Emerging Drug List

NATEGLINIDE Nateglinide (Starlix ®) Novartis Pharmaceuticals As monotherapy, or in combination with metformin, for patients with type 2 diabetes whose blood glucose is not controlled by diet and exercise alone. In the United States, nateglinide received marketing approval by the Food and Drug Administration (FDA) in December 2000. It is also approved in other countries worldwide , including Japan, Switzerland, Brazil, Mexico and Venezuela. Currently, nateglinide is under review in Canada, with a projected marketing date of mid to late 2001. Diabetes mellitus is a common chronic disease, which has been diagnosed in over 1.5 million Canadians. Treatment is aimed at improving metabolic control, thereby preventing the development, or delaying the progression, of complications associated with the disease (such as nephropathy, retinopathy, neuropathy). Nateglinide is a D-phenylalanine derivative, also classed as a meglitinide analogue. Its therapeutic effect is derived from its action on the ATP-regulated potassium channels. This is similar to sufonylureas, however, it does bind at different sites on the beta cells. It is aimed at minimizing the post-prandial rises in blood glucose, stimulating rapid, short-acting postprandial insulin secretion. In comparison to repaglinide, it is thought to be faster acting and have a shorter duration of action, thereby minimizing the risk of post-absorptive hypoglycemia. This difference will need to be borne out in comparative clinical trials. The typical dose would range from 60-120 mg three times daily, given shortly before meals. For some patients, diet and exercise alone are acceptable means for controlling blood glucose. However, for many patients, this intervention does not suffice and pharmacologics are required. There are many different classes of medications, with varied mechanisms of action, that can be used in patients with type 2 diabetes. In Canada, there are numerous products belonging to several classes. Typically, In the U.S., a dose of 60 mg tid and 120 mg po tid are approximately $70.00-$79.99 and $80.00-$89.99/month, respectively. To date, clinical trials with nateglinide have included more than 3,100 type 2 diabetics. The studies have examined both monotherapy and combination therapy with nateglinide. Horton et al conducted a 24-week trial assessing the efficacy and tolerability of nateglinide and metformin alone or in combination in type 2 diabetics. At enrollment, patients had a glycated hemoglobin of 6.8 to 11.0 %. Patients were randomized in a double-blind fashion to receive nateglinide 120 mg before meals (n=179), metformin 500 mg three times daily (n=178), a combination of both medications …