EMBARGO -- June 23, 2001
Contact:Lisa KennedyAventis Pharmaceuticals908/243-6361[email protected]Melissa Leier 908/243-7080[email protected]
AMARYL(r) (glimepiride tablets) IS PREFERABLE TO GLYBURIDE AS INITIAL THERAPY FOR TYPE 2 DIABETES
Study Shows Amaryl Causes Less Hypoglycemia Than Glyburide After Initial Dose
PHILADELPHIA, Pa., June 23, 2001 -- Amaryl(r) (glimepiride tablets) showed a reduced risk of early hypoglycemia after initial dose compared to glyburide, making it preferable as initial therapy for type 2 diabetes patients, according to the results of a head-to-head crossover study presented today at the American Diabetes Association (ADA) annual meeting.
"The American Diabetes Association recommends monotherapy with an oral agent as a first-line treatment for type 2 diabetes patients," said lead investigator Matthew C. Riddle, M.D., head of the section of diabetes and professor of medicine at Oregon Health Sciences University. "The results of our study show that Amaryl lacks the large 'first-dose' insulin secretory effect associated with glyburide. Therefore, Amaryl is a good first-choice sulfonylurea because there is less concern about unwanted early hypoglycemia."
The findings are based on "First-Dose C-peptide Response and Risk of Hypoglycemia are Lower with Glimepiride than Glyburide," a study that tested whether the agents differed in the insulin response and hypoglycemia effect during fasting after an initial dose.
MethodDuring a double-masked, random-order crossover trial, 30 patients, mean age 59 years, with type 2 diabetes, and a BMI of 31 kg/m2 each took 1mg of Amaryl or 2.5mg of glyburide daily in the morning for one week. After two weeks off each medication, they were switched to the other therapy.
The patients' glucose and C-peptide profiles were measured during a 10-hour extension of overnight fasting on the first and seventh days of each treatment. Prior to beginning the study, all 30 patients stopped taking their prior sulfonylurea or metformin therapy for at least two weeks, and had a fasting plasma glucose (FPG) of 140 to 200 mg/dL.
ResultsAfter six days, the therapies reduced FPG equally, from 182 to 156 mg/dL for patients on Amaryl and 181 to 152 mg/dL for patients on glyburide. On the first day, however, the average C-peptide increment at two hours was greater (32 percent versus 8 percent, p<0.01), the slope of the glycemia decline steeper (p<0.001), and the nadir of the glucose lower (92 versus 107 mg/dL, p<0.01) with glyburide. On the seventh day, little C-peptide rise appeared with either therapy, but the average glycemic slope was steeper (p<0.001) and the nadir lower (87 versus 95 mg/dL, p<0.001) with glyburide. Ten patients (33 percent) had glucose values documented at less than 70mg/dL on glyburide versus two subjects on Amaryl (p<0.05).
Amaryl UsageAmaryl offers type 2 diabetes patients a once-daily oral therapy with 24-hour glucose control. Amaryl is the first and only sulfonylurea with three indications: monotherapy, in combination with insulin, and in combination with metformin.
Amaryl is indicated as an adjunct to diet and exercise to lower blood glucose in people with type 2 diabetes whose blood glucose cannot be controlled by diet and exercise alone. The most common adverse reactions include dizziness, asthenia, headache, nausea, and hypoglycemia. Combined use of Amaryl with metformin or insulin may increase the potential for hypoglycemia. As with all sulfonylureas, severe hypoglycemia may occur.
Held in Philadelphia, Pa., the American Diabetes Association 61st Scientific Sessions includes academic and clinical data from diabetologists, endocrinologists, and clinical researchers. Studies are presented in seminars, scientific workshops, symposia, and poster sessions.
Aventis PharmaceuticalsAventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.
Aventis Pharma AG is the pharmaceutical company of Aventis S.A. (NYSE:AVE). Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, Pa.
Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 92,500 people in more than 120 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc S.A.
Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharma-us.com. Also available at this U.S. Web site are copies of this release or any recent release, or call 800/207-8049.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.
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