers JJ, Hoff C, Ogilvie JT, Warnick GR, Burrows E, Retzlaff B, Poole M. Contrasting effects of unmodified and time-release forms of niacin on lipoproteins in hyperlipidemic subjects: clues to mechanism of action of niacin. Metabolism 1985;34:642-650.
11. Gray DR, Morgan T, Chretien SD, Kashyap MD. Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans. Ann Intern Med 1994; 121:252-258.
12. Knopp RH. Niacin and hepatic failure. (Abstr.) Ann Intern Med 1989;111: 769.
13. Mullin GE, Greenson JK, Mitchell MC. Fulminant hepatic failure after ingestion of sustained-release nicotinic acid. Ann Intern Med 1989;111:253-255.
14. Hodis HN. Acute hepatic failure associated with the use of low-dose sustained-release niacin. (Abstr.) JAMA 1990;264:181.
15. McKenney JM, Proctor JD, Harris S, Chinchili VM. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA 1994;271:672-677.
16. Goldberg AC, Alagona P, Capuzzi DM, Guyton J, Morgan JM, Rodgers J, Sachson R, Samuel P. Multiple dose efficacy and safety of an extended-release form of niacin in the management of hyperlipidemia. Am J Cardiol 1998; 82(12A):35U-38U.
17. Knopp RH. Clinical profiles of plain versus sustained-release niacin and the physiologic rationale for nighttime dosing. Am J Cardiol 1998;82(12A):35U-38U.
18. Morgan JM, Capuzzi DM, Guyton JR, Centor RM, Goldberg R, Robbins DC, DiPette D, Jenkins S, Marcovina S. Treatment effect of Niaspan, a controlled-release niacin, in patients with hypercholesterolemia: a placebo-controlled trial. J Cardiovasc Pharmacol 1996;1:195-202.