Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes

a randomized, prospective study.

Yehuda Handelsman, Ronald B Goldberg, W. Timothy Garvey, Vivian A. Fonseca, Julio Rosenstock, Michael R. Jones, Yu Ling Lai, Xiaoping Jin, Soamnauth Misir, Sukumar Nagendran, Stacey L. Abby

Research output: Contribution to journalArticle

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Abstract

To assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes. In this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test [OGTT] glucose > or =140 to 199 mg/dL, fasting plasma glucose [FPG] > or =110 to 125 mg/dL, or both), low-density lipoprotein cholesterol (LDL-C) > or =100 mg/dL, and triglycerides <500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo. The primary end point was percent change in LDL-C from baseline to week 16 with last observation carried forward. Secondary end points included change in FPG, hemoglobin A1c (A1C), and 2-hour post-OGTT glucose level from baseline to week 16 and attainment of LDL-C and FPG targets. In total, 216 patients were randomized (colesevelam, 108; placebo, 108). In comparison with placebo, colesevelam significantly reduced LDL-C (mean treatment difference, -15.6%), non-high-density lipoprotein cholesterol (-9.1%), total cholesterol (-7.2%), apolipoprotein B (-8.1%) (P<.001 for all the foregoing), FPG (median, -2.0 mg/dL; P = .02), and A1C (mean, -0.10%; P = .02). Colesevelam did not significantly change 2-hour post-OGTT glucose (-1.9 mg/dL; P = .75) or high-density lipoprotein cholesterol (-0.5%; P = .80). In addition, colesevelam significantly increased triglyceride levels relative to placebo (median, 14.3%; P<.001). The proportion of patients achieving target levels with colesevelam versus placebo, respectively, was as follows: LDL-C <100 mg/dL (29% versus 11%; P<.001), A1C <6.0% (37% versus 25%; P = .05), FPG <110 mg/dL (48% versus 56%; P = .97), and normalization of glucose (FPG <100 mg/dL [40% versus 23%; P = .06]). Colesevelam had a weight-neutral effect and was well tolerated. Colesevelam is an option for managing the lipid profile and normalizing glucose levels in patients with hypercholesterolemia and prediabetes. Further study is warranted to determine whether colesevelam slows or prevents progression of prediabetes to type 2 diabetes.

Original languageEnglish
Pages (from-to)617-628
Number of pages12
JournalEndocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Volume16
Issue number4
StatePublished - Jul 1 2010
Externally publishedYes

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Prediabetic State
Hypercholesterolemia
Prospective Studies
Glucose
Fasting
LDL Cholesterol
Glucose Tolerance Test
Placebos
Triglycerides
Colesevelam Hydrochloride
Apolipoproteins B
Bile Acids and Salts
Double-Blind Method
Type 2 Diabetes Mellitus
HDL Cholesterol
Hemoglobins
Cholesterol
Observation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes : a randomized, prospective study. / Handelsman, Yehuda; Goldberg, Ronald B; Garvey, W. Timothy; Fonseca, Vivian A.; Rosenstock, Julio; Jones, Michael R.; Lai, Yu Ling; Jin, Xiaoping; Misir, Soamnauth; Nagendran, Sukumar; Abby, Stacey L.

In: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, Vol. 16, No. 4, 01.07.2010, p. 617-628.

Research output: Contribution to journalArticle

Handelsman, Yehuda ; Goldberg, Ronald B ; Garvey, W. Timothy ; Fonseca, Vivian A. ; Rosenstock, Julio ; Jones, Michael R. ; Lai, Yu Ling ; Jin, Xiaoping ; Misir, Soamnauth ; Nagendran, Sukumar ; Abby, Stacey L. / Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes : a randomized, prospective study. In: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. 2010 ; Vol. 16, No. 4. pp. 617-628.
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abstract = "To assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes. In this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test [OGTT] glucose > or =140 to 199 mg/dL, fasting plasma glucose [FPG] > or =110 to 125 mg/dL, or both), low-density lipoprotein cholesterol (LDL-C) > or =100 mg/dL, and triglycerides <500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo. The primary end point was percent change in LDL-C from baseline to week 16 with last observation carried forward. Secondary end points included change in FPG, hemoglobin A1c (A1C), and 2-hour post-OGTT glucose level from baseline to week 16 and attainment of LDL-C and FPG targets. In total, 216 patients were randomized (colesevelam, 108; placebo, 108). In comparison with placebo, colesevelam significantly reduced LDL-C (mean treatment difference, -15.6{\%}), non-high-density lipoprotein cholesterol (-9.1{\%}), total cholesterol (-7.2{\%}), apolipoprotein B (-8.1{\%}) (P<.001 for all the foregoing), FPG (median, -2.0 mg/dL; P = .02), and A1C (mean, -0.10{\%}; P = .02). Colesevelam did not significantly change 2-hour post-OGTT glucose (-1.9 mg/dL; P = .75) or high-density lipoprotein cholesterol (-0.5{\%}; P = .80). In addition, colesevelam significantly increased triglyceride levels relative to placebo (median, 14.3{\%}; P<.001). The proportion of patients achieving target levels with colesevelam versus placebo, respectively, was as follows: LDL-C <100 mg/dL (29{\%} versus 11{\%}; P<.001), A1C <6.0{\%} (37{\%} versus 25{\%}; P = .05), FPG <110 mg/dL (48{\%} versus 56{\%}; P = .97), and normalization of glucose (FPG <100 mg/dL [40{\%} versus 23{\%}; P = .06]). Colesevelam had a weight-neutral effect and was well tolerated. Colesevelam is an option for managing the lipid profile and normalizing glucose levels in patients with hypercholesterolemia and prediabetes. Further study is warranted to determine whether colesevelam slows or prevents progression of prediabetes to type 2 diabetes.",
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T1 - Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes

T2 - a randomized, prospective study.

AU - Handelsman, Yehuda

AU - Goldberg, Ronald B

AU - Garvey, W. Timothy

AU - Fonseca, Vivian A.

AU - Rosenstock, Julio

AU - Jones, Michael R.

AU - Lai, Yu Ling

AU - Jin, Xiaoping

AU - Misir, Soamnauth

AU - Nagendran, Sukumar

AU - Abby, Stacey L.

PY - 2010/7/1

Y1 - 2010/7/1

N2 - To assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes. In this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test [OGTT] glucose > or =140 to 199 mg/dL, fasting plasma glucose [FPG] > or =110 to 125 mg/dL, or both), low-density lipoprotein cholesterol (LDL-C) > or =100 mg/dL, and triglycerides <500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo. The primary end point was percent change in LDL-C from baseline to week 16 with last observation carried forward. Secondary end points included change in FPG, hemoglobin A1c (A1C), and 2-hour post-OGTT glucose level from baseline to week 16 and attainment of LDL-C and FPG targets. In total, 216 patients were randomized (colesevelam, 108; placebo, 108). In comparison with placebo, colesevelam significantly reduced LDL-C (mean treatment difference, -15.6%), non-high-density lipoprotein cholesterol (-9.1%), total cholesterol (-7.2%), apolipoprotein B (-8.1%) (P<.001 for all the foregoing), FPG (median, -2.0 mg/dL; P = .02), and A1C (mean, -0.10%; P = .02). Colesevelam did not significantly change 2-hour post-OGTT glucose (-1.9 mg/dL; P = .75) or high-density lipoprotein cholesterol (-0.5%; P = .80). In addition, colesevelam significantly increased triglyceride levels relative to placebo (median, 14.3%; P<.001). The proportion of patients achieving target levels with colesevelam versus placebo, respectively, was as follows: LDL-C <100 mg/dL (29% versus 11%; P<.001), A1C <6.0% (37% versus 25%; P = .05), FPG <110 mg/dL (48% versus 56%; P = .97), and normalization of glucose (FPG <100 mg/dL [40% versus 23%; P = .06]). Colesevelam had a weight-neutral effect and was well tolerated. Colesevelam is an option for managing the lipid profile and normalizing glucose levels in patients with hypercholesterolemia and prediabetes. Further study is warranted to determine whether colesevelam slows or prevents progression of prediabetes to type 2 diabetes.

AB - To assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes. In this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test [OGTT] glucose > or =140 to 199 mg/dL, fasting plasma glucose [FPG] > or =110 to 125 mg/dL, or both), low-density lipoprotein cholesterol (LDL-C) > or =100 mg/dL, and triglycerides <500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo. The primary end point was percent change in LDL-C from baseline to week 16 with last observation carried forward. Secondary end points included change in FPG, hemoglobin A1c (A1C), and 2-hour post-OGTT glucose level from baseline to week 16 and attainment of LDL-C and FPG targets. In total, 216 patients were randomized (colesevelam, 108; placebo, 108). In comparison with placebo, colesevelam significantly reduced LDL-C (mean treatment difference, -15.6%), non-high-density lipoprotein cholesterol (-9.1%), total cholesterol (-7.2%), apolipoprotein B (-8.1%) (P<.001 for all the foregoing), FPG (median, -2.0 mg/dL; P = .02), and A1C (mean, -0.10%; P = .02). Colesevelam did not significantly change 2-hour post-OGTT glucose (-1.9 mg/dL; P = .75) or high-density lipoprotein cholesterol (-0.5%; P = .80). In addition, colesevelam significantly increased triglyceride levels relative to placebo (median, 14.3%; P<.001). The proportion of patients achieving target levels with colesevelam versus placebo, respectively, was as follows: LDL-C <100 mg/dL (29% versus 11%; P<.001), A1C <6.0% (37% versus 25%; P = .05), FPG <110 mg/dL (48% versus 56%; P = .97), and normalization of glucose (FPG <100 mg/dL [40% versus 23%; P = .06]). Colesevelam had a weight-neutral effect and was well tolerated. Colesevelam is an option for managing the lipid profile and normalizing glucose levels in patients with hypercholesterolemia and prediabetes. Further study is warranted to determine whether colesevelam slows or prevents progression of prediabetes to type 2 diabetes.

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