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Efficacy of Welchol in Type 2 Diabetes

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Significant A1C reductions

When added to preexisting anti-diabetic therapy, Welchol significantly lowered A1C.

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Welchol: Add-on therapy to improve glycemic control


In the GLOWS pilot study, adding Welchol helped patients already on anti-diabetic therapy significantly reduce A1C, FPG, and PPG.1

Welchol (colesevelam HCl)

Welchol (colesevelam HCl)

The following data were based on a subgroup analysis determined prior to unblinding:

Welchol (colesevelam HCl)

Make Welchol your preferred add-on therapy for additional A1C and LDL-C reductions


Welchol can help your adult patients with T2DM and primary hyperlipidemia achieve the additional A1C and LDL-C reductions they need.2-4

Welchol (colesevelam HCl)

Please see study designs A1

In a POST-HOC analysis of the Bays pivotal study...
Welchol + metformin combination therapy vs metformin combination therapy helped more patients achieve the ADA and NCEP§ goals for A1C and LDL-C2,4,5,6

Welchol (colesevelam HCl)

In this clinical trial, the most common adverse reaction observed by ≥5% of the subjects after receiving Welchol was constipation.

Please see study designs A2

Welchol (colesevelam HCl)

Contraindications

Welchol is contraindicated in individuals with bowel obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL, or with a history of hypertriglyceridemia-induced pancreatitis.

Welchol: A bile acid sequestrant that goes beyond primary hyperlipidemia


Increasing evidence suggests that bile acids may function as signaling molecules in the liver and GI tract for lipid and glucose metabolism.7

Welchol (colesevelam HCl)

Welchol delivers efficacy without being systemically absorbed


Welchol binds to bile acids in the intestine without being metabolized by the liver and kidney

Welchol (colesevelam HCl)

Welchol may increase triglyceride levels especially in patients on a sulfonylurea- or insulin-based therapy. Periodic monitoring of lipid parameters including TG and non–HDL-C levels is recommended. The long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain.

Study Designs

Study Design A1 (Bays HE, Arch Intern Med. 2008)

Results from a double-blind, 26-week, placebo-controlled pivotal study of 316 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting metformin-based therapy. Either Welchol or placebo was added to metformin alone or metformin in combination with other anti-diabetic therapies for 26 weeks. The primary efficacy endpoint was mean change in A1C from baseline; secondary endpoints included mean change in LDL-C from baseline.2,3

Study Design A2 (Post-hoc analysis of the Bays pivotal study)

This post-hoc analysis evaluated the percentages of patients achieving A1C and LDL-C goals. Of the total number of patients (N=69) in the Welchol + metformin combination therapy group, 17 patients (25%) achieved a reduction in A1C of <7% compared with 4 patients (5%) in the metformin combination therapy group (N=76). Additionally, 22 patients (37%) in the Welchol + metformin combination therapy group (N=59) and 8 patients (12%) in the metformin combination therapy group (N=65) achieved an LDL-C <70 mg/dL.4

Of the total number of patients (N=79) in the Welchol + metformin monotherapy group, 16 patients (20%) achieved a reduction in A1C of <7% compared with 5 patients (7%) in the metformin monotherapy group (N=76). Additionally, 17 patients (26%) in the Welchol + metformin monotherapy group (N=66) and 12 patients (20%) in the metformin monotherapy group (N=61) achieved an LDL-C <70 mg/dL.4

Flexible Dosing

Welchol offers two dosing options for your patients.

Important Safety Information
Important Safety Information

References

1. Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of Welchol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007;29(1):74-83.

2. Welchol (colesevelam HCl). Prescribing Information. Daiichi Sankyo, Inc., Parsippany, NJ, 2009.

3. 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.

4. Data on file. Daiichi Sankyo, Inc., Parsippany, NJ.

5. American Diabetes Association. Standards of medical care in diabetes – 2010. Diabetes Care. 2010;33(suppl 1): S11–S61.

6. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Pressure in Adults. Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): final report. Bethesda, MD: National Institutes of Health; 2002. NIH publication 02-215. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf. Accessed April 26, 2010.

7. American College of Endocrinology and American Association of Clinical Endocrinologists Road Map Task Force. Road maps to achieve glycemic control in type 2 diabetes mellitus. http://www.aace.com/pub/pdf/GlycemicControlAlgorithmPPT.pdf Revised December 2009. Accessed January 28, 2009.

8. Joslin Diabetes Center & Joslin Clinic. Clinical guideline for pharmacological management of type 2 diabetes. http://www.joslin.org/Files/Clinical-Guidelines-for-Pharmacological-Management-of-Type2-Diabetes.pdf. Revised January 9, 2009. Accessed January 28, 2009.

9. Brufau G, Kuipers F, Prado K,et al. Altered bile salt metabolism in type 2 diabetes mellitus (T2DM). Poster presented at: 68th Scientific Sessions of the American Diabetes Association; June 6-10, 2008; San Francisco, CA. Poster No. 1553-P

10. Brufau G, Stellaard F, Prado K, et al. Effects of colesevelam on bile acid metabolism in healthy and diabetic subjects. Poster presented at: 69th Scientific Sessions of the American Diabetes Association; June 2009; New Orleans, LA.

11. Beysen C, Deines KC, Tsang EL, et al. Colesevelam HCl improves glucose metabolism and increases plasma glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide concentrations in subjects with type 2 diabetes. Abstract at the 45th Annual Meeting of the European Association for the Study of Diabetes, Vienna, Austria (September 29-October 2, 2009). Abstract No. 171.

12. Thomas C, Pellicciari R, Pruzanski M, Auswerx J, Schoonjans K. Targeting bile-acid signalling for metabolic diseases. Nat Rev Drug Discov. 2008;7(8):678-693.

13. Staels B. A review of bile acid sequestrants: potential mechanism(s) for glucose-lowering effects in type 2 diabetes mellitus. Postgrad Medi. 2009;121(3):25-30.

14. De Fabiani E, Mitro N, Gilardi F, Caruso D, Galli G, Crestani M. Coordinated control of cholesterol catabolism to bile acids and of gluconeogenesis via a novel mechanism of transcription regulation linked to the fasted-to-fed cycle. J Biol Chem. 2003;278 (40):39124-39132.

15. Kobayashi M, Ikegami H, Fujisawa T, et al. Prevention and treatment of obesity, insulin resistance, and diabetes by bile acid-binding resin. Diabetes. 2007;56:239-247.

16. Cariou B, Duran-Sandoval D, Kuipers F, Staels B. Farnesoid X receptor: a new player in glucose metabolism? Endocrinology. 2005;146(3):981-983.

17. Braunlin W, Zhorov E, Smisek D, et al. In vitro comparison of bile acid binding to colesevelam HCl and other bile acid sequestrants. Polymer Preprints. 2000;41(1):708-709.

This information is intended for U.S. healthcare professionals only.
© 2010 Daiichi Sankyo, Inc.