Welchol Logo - Two goals, one therapy

Sitemap | Contact Us

Daiichi-Sankyo

Home > About Welchol > Efficacy in Primary Hyperlipidemia

Efficacy of Welchol in Primary Hyperlipidemia

Sign Up for Updates

Be notified about site updates, educational opportunities, and more.

Sign Up Now

Significant LDL-C Reductions

In patients with primary hyperlipidemia, add Welchol to a statin for greater efficacy. Welchol increased efficacy without increasing the statin dose.

On this page:

Welchol + atorvastatin

ADA/ACC* Recommend Aggressive Treatment of Both T2DM and Primary Hyperlipidemia.1-3

Welchol added to atorvastatin 10 mg achieved 48% total mean LDL-C reduction from baseline†,2,4

LDL-C reductions: Welchol when added to atorvastatin 10 mg

*ADA = American Diabetes Association; ACC = American College of Cardiology
†T2DM was not an inclusion criteria for these studies.

Welchol also provided a mean HDL-C increase of 11% when added to atorvastatin 10 mg (P<0.05 vs baseline; n=18) vs an 8% and 6% increase with atorvastatin 10 mg and 80 mg, respectively. No statistical significance was observed between treatment groups.4

Please see Study Design B

Click here for Important Safety Information about Welchol
Back to top

Welchol + simvastatin

Welchol added to simvastatin 10 mg achieved 42% total mean LDL-C reduction†,2,5

LDL-C reductions: Welchol when added to simvastatin 10 mg

Welchol also provided a median HDL-C increase of 10% when added to simvastatin 10 mg (P<0.001 vs baseline; n=34) vs a 3% increase with simvastatin 10 mg. Results were significant between treatment groups (P<0.05).5

Please see Study Design C

Click here for Important Safety Information about Welchol
Back to top

Study Designs

Study Design B (Hunninghake D, Atherosclerosis. 2001)

Results from a randomized, double-blind, placebo-controlled, 4-week study of 94 randomized patients with moderate hypercholesterolemia* (LDL-C ≥160 mg/dL, TG ≤300 mg/dL) and
LDL-C levels ranging from 156-236 mg/dL. Patients were assigned to 1 of 5 treatment groups: placebo, Welchol 3.8 g/day, atorvastatin 10 mg/day, atorvastatin 80 mg/day, or atorvastatin 10 mg/day + Welchol 3.8 g/day.1,2

*Hypercholesterolemia is now referred to as primary hyperlipidemia

Click here for Important Safety Information about Welchol
Back to top

Study Design C (Knapp HH, Am J Med. 2001)

Results from a 6-week, multicenter, randomized, double-blind, placebo-controlled study of 258 randomized patients with moderate hypercholesterolemia* (LDL-C ≥160 mg/dL;
TG ≤300 mg/dL) who were not on lipid-lowering medication. Patients were randomized to 1 of the following treatment regimens: placebo, Welchol 3.8 g/day, simvastatin 10 mg/day, Welchol 3.8 g/day + simvastatin 10 mg/day, Welchol 2.3 g/day, simvastatin 20 mg/day, or Welchol 2.3 g/day + simvastatin 20 mg/day.1,3

Click here for Important Safety Information about Welchol
Back to top

Please see Important Safety Information about Welchol below

Welchol On Demand

Access recent Webcasts from leading physicians

Learn More

References

1. 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.

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

3. 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.

4. Hunninghake D, Insull W Jr, Toth P, et al. Coadministration of colesevelam hydrochloride with atorvastatin lowers LDL cholesterol additively. Atherosclerosis. 2001;158:407-416.

5. 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(5):352-360.

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.

DCSIMG