PDF KB. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels LDL-C. The ADA estimates that Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.
Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. Further, the total Welchol treatment group, when treated with either metformin monotherapy or metformin-combination therapy, achieved significantly greater reductions in A1C levels compared to placebo mean reduction of 0. The study further demonstrated that the total Welchol treatment group achieved significantly lower LDL-C levels compared to the placebo group mean reduction of In addition, two other pivotal studies showed similar results in A1C reductions when Welchol was added to either sulfonylurea-based therapy or insulin-based therapy.
In patients with type 2 diabetes who were inadequately controlled on sulfonylurea-based therapy the addition of Welchol was shown to have a significant reductions in A1C mean reduction of 0.
In patients inadequately controlled with insulin, alone or in combination with other anti-diabetic agents, the addition of Welchol was shown to have significant mean reduction in A1C mean reduction of 0. Once clinical cardiovascular disease develops, these patients have a poorer prognosis than normoglycemic patients. It is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys.
Therefore, Welchol is not expected to have drug interactions via the cytochrome P pathway. Welchol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia Fredrickson Type IIb , and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. Welchol is not indicated for use in combination with fenofibrate or in the treatment of mixed dyslipidemia or lipid parameters other than LDL-C.
Welchol is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. In total, patients completed the double-blind treatment period.
After 8 weeks of treatment, Welchol 3. A moderate, non-statistically significant increase in TG was observed versus placebo. The FDA approval of Welchol for this indication was based on the results of three clinical trials. These double-blind, placebo-controlled add-on therapy trials enrolled a total of 1, subjects with baseline A1C 7. The subjects received Welchol, in combination with metformin, sulfonylureas or insulin or placebo administered either as 3 tablets twice daily with lunch and dinner or as 6 tablets with dinner alone.
Add-on Combination Therapy with Metformin: Welchol 3. The combination of Welchol plus metformin resulted in statistically significant placebo-corrected reductions in A1C with a The mean change in body weight was Add-on Combination Therapy with Sulfonylurea: Welchol 3. In combination with a sulfonylurea, Welchol resulted in statistically significant placebo corrected reductions in A1C and FPG. The mean change in body weight was 0. Add-on Combination Therapy with Insulin: Welchol 3. At baseline, the median daily insulin dose was 70 units in the Welchol group and 65 units in the placebo group.
In combination with insulin, Welchol resulted in a statistically significant placebo-corrected reduction in A1C Table Lundbeck Takeda Pharmaceuticals U. Welchol colesevelam hydrochloride Profile. Currently Enrolling Trials Show More. Welchol colesevelam hydrochloride - 3 Indications Scroll down for more information on each indication: to reduce elevated low-density lipoprotein cholesterol LDL-C in adults with primary hyperlipidemia; approved in to reduce LDL-C in pediatrics 10 to 17 years of age with heterozygous familial hypercholesterolemia HeFH ; approved in for the treatment of glycemic control in type 2 diabetes mellitus; approved January General Information Welchol contains colesevelam hydrochloride, a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent.
Welchol is specifically indicated for the following: reduce elevated low-density lipoprotein cholesterol LDL-C in adults with primary hyperlipidemia reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia HeFH improve glycemic control in adults with type 2 diabetes mellitus Welchol is supplied as tablets and as an oral suspension. The recommended dosage for adults and children 10 to 17 years old with primary hyperlipidemia is 3.
The recommended dosage for adults with type 2 diabetes mellitus is 3. Welchol should be taken as follows: Tablets: Take 6 tablets once daily or 3 tablets twice daily with a meal and liquid.
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