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WelChol Improves Glycemic Control and Cholesterol in Uncontrolled Type 2’s

This is the first study ever to evaluate WelChol in combination with insulin, and it demonstrated A1C reductions of 0.5%. Data presented last week at the American Heart Association’s (AHA) Scientific Sessions 2006 in Chicago demonstrated that WelChol(R) (colesevelam HCl), when added to insulin in uncontrolled patients with type 2 diabetes mellitus, improves glycemic control. This is the first study ever to evaluate WelChol in combination with insulin, and it demonstrated A1C reductions of 0.5% compared to placebo (- 0.41% vs. +0.09%, p <0.001). The same A1C effect was demonstrated in a smaller WelChol study presented at the American Diabetes Association’s (ADA) annual scientific sessions in June 2006.

The Glucose Lowering Effect Of WelChol Study (GLOWS) demonstrated that WelChol added to oral antidiabetic (OAD) therapy in type 2 patients yielded A1C lowering of 0.5% compared to placebo (p=0.007).

Poster presentation #1581, entitled "Colesevelam HCl Improves Glycemic Control in Type 2 Diabetes Mellitus Subjects Managed with Insulin Therapy," documented findings beyond glycemic control. The study also demonstrated a substantial mean reduction in lipid parameters as compared to placebo,including LDL-C ("bad cholesterol") reductions in the WelChol group of 12.8%, apo B reductions of 5.3%, and apo A-1 level increases of 2.3%. The inclusion of WelChol in the treatment regimen did not affect hypoglycemic events, nor did it cause patients to gain weight — a common side effect seen in other diabetes therapies.

As a result, a compound that can help lower both of these important cardiovascular risk factors, A1C and LDL-cholesterol,may be of great benefit for many patients.

The study was a 16-week, multi-center, randomized, double-blind, placebo-controlled study analyzed the antihyperglycemic effect of adding WelChol to insulin alone or in combination with oral antihyperglycemics in subjects with uncontrolled type 2 diabetes. The study involved 280 patients with A1C between 7.5 and 9.5% (mean baseline A1C was 8.3%). Following a two-week, single-blind, placebo run-in, subjects were randomized to receive either WelChol (3.75 g/day) or placebo. Daily mean insulin use was similar for both groups at baseline and subjects continued to take their existing oral antihyperglycemic medications. Throughout the study, insulin doses remained within 10% of the baseline dose.

The primary endpoint was placebo-corrected change in A1C over the course of the study. The secondary endpoints included mean reductions in LDL-C, mean reductions in apo B, increase in apo A-1 and mean triglyceride decreases.

WelChol is indicated for LDL-C lowering and was approved by the FDA for marketing in May 2000. WelChol 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. Systemic medications, which include statins, fibrates, and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.

Study Presented November 17, 2006 at the American Heart Association’s Scientific Sessions

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