Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Seaton, R.A.; Gonzalez-Ruiz, Armando; Cleveland, Kerry O.; Couch, Kimberly A; Pathan, Rashidkhan; Hamed, Kamal

doi:10.1186/s12941-016-0130-8

Cited by 45 publications

(49 citation statements)

References 55 publications

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“…In a pooled analysis of the two large real-world registries, CORE in the USA and EU-CORE in Europe, daptomycin usage was analysed in 11 557 patients, of whom 8.6% were treated for osteomyelitis, with or without material, with an estimated clinical success rate of 77.7%. The promising role of daptomycin in such infections has been strengthened by the ability to use higher dosages of this molecule, up to 12 mg/kg, but also by in vitro studies showing its ability to penetrate bone tissue (Malizos et al, 2016;Seaton et al, 2016;Senneville et al, 2016). Traunmüller et al provided the first in vitro data regarding daptomycin bone penetration in 2010.…”

Section: Introductionmentioning

confidence: 99%

Bone penetration of daptomycin in diabetic patients with bacterial foot infections

Grillon

Gaudias²,

Ronde-Ousteau³

et al. 2019

International Journal of Infectious Diseases

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Objectives: Daptomycin has shown clinical efficacy in diabetic foot infections (DFI). However, only limited data are available on its bone penetration in this particular population. The aim of this study was to determine daptomycin bone concentrations in patients with DFI undergoing surgery after multiple daptomycin infusions and to determine bone daptomycin inhibitory quotients (IQs) for the predominant gram-positive species involved in DFI. Methods: Fourteen adult patients hospitalized with DFI treated with daptomycin and requiring surgical bone debridement and amputation were included in this single-centre prospective study. Daptomycin concentrations in serum and bone were determined by HPLC at steady state. Bone IQs were then calculated according to different minimum inhibitory concentrations (MICs; range 0.25-4 mg/l) that are representative of the main MICs for Staphylococcus aureus, coagulase-negative staphylococci (CoNS), and Enterococcus sp populations. Results: Residual and peak concentrations varied from 4.5 mg/l to 39.9 mg/l and from 31.8 mg/l to 110.9 mg/ l, respectively. Bone daptomycin concentrations at the moment of surgery varied from 1.2 mg/l to 17 mg/l. Up to a MIC of 1 mg/l, which is the epidemiological cut-off value (ECOFF) and breakpoint value for S. aureus and CoNS, all bone daptomycin IQs were positive. The highest bone IQs were observed with Staphylococcus species. Calculated bone IQs for Enterococcus species were often weak at MIC values near the ECOFF. Conclusions: Daptomycin penetrates bone well in patients treated for DFI. At an initially recommended dosage of 6 mg/kg, bone concentrations are likely to be effective against staphylococcal infections and infections due to low-MIC Enterococcus.

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Section: Introductionmentioning

confidence: 99%

Bone penetration of daptomycin in diabetic patients with bacterial foot infections

Grillon

Gaudias²,

Ronde-Ousteau³

et al. 2019

International Journal of Infectious Diseases

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“…Two patients in our cohort developed eosinophilic pneumonitis, an unusual and poorlyunderstood complication associated with daptomycin. The largest study to date of complications secondary to daptomycin administration found, in 11,557 patients, an estimated incidence of eosinophilic pneumonitis of 0.03% 24 . A review of the US FDA Adverse Event Reporting System database identified 7 definite, 13 probable, and 38 possible cases of daptomycin-induced eosinophilic pneumonia 25 .…”

Section: Discussionmentioning

confidence: 99%

Assessing the Role of Daptomycin as Antibiotic Therapy for Staphylococcal Prosthetic Joint Infection

Carli

Miller

Kapadia

et al. 2020

J. Bone Joint Infect.

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Background: The role of daptomycin, a potent, safe, convenient anti-staphylococcal antibiotic, in treatment of prosthetic joint infection (PJI) is unclear. We evaluated our experience with the largest cohort of patients with staphylococcal PJI managed with daptomycin. Methods: A cohort of staphylococcal hip and knee PJI treated with daptomycin was identified by hospital records from 2009 to 2016. All cases met Musculoskeletal Infection Society International Consensus criteria for PJI. The primary endpoint was 2 year prosthesis retention. Univariate analyses and regression statistics were calculated. Results: 341 patients with staphylococcal PJI were analyzed. 154 two-stages (77%) and 74 DAIR procedures (52%) met criteria for treatment success at 2 years. 77 patients were treated with daptomycin, of which 34 two-stages (68%) and 15 DAIRs (56%) achieved treatment success. Pairwise and regression analysis found no association between treatment success and daptomycin use. Organism (DAIR only) and Charlson Comorbidity Index scores (DAIR and two-stage) were significantly associated with treatment outcome. Six daptomycin patients (7.8%) had adverse side effects. Discussion: Daptomycin fared no better or worse than comparable antibiotics in a retrospective cohort of staphylococcal hip and knee PJI patients, regardless of surgical strategy. Conclusion: The convenient dosing, safety, and potency of daptomycin make it an attractive antibiotic for staphylococcal PJI. However, these advantages must be weighed against higher costs and rare, but serious side effects.

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“…It is also reported that daptomycin has an adverse effect concerning creatinine phosphokinase (CPK) elevation . To date, the safety of daptomycin treatment has been widely investigated in relation to various types of infections and pathogens . Although a few reports describe the higher risk of CPK elevation in high‐dose treatment, almost all other previous reports demonstrated the safety of daptomycin treatment with a low or no significant incidence of CPK elevation or other adverse effects, even with high‐dose treatment .…”

Section: What Is Known and Objectivementioning

confidence: 99%

“…5 To date, the safety of daptomycin treatment has been widely investigated in relation to various types of infections and pathogens. [6][7][8][9][10][11][12][13][14][15] Although a few reports describe the higher risk of CPK elevation in high-dose treatment, 12 almost all other previous reports demonstrated the safety of daptomycin treatment with a low or no significant incidence of CPK elevation or other adverse effects, even with high-dose treatment. 7,8,10,[12][13][14][15] Previously, C trough levels of 24.3 μg/mL were reported as a breakpoint of CPK elevation.…”

Section: What Is K Nown and Objec Tivementioning

confidence: 99%

Observational retrospective single‐centre study in Japan to assess the clinical significance of serum daptomycin levels in creatinine phosphokinase elevation

et al. 2019

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What is known and objective Daptomycin‐induced creatinine phosphokinase (CPK) elevation is reported to be associated with its trough level (Ctrough; breakpoint of 24.3 μg/mL). However, even with high‐dose treatment (ie, > 8 mg/kg), the safety of daptomycin treatment is widely demonstrated with low or no significant incidence of CPK elevation or other adverse effects, despite the possibility of Ctrough above 24.3 μg/mL. Therefore, we questioned the clinical significance of Ctrough levels of 24.3 μg/mL. In this study, we retrospectively evaluated the significance of Ctrough in the clinical setting, in addition to completing a retrospective safety assessment of daptomycin utilizing electronic health records. Methods Patients who had received daptomycin treatment for > 4 days from July 2011 to June 2015 were enrolled. Serum daptomycin levels, including Ctrough and peak (Cpeak), were measured by high‐performance liquid chromatography equipped with a photodiode array. To evaluate the safety, patients’ characteristics and relevant laboratory test values were reviewed retrospectively using an electronic medical record system. Results and discussion A total of 52 therapeutic cases for 46 patients were identified; of these, Ctrough and Cpeak levels were measured in 27 and 28 cases, respectively, and 6 patients received multiple courses of daptomycin treatment. The median age of the 52 patients was 68 years (range: 19‐88 years), and 14 patients initially had an estimated creatinine clearance of less than 30 mL/min. Seven cases indicated a Ctrough of above 24.3 μg/mL; however, none of these presented CPK elevation, which meets with the study definition for abnormality. Furthermore, of the two patients with abnormal CPK elevations, only one patient had a measured Ctrough (of 10.9 μg/mL). Their CPK abnormalities were temporal and did not result in treatment discontinuation. The other four patients discontinued daptomycin treatment due to suspicions of adverse effects. Of the discontinued patients, two had measured Ctrough levels; these were 8.6 and 8.1 μg/mL. All patients with abnormal CPK elevation or treatment discontinuation exhibited Ctrough levels lower than 24.3 μg/mL. In this study, two patients receiving high‐dose daptomycin (ie, 9.4 and 10.0 mg/kg) had observed Ctrough levels similar to patients who received doses of daptomycin < 9 mg/kg. What is new and conclusions The safety of daptomycin treatment was suggested in this study. Ctrough level of 24.3 μg/mL was not suggested as a significant clinical index for the incidence of CPK elevation, adverse effects or treatment discontinuation. Thus, acceptable tolerability towards higher Ctrough levels than 24.3 μg/mL was also suggested, though further studies are required. On the other hand, low levels of daptomycin in blood were unexpectedly observed in two cases, despite the high‐dose treatments. Accordingly, the monitoring of serum daptomycin levels may also be useful to assess cases in which subtherapeutic levels were achieved.

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Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Cited by 45 publications

References 55 publications

Bone penetration of daptomycin in diabetic patients with bacterial foot infections

Bone penetration of daptomycin in diabetic patients with bacterial foot infections

Assessing the Role of Daptomycin as Antibiotic Therapy for Staphylococcal Prosthetic Joint Infection

Observational retrospective single‐centre study in Japan to assess the clinical significance of serum daptomycin levels in creatinine phosphokinase elevation

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