New Data Show Doripenem as Effective as Commonly Used Therapies in Treating Hospital-Acquired ...(er trial of 448patients with nosocomial ...),Health

Date:9/18/2007

er trial of 448 patients with nosocomial pneumonia (not associated with mechanical ventilation or early onset ventilator-associated pneumonia) were treated with either a one-hour IV infusion of 500 mg of doripenem every eight hours (500 mg q8h) or a 30-minute IV infusion of 4.5 g piperacillin/tazobactam administered every six hours (4.5 g q6h). After treatment with either therapy for at least 72 hours, subjects who met the criteria for clinical improvement were permitted to switch to 750 mg of oral levofloxacin, once a day (750 mg qd), to allow for hospital discharge. Cure rates in clinically evaluable patients were 81.3% (doripenem) and 79.8% (piperacillin/tazobactam).

The study demonstrated that a greater proportion of bacteria were resistant to piperacillin/tazobactam compared with doripenem. Resistance rates to piperacillin/tazobactam and doripenem (doripenem resistance defined as a minimum inhibitory concentration (MIC) of greater than or equal to 16 mcg/mL) in patients with Pseudomonas aeruginosa were 27% vs. 4%, respectively and in patients with Klebsiella pneumoniae were 43% vs. 0%, respectively.

In a second large, open-label, randomized, multi-center trial, 531 patients with VAP and hospitalized in the Intensive Care Unit (ICU) were randomized to receive either a four-hour IV infusion of 500 mg of doripenem every eight hours (500 mg q8h) or an IV infusion of imipenem 500 mg four times a day or 1000 mg every eight hours (500 mg q6h or 1000 mg q8h for 30 or 60 minutes, respectively). At baseline, Pseudomonas aeruginosa isolates were less resistant to doripenem than imipenem (0% vs. 13% respectively, MIC of greater than or equal to 16 mcg/mL). Cure rates in clinically evaluable patients were similar for doripenem compared to imipenem (68.3% vs. 64.8%, respectively). Cure rates in the clinically modified intent-to-treat population were similar between doripenem and imipenem (59% vs. 57.8%, respectively).

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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Copyright©2007 PR Newswire. All rights reserved

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