To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Prandin Lessens Risk Of Hypoglycaemia Associated With Missed Meals URL: http://www.pslgroup.com/dg/FF7DE.htm Doctor's Guide May 21, 1999
PRINCETON, NJ -- May 21, 1999 -- Patients with type II diabetes who miss a meal may be less likely to have a hypoglycaemic episode if they use Novo Nordisk Pharmaceuticals, Inc.'s oral antidiabetic drug (OAD) Prandin(TM) (repaglinide) tablets rather than a long-acting sulfonylurea (SU) to manage their disease, a new study shows. Because Prandin is short acting and taken only at mealtimes, a patient's blood glucose levels are maintained even when a meal is missed. The study in Diabetes Care evaluated the effect of a skipped meal on blood glucose levels in 83 patients with type II diabetes who were well controlled on either Prandin or glyburide treatment. The results found patients treated with Prandin maintained blood glucose control and reported no hypoglycaemic events, even when a meal had been skipped. In comparison, those treated with glyburide, a long-acting SU, experienced a decrease in blood glucose levels when they did not eat a scheduled meal and reported a total of six hypoglycaemic events. "Preventing hypoglycaemia in patients with diabetes is a critical issue," said Jay Skyler, M.D., professor of medicine, University of Miami. "These results suggest that in type II diabetes one way for providing flexibility in meals is to use repaglinide, which can be omitted when a meal is skipped." With SU treatment, insulin release is stimulated and sustained over a long period of time. As a result, patients must adhere to a fixed meal plan in order to avoid hypoglycaemia. While hypoglycaemia occurs most frequently with long-acting SU drugs, such as glyburide, even a shorter-acting SU, such as glipizide, remains at a therapeutic level for 12 to 16 hours following a single dose of 2.5-5 mg. Prandin, the first of a new class of drugs called meglitinides, is a short-acting OAD with a flexible dosing schedule. Its rapid onset of action and short half-life enables Prandin to be taken before each meal. As a result, Prandin augments insulin release when it is needed, after each meal when blood glucose levels are high. Between meals and during the night, insulin levels return toward baseline, which may reduce the occurrence of severe hypoglycaemia and hyperinsulinemia (excess insulin). If a meal is missed, Prandin is not taken and an increased amount of insulin is not released. Hypoglycaemia is a condition in which glucose in the blood is abnormally low, resulting in symptoms such as unusual hunger, feelings of anxiousness, shaking, rapid heart rate, impaired vision, headache, irritability, sweating, weakness or fatigue. If left untreated, hypoglycaemia may result in coma, a life-threatening condition, or death. More than 16 million Americans suffer from diabetes, 95 percent of whom are classified as type II. Diabetes is a metabolic disorder associated with a variety of long-term complications, including cardiovascular disease, peripheral vascular disease, stroke, visual impairment and blindness and kidney and nerve damage. Although some patients with type II diabetes can be treated initially with a combination of diet and exercise, more than 90 percent of patients with type II diabetes eventually require drug therapy to control their blood glucose. This double-blind, randomised study comprised 83 patients with type II diabetes (42 Prandin; 41 glyburide), whose mean fasting blood glucose (FBG) value after Prandin/glyburide titration and stabilisation was in the range of 90 to 140 mg/dL. During the three-day study period, half of the patients in each group received two meals on the first day and three meals on the following two days. In the other half, this sequence was reversed. Prandin was administered before each meal and glyburide was administered as recommended in current labelling, regardless of whether lunch had been omitted. Of the 83 randomised patients, 43 entered into the three-day study period and completed the trial. No significant difference was found between the Prandin and glyburide groups when comparing average fluctuation from fasting blood glucose. The effects of omitting a meal on mean minimum blood glucose concentration from 12:45 to 5:45 PM (BG min) differed significantly between the Prandin and glyburide groups. In the glyburide group, BGmin decreased from 77 to 61 mg/dL as a result of omitting lunch, whereas in the Prandin group, BGmin was essentially unchanged for the two-meal day (78 mg/dL) and the three-meal day (76 mg/dL). All hypoglycaemic events occurred in the glyburide group on the two-meal day, in connection with omitting lunch. No hypoglycaemic events were recorded in the Prandin group. Hypoglycaemic events were identified in the study as either symptomatic or biochemical. Symptomatic hypoglycaemia was defined as symptoms of hypoglycaemia (sweating, strong hunger, dizziness, tremor, etc.) which required treatment. Biochemical hypoglycaemia was defined as a blood glucose meter measurement of below 45 mg/dL, without symptoms. Although patients experiencing symptomatic hypoglycaemia did have their blood glucose levels measured, the value did not have to be below 45 mg/mL for classification as a symptomatic hypoglycaemic event, nor did the hypoglycaemia have to be symptomatic to be recorded as a biochemical event. Prandin has been approved by the U.S. Food and Drug Administration for first-line therapy as an adjunct to diet and exercise to lower the blood glucose in patients with type II diabetes. Prandin is also indicated for use in combination with metformin in patients inadequately controlled by either drug alone. In long-term clinical trials with Prandin versus sulfonylureas, no participants on Prandin reported hypoglycaemia that resulted in coma or required hospitalisation. In these clinical trials, hypoglycaemia was reported in 16 percent of Prandin-treated patients and 20 percent of sulfonylurea-treated patients (glyburide and glipizide). The most common adverse events leading to discontinuation in these trials were hyperglycemia, hypoglycaemia, and related symptoms. Other than hypoglycaemia, the most common adverse events reported in clinical trials were cold- and flu-like symptoms, headache, diarrhea, joint ache and back pain. --------------------------------------------------------------------------------------------- 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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