Equivalent efficacy of a time-release form of niacin (Niaspan) given once-a-night versus plain niacin in the management of hyperlipidemia

Knopp, R.H.; Davidson, M.; Goldberg, A.C.; Kafonek, S.D.; Kashyap, M.; Sprecher, D.; Superko, H.R.; Jenkins, S.; Marcovina, S.

« Previous Next »Metabolism - Clinical and Experimental
Volume 47, Issue 9 , Pages 1097-1104, September 1998

Equivalent efficacy of a time-release form of niacin (Niaspan) given once-a-night versus plain niacin in the management of hyperlipidemia☆

R.H. Knopp
- Address reprint requests to R.H. Knopp, MD, Northwest Lipid Research Clinic, #359720, 326 Ninth Ave, Seattle, WA 98104.
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
M. Davidson
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
A.C. Goldberg
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
S.D. Kafonek
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
M. Kashyap
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
D. Sprecher
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
H.R. Superko
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
S. Jenkins
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA
S. Marcovina
- Northwest Lipid Research Clinic, University of Washington, School of Medicine, Seattle, WA, USA
- St. Joseph's Heart Institute, Tampa, FL, USA
- Chicago Center for Clinical Research, Chicago, IL, USA
- Washington University School of Medicine, St. Louis, MO, USA
- Johns Hopkins University, Baltimore, MD, USA
- VA Medical Center, Cholesterol Center, Long Beach, CA, USA
- Center for Cholesterol Research, University Hospital, Cincinnati, OH, USA
- Berkeley Heart Lab and University of California, Berkeley, CA, USA
- College of Medicine, University of Cincinnati, Cincinnati, OH, USA

Received 6 October 1997; accepted 4 March 1998.

Abstract

This study compared the efficacy and safety of a once-a-night, time-release niacin formulation, Niaspan (Kos Pharmaceuticals, Miami Lakes, FL), with plain niacin and placebo for the treatment of primary hypercholesterolemia. The study was conducted in nine academic lipid research clinics in a randomized, double-blind design. Niaspa 1.5 g at bedtime was compared with plain niacin 1.5 g/d after 8 weeks and 3.0 g/d after 16 weeks in divided doses and with placebo. A total of 223 hypercholesterolemic adult men and women participated. Compared with placebo at 8 weeks, Niaspan versus plain niacin at 1.5 g/d showed comparable efficacy, comparably lowering total cholesterol (C) (), triglycerides ), low-density lipoprotein (LDL)-C (), apolipoprotein (apo B) (), apo E (), and lipoprotein(a) [Lp(a)] (), and raising high-density lipoprotein (HDL)-C (), HDL₂-C (37), HDL₃-C (), and apo A-I () (P ≤ .05 in all instances). After 16 weeks, the Niaspan effect on LDL-C and triglyceride was unchanged while the plain niacin effect approximately doubled. At equal doses of 1.5 g/d of Niapan versus plain niacin, respectively, AST increased 5.0% versus 4.8% (difference not significant [NS]), fasting plasma glucose increased 4.8% versus 4.5% (NS), and uric acid concentrations increased less, 6% versus 16% (P = .0001). Flushing events were more frequent with plain niacin versus Niaspan (1,905 v 576, P < .001). Flushing severity was slightly greater with Niaspan, but still well tolerated. In conclusion, Niaspan 1.5 g hour of sleep (hs) has comparable efficacy, a lower incidence of flushing, a lesser uric acid rise, and an equivalent hepatic enzyme effect than 500 mg thrice-daily plain niacin in hyperlipidemic subjects. Niaspan may be an equivalent or better alternative to plain niacin at moderate doses in the management of hyperlipidemia.