TEPPLER H, WOODS G, JONAS L, ISAACS R; Interscience Conference on Antimicrobial Agents and Chemotherapy (42nd : 2002 : San Diego, Calif.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2002 Sep 27-30; 42: abstract no. L-377.

Merck Research Labs, West Point, PA.

BACKGROUND: ETP is a once-a-day parenteral beta-lactam that may eliminate the need for combination and multi-dose regimens for many patients for the treatment of various community-acquired and mixed aerobic-anaerobic infections. The objective of this analysis was to assess the ETP safety profile. METHODS: Safety and tolerability of ETP, 1 g once a day, were evaluated in 13 randomized multinational double-blind trials for treatment of adults with intra-abdominal, skin, urinary tract, or acute pelvic infection, or community-acquired pneumonia. Comparator drugs were piperacillin-tazobactam (P/T) 3.375 g Q6H and ceftriaxone (CRO) 1 g once a day. Safety was assessed in all treated patients (pts) daily during study therapy (parenteral + optional oral) and for 14 days thereafter. RESULTS: Of randomized pts, 1954, 774, and 942 received >/= 1 dose of ETP, P/T, and CRO, respectively. Patient demographics and duration of therapy were similar for all treatment groups. Clinical drug-related adverse experiences (DRAEs) were reported in 23, 23, and 27% of pts in the ETP, P/T, and CRO groups, respectively; laboratory DRAEs were reported in 14, 15, and 12%. The frequency of the most common DRAEs for ETP, P/T, and CRO, respectively, were: diarrhea, 6, 7, and 6%; nausea, 3, 3, and 3%; ALT, 6% (105/1736), 4% (30/685), and 5% (42/827); and AST 5% (95/1813), 5% (33/726), and 4% (37/866). Parenteral study therapy was stopped due to a clinical DRAE in 2, 2, and 1% of pts who received ETP, P/T, and CRO, respectively. Of pts treated with ETP, P/T, and CRO, respectively, 8, 9, and 7% experienced symptoms of moderate to severe intensity at the IV infusion site (most often pain). 35 pts (2%) in the ETP group, 12 (2%) in the P/T group, and 15 (2%) in the CRO group died during study therapy and the 14-day follow up; none of the deaths was considered drug related. CONCLUSIONS: ETP, 1 g once a day, was generally well tolerated and had an overall safety profile comparable to P/T and CRO. The most common DRAEs for ETP, P/T, and CRO were minor gastrointestinal symptoms and elevated aminotransferases.

Publication Types:

• Meeting Abstracts

Keywords:

• Adult
• Ceftriaxone
• Double-Blind Method
• Humans
• Lactams
• Pelvic Infection
• Penicillanic Acid
• Piperacillin
• ertapenem
• piperacillin-tazobactam combination product
• therapy

Other ID:

• GWAIDS0027256

UI: 102266880

From Meeting Abstracts