The FDA has approved Welchol (colesevelam hydrochloride) to reduce blood glucose in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other agents, according to Daiichi Sankyo, Inc., of Parsippany, N.J.


Welchol is the only medication approved to reduce both glucose levels and LDL cholesterol levels. Forty percent of type 2 diabetes patients also have high LDL levels, so the newly approved option treats both these chronic conditions.

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Pivotal data have demonstrated that Welchol can lower both hemoglobin A1c and LDL levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen.


“Welchol now offers physicians a treatment option that addresses two major cardiovascular risk factors,” said Ronald B. Goldberg, MD, professor of medicine in the division of diabetes and metabolism and associate director of the Diabetes Research Institute at the University of Miami Miller School of Medicine.


“Cardiovascular risk factors are of great concern because patients with type 2 diabetes have a significantly increased risk of developing cardiovascular disease.”