Clinical effects of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes.
OBJECTIVE
To evaluate the efficacy and safety of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes.


METHODS
A 16-week, randomized, double-blind, placebo-controlled, multinational study evaluating colesevelam in participants with primary hyperlipidemia (low-density lipoprotein cholesterol [LDL-C] level ≥ 100 mg/dL) and prediabetes (fasting plasma glucose level ≥ 110 to ≤ 125 mg/dL, or 2-hour postload glucose level ≥ 140 to < 200 mg/dL during an oral glucose tolerance test) was conducted between January 14, 2008 and April 3, 2009. Participants were randomized 1:1 to colesevelam 3.75 g/day or placebo. The primary efficacy endpoint was mean change from baseline in LDL-C level with colesevelam compared with placebo. Participants who self-identified as Hispanic during enrollment were included in this exploratory analysis evaluating the efficacy of colesevelam in Hispanics with primary hyperlipidemia and prediabetes.


RESULTS
From a total of 216 subjects with primary hyperlipidemia and prediabetes, 153 Hispanics were included in this post hoc analysis; 77 subjects were randomized to colesevelam and 76 subjects were randomized to placebo. At week 16, LDL-C levels were significantly reduced with colesevelam compared with placebo (mean treatment difference, -19.4%; P < 0.0001). Achievement of LDL-C level < 100 mg/dL was more frequent with colesevelam than with placebo (27% vs 11%; P = 0.002). In addition, significant mean reductions in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B levels (P ≤ 0.0002 for all), and a significant median increase in triglyceride levels (P = 0.003), were seen with colesevelam compared with placebo. At study end, there was a significant mean reduction in glycated hemoglobin levels and median reduction in fasting plasma glucose levels with colesevelam compared with placebo (P ≤ 0.02 for both). A fasting plasma glucose level < 100 mg/dL was achieved in 44% of colesevelam recipients compared with 23% of placebo recipients (P < 0.05). Overall, colesevelam was well tolerated.


CONCLUSIONS
Colesevelam may be a treatment option for Hispanic subjects with primary hyperlipidemia and prediabetes, mainly to reduce LDL-C levels, with added beneficial effect on glucose levels.


BACKGROUND
www.ClinicalTrials.gov identifier NCT00570739.
Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX 75230 , USA. juliorosenstock@dallasdiabetes.com
Julio
J
Rosenstock
Eric
E
Hernandez-Triana
Yehuda
Y
Handelsman
Soamnauth
S
Misir
Michael R
MR
Jones
D000499:Allylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001055:Apolipoproteins B; D001786:Blood Glucose; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects; D000069472:Colesevelam Hydrochloride; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin; D006630:Hispanic or Latino; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy / Q000208:ethnology*; D008075:Lipoproteins, HDL; D008297:Male; D011236:Prediabetic State / Q000188:drug therapy / Q000208:ethnology*; D016896:Treatment Outcome
D000499:Allylamine; D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001786:Blood Glucose; D008078:Cholesterol, LDL; D000069472:Colesevelam Hydrochloride; D006442:Glycated Hemoglobin; D008075:Lipoproteins, HDL