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

Moti L. Kashyap, Mark E. McGovern, Kathleen Berra, John R. Guyton, Peter O. Kwiterovich, Wayne L. Harper, Phillip D. Toth, Laurence K. Favrot, Boris Kerzner, Stephen D. Nash, Harold E. Bays, Phillip D. Simmons

Research output: Contribution to journalArticle

Abstract

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 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.

Original languageEnglish (US)
Pages (from-to)672-678
Number of pages7
JournalThe American Journal of Cardiology
Volume89
Issue number6
DOIs
StatePublished - Mar 15 2002

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Lovastatin
Niacin
Dyslipidemias
Lipids
Safety
Drug Compounding
LDL Cholesterol
HDL Cholesterol
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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*. The American Journal of Cardiology, 89(6), 672-678. https://doi.org/10.1016/S0002-9149(01)02338-4

Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia*. / Kashyap, Moti L.; McGovern, Mark E.; Berra, Kathleen; Guyton, John R.; Kwiterovich, Peter O.; Harper, Wayne L.; Toth, Phillip D.; Favrot, Laurence K.; Kerzner, Boris; Nash, Stephen D.; Bays, Harold E.; Simmons, Phillip D.

In: The American Journal of Cardiology, Vol. 89, No. 6, 15.03.2002, p. 672-678.

Research output: Contribution to journalArticle

Kashyap, ML, McGovern, ME, Berra, K, Guyton, JR, Kwiterovich, PO, Harper, WL, Toth, PD, Favrot, LK, Kerzner, B, Nash, SD, Bays, HE & Simmons, PD 2002, 'Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia*', The American Journal of Cardiology, vol. 89, no. 6, pp. 672-678. https://doi.org/10.1016/S0002-9149(01)02338-4
Kashyap, Moti L. ; McGovern, Mark E. ; Berra, Kathleen ; Guyton, John R. ; Kwiterovich, Peter O. ; Harper, Wayne L. ; Toth, Phillip D. ; Favrot, Laurence K. ; Kerzner, Boris ; Nash, Stephen D. ; Bays, Harold E. ; Simmons, Phillip D. / Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia*. In: The American Journal of Cardiology. 2002 ; Vol. 89, No. 6. pp. 672-678.
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