Overview
Bile acid sequestrants like colestipol have been in use since the 1970s. And even though such an agent may very well be useful in reducing elevated cholesterol levels and decreasing the risk for atherosclerotic vascular disease due to hypercholesterolemia, colestipol is still generally only employed as an adjunct therapy and the relatively physical nature of its pharmacological activity sometimes limits its usefulness. In particular, as colestipol's general mechanism of action ultimately results in the decreased absorption and enhanced secretion of bile acids and lipids in the feces, patients who take complicated medication regimens, experience constipation or biliary obstruction, etc. may not be good candidates for using the agent owing to its physical effects on the gut. Alternatively, colestipol predominantly elicits its activities within the gut environment because it undergoes little absorption and metabolism. The resultant lack of systemic exposure consequently means the medication generally demonstrates very few adverse effects inside the body.
Background
Bile acid sequestrants like colestipol have been in use since the 1970s. And even though such an agent may very well be useful in reducing elevated cholesterol levels and decreasing the risk for atherosclerotic vascular disease due to hypercholesterolemia, colestipol is still generally only employed as an adjunct therapy and the relatively physical nature of its pharmacological activity sometimes limits its usefulness. In particular, as colestipol's general mechanism of action ultimately results in the decreased absorption and enhanced secretion of bile acids and lipids in the feces, patients who take complicated medication regimens, experience constipation or biliary obstruction, etc. may not be good candidates for using the agent owing to its physical effects on the gut. Alternatively, colestipol predominantly elicits its activities within the gut environment because it undergoes little absorption and metabolism. The resultant lack of systemic exposure consequently means the medication generally demonstrates very few adverse effects inside the body.
Indication
1.Ⅱa型高脂蛋白血症、冠心病危险性大而控制饮食治疗无效者。本品降低血浆总胆固醇和低密度脂蛋白胆固醇浓度,对血清甘油三酯浓度无影响或使之轻度升高,因此,对单纯甘油三酯升高者无效;2.胆管不完全阻塞所致的瘙痒。
Associated Conditions
- Primary Hypercholesterolemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/03/27 | Phase 2 | Completed | |||
2014/10/13 | Phase 1 | Terminated | Derrick Scott Robertson | ||
2011/08/25 | Phase 2 | Completed | |||
2005/09/20 | Phase 4 | Completed | |||
1999/10/28 | Phase 3 | Completed | |||
1999/10/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Carilion Materials Management | 68151-4361 | ORAL | 1 g in 1 1 | 4/11/2016 | |
Pharmacia & Upjohn Company LLC | 0009-0260 | ORAL | 5 g in 5 g | 11/29/2023 | |
Physicians Total Care, Inc. | 54868-0610 | ORAL | 1 g in 1 1 | 10/19/2010 | |
Amneal Pharmaceuticals of New York LLC | 0115-2142 | ORAL | 1 g in 1 1 | 11/11/2023 | |
Amneal Pharmaceuticals of New York LLC | 0115-5213 | ORAL | 5 g in 1 1 | 12/30/2023 | |
ANI Pharmaceuticals, Inc. | 62559-395 | ORAL | 1 g in 1 1 | 4/26/2023 | |
Amneal Pharmaceuticals of New York LLC | 0115-5211 | ORAL | 1 g in 1 1 | 9/20/2023 | |
Greenstone LLC | 59762-0450 | ORAL | 1 g in 1 1 | 11/18/2022 | |
Pharmacia & Upjohn Company LLC | 0009-0450 | ORAL | 1 g in 1 1 | 11/16/2022 | |
Greenstone LLC | 59762-0260 | ORAL | 5 g in 5 g | 11/18/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |