21 Cubicin (daptomycin) posters at ICAAC later this month. This one looks significant:
Comparison of Efficacy and Safety of Daptomycin (DAP) Versus Semi-synthetic Penicillin (SSP) and Vancomycin (VAN) in Patients with Complicated Skin and Skin Structure Infections (cSSSI)
Category: L1
E. S. CAMPANARO1, F. P. TALLY 1, B. I. EISENSTEIN 1, R. D. ARBEIT 2;
1Cubist Pharmaceuticals, Inc., Lexington, MA, 2Paratek Pharmaceuticals, Inc., Boston, MA.
Presentation Number: L-737
Keywords: daptomycin, lipopeptide, gram-positive
Background: DAP is a novel lipopeptide class antibiotic currently in late stage clinical development. It has in vitro activity against both drug-susceptible and -resistant Gram-positive bacteria, including MRSA, VRE and PRSP. Methods: In two multi-centered, multi-national, double-blind, randomized phase 3 studies of cSSSI in adults, DAP (4 mg/kg IV once daily) was compared with semi-synthetic penicillin (SSP) 4-12g/day or vancomycin (VAN) 1g q12h IV for planned treatment of 7-14 days. Prior to randomization a blinded investigator evaluated each subject and determined which comparator agent, either SSP or VAN, was to be given if randomized to the comparator arm. Each group was then randomized to receive either DAP or comparator based on pre-randomization selection. Results: A total of 913 subjects were analyzed in the clinically evaluable group. Of these, 429 patients received DAP, 299 received SSP, and 185 received VAN. Of the 429 randomized to DAP, 312 of the subjects were pre-randomized to receive SSP (D-SSP group); 117 of the DAP subjects were pre-randomized to receive VAN (D-VAN group). Clinical outcomes as measured by clinical success for DAP (D-SSP group) were 85.8% (268/312) compared to 88.6% (265/299) for SSP (95% CI, -2.6, 7.8). Clinical success for DAP (D-VAN group) were 81.1% (95/117) compared to 73.5% (136/185) for VAN (95%CI, -15.5, 2.0). The most frequent adverse events (AEs) for subjects in the DAP (D-SSP group) were dermatitis (3.6%), nausea (3.3%); and for SSP were nausea (5.3%), injection site thrombosis (3.8%). AEs in the DAP (D-VAN group) were nausea (9.7%), diarrhea (7.6%); and for VAN were nausea (14.5%), pruritis (7.7%). Conclusions: Clinical success rates and AEs for once daily daptomycin and comparators were similar, with a trend toward greater clinical success rate for DAP (D-VAN group) compared to those subjects that received VAN.
Commercial Relationship: E.S. Campanaro, Cubist Pharmaceuticals, Inc. F.
So looks like Cubicin does a little better (but not reaching stat significance) than vanco in these infections.
Peter |
