Page last updated: 2024-10-23

berberine and Arteriosclerosis, Coronary

berberine has been researched along with Arteriosclerosis, Coronary in 3 studies

Research Excerpts

Excerpt	Relevance	Reference
"A double-blind, randomized, placebo-controlled, dose ranging study was carried out that compared three doses of berberine ursodeoxycholate (BUDCA) to placebo in a cohort of subjects with a history of hypercholesterolemia and serum LDL cholesterol levels above 2."	5.34	Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia. ( Bai, R; Di Bisceglie, AM; Lavin, P; Liu, L; Watts, GF; Yu, M, 2020)

Research

Studies (3)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	3 (100.00)	2.80

Authors

Authors	Studies
Long, T	3
Pan, W	3
Li, F	3
Sheikh, SA	3
Xie, Q	3
Zhang, C	3
Xu, M	1
Qi, Q	1
Men, L	1
Wang, S	2
Li, M	1
Xiao, M	1
Chen, X	1
Wang, G	1
Jia, H	1
Liu, C	1
Di Bisceglie, AM	1
Watts, GF	1
Lavin, P	1
Yu, M	1
Bai, R	1
Liu, L	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia[NCT03381287]			Phase 1/Phase 2	50 participants (Actual)	Interventional	2018-04-13	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration

(NCT03381287)
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

Intervention	ng/mL (Mean)
	Berberine (BBR)	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg BID	1.770	3370
HTD1801 250 mg BID	0.676	962
HTD1801 500 mg BID	1.510	1900

Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration

(NCT03381287)
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

Intervention	ng/mL (Mean)
	Berberine (BBR)	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg	0.865	2900
HTD1801 250 mg	0.390	923
HTD1801 500 mg	0.441	1900

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug. (NCT03381287)
Timeframe: 4 weeks

,,,

Intervention	Participants (Count of Participants)
	TEAE	Serious TEAE	Severe TEAE	Drug-related TEAEs	TEAEs leading to treatment interrupted or discontinued
HTD1801 1000 mg BID	11	1	0	6	1
HTD1801 250 mg BID	10	0	0	2	0
HTD1801 500 mg BID	8	0	0	7	0
Placebo	8	0	1	4	0

Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups

(NCT03381287)
Timeframe: Baseline, Day 14, Day 28

,,,

Intervention	percentage change from baseline (Mean)
	Percent Change from Baseline to Day 14	Percent Change from Baseline to Day 28
HTD1801 1000 mg BID	-32.192	-34.382
HTD1801 250 mg BID	-38.672	-46.458
HTD1801 500 mg BID	-41.295	47.246
Placebo	-41.743	-33.153

Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups

(NCT03381287)
Timeframe: Baseline, Day 14, Day 28

,,,

Intervention	percentage change from baseline (Mean)
	Percent Change from Baseline to Day 14	Percent Change from Baseline to Day 28
HTD1801 1000 mg BID	-13.034	-21.916
HTD1801 250 mg BID	-19.527	-11.239
HTD1801 500 mg BID	222.4113	242.570
Placebo	-4.975	10.582

Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups

(NCT03381287)
Timeframe: Baseline, Day 14, Day 28

,,,

Intervention	percentage change from baseline (Mean)
	Percent Change from Baseline to Day 14	Percent Change from Baseline to Day 28
HTD1801 1000 mg BID	-9.296	-9.767
HTD1801 250 mg BID	-3.390	-7.674
HTD1801 500 mg BID	-1.1550	0.372
Placebo	3.624	-3.585

Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups

(NCT03381287)
Timeframe: Baseline, Day 14, Day 28

,,,

Intervention	percentage change from baseline (Mean)
	Percent Change from Baseline to Day 14	Percent Change from Baseline to Day 28
HTD1801 1000 mg BID	-2.240	6.256
HTD1801 250 mg BID	-5.788	7.684
HTD1801 500 mg BID	12.798	25.882
Placebo	1.724	36.778

Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration

(NCT03381287)
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

Intervention	hours (Mean)
	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg BID	7.53
HTD1801 500 mg BID	7.60

Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration

(NCT03381287)
Timeframe: 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

Intervention	hours (Mean)
	Berberine (BBR)	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg	7.79	5.24
HTD1801 250 mg	9.04	2.79
HTD1801 500 mg	10.60	8.43

Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration

(NCT03381287)
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

Intervention	hours (Median)
	Berberine (BBR)	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg BID	4.0	3.0
HTD1801 250 mg BID	4.0	3.0
HTD1801 500 mg BID	4.0	4.0

Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration

(NCT03381287)
Timeframe: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

Intervention	hours (Median)
	Berberine (BBR)	Ursodeoxycholic Acid (UDCA)
HTD1801 1000 mg	4.0	4.0
HTD1801 250 mg	3.5	2.0
HTD1801 500 mg	4.0	3.0

Trials

1 trial available for berberine and Arteriosclerosis, Coronary

Article	Year
Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia. Lipids in health and disease, 2020, Nov-12, Volume: 19, Issue:1 Topics: Adult; Aged; Berberine; Cholesterol; Cholesterol, LDL; Coronary Artery Disease; Diabetes Mellitus; D	2020

Other Studies

2 other studies available for berberine and Arteriosclerosis, Coronary

Article	Year
Berberine up-regulates miR-340-5p to protect myocardial ischaemia/reperfusion from HMGB1-mediated inflammatory injury. ESC heart failure, 2023, Volume: 10, Issue:2 Topics: Animals; Berberine; Coronary Artery Disease; HMGB1 Protein; Inflammation; MicroRNAs; Myocardial Infa	2023
Berberine up-regulates miR-340-5p to protect myocardial ischaemia/reperfusion from HMGB1-mediated inflammatory injury. ESC heart failure, 2023, Volume: 10, Issue:2 Topics: Animals; Berberine; Coronary Artery Disease; HMGB1 Protein; Inflammation; MicroRNAs; Myocardial Infa	2023
Berberine up-regulates miR-340-5p to protect myocardial ischaemia/reperfusion from HMGB1-mediated inflammatory injury. ESC heart failure, 2023, Volume: 10, Issue:2 Topics: Animals; Berberine; Coronary Artery Disease; HMGB1 Protein; Inflammation; MicroRNAs; Myocardial Infa	2023
Berberine up-regulates miR-340-5p to protect myocardial ischaemia/reperfusion from HMGB1-mediated inflammatory injury. ESC heart failure, 2023, Volume: 10, Issue:2 Topics: Animals; Berberine; Coronary Artery Disease; HMGB1 Protein; Inflammation; MicroRNAs; Myocardial Infa	2023
Berberine protects Kawasaki disease-induced human coronary artery endothelial cells dysfunction by inhibiting of oxidative and endoplasmic reticulum stress. Vascular pharmacology, 2020, Volume: 127 Topics: Antioxidants; Apoptosis; Berberine; Case-Control Studies; Cells, Cultured; Coronary Artery Disease;	2020