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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 for patients with uncontrolled A1C

In the GLOWS pilot study (N=65), Welchol significantly reduced A1C, fasting plasma glucose, and postprandial glucose when added to preexisting anti-diabetic therapy.*1

Primary endpoint: Placebo-adjusted mean change in A1C
Secondary endpoints included: Fasting plasma glucose and postprandial glucose fructosamine, LDL-C from baseline to week 12

Welchol (colesevelam HCl)

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

Welchol (colesevelam HCl)

Results from a prospective, randomized, double-blind, placebo-controlled, parallel-group pilot study. Adult subjects (N=65) with A1C levels 7%-10% were included if they had type 2 diabetes that had been inadequately controlled on an anti-diabetic therapy. Patients were maintained on preexisting sulfonylurea and/or metformin therapy throughout the study. Primary endpoint was mean change in A1C from baseline to Week 12. Secondary endpoints included mean changes in fructosamine, FPG, PPG, and LDL-C from baseline to Week 12.
(*sulfonylurea, metformin, or both)

Welchol: Add-on therapy for consistent mean A1C and LDL-C reductions

In 3 pivotal studies, Welchol significantly reduced A1C and LDL-C when added to preexisting anti-diabetic therapy.2-5

Welchol (colesevelam HCl)

In these same studies, patients taking Welchol also achieved significant LDL-C reductions5,6

Welchol (colesevelam HCl)

Please see Study Designs A1, A2, A3

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.

Effective A1C and LDL-C reductions when added to one or more common anti-diabetic therapies

Welchol added to preexisting anti-diabetic monotherapy (metformin alone, sulfonylurea alone, or insulin alone) demonstrated further A1C and LDL-C lowering.2-5

Welchol (colesevelam HCl)

In these studies, patients taking Welchol also achieved significant
LDL-C reductions5,6

Welchol (colesevelam HCl)

Please see Study Designs A1, A2, A3

Welchol added to anti-diabetic combination therapies demonstrated further A1C and LDL-C lowering.2-5

Welchol added to pre-existing anti-diabetic combination therapy (metformin, sulfonylurea, or insulin based multi-agent therapy) demonstrated further A1C and LDL-C lowering.

Welchol (colesevelam HCl)

In these studies, patients taking Welchol also achieved significant
LDL-C reductions5,6

Welchol (colesevelam HCl)

Welchol has not been studied in combination with all anti-diabetic agents.

Please see Study Designs A1, A2, A3

Welchol (colesevelam HCl)

*ACE = American College of Endocrinology; AACE = American Association of Clinical Endocrinologists

Welchol: A bile acid sequestrant for more than just primary hyperlipidemia

Patients with T2DM may have an altered bile acid metabolism9

  • While the exact mechanism by which Welchol improves glycemic control is unknown, there is increasing evidence that bile acids play a role in glucose metabolism, in addition to lipid metabolism.10

Welchol is a specifically engineered bile acid sequestrant

  • Welchol is a high-affinity, high-capacity bile-acid–binding molecule.11

Welchol (colesevelam HCl)

Clinical significance of in vitro data is unknown.

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.2,5

Study Design A2 (Fonseca VA, Diabetes Care. 2008)

Results from a double-blind, 26-week, placebo-controlled pivotal study of 460 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting sulfonylurea-based therapy. Either Welchol or placebo was added to sulfonylurea alone or sulfonylurea 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.3,5

Study Design A3 (Goldberg RB, Arch Intern Med. 2008)

Results from a double-blind, 16-week, placebo-controlled pivotal study of 287 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting insulin-based therapy. Either Welchol or placebo was added to insulin alone or insulin in combination with other anti-diabetic therapies for 16 weeks. The primary efficacy endpoint was mean change in A1C from baseline; secondary endpoints included mean change in LDL-C from baseline.4,5

Please see Important Safety Information about Welchol below

New Formulation

A new way to take down two with one

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. Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy inpatients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008;168(18):1975-1983.

3. Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCI improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008;31(8):1479-1484.

4. Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008;168(14):1531-1540.

5. Welchol (colesevelam HCI). Prescribing Information. Daiichi Sankyo, Inc., Parsippany, NJ, 2009.

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

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.pdfRevised 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.

10. 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.

11. 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.

IMPORTANT INFORMATION ABOUT WELCHOL (colesevelam HCl)

Indications

Welchol is indicated as an adjunct to diet and exercise to:

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethylglutaryl-coenyme (HMG CoA) reductase inhibitor
  • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
  • improve glycemic control in adults with type 2 diabetes mellitus

Important Limitations of Use

  • Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones
  • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias
  • Welchol has not been studied in children younger than 10 years of age or in premenarchal girls

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.

Warnings and Precautions

The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

Welchol can increase serum TG concentrations particularly when used in combination with sulfonylureas or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies.

Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol reduces gastrointestinal absorption of some drugs. Drugs with a known interaction with colesevelam (glyburide, levothyroxine, and oral contraceptives [ethinyl estradiol, norethindrone]) should be administered at least 4 hours prior to Welchol. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug.

To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form.

Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

Phenylketonurics: Welchol for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.

Adverse Reactions

In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo, regardless of investigator assessment of causality seen in:

  • Adults with Primary Hyperlipidemia were: constipation (11.0% vs 7.0%), dyspepsia (8.3% vs 3.5%), nausea (4.2% vs 3.9%), accidental injury (3.7% vs 2.7%), asthenia (3.6% vs 1.9%), pharyngitis (3.2% vs 1.9%), flu syndrome (3.2% vs 3.1%), rhinitis (3.2% vs 3.1%) and myalgia (2.1% vs 0.4%)
  • Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis (6.2% vs 4.6%), headache (3.9 vs 3.1%), fatigue (3.9% vs 1.5%), creatine phosphokinase increase (2.3% vs 0.0%), rhinitis (2.3% vs 0.0%) and vomiting (2.3% vs 1.5%)
  • Adult patients with Type 2 Diabetes were: constipation (8.7% vs 2.0%), nasopharyngitis (4.1% vs 3.6%), dyspepsia (3.9% vs 1.4%), hypoglycemia (3.0% vs 2.3%), nausea (3.0% vs 1.4%) and hypertension (2.8% vs 1.6%)

Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship.

  • Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol.
  • Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol.
  • Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy.

Pregnancy

Welchol is Pregnancy Category B.

Please see Full Prescribing Information for Welchol by clicking here.

This information is intended for U.S. healthcare professionals only.
© 2009 Daiichi Sankyo, Inc.

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