SOURCE: Daiichi Sankyo, Inc.

November 15, 2006 10:00 ET

New Study Confirms WelChol Improves Glycemic Control in Patients With Uncontrolled Type 2 Diabetes Mellitus on Insulin

Study Presented Today at the American Heart Association's Scientific Sessions 2006 Found That WelChol Provided Further Reductions in A1C in Patients Uncontrolled on Insulin

PARSIPPANY, NJ -- (MARKET WIRE) -- November 15, 2006 -- Data presented today at the American Heart Association's (AHA) Scientific Sessions 2006 in Chicago demonstrated that WelChol® (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 levels increase 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.

"Every physician who treats diabetes is looking to lower A1C as effectively as possible, resulting in a constant lookout for improved combinations of therapy," said Ronald B. Goldberg, MD, lead study investigator and Professor of Medicine, the Division of Diabetes and Metabolism and Associate Director, Diabetes Research Institute at the University of Miami Miller School of Medicine. "The same can be said for LDL-cholesterol as well. As a result, a compound that can help lower both of these important cardiovascular risk factors, A1C and LDL-cholesterol, can be of great benefit for many patients. Though we've come a long way, there still remains a vast population not yet meeting the treatment goals in either diabetes or cholesterol. And as we know, that puts many people at risk of developing cardiovascular disease."

The ADA estimates that there are 20.8 million people in the United States with diabetes, 90-95% of this population are diagnosed as type 2. Type 2 patients are recommended to target an A1C level of < 7%.(1) Furthermore, the National Cholesterol Education Program (NCEP) recommends that patients with type 2 diabetes keep their cholesterol levels in check and target a more stringent LDL-C goal of < 100 mg/dL.(2)

About the Study

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 mellitus.

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.

About WelChol

WelChol is indicated for LDL-C lowering and was approved by the U.S. Food and Drug Administration (FDA) for marketing in May 2000. WelChol is the top-selling branded drug in the bile acid sequestrants (BAS) class. 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.

WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver-function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.

In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15 to 18%.

When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin.

Because WelChol is engineered for affinity, specificity and high capacity bile acid binding, it may have a lower drug-drug interaction potential than conventional bile acid sequestrants. It has been studied with four commonly prescribed statins -- Lipitor® (atorvastatin calcium), Zocor® (simvastatin), Pravachol® (pravastatin sodium) and Mevacor® (lovastatin). Additionally, WelChol has been studied with fenofibrate and had no effect on the bioavailability on fenofibrate. Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol.

WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas. WelChol, either alone or in combination with a statin or fenofibrate, has not been shown to prevent heart disease or heart attacks.

WelChol is only indicated for the reduction of LDL-C either alone or in combination with a statin in patients with primary hypercholesterolemia. WelChol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson Type II B), and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. Additionally, WelChol has demonstrated beneficial effects on other lipid parameters such as HDL-C, APO-B , and hs-CRP levels in other clinical trials. However, WelChol is not indicated for use in treatment of these lipid parameters or in patients with mixed dyslipidemia.

For more information on WelChol, call 877-4-DSPROD (877-431-7763), or go to the WelChol web site at www.WelChol.com.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. is the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. Headquartered in Parsippany, New Jersey, the company's strategic focus is on cardiovascular diseases. Research and development of new therapies is also focused in the areas of glucose metabolic disorders, infectious diseases, cancer, immunology and bone and joint diseases. Daiichi Sankyo's portfolio includes BENICAR® (olmesartan medoxomil) and BENICAR HCT® (olmesartan medoxomil/hydrochlorothiazide), the fastest growing angiotensin receptor blocker on the market, and WelChol®, the number one branded bile acid sequestrant.(3) (4)

For more information, please visit www.daiichisankyo-us.com.

Trademarks not owned by Daiichi Sankyo, Inc., are the property of their respective owners.

(1) American Diabetes Association: Standards of medical care in diabetes – 2006. Diabetes Care 29(Suppl 1):S4-S42,2006

(2) Grundy SM, Cleeman JI, Merz CN, Brewer HB, Jr., Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 110: 227-239, 2004

(3) Data are representing May 2002 – February 2006 from IMS Health. National Prescription Audit, February 2006

(4) IMS Health National Prescription Audit, September 2006

Contact Information