SAN FRANCISCO – Daptomycin demonstrated an overall clinical success rate of 83% when used as a first-line treatment of catheter-related bacteremia, according to analysis of a large European database.
"In Europe, we have seen daptomycin being used as more of a salvage therapy for catheter-related bacteremia," study investigator Mike Allen, Ph.D., said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. "This is our first opportunity with a reasonable number of patients to ask how it performs as a first-line treatment."
Mike Allen, Ph.D.
Dr. Allen, senior medical development adviser at Novartis Pharmaceuticals UK, and his associates reported results from 487 patients in the EUCORE (European Cubicin Outcomes Registry and Experience) trial, an ongoing noninterventional multicenter study designed to assess the characteristics and clinical outcomes of patients with catheter-related bacteremia who were treated with at least one dose of daptomycin (Cubicin). Investigators followed protocol criteria and were asked to rate outcomes following daptomycin therapy as improved, failure, or nonevaluable. An outcome of cured or improved was considered a clinical success.
Of the 487 patients, 148 received daptomycin as a first-line therapy. Of these, 59% were male and 34% were aged 65 years or older. The majority (97%) had significant underlying diseases, particularly cardiovascular disease (44%) and oncologic disease (28%).
"This registry includes all comers, so what we have is a snapshot of clinical practice," Dr. Allen said. "It gives us a far better feel for how the drug is actually used. We don’t have the caveats of a clinical trial whereby we’re limited to a certain patient population."
Samples for microbiologic analysis were available for 134 patients, with 117 (87%) yielding positive culture. The two most common pathogens were coagulase-negative staphylococci (55%) and Staphylococcus aureus (27%), followed by enterococci (10%) and other pathogens.
The most frequent initial dose of daptomycin was 6 mg/kg and the median duration of therapy was 10 days. A majority of patients met the definition of clinical success (57% cured, 26% improved). Success rates reached 79% against methicillin-resistant S. aureus and S. epidermidis and 87% against other coagulase-negative staphylococci.
Among all 148 patients who received daptomycin as first-line therapy, 16 (11%) experienced mild to severe adverse events regardless of relationship to daptomycin treatment, including infections and renal and urinary disorders urinary disorders, and two of skin and subcutaneous tissue disorders.
The study was funded by Novartis. Dr. Allen is employed by Novartis Pharmaceuticals UK, which markets daptomycin in the EU.
The meeting was sponsored by the American Society for Microbiology.