The FDA recently approved Astra Zeneca's antibiotic Merrem IV (meropenem) for the treatment of complicated skin and skin structure infections including complicated cellulitis, skin abscesses, and peri-rectal abscesses. This approval was based on a Phase III randomized, double-blinded, multicenter trial consisting of 1,037 patients with complicated skin and skin structure infections comparing the efficacy and safety of Merrem 500 mg IV every 8 hours with that of imipenem-cilastatin 500 mg IV every 8 hours. The primary endpoint was clinical outcome at follow-up. Merrem IV demonstrated a similar success rate, 86%, compared to imipenem-cilastatin, 83%. Adverse events were similar in both groups and included headache, nausea, diarrhea, constipation, pruritus, pain, and anemia. Interestingly, Merrem IV showed greater efficacy compared to imipenem-cilastatin in patients older than 65 years, 81% versus 72%, as well as in patients with diabetes, 86% versus 72%. Merrem IV demonstrates antimicrobial activity against aerobic gram-positive, aerobic gram-negative, and anaerobic bacteria. It provides physicians with another therapeutic option for the treatment of complicated skin infections.
COPYRIGHT 2005 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2005 Gale Group
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