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Efficacy and safety of an extended-release niacin (Niaspan): a long-term study.

Publication ,  Journal Article
Capuzzi, DM; Guyton, JR; Morgan, JM; Goldberg, AC; Kreisberg, RA; Brusco, OA; Brody, J
Published in: Am J Cardiol
December 17, 1998

Crystalline nicotinic acid (immediate-release niacin) is effective therapy for lipoprotein regulation and cardiovascular risk reduction. However, inconvenient regimens and unpleasant side effects decrease compliance. Sustained-release formulations designed to circumvent these difficulties increase hepatotoxicity. Niaspan, a new US Food and Drug Administration (FDA)-approved, once-daily, extended-release form, has been found effective and safe in short-term trials. The long-term efficacy and safety of Niaspan lipid monotherapy was studied in 517 patients (aged 21-75 years) for < or =96 weeks in dosages < or =3,000 mg/day. Primary efficacy endpoints were low-density lipoprotein (LDL) cholesterol and apolipoprotein B (apo B) changes from baseline; secondary efficacy endpoints were changes in total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, lipoprotein(a), and total cholesterol/HDL-cholesterol ratio; safety data included adverse events and laboratory values over the 2-year study period. LDL-cholesterol levels decreased significantly: 18% at week 48 and 20% at week 96; apo B reduction was similar (16% decrease at week 48 and 19% at week 96). Large elevations in HDL cholesterol (26%, week 48; 28%, week 96) allowed only modest decreases in total cholesterol (12% and 13%, respectively), whereas total cholesterol/HDL-cholesterol ratio decreased by almost one third. Triglyceride and lipoprotein(a) levels were decreased by 27% and 30%, respectively (week 48), and by 28% and 40%, respectively (week 96). All changes from baseline were significant (p <0.001). Niaspan was generally well tolerated, although flushing was common (75%); however, there was a progressive decrease in flushing with time from 3.3 episodes in the first month to < or = 1 episode by week 48. Aspirin was used by one third of patients before Niaspan dosing to minimize flushing episodes. Although serious adverse events occurred in about 10% of patients, none were considered probably or definitely related to Niaspan. Adverse events in general varied widely, but their true relation to the study drug is difficult to ascertain without a placebo (control) group. No deaths occurred. There were statistically significant changes in hepatic transaminases, alkaline phosphatase, direct bilirubin, phosphorus, glucose, amylase, and uric acid. However, these changes were mostly small and are not likely to be biologically or clinically significant (the decrease in phosphorus is a new finding in niacin therapy). No myopathy was observed. Thus, this long-term study confirms the earlier short-term findings that Niaspan is safe and effective as monotherapy in plasma lipoprotein regulation.

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Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

December 17, 1998

Volume

82

Issue

12A

Start / End Page

74U / 81U

Location

United States

Related Subject Headings

  • Niacin
  • Middle Aged
  • Male
  • Lipids
  • Hypolipidemic Agents
  • Hypercholesterolemia
  • Humans
  • Female
  • Delayed-Action Preparations
  • Clinical Trials as Topic
 

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Capuzzi, D. M., Guyton, J. R., Morgan, J. M., Goldberg, A. C., Kreisberg, R. A., Brusco, O. A., & Brody, J. (1998). Efficacy and safety of an extended-release niacin (Niaspan): a long-term study. Am J Cardiol, 82(12A), 74U-81U. https://doi.org/10.1016/s0002-9149(98)00731-0
Capuzzi, D. M., J. R. Guyton, J. M. Morgan, A. C. Goldberg, R. A. Kreisberg, O. A. Brusco, and J. Brody. “Efficacy and safety of an extended-release niacin (Niaspan): a long-term study.Am J Cardiol 82, no. 12A (December 17, 1998): 74U-81U. https://doi.org/10.1016/s0002-9149(98)00731-0.
Capuzzi DM, Guyton JR, Morgan JM, Goldberg AC, Kreisberg RA, Brusco OA, et al. Efficacy and safety of an extended-release niacin (Niaspan): a long-term study. Am J Cardiol. 1998 Dec 17;82(12A):74U-81U.
Capuzzi, D. M., et al. “Efficacy and safety of an extended-release niacin (Niaspan): a long-term study.Am J Cardiol, vol. 82, no. 12A, Dec. 1998, pp. 74U-81U. Pubmed, doi:10.1016/s0002-9149(98)00731-0.
Capuzzi DM, Guyton JR, Morgan JM, Goldberg AC, Kreisberg RA, Brusco OA, Brody J. Efficacy and safety of an extended-release niacin (Niaspan): a long-term study. Am J Cardiol. 1998 Dec 17;82(12A):74U-81U.
Journal cover image

Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

December 17, 1998

Volume

82

Issue

12A

Start / End Page

74U / 81U

Location

United States

Related Subject Headings

  • Niacin
  • Middle Aged
  • Male
  • Lipids
  • Hypolipidemic Agents
  • Hypercholesterolemia
  • Humans
  • Female
  • Delayed-Action Preparations
  • Clinical Trials as Topic