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Drugs

, Volume 67, Issue 10, pp 1483–1512 | Cite as

Daptomycin

A Review of its Use in the Management of Complicated Skin and Soft-Tissue Infections and Staphylococcus aureus Bacteraemia
  • Philip I. HairEmail author
  • Susan J. Keam
Adis Drug Evaluation

Summary

Abstract

Daptomycin (Cubicin®) is the first of a new class of antibacterials, the cyclic ipopeptides, and is approved for use in the treatment of complicated skin and soft-tissue or skin-structure infections (hereafter referred to as cSSTI) caused by Gram-positive bacteria and Staphylococcus aureus bacteraemia including right-sided infective endocarditis.

Daptomycin has activity in vitro against a wide variety of Gram-positive bacteria, including meticillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci.

When administered as a once-daily intravenous infusion, daptomycin was not inferior to standard parenteral therapy (vancomycin or semi-synthetic penicillins) in terms of clinical and microbiological efficacy in patients with cSSTI or S. aureus bacteraemia with or without infective endocarditis (including MRSA infection) and was well tolerated.

With the advantage of once-daily administration and a low potential for drug interactions, daptomycin is a useful addition to the range of parenteral antibacterial agents available for the treatment of patients with cSSTI or S. aureus bacteraemia with or without right-sided infective endocarditis. Efficacy against both meticillin-susceptible S. aureus (MSSA) and MRSA infections makes daptomycin suitable for empirical therapy in patients with serious Gram-positive infections.

Pharmacological Properties

Daptomycin, a cyclic lipopeptide derived from Streptomyces roseosporus, has a unique mechanism of antibacterial action that involves calcium-dependent binding of the drug to the cytoplasmic membrane. This results in altered membrane function, with cell death ensuing because of impairment of potassium-dependent macromolecular synthesis following efflux of potassium from the cell.

Daptomycin demonstrated rapid, concentration-dependent bactericidal activity in vitro against a variety of Gram-positive organisms, including S. aureus (both MSSA and MRSA), Enterococcus faecalis (both vancomycin-susceptible and — resistant), and β-haemolytic streptococci (including Streptococcus agalactiae, S. pyogenes and S. dysgalactiae subspecies equisimilis). Minimum inhibitory concentrations of daptomycin required to inhibit 90% of strains (MIC90) were ≤1 mg/ L against S. aureus (including MRSA), ≤4 mg/L against E. faecalis (including vancomycin-resistant organisms) and ≤0.5 mg/L against β-haemolytic streptococci. It showed a strong post-antibiotic effect against S. aureus, including MRSA, and was active against both growing and stationary-phase bacteria. The generation of daptomycin-resistant strains in the laboratory has proven difficult and the incidence of nonsusceptibility to daptomycin among S. aureus isolates from patients is low. p ]Inhibition of biofilm production by staphylococci was demonstrated in vitro at daptomycin concentrations approximating those achieved in plasma at steady state with therapeutic dosages.

The pharmacokinetics of daptomycin were generally linear and steady state was achieved after 3 days of intravenous, once-daily administration. The distribution of daptomycin is limited mostly to plasma and extracellular space, with preferential movement into highly vascularised tissues. Despite a high degree of binding (unbound fraction ≈8%) to plasma proteins (which is reversible), therapeutic concentrations of daptomycin are achieved in tissues, including inflammatory blister fluid.

Renal excretion predominates, and daptomycin is excreted as unchanged drug or inactive metabolites, with a mean elimination half-life of approximately 8 hours. Dosage adjustment is recommended in patients with severe renal impairment (creatinine clearance <30 mL/min [<1.8 L/h]). Daptomycin has no significant pharmacokinetic interactions with commonly administered drugs, such as aztreonam, warfarin, probenecid or simvastatin, and is not metabolised by cytochrome P450 (CYP) isoenzymes; consequently, it is unlikely to affect the CYP-dependent metabolism of drugs.

Clinical Efficacy

Daptomycin has demonstrated noninferiority to standard therapy (vancomycin or semi-synthetic penicillins) in phase III clinical trials when administered at dosages of 4 mg/kg in patients with cSSTI and 6 mg/kg in patients with S. aureus bacteraemia with or without infective endocarditis.

In patients with cSSTI, the clinical success rate with daptomycin was not inferior to that seen with standard therapy (71.5% vs 71.1% in the intent-to-treat [ITT] analysis; 83.4% vs 84.2% in the clinically evaluable analysis). Bacteriological eradication rates in the microbiologically evaluable population were 73–100% in the daptomycin group and 69–91% in the standard therapy group. Clinical success rates with daptomycin or standard therapy that were achieved in patients with MRSA infections and in patients with comorbidities such as diabetic foot ulcer were close to the values in the ITT population.

In patients with S. aureus bacteraemia with or without infective endocarditis, daptomycin was not inferior to standard therapy; clinical success rates were 44% versus 42% in the modified ITT population and 54% versus 53% in the perprotocol population, respectively. Overall survival rates with either treatment did not differ. The median time to clearance of S. aureus bacteraemia was not significantly different in daptomycin and standard therapy recipients.

Retrospective data from the CORE (Cubicin® Outcomes Registry and Experience) post-marketing study showed high clinical response rates and short median response times with daptomycin therapy in patients with MRSA cSSTI or non-catheter-related bacteraemia.

Tolerability

Daptomycin was generally well tolerated in phase III clinical trials, with the majority of adverse events being mild to moderate in severity. The incidence and pattern of adverse events did not differ from those of comparator antibacterials. The most common adverse events in both both daptomycin-treated and comparator-treated patients were constipation, nausea, injection-site reaction and headache.

In patients with S. aureus bacteraemia, but not cSSTI, daptomycin therapy was associated with a higher incidence of elevated serum creatine phosphokinase and a lower incidence of renal dysfunction than standard therapy. Almost all patients in the standard therapy group received initial treatment with gentamicin.

Keywords

Infective Endocarditis Linezolid Teicoplanin Daptomycin Minimum Inhibitory Concentration 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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© Adis Data Information BV 2007

Authors and Affiliations

  1. 1.Wolters Kluwer Health ¦ AdisMairangi Bay, North Shore 0754, AucklandNew Zealand
  2. 2.Wolters Kluwer HealthConshohockenUSA

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