Niacin revisited. A randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia.
Two hundred one male and female subjects, aged 20 to 70 years, with elevated low-density lipoprotein cholesterol values (in the 75th to 95th percentiles), participated in a randomized, controlled, double-blind study using a new form of niacin (Enduracin), which employs a wax-matrix vehicle for sustained release. Four niacin treatment groups (daily doses of 2000, 1500, 1250, and 1000 mg) were compared with placebo- and diet-treated controls to determine side-effect profile and optimal range of efficacy. The groups given 2000 and 1500 mg demonstrated significant reductions in values of low-density lipoprotein cholesterol (-26% and -19.3%, respectively), total cholesterol (-18.4% and -13.3%), and total cholesterol-high-density lipoprotein cholesterol ratio (-20.4% and -19.4%) when compared with diet- and placebo-treated controls. Smaller improvements were seen in high-density lipoprotein cholesterol and triglyceride levels. Blood chemistry monitoring indicated that reduction in low-density lipoprotein cholesterol level strongly correlated with an increase in baseline levels of some enzymes for niacin-treated subjects. The improved side-effect profile of the wax-matrix form of niacin was particularly notable. The dropout rate due to side effects was only 3.4% and was coupled with good medication compliance.
Keenan
J M
JM
Department of Family Practice and Community Health, University of Minnesota, Minneapolis.
Fontaine
P L
PL
Wenz
J B
JB
Myers
S
S
Huang
Z Q
ZQ
Ripsin
C M
CM
D000328:Adult; D000368:Aged; D002626:Chemistry, Pharmaceutical; D002784:Cholesterol / Q000097:blood; D002791:Cholesterol, Dietary / Q000008:administration & dosage; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003692:Delayed-Action Preparations; D004041:Dietary Fats / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D009525:Niacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D010349:Patient Compliance; D011795:Surveys and Questionnaires
D002791:Cholesterol, Dietary; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003692:Delayed-Action Preparations; D004041:Dietary Fats; D009525:Niacin; D002784:Cholesterol