Pramlintide acetate

• Published in: American journal of health-system pharmacy 2005-11, Vol.62 (22), p.2363-2372
• Main Author: McQueen, Joanna
• Format: Article
• Language: English
• Subjects: Amyloid - pharmacokinetics; Amyloid - pharmacology; Amyloid - therapeutic use; Clinical Trials as Topic; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 2 - drug therapy; Drug Therapy, Combination; Humans; Hypoglycemic Agents - pharmacokinetics; Hypoglycemic Agents - pharmacology; Hypoglycemic Agents - therapeutic use; Insulin - therapeutic use; Islet Amyloid Polypeptide; Product Surveillance, Postmarketing
• ISSN: 1079-2082; 1535-2900
• DOI: 10.2146/ajhp050341

The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of pramlintide are reviewed. Pramlintide, a synthetic analogue of the human hormone amylin, is the first of a new class of amylinomimetic compounds. It was approved in March 2005 as a subcutaneous injection for the adjunctive treatment of patients who have type 1 or 2 diabetes mellitus and have failed to achieve glycemic control despite optimal therapy with insulin. Pramlintide complements the effects of insulin in postprandial glucose regulation by decreasing glucagon secretion. Pramlintide exhibits linear pharmacokinetics, and peak serum levels are reached within 30 minutes of administration. The drug is predominantly renally eliminated, with a mean elimination half-life of 30-50 minutes. Clinical trials have shown that pramlintide suppresses postmeal glucagon secretion, slows gastric emptying, reduces postprandial glucose levels, and improves glycemic control while managing weight loss. Pramlintide has also been shown to decrease hemoglobin A(1c), serum fructosamine, and total cholesterol levels. Pramlintide has been associated with an increased risk of insulin-induced severe hypoglycemia; other adverse events include nausea, anorexia, fatigue, and vomiting. The dosage varies with the type of diabetes. Because of the cost associated with the complications of uncontrolled diabetes, pramlintide may have a beneficial effect on total costs associated with this chronic disease. Pramlintide in combination with insulin is a potential therapeutic option for improving glycemic control in patients with diabetes, but the increased risk of hypoglycemia must be aggressively monitored.