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About Welchol

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Efficacy of Welchol in Primary Hyperlipidemia

In patients with primary hyperlipidemia, add Welchol™ (colesevelam HCl) to a low-dose statin for greater efficacy.¹ Welchol also increased efficacy without increasing the statin dose.²

Statin + Welchol vs statin titration¹

When coadministered with a statin, Welchol may provide efficacy similar to the 3 titration steps of a statin
Doubling the statin dose does not equal double statin efficacy
For each doubling of a statin dose, only an additional 5% to 6% further lowering of LDL-C is achieved
Welchol achieves maximum efficacy in the reduction of LDL-C within 2 weeks

Welchol + atorvastatin: LDL-C reduction²

*p<0.0001 vs baseline
†p<0.05 vs atorvastatin 10 mg

Efficacy with Welchol + atorvastatin 10 mg was not statistically different from atorvastatin 80 mg²
Welchol 3.8 g achieved a total mean LDL-C reduction of 42% when added to simvastatin 10 mg (p<0.0001)³

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

References

1. Bays H, Dujovne C. Colesevelam HCl: a non-systemic lipid-altering drug. Expert Opin Pharmacother. 2003;4:779–90.

2. Hunninghake D, Insull W Jr, Toth P, Davidson D, Donovan JM, Burke SK. Coadministration of colesevelam hydrochloride with atorvastatin lowers LDL cholesterol additively. Atherosclerosis. 2001;158:407-16.

3. Knapp HH, Schrott H, Ma P, et al. Efficacy and safety of combination simvastatin and colesevelam in patients with primary hypercholesterolemia. Am J Med. 2001;110:352-60.

Effective Therapy

For patients with type 2 diabetes, adding Welchol can provide additional A1C reductions.

See A1C Data

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.

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