In a recent 16-week randomized, open-label pilot study, 169 patients were randomized to receive Welchol (n=57), Januvia (n=56), or Avandia (n=56).1 The results demonstrated that Welchol (colesevelam HCl) significantly improved glycemic control and reduced mean LDL cholesterol (LDL-C) when added to metformin monotherapy in patients with type 2 diabetes. In the study, Januvia® (sitagliptin) and Avandia® (rosiglitazone) also significantly improved glycemic control, but LDL-C increased in patients on both of these treatment regimens.
“Seventy percent of patients with type 2 diabetes have elevated LDL cholesterol and are not at the recommended goal of less than 100 mg/dL, which greatly increases their risk for cardiovascular disease,” said Yehuda Handelsman, MD, FACP, FACE, medical director of the Metabolic Institute of America in Tarzana, California, and principal investigator of the study. “These new data further support that Welchol reduces these two risk factors for cardiovascular disease in patients with type 2 diabetes by significantly lowering A1c and LDL, or ‘bad’ cholesterol, thereby offering physicians a unique therapeutic option.”
Data derived from a separate study, a post-hoc analysis of the metformin arm of a 52-week open label extension study (n=146) were also presented. The results demonstrated that Welchol was well tolerated and effective for up to 78 weeks when added to metformin-based therapy, an Important finding in light of the chronic and progressive nature of type 2 diabetes.3
About Type 2 Diabetes and Cholesterol
According to the American Diabetes Association (ADA), about 23.6 million people, or 8 percent of the population of the United States, have diabetes, and approximately 90 to 95 percent of people diagnosed with diabetes have type 2 diabetes.4,5 In addition, 70 percent of adults with type 2 diabetes also have high LDL cholesterol, the “bad” cholesterol that can cause build-up in the arteries.2
The ADA and the American College of Cardiology emphasize that it is critical to reduce both A1c’s (a measure of average blood glucose) and LDL cholesterol.6,7,8 The ADA recommends that patients with type 2 diabetes target an A1c level of less than 7 percent, and the National Cholesterol Education Program (NCEP) recommends that patients with type 2 diabetes target an LDL cholesterol goal of less than 100 mg/dL.9,10
Source: Daiichi Sankyo, Inc.
1) Handelsman Y, Rigby SP, et al. Effect of Colesevelam HCl (Welchol®), Rosiglitazone (Avandia®), or Sitagliptin (Januvia®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Monotherapy. Abstract at American Association of Clinical Endocrinologists annual meeting (May 13-17, 2009).
2) Jacobs MJ, Kleisli T, et al. Prevalence and control of dyslipidemia among persons with diabetes in the United States. Diabetes Research and Clinical Practice. 2005; 70: 263-269.
3) Bays HE, Goldfine AB, et al. Long-Term Use of Colesevelam HCl in Subjects with Type 2 Diabetes Mellitus on Metformin Therapy. Abstract at American Association of Clinical Endocrinologists annual meeting (May 13-17, 2009).
4) American Diabetes Association, Diabetes Statistics. http://www.diabetes.org/diabetesstatistics/prevalence.jsp. Accessed April 8, 2009.
5) Center for Disease Control, National Diabetes Fact Sheet 2007.
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed April 8, 2009.
6) Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American Diabetes Association and the American College of Cardiology Foundation. Diabetes Care. 2008;31(4):811-822.
7) Buse JB, Ginsberg HN, Bakris GL, et al. Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A Scientific Statement From the American Heart Association and the American Diabetes Association. Circulation. 2007;115:114-126. http://circ.ahajournals.org/cgi/content/full/115/1/114.
Accessed April 8, 2009.
8) Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008;168(18):1975-1983.
9) American Diabetes Association: Standards of medical care in diabetes – – 2006. Diabetes Care 29(Suppl 1):S4-S42,2006.
10) 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.