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Efficacy of Welchol in Primary Hyperlipidemia
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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.
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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

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

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
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
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
Please see Important Safety Information about Welchol below
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.