To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Lantus (Insulin Glargine [rDNA Origin] Injection) Once-A-Day Treatment for Diabetes Available in US URL: http://www.pslgroup.com/dg/1FBDD2.htm Doctor's Guide May 22, 2001
BRIDGEWATER, NJ -- May 22, 2001 -- Aventis Pharmaceuticals announced today that Lantus® (insulin glargine [rDNA origin] injection), the first and only insulin analog that provides 24-hour glucose lowering activity with just one shot, is now available by prescription in the United States for people with type 2 and type 1 diabetes. Lantus is unique in that it has no pronounced peak and is indicated for once-daily administration at bedtime in the treatment of adult and pediatric patients (six years of age and older) with type 1 diabetes or adult patients with type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia. Lantus works almost twice as long as neutral protamine Hagedorn (NPH), the most commonly used intermediate-acting insulin available. Lantus' duration of action is 24 hours versus 14.5 hours with NPH insulin. In order to provide full basal insulin coverage, two NPH injections are required. Lantus demonstrates a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours. "Lantus is an exciting new treatment option," according to Matthew C. Riddle, M.D., Head, Section of Diabetes and Professor of Medicine at Oregon Health Sciences University. "Lantus may change the way diabetes is treated because it may allow people with diabetes who have needed multiple daily injections of long-acting insulin to only take one injection a day to manage their basal insulin needs." Susan Martin, Senior Director for Metabolism at Aventis Pharmaceuticals, said, "We are excited about Lantus because it represents an innovation for patients in diabetes therapy, as well as the company's commitment to the discovery and development of diabetes advancements that benefit patients in various stages of this disease." All people with type 1 diabetes, and some people with type 2 diabetes, require insulin to help control blood glucose levels. Only a doctor can decide for sure if Lantus is the right therapy. However, patients may want to discuss Lantus with their doctor or health care provider if any of these apply: -- A patient's blood sugar is too high in spite of efforts to control it with diet, exercise or oral diabetes medications. -- A patient is currently using an intermediate-acting insulin (such as NPH) once a day and wants 24-hour basal coverage. -- A patient would rather take one injection of Lantus than two of NPH. "Many people with type 2 diabetes don't know that insulin is a treatment option at the beginning of their disease," said Dr. Riddle. "Unlike people with type 1 diabetes who depend on insulin injections from the moment they are diagnosed, people with type 2 diabetes often begin taking oral medications and add on insulin later as their disease progresses. For people with type 2 diabetes whose glucose levels are currently not in control on oral medications, the availability of Lantus may make the earlier use of insulin more appealing because it only requires one shot a day to work for a full 24 hours." Lantus received approval by the U.S. Food and Drug Administration (FDA) in April 2000 for the treatment of type 2 diabetes in adults and type 1 diabetes in adults and children (six years of age and older). The safety and effectiveness of Lantus injection given once-daily at bedtime was studied in more than 4,000 patients in six open-label, randomized, parallel studies and was compared to the safety and efficacy of NPH human insulin. Lantus is not meant to replace short-acting insulins such as Regular or Humalog®, which provide a "bolus" at mealtime. Lantus, in combination with oral hypoglycemic agents, was as effective as once-daily NPH in combination with oral hypoglycemic agents. These oral agents include sulfonylureas, metformin, and acarbose. Therefore, Lantus can be used with oral diabetes medications and/or short-acting insulin to help control diabetes. Lantus must not be diluted of mixed with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. The adverse events commonly associated with Lantus include the following: hypoglycemia; lipodystrophy; skin reactions (such as injection-site reaction, pruritus, rash); and allergic reactions. Hypoglycemia is the most common adverse effect of insulins, including Lantus.
SOURCE: Aventis Pharmaceuticals.
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