A pilot study of the safety and efficacy of cholestin in treating HIV-related dyslipidemia.
OBJECTIVE
We collected preliminary safety and efficacy data on the effects of Cholestin, a statin-containing dietary supplement, in individuals with dsylipidemia related to human immunodeficiency virus.


METHODS
Fourteen adults with dsylipidemia related to human immunodeficiency virus characterized by hypercholesterolemia, hypertriacylglycerolemia, or both participated in a randomized, double-blind, placebo-controlled pilot study in an infectious disease clinic based in an academic medical center. Participants were randomly assigned to receive 1.2 g of Cholestin twice daily (n = 7) or placebo (n = 7) for 8 wk. The main outcome measures were safety (hepatic function tests, plasma human immunodeficiency virus-1 RNA levels, CD4(+) cell counts, adverse effects) and efficacy (fasting serum cholesterol: total, high- and low-density lipoproteins, and fasting serum triacylglycerols). Safety and efficacy outcomes were evaluated at 2- and 8-wk intervals.


RESULTS
Twelve participants (n = 6 per group) completed the 8-wk treatment protocol. After 8 wk of treatment with Cholestin, there were significant declines from baseline in mean (+/- standard error of the mean) fasting total cholesterol (-30.8 +/- 8.8 versus 7.7 +/- 5.6; P = 0.01) and low-density lipoprotein cholesterol (-32.2 +/- 7.2 versus 26.3 +/- 14.2; P = 0.01) versus placebo. Moreover, the decline in fasting total cholesterol was significant (-40.2 +/- 4.8 versus 2.8 +/- 11.9; P = 0.006) after 2 wk of therapy, at which time the low-density lipoprotein cholesterol approached significance (-30.2 +/- 7.4 versus 4.4 +/- 15.2; P = 0.068). High-density lipoprotein cholesterol and triacylglycerol levels did not change at either time point. No adverse effects were seen with Cholestin.


CONCLUSIONS
Cholestin may safely lower total and low-density lipoprotein cholesterol in patients with dsylipidemia related to human immunodeficiency virus. Larger and longer-term trials of this approach are warranted.
Keithley
Joyce K
JK
Rush University College of Nursing, Chicago, Illinois 60612, USA. jkeithley@rushu.rush.edu
Swanson
Barbara
B
Sha
Beverly E
BE
Zeller
Janice M
JM
Kessler
Harold A
HA
Smith
Kimberly Y
KY
D000328:Adult; D000924:Anticholesteremic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001688:Biological Products / Q000494:pharmacology* / Q000627:therapeutic use; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000503:physiopathology*; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy* / Q000209:etiology; D008111:Liver Function Tests; D008297:Male; D010865:Pilot Projects; D012449:Safety; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D019562:Viral Load
D000924:Anticholesteremic Agents; D001688:Biological Products; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D014280:Triglycerides; C117343:red yeast rice; D002784:Cholesterol