Two Studies at AACE 2009 Annual Meeting Highlight Effects of Welchol(R) (colesevelam HCl) on Blood Glucose and LDL-C in Patients with Type ...( - Welchol Added to Metformin Signific...),Health

- Welchol Added to Metformin Significantly Reduced A1C and LDL-C in Patients with Type 2 Diabetes

- Open-Label Extension Study Demonstrated the Safety and Durability of Welchol for up to 78 Weeks of Treatment

PARSIPPANY, N.J., May 15 /PRNewswire/ -- Daiichi Sankyo, Inc. (DSI) announced today that data from a 16-week, randomized, open-label pilot study demonstrated that Welchol(R) (colesevelam HCl) significantly improved glycemic control and reduced mean LDL cholesterol (LDL-C) when added to metformin monotherapy in patients with type 2 diabetes. In this study, Januvia(R) (sitagliptin) and Avandia(R) (rosiglitazone) also significantly improved glycemic control, but LDL-C increased in patients on both of these treatment regimens. In total, 169 patients were randomized to receive either Welchol (n=57), Januvia (n=56) or Avandia (n=56).(1)

"Seventy percent of patients with type 2 diabetes have elevated LDL cholesterol and are not at the recommended goal of less than 100 mg/dL, which greatly increases their risk for cardiovascular disease,"(2) said Yehuda Handelsman, MD, FACP, FACE, Medical Director of the Metabolic Institute of America in Tarzana, Calif. and principal investigator of the study. "These new data further support that Welchol reduces these two risk factors for cardiovascular disease in patients with type 2 diabetes by significantly lowering A1C and LDL or 'bad' cholesterol, thereby offering physicians a unique therapeutic option."*

Data derived from a separate study, a post-hoc analysis of the metformin arm of a 52-week open-label extension study (n=146) were also presented. The results demonstrated that Welchol was well-tolerated and effective for up to 78 weeks when added to metformin-based therapy, which is important considering the chronic and progressive nature of type 2 diabetes.(3)

"The safety of Welchol(R) (colesevelam HCl) has been established throug
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