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Diabetes mellitus: FDA has approved Symlin


The FDA ( Food and Drug Administration ) approved Symlin, an injectable drug to control blood sugar for adults with type 1 and type 2 diabetes.
Symlin is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugars on intensive insulin therapy alone.

Symlin ( Pramlintide ) is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin.

In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals.

The use of Symlin contributes to glucose control after meals.

The safety and efficacy of Symlin were studied in approximately 5000 patients.
Overall Symlin therapy was associated, in patients with both types of diabetes, with improvements in the control of blood glucose and with weight loss.

Symlin is to be used only in combination with insulin to help lower blood sugar during the 3 hours after meals.

The principle risk associated with Symlin therapy is hypoglycemia, and this risk is greatest in patients with type 1 diabetes and in patients with gastroparesis ( motility problems of the stomach ).

Other adverse events commonly observed with Symlin when co-administered with Insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported.
The incidence of nausea was higher at the beginning of Symlin treatment and decreased with time in most patients.
The incidence and severity of nausea are reduced when Symlin is gradually increased to the recommended doses.

Side effects associated with Symlin include but are not limited to vomiting, abdominal pain, headache, fatigue and dizziness.

Symlin should not be used if patients cannot tell when their blood sugar is low, have gastroparesis ( slow stomach emptying ), or are allergic to Pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate.

Symlin has not been evaluated in the pediatric population.

Source: FDA, 2005

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