Abstract | BACKGROUND: METHODS: Thirty-six dyslipidemic patients, 21 females, mean age 63 years, were randomized to 2.5 mg or 5 mg elobixibat or placebo once daily for four weeks. The primary endpoint was the change in low density lipoprotein ( LDL) cholesterol. Secondary endpoints included other lipid parameters and serum 7α-hydroxy-4-cholesten-3-one (C4), a marker of BA ( bile acid) synthesis. Another study, in 36 patients with CC treated with high dose elobixibat; 15 mg or 20 mg/day or placebo for 14 days, was evaluated for changes in GLP-1. RESULTS: In the dyslipidemia study LDL cholesterol was reduced by 7.4 % (p = 0.044), and the LDL/HDL ratio was decreased by 18 % (p = 0.004). Serum C4 increased, indicating that BA synthesis was induced. No serious adverse events were recorded. In the CC study, GLP-1 increased significantly in both the 15 mg (20.7 ± 2.4 pmol/L; p = 0.03) and the 20 mg group (25.6 ± 4.9 pmol/L; p = 0.02). CONCLUSIONS:
Elobixibat reduces LDL cholesterol and LDL/HDL ratio and increase circulating peak GLP-1 levels, the latter in line with increased intestinal BA mediated responses in humans. TRIAL REGISTRATIONS: ClinicalTrial.gov: NCT01069783 and NCT01038687 .
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Authors | Mats Rudling, Michael Camilleri, Hans Graffner, Jens Juul Holst, Leif Rikner |
Journal | BMC cardiovascular disorders
(BMC Cardiovasc Disord)
Vol. 15
Pg. 75
(Jul 22 2015)
ISSN: 1471-2261 [Electronic] England |
PMID | 26197999
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bile Acids and Salts
- Cholestenones
- Cholesterol, HDL
- Cholesterol, LDL
- Dipeptides
- Lipids
- Thiazepines
- Triglycerides
- 7 alpha-hydroxy-4-cholesten-3-one
- elobixibat
- Glucagon-Like Peptide 1
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Bile Acids and Salts
(biosynthesis)
- Cholestenones
(blood)
- Cholesterol, HDL
(blood)
- Cholesterol, LDL
(blood)
- Chronic Disease
- Constipation
(blood, drug therapy)
- Dipeptides
(adverse effects, therapeutic use)
- Dyslipidemias
(blood, drug therapy)
- Female
- Glucagon-Like Peptide 1
(blood)
- Humans
- Lipids
(blood)
- Male
- Middle Aged
- Thiazepines
(adverse effects, therapeutic use)
- Triglycerides
(blood)
- Young Adult
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