Efficacy in Type 2 Diabetes

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Efficacy of Welchol in Type 2 Diabetes

In patients on preexisting antidiabetic (AD) monotherapy, Welchol™ (colesevelam HCl) achieved additional mean A1C reductions of 0.8%, 0.5%, and 0.6% when added to preexisting monotherapy with a sulfonylurea, metformin, or insulin, respectively.*


Welchol + preexisting sulfonylurea monotherapy:
Additional mean A1C reduction



p<0.001
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 26-week, double-blind, placebo-controlled pivotal trial of patients (n=460) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.8% when added to preexisting sulfonylurea monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.

  • No washout period — ie, no discontinuation of preexisting type 2 diabetes therapy

Welchol is the first and only therapy approved to reduce both A1C and LDL-C

*Results from 3 double-blind, placebo-controlled pivotal trials of patients (n=1018) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved the following mean A1C reductions with preexisting AD therapy: metformin (0.5%, n=316), a sulfonylurea (0.8%, n=460), or insulin (0.6%, n=287). Patients were enrolled and maintained on their preexisting type 2 diabetes therapy. Either Welchol or placebo was added to a sulfonylurea or metformin for 26 weeks or to insulin for 16 weeks.

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 + preexisting metformin monotherapy

In patients on preexisting antidiabetic (AD) monotherapy, Welchol achieved a significant additional mean A1C reduction of 0.5% when added to metformin.

Welchol + preexisting metformin monotherapy:
Additional mean A1C reduction



p=0.002
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 26-week, double-blind, placebo-controlled pivotal trial of patients (n=316) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.5% when added to preexisting metformin monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.

Welchol is the first and only therapy approved to reduce both A1C and LDL-C


Welchol + preexisting insulin monotherapy

In patients on preexisting antidiabetic (AD) monotherapy, Welchol achieved an additional mean A1C reduction of 0.6% when added to insulin.

Welchol + preexisting insulin monotherapy:
Additional mean A1C reduction



p<0.001
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 16-week, double-blind, placebo-controlled pivotal trial of patients (n=287) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.6% when added to preexisting insulin monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.


Welchol in hard-to-treat patients

With preexisting antidiabetic (AD) monotherapy and combination therapy, Welchol achieved consistent and significant additional mean A1C reductions of 0.5% with a sulfonylurea, metformin, or insulin alone and in combination with other ADs.1

Welchol + preexisting AD therapy:
Additional mean A1C reductions



†Represents the treatment difference of Welchol reductions minus placebo reductions

Results from 3 double-blind, placebo-controlled pivotal trials of patients (n=1018) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved the following mean A1C reductions with preexisting AD monotherapy: a sulfonylurea (0.8%, n=69), metformin (0.5%, n=79), or insulin (0.6%, n=54). Welchol achieved the following mean A1C reductions with preexisting AD combination therapy that included: a sulfonylurea (0.4%, n=149), metformin (0.6%, n=69), or insulin (0.4%, n=90). Welchol achieved the following mean A1C reductions with preexisting AD monotherapy and combination therapy: metformin (0.5%, n=144), a sulfonylurea (0.5%, n=218), or insulin (0.5%, n=144). Patients were enrolled and maintained on their preexisting type 2 diabetes therapy. Either Welchol or placebo was added to a sulfonylurea or metformin, alone and in combination with other AD therapy, for 26 weeks or insulin, alone and in combination with other AD therapy, for 16 weeks.

Welchol provided consistent and sustained mean A1C reductions

Next: Efficacy in primary hyperlipidemia

Reference

1. Data on file. Daiichi-Sankyo, Inc., Parsippany, NJ.

Effective Therapy

For patients with primary hyperlipidemia, adding Welchol can provide additional LDL-C reductions.

IMPORTANT INFORMATION ABOUT WELCHOL

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 hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor
  • 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

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

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.

ADVERSE REACTIONS

Primary Hyperlipidemia: In clinical trials, the adverse reactions observed in placebo – regardless of investigator assessment of causality 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%). Type 2 Diabetes: In clinical trials, the adverse reactions observed in placebo – regardless of investigator assessment of causality 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.

PREGNANCY

Welchol is Pregnancy Category B.

The photos on this site depict models, not actual patients or healthcare professionals.

This information is intended for U.S. healthcare professionals only.
© 2008 Daiichi Sankyo, Inc.