CUBICIN(R) Outcomes Registry and Experience (CORE(R)) Marks Milestone
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) continues to leverage its powerful CUBICIN patient registry and experience database known by the acronym CORE. In September, the database registered its 5,000th patient entry.
Researchers are presenting four posters at this year’s ICAAC/IDSA joint conference based on data derived from the CORE database.
1. D. P. Levine, H. Hoffman-Roberts , J. Brown , K. C. Lamp. Outcomes with Daptomycin (DAP) for Infective Endocarditis (IE). Summary: This poster describes endocarditis patients from CORE 2007; 41 were evaluable for outcome. Valve involvement; aortic n=20 (multiple valves involved n=5); tricuspid only n=9; mitral only n=8, nonvalvular n=3, unreported n=1. A prosthetic valve was present in 6 pts (aortic n=4, mitral n=1, aortic and/or mitral n=1). The success rates by valve were: aortic (85%), tricuspid only (89%), mitral only (63%) and nonvalvular or unreported (100%). Surgery was associated with higher success for native and prosthetic valves. These data support that surgical intervention optimizes IE outcomes. Daptomycin appears effective against a variety of clinical presentations of IE. Further clinical studies on left-sided IE are warranted. (Session Number: 127. Treatment of Endovascular Infections. Sunday, Oct. 26th, 12:15 p.m. – 1:15 p.m. Hall C, L-1518.)
2. G. Forrest, D. Culshaw , B. Donovan , K. C. Lamp. Daptomycin (DAP) for the Treatment of Documented Gram-positive (GP) Catheter-Related Bacteremia (CRB). Summary: This poster describes catheter-related bacteremia patients from CORE 2007; 90 were evaluable for outcome. The success rate was 93% (84/90). The success rate for S. aureus, CoNS and enterococci were 93%, 97% and 92%, respectively. The success rate for those patients with and without surgical removal or replacement was 95% (38/40) and 92% (46/50), respectively. Daptomycin appears to be effective in treating catheter-related bacteremia caused by S. aureus, CoNS and enterococci. Further studies are warranted. (Session Number: 127. Treatment of Endovascular Infections. Sunday, Oct. 26th, 12:15 p.m. – 1:15 p.m. Hall C, L-1519.)
3. J. Mohr, D. North , L. Friedrich , K. C. Lamp, B. E. Murray. Clinical Experience with Daptomycin (DAP) for the Treatment of Enterococcal Bacteremia (EB). Summary: Eighty-seven evaluable enterococcal bacteremia patients from CORE 2007 are described in this poster. Thirty-one percent had an ANC (less than)1000 cells/mm3. Successful outcomes were reported in 76% (66/87); 75% (41/55) E. faecium, 76% (19/25) E. faecalis, and 86% (6/7) non-speciated. If VR was present, success rate was 71% (39/55). In this population, daptomycin appears to be a useful agent for enterococcal bacteremia due to either E. faecium or E. faecalis. Further studies are warranted. (Session Number: 127. Treatment of Endovascular Infections. Sunday, Oct. 26th, 12:15 p.m. – 1:15 p.m. Hall C, L-1520.)
4. P. A. Moise, E. Hershberger, M. I. Amodio-Groton, K. C. Lamp. Safety and Clinical Outcomes of High-Dose Daptomycin (DAP) ((greater than or equal to) 8 mg/kg). Summary: Ninety-four patients in the CORE 2005 to 2007 program received (greater than or equal to) 8 mg/kg of daptomycin and were assessed for safety and efficacy. Six (6.4%) of the 94 pts experienced 1 or more adverse events (AE) or abnormal laboratory changes possibly related to daptomycin; in 2 (2.1%) of the 94 pts daptomycin was discontinued due to treatment related AE. The overall clinical success rate was 89% (47% cure, 42% improved). Daptomycin was well tolerated and effective at doses of (greater than or equal to)8 mg/kg in pts with clinically significant Gram-positive infections. Further studies of daptomycin at doses above 6 mg/kg are warranted. (Session Number: 126. New Treatment Options in Skin and Soft Tissue Infections. Sunday, Oct. 26th, 12:15 p.m. – 1:15 p.m. Hall C, L-1511.)
Overall, at this year’s ICAAC/IDSA joint conference, 105 presentations mention daptomycin, including 53 that mention daptomycin in the title. Cubist’s researchers were contributing authors on 15 presentations, and Cubist sponsored approximately 35 presentations, which means that we provided financial or other support to the researchers.
CUBICIN is approved in the U.S. and many other markets as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria. CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant and methicillin susceptible strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes ecallantide, a recombinant human protein in Phase 2 clinical trials for the prevention of blood loss during cardiothoracic surgery, and pre-clinical programs that address unmet medical needs in Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist’s web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.