Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients... (ater than or equal to 65 andless than 65...)

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Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated

Date:5/30/2008

ater than or equal to 65 and less than 65 years), gender, and race (Caucasian, Black, and Hispanic). Efficacy parameters included reductions in A1C and LDL-C across these subgroups.

Patients aged 65 or older had a 0.59% mean reduction in A1C (P<0.0001) and a mean reduction in LDL-C of 14.73 (P<0.0001), whereas patients younger than 65 had a 0.54% mean reduction in A1C (P<0.0001) and a mean reduction in LDL-C of 15.50 (P<0.0001). Regarding gender, male patients had a 0.60% mean reduction in A1C (P<0.0001) and a mean reduction in LDL-C of 14.49 (P<0.0001), while female patients had a mean reduction in A1C of 0.48% (P<0.0001) and a mean LDL-C reduction of 16.13% (P<0.0001).

When patients were stratified by race, all subgroups had comparable reductions in both A1C and LDL-C: Caucasian patients had a mean reduction in A1C of 0.48% (P<0.0001) and a mean reduction in LDL-C of 16.16 (P<0.0001); Black patients had a 0.77% mean reduction in A1C (P<0.0002) and a mean reduction in LDL-C of 19.64 (P<0.0001); and Hispanic patients had a 0.54% mean reduction in A1C (P<0.0001) and a mean reduction in LDL-C of 11.31 (P<0.0001).

IMPORTANT INFORMATION ABOUT WELCHOL

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. Welchol is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. It 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 dyslipidemi
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Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients...(ater than or equal to 65 andless than 65...),Health