To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Starlix (Nateglinide) Available In US For Type 2 Diabetes URL: http://www.pslgroup.com/dg/1F200E.htm Doctor's Guide February 12, 2001
EAST HANOVER, NJ -- February 12, 2001 -- Novartis Pharmaceuticals Corporation today announced that Starlix® (nateglinide), the first D-phenylalanine (amino-acid) derivative, is now available nationwide for the treatment of type 2 diabetes. Starlix has been approved by the U.S. Food & Drug Administration (FDA) for use as both initial monotherapy and in combination with metformin, another oral antidiabetic medication, in patients whose blood glucose (sugar) is not controlled by diet and exercise. Starlix works by stimulating rapid, short-acting insulin secretion that reduces the mealtime increase in blood glucose levels or spikes and effectively lowers overall blood sugar levels as measured by HbA1c (average level of glucose in the blood). Most people with type 2 diabetes experience these sudden increases in blood glucose levels following meals, which contribute to worsening overall blood glucose control. The elevated blood glucose levels that occur in type 2 diabetes can lead to serious long-term damage to organs such as eyes, kidneys and nerves. It also makes heart and blood vessel disease more likely. "The availability of this innovative product offers a new treatment approach and is a step forward for many patients with type 2 who are experiencing post-meal glucose spikes and the resulting elevation of their HbA1c," said William L. Daley, M.D., Executive Director, Cardiovascular and Metabolic Medical Affairs at Novartis Pharmaceuticals Corporation. "Now, patients have access to a medication that has been shown to improve overall glycemic control while at the same time blunting the mealtime rise in glucose." Controlling mealtime glucose is believed by physicians to be an important factor in managing type 2 diabetes. However, because diabetes management has traditionally focused on lowering fasting plasma glucose levels (measurement of glucose in the absence of food), the importance of managing the glucose spikes that typically occur in patients with type 2 diabetes has often been overlooked. The American Diabetes Association is expected to consider this issue of post-meal glucose control as it develops new guidelines for the clinical treatment of diabetes. "Patients may spend much of their day with elevated post-meal glucose levels," said Lawrence S. Phillips, MD, nateglinide clinical investigator and Professor of Medicine in the Division of Endocrinology and Metabolism at Emory University School of Medicine in Atlanta. "With Starlix, treatment to control these spikes is now effective, convenient and safe." The Food and Drug Administration (FDA) approved Starlix on December 22, 2000 based on data from clinical trials involving more than 3,100 patients with type 2 diabetes. One 24-week, randomized, double-blind, placebo-controlled study of 701 patients with type 2 diabetes evaluated the effects of Starlix, metformin, and the combination of Starlix with metformin on glycemic control, including postprandial glucose control, and assessed the tolerability and safety of these treatment regimens. The study reported that Starlix effectively controlled mealtime glucose spikes and reduced overall glucose levels as measured by HbA1c. Researchers concluded that the combination of Starlix and metformin was complementary and resulted in even greater reductions in HbA1c than either agent alone. In all studies, Starlix has an excellent safety and tolerability profile. By stimulating early, short-acting insulin secretion, Starlix avoids chronic stimulation of the pancreas and thus has a low potential for hypoglycemia. In clinical trials, 2.4 percent of Starlix patients experienced hypoglycemia compared to 0.4 percent for placebo, and only 0.3 percent of Starlix patients discontinued participation in these trials due to hypoglycemia. Starlix also offers gastrointestinal tolerability comparable to placebo. Additionally, no liver function testing or special monitoring is required. The most common adverse events associated with Starlix vs placebo are upper respiratory infection (10.5 percent vs 8.1 percent), back pain (4.0 percent vs 3.7 percent), flu symptoms (3.6 percent vs 2.6 percent), dizziness (3.6 percent vs 2.2 percent) and arthropathy (3.3 percent vs 2.2 percent). Patients whose hyperglycemia has not been adequately controlled with a sulfonylurea should not add or be switched to Starlix. For most patients, the recommended starting and maintenance dose of Starlix alone or in combination with metformin is 120 mg. For some patients who are closer to HbA1c goal, 60 mg of Starlix may be sufficient. Starlix has a mealtime dosing regimen and is taken prior to three main meals. It can be taken from one to 30 minutes prior to eating. Starlix has previously been cleared for marketing in several countries, including Japan, Switzerland, Brazil, Mexico and Venezuela. Related Link: Novartis Pharmaceuticals Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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