Skip to main content
Journal cover image

Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia.

Publication ,  Journal Article
Kashyap, ML; McGovern, ME; Berra, K; Guyton, JR; Kwiterovich, PO; Harper, WL; Toth, PD; Favrot, LK; Kerzner, B; Nash, SD; Bays, HE; Simmons, PD
Published in: Am J Cardiol
March 15, 2002

Combination therapy is increasingly recommended for patients with multiple lipid disorders, especially those at high risk for coronary events. We investigated the long-term safety and effectiveness of a new drug formulation containing once-daily extended-release niacin and lovastatin. A total of 814 men and women (mean age 59 years) with dyslipidemia were enrolled in a 52-week multicenter, open-label study. We used 4 escalating doses (niacin/lovastatin in milligrams): 500/10 for the first month, 1,000/20 for the second, 1,500/30 for the third, and 2,000/40 for the fourth month through week 52. Dose-dependent effects were observed for all major lipid parameters. At week 16, mean low-density lipoprotein (LDL) cholesterol and triglycerides were reduced by 47% and 41%, respectively; mean high-density lipoprotein (HDL) cholesterol was increased by 30% (all p <0.001). LDL/HDL cholesterol and total/HDL cholesterol ratios were also decreased by 58% and 48%, respectively. These effects persisted through week 52, except for the mean increase in HDL cholesterol, which had increased to 41% at 1 year. Lipoprotein (a) and C-reactive protein also decreased in a dose-related manner (by 25% and 24%, respectively, on 2,000/40 mg; p <0.01 vs baseline). Treatment was generally well tolerated. The most common adverse event was flushing, which caused 10% of patients to withdraw. Other adverse events included gastrointestinal upset, pruritus, rash, and headache. Drug-induced myopathy did not occur in any patient. The incidence of elevated liver enzymes to >3 times the upper limit of normal was 0.5%. Once-daily niacin/lovastatin exhibits substantial effects on multiple lipid risk factors and represents a significant new treatment option in the management of dyslipidemia.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

March 15, 2002

Volume

89

Issue

6

Start / End Page

672 / 678

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Risk Factors
  • Niacin
  • Middle Aged
  • Male
  • Lovastatin
  • Lipoprotein(a)
  • Hyperlipidemias
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Kashyap, M. L., McGovern, M. E., Berra, K., Guyton, J. R., Kwiterovich, P. O., Harper, W. L., … Simmons, P. D. (2002). Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. Am J Cardiol, 89(6), 672–678. https://doi.org/10.1016/s0002-9149(01)02338-4
Kashyap, Moti L., Mark E. McGovern, Kathleen Berra, John R. Guyton, Peter O. Kwiterovich, Wayne L. Harper, Phillip D. Toth, et al. “Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia.Am J Cardiol 89, no. 6 (March 15, 2002): 672–78. https://doi.org/10.1016/s0002-9149(01)02338-4.
Kashyap ML, McGovern ME, Berra K, Guyton JR, Kwiterovich PO, Harper WL, et al. Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. Am J Cardiol. 2002 Mar 15;89(6):672–8.
Kashyap, Moti L., et al. “Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia.Am J Cardiol, vol. 89, no. 6, Mar. 2002, pp. 672–78. Pubmed, doi:10.1016/s0002-9149(01)02338-4.
Kashyap ML, McGovern ME, Berra K, Guyton JR, Kwiterovich PO, Harper WL, Toth PD, Favrot LK, Kerzner B, Nash SD, Bays HE, Simmons PD. Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. Am J Cardiol. 2002 Mar 15;89(6):672–678.
Journal cover image

Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

March 15, 2002

Volume

89

Issue

6

Start / End Page

672 / 678

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Risk Factors
  • Niacin
  • Middle Aged
  • Male
  • Lovastatin
  • Lipoprotein(a)
  • Hyperlipidemias
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors