Long-term Safety and Tolerability of Colesevelam HCl in Subjects with Type 2 Diabetes
| Autor: | D. M. Ford, Kenneth E. Truitt, M. R. Jones, A. C. Wang, Allison B. Goldfine, Vivian Fonseca |
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| Rok vydání: | 2009 |
| Předmět: |
Male
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions medicine.drug_class Endocrinology Diabetes and Metabolism Clinical Biochemistry Population Colesevelam Hydrochloride Type 2 diabetes Biochemistry Drug Administration Schedule law.invention Allylamine Endocrinology Randomized controlled trial Double-Blind Method Bile acid sequestrant law Internal medicine Medicine Humans Hypoglycemic Agents Adverse effect education Glycemic Aged education.field_of_study Dose-Response Relationship Drug business.industry Biochemistry (medical) General Medicine Drug Tolerance Middle Aged medicine.disease Treatment Outcome Tolerability Diabetes Mellitus Type 2 Female business |
| Zdroj: | Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme. 42(1) |
| ISSN: | 1439-4286 |
| Popis: | The bile acid sequestrant, colesevelam hydrochloride, is approved for glycemic control in adults with type 2 diabetes. In three double-masked, placebo-controlled studies, colesevelam hydrochloride 3.75 g/day demonstrated its glycemic-lowering properties when added to existing metformin-, insulin-, or sulfonylurea-based therapy in adults with inadequately controlled type 2 diabetes. This was a 52-week open-label extension study conducted at 63 sites in the United States and one site in Mexico to further evaluate the safety and tolerability of colesevelam hydrochloride in subjects with type 2 diabetes. All subjects who completed the three double-masked, placebo-controlled studies were eligible to enroll in this open-label extension. In total, 509 subjects enrolled and received open-label colesevelam hydrochloride 3.75 g/day for 52 weeks. Safety and tolerability of colesevelam hydrochloride was evaluated by the incidence and severity of adverse events. In total, 360 subjects (70.7%) completed the extension. Of the safety population, 361 subjects (70.9%) experienced an adverse event, most (88.1%) being mild or moderate in severity. Fifty-six adverse events (11.0%) were drug-related; the most frequent drug-related adverse events were constipation and dyspepsia. Thirty-five subjects (6.9%) discontinued due to an adverse event. Fifty-four subjects (10.6%) experienced a serious adverse event; only one was considered drug-related (diverticulitis). Seventeen subjects (3.3%) experienced hypoglycemia; most episodes were mild or moderate in severity. Glycemic improvements with colesevelam hydrochloride were seen without change in weight over 52 weeks (0.2 kg mean reduction from baseline). Colesevelam hydrochloride was safe and well-tolerated as long-term therapy for patients with type 2 diabetes. |
| Databáze: | OpenAIRE |
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