To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Health Canada Approves Invanz (Ertapenem Sodium), Once Daily Injectable Antibiotic URL: http://www.pslgroup.com/dg/2396B6.htm Doctor's Guide September 3, 2003
TORONTO, ON -- September 3, 2003 -- Merck Frosst Canada Ltd. announced that Health Canada has approved Invanz (ertapenem sodium), a new antibiotic indicated for the treatment of adults with moderate to severe infections caused by a wide range of bacteria. Ertapenem offers the convenience of a once a day monotherapy and clinical studies have found the efficacy of ertapenem similar to multi-dose combination therapies.1,2 Potential advantages of a once daily dosing regimen using a single agent include decreased resource utilization and possible reduction of medication error rate in hospitalized patients. Furthermore, ertapenem provides physicians with flexibility as it can be administered intravenously or intramuscularly. " Ertapenem is an excellent therapeutic choice because it simplifies treatment and studies have shown it to be effective against many complicated bacterial infections including intra-abdominal, skin and skin structure and community-acquired pneumonia, " said Dr. Ori Rotstein, Professor of Surgery University of Toronto. Ertapenem is a structurally unique 1-b methyl-carbapenem related to the class of antibiotics known as beta-lactams. Like other beta-lactams, ertapenem works by blocking the formation of the bacterial cell wall causing cell death. This new antibiotic has shown efficacy against a wide spectrum of gram-positive and gram-negative aerobic and anaerobic bacteria.2 Efficacy similar to drugs dosed multiple times a day Ertapenem was studied in clinical trials with commonly prescribed treatment regimens for complicated intra-abdominal infections acquired in a community setting that require multiple daily dosing and/or a combination of anti-microbial agents. A prospective, multi-centred, randomized, controlled, double-blind study conducted in 633 patients with complicated intra-abdominal infections demonstrated that one-gram of ertapenem injected once daily was statistically equivalent to 3.375 grams of piperaclilin/tazobactam given to patients every six hours.1 Ertapenem monotherapy was studied with a combination therapy of ceftriaxone plus metronidazole in a prospective, randomized, multi-centred, controlled, double-blind trial on the treatment of complicated intra-abdominal infections in adults. Ertapenem one-gram once daily, with the option to switch to an oral regimen after clinical improvement, appeared similar to the combined regimen of ceftriaxone two grams daily plus metronidazole 500 mg every eight hours, with the same oral switch option.2 Efficacy demonstrated across all indications. The pivotal Phase IIb/III trials demonstrated the results for clinical success rates with ertapenem compared to widely used antibiotics for patients treated for: Complicated intra-abdominal infections: 86.7 per cent of patients on ertapenem were clinically and microbiologically cured at four to six weeks post-therapy compared with 81.3 per cent for piperacillin/tazobactam; 3 Complicated skin and skin structure infections: 82.2 per cent of patients on ertapenem were clinically cured 10 to 21 days post-therapy compared with 84.5 per cent for piperacillin/tazobactam; 3 Community-acquired pneumonia: ertapenem was evaluated comparing one-gram once a day of ertapenem with ceftriaxone. The clinical success rates (of the combined studies) at seven to 14 days post therapy were 92 per cent for ertapenem and 91.8 per cent for ceftriaxone;3 Complicated urinary tract infections: 89.5 per cent of patients on ertapenem were microbiologically cured five to nine days post-therapy compared with 91.1 per cent for ceftriaxone in the combined studies; 3 Acute pelvic infections: 93.9 per cent of patients on ertapenem were clinically cured two to four weeks post-therapy compared with 91.5 per cent for piperacillin/tazobactam.3 Ertapenem has limited activity against Pseudomonas and Acinetobacter species--pathogens typically associated with hospital-acquired infections. Enterococcci and methicillin resistant staphylococci are resistant to ertapenem. Proven tolerability The overall tolerability profile of ertapenem in clinical studies was comparable to ceftriaxone and piperacillin/tazobactam. Across studies in five infectious disease categories, the most common clinical side effects were infused vein complications (3.9 per cent), phlebites/thrombophlebitis (1.3 per cent), diarrhea (4.3 per cent), nausea (2.9 per cent), headache (2.1 per cent) and vomiting (1.0 per cent).3 Guideline recommendations Ertapenem is recommended in the Surgical Infection Society (U.S.) guidelines4 as a single agent for antimicrobial regimens for patients with intra-abdominal infections. Trademark of Merck & Co., Inc. Used under license References 1. Solomkin JS, Yellin AE et al. Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Complicated Intraabdominal Infections: Results of a Double-Blind, Randomized Comparative Phase III Trial. Annals of Surgery 237(2): 235-245; Feb 2003 2. Yellin AE, Hassett JM et al. Ertapenem monotherapy versus combination therapy with ceftriaxone plus metronidazole for treatment of complicated intra-abdominal infections in adults. International Journal of Antimicrobial Agents 20 (2002) 165-173 3. INVANZ™ Canadian Product Monograph 4. Mazuski JE, Sawyer RG et al. The Surgical Infection Society Guidelines on Antimicrobial Therapy for Intra-Abdominal Infections: An Executive Summary. Surgical Infections 3 (3), 2002 161-173 SOURCE: Merck Frosst Canada Ltd. --------------------------------------------------------------------------------------------- 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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