Banner-Welchol Clinical Studies

Free Welchol Samples
Register to receive in-office support materials, patient savings information, and free samples of Welchol.

Welchol Clinical Studies

Request Samples

Welchol Clinical Studies

LDL-C and A1C reductions

In the appropriate patient, as an adjunct to diet and exercise, Welchol is the only bile acid sequestrant FDA-approved to provide both LDL-C and A1C reductions in adults with primary hyperlipidemia and T2DM. See how Welchol compares to atorvastatin, simvastatin, and metformin.

WELCHOL + ATORVASTATIN 10 mg:

Lowered LDL-C and raised HDL-C without statin titration
Adding Welchol to atorvastatin 10 mg significantly lowered LDL-C comparable to atorvastatin 80 mg1,2
Welchol® LDL-C levelsWelchol® LDL-C levelsWelchol® HDL-C levelsWelchol® HDL-C levels
  • The most common adverse events were flatulence (26%) and constipation (21%) in the Welchol + atorvastatin 10 mg group and infection (24%) in the Welchol 3.8 g alone group2
  • T2DM was not an inclusion criterion for this study
  • Reduction in HDL-C was a secondary endpoint in this study and Welchol is not indicated to raise HDL-C

Welchol (n=18) vs placebo (n=19).

Hunninghake D, et al. Atherosclerosis. 2001. Please see study design B.

As an add-on,
Welchol + atorvastatin 10 mg lowered APO B by 38%1,2
Welchol® APO B LevelsWelchol® APO B Levels

Welchol is not indicated to lower APO B. APO B was a secondary endpoint in this study.

  • T2DM was not an inclusion criterion for this study
  • This most common reported adverse events were flatulence (26%) and constipation (21%) in the Welchol + atorvastatin 10 mg group and infection (24%) in the Welchol 3.8 g alone group2

ǁWelchol (n=18) vs placebo (n=19).

At baseline, 68% of patients had LDL cholesterol levels <190 mg/dl, and 32% of patients had LDL cholesterol levels >190 mg/dl.2

Hunninghake D, et al. Atherosclerosis. 2001. Please see study design B.

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.

Please see Important Safety Information about Welchol below.

Welchol & Simvastatin Clinical Study

42% mean reduction in LDL-C and 10% median increase in HDL-C when Welchol 3.8 g was added to simvastatin 10 mg1,3

Welchol is not indicated to raise HDL-C. HDL-C was a secondary endpoint in this study.

T2DM was not an inclusion criteria for these studies.

The most common adverse events (≥10%) were flatulence and constipation.

Please see Important Safety Information about Welchol below.

Treatment groups had similar baseline characteristics, except for serum triglyceride levels (P <0.05). Among study patients, 62% (n=155) had fewer than two risk factors for coronary heart disease, and 26% (n=66) had two or more risk factors, whereas 12% (n=30) had preexisting coronary heart disease.3

Knapp HH, et al. Am J Med. 2001. Please see study design A.

Study Design A (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

*Hypercholesterolemia is now referred to as primary hyperlipidemia.

Welchol + Metformin

In a type 2 diabetes pivotal trial,
Welchol provided significant A1C and LDL-C mean treatment reductions when added to metformin and metformin combination therapies1,5
​ ​

* Welchol has not been studied in combination with all antidiabetic agents.

Reductions in A1C represent the mean treatment difference in Welchol (n=69) vs placebo (n=76). Reductions in LDL-C represent the mean treatment difference in Welchol (n=59) vs placebo (n=65).

Bays HE, et al. Arch Intern Med. 2008. Please see study design A.

Welchol + metformin monotherapy resulted in a mean treatment difference in A1C of -0.5%, N=155 (Welchol n=79, placebo n=76) (P=0.002)1

  • The most common treatment-emergent adverse event in ≥5% of patients was constipation5
  • Welchol was not associated with weight gain, and incidence of hypoglycemia was comparable to placebo5

Welchol has been shown to increase levels of metformin when coadministered with metformin extended release (ER).1

Welchol can increase triglycerides so lipids, including TGs and non-HDL-C, should be monitored. Welchol can increase serum TG concentrations particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Because of its constipating effect, Welchol should not be used in patients at risk of bowel obstruction.

Adding Welchol may help patients reach their A1C and LDL-C goals

In a post-hoc analysis of the Bays pivotal study, Welchol + metformin combination therapy (N=69) vs metformin combination alone (N=76), adding Welchol helped some patients achieve the ADA and NCEP§ goals for A1C and LDL-C (n=17, n=4, respectively).1,6,7

In the same post-hoc analysis, 20% of patients on Welchol + metformin monotherapy (N=79; n=16) vs 7% of patients on metformin monotherapy (N=76; n=5) achieved a reduction in A1C to <7%. Additionally, 26% of patients on Welchol + metformin monotherapy (N=66; n=17) vs 20% of patients on metformin monotherapy (N=61; n=12) achieved an LDL-C <70 mg/dL.

Please see Important Safety Information about Welchol below.

ADA=American Diabetes Association.
§NCEP=National Cholesterol Education Program.

Baseline demographic characteristics for the total population revealed no significant differences between the colesevelam and placebo groups at randomization. When other oral anti-DM drugs were used in combination with background metformin, most were sulfonylureas and thiazolidinediones.5

Study Design A (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.5

Study Design A1 (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 to <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.6

Free Welchol Samples

Free Welchol Samples

Register to receive in-office support materials, patient savings information, and free samples of Welchol.

REQUEST SAMPLES

Welchol Clinical Studies Story Navigation

Important Safery Information

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 (statin)
  • 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 in combination with a dipeptidyl peptidase-4 inhibitor
  • 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

IMPORTANT SAFETY INFORMATION ABOUT WELCHOL (colesevelam HCI)

Contraindications

Welchol is contraindicated in:

  • individuals with a history of bowel obstruction
  • those with serum triglyceride (TG) concentrations of >500 mg/dL, or
  • those 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 pioglitazone, 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, a history of major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol interacts with some drugs. Drugs with a known interaction with colesevelam (cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives [ethinyl estradiol, norethindrone], and metformin extended release [ER]) 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 27 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:

  • Adult patients with Primary Hyperlipidemia were: constipation, dyspepsia, nausea, accidental injury, asthenia, pharyngitis, flu syndrome, rhinitis, and myalgia
  • Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis, headache, fatigue, creatine phosphokinase increase, rhinitis, and vomiting
  • Adult patients with Type 2 Diabetes were: constipation, hypoglycemia, dyspepsia, nausea, hypertension, and back pain

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) has been reported in patients receiving thyroid hormone replacement therapy
  • Dysphagia has been reported with both tablet and oral suspension formulations
Pregnancy

Welchol is Pregnancy Category B.

Please click here for Full Prescribing Information about Welchol.

Move Up Button

Welchol Clinical Studies Footer Reference

Site global Footer