Intradialytic Administration of Daptomycin in End Stage Renal Disease Patients on Hemodialysis

Salama, Noha N.; Segal, Jonathan H.; Churchwell, Mariann D.; Patel, J. R.; Gao, Lihong; Heung, Michael; Mueller, Bruce A.

doi:10.2215/cjn.01650309

Cited by 41 publications

(39 citation statements)

References 10 publications

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“…However, several notable characteristics of these studies account for the dissimilar findings. The average weight (standard deviation) in one study of Salama et al was 64.1 (14.1) kg (12). In contrast, the average weight in our study was 81.2 (11.9) kg.…”

Section: Discussioncontrasting

confidence: 79%

“…In our study, HD sessions were fixed at 3.5 h (with blood and dialysate flow rates of 300 and 600 ml/min, respectively), while the flow rates and duration of the dialysis were not fixed in the studies by Salama et al Our study simulated intradialytic dosing during the last hour of dialysis, while Salama et al administered daptomycin during the last half hour. There were also notable differences in the exposure end points studied (12,13). One of the major advantages of Monte Carlo simulation is that it permits different covariate inputs, such as HD duration and weight.…”

Section: Discussionmentioning

confidence: 99%

“…Two studies performed by Salama et al also examined intra-HD and post-HD administration of daptomycin (12,13). On a superficial level, these studies look like they provide different results.…”

Section: Discussionmentioning

confidence: 99%

“…While the pharmacokinetic (PK) properties of daptomycin are well described for the general population, there are scant data for patients on HD (12,13). An understanding of how PK changes during HD is essential to determining optimal dosing schemes for these patients.…”

mentioning

confidence: 99%

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Use of Pharmacokinetic and Pharmacodynamic Principles To Determine Optimal Administration of Daptomycin in Patients Receiving Standardized Thrice-Weekly Hemodialysis

Patel

Cardone

Grabe

et al. 2011

Antimicrob Agents Chemother

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This study identified optimal daptomycin dosing for patients receiving thrice-weekly hemodialysis (HD). Twelve adult patients on HD received daptomycin at 6 mg/kg of body weight intravenously (i.v.) one time; plasma and dialysate samples were collected over 3 days. A 2-compartment model with separate HD and non-HD clearance terms was fit to the data. A series of 9,999-subject Monte Carlo simulations (MCS) was performed to identify HD dosing schemes providing efficacy and toxicity profiles comparable to those obtained for MCS employing the daptomycin population pharmacokinetic (PK) model derived from patients in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) study. For efficacy, we selected the HD dosing scheme which generated an area-under-the-curve (AUC) exposure profile comparable to that for the SAB-IE population model. For toxicity, we selected HD dosing schemes that minimized trough concentrations of >24. Daptomycin is a lipopeptide approved for the treatment of Staphylococcus aureus bacteremia and complicated skin and skin structure infections, both of which are common in patients receiving hemodialysis (HD) (1,4,(14)(15)(16)(17)(18). While the pharmacokinetic (PK) properties of daptomycin are well described for the general population, there are scant data for patients on HD (12, 13). An understanding of how PK changes during HD is essential to determining optimal dosing schemes for these patients. Furthermore, such dosage adjustments necessitate cognizance of interactions between antibiotic exposure, efficacy, and toxicity. Given the dearth of treatment options available against methicillin-resistant S. aureus (MRSA), it is imperative that daptomycin regimens be optimized for those on HD.The two objectives of this study were (i) to characterize the PK profile of daptomycin in patients receiving traditional thrice-weekly hemodialysis and (ii) to identify the optimal dosing scheme for daptomycin among patients on HD. With respect to the latter, the intent was to identify HD dosing schemes with efficacy and toxicity profiles comparable to those obtained from Monte Carlo simulations (MCS) employing the daptomycin population PK model derived from patients enrolled in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) clinical study for doses of 4 mg/kg of body weight given intravenously (i.v.) every 24 h (q24h) and 6 mg/kg given i.v. q24h (2, 7).Separate dosing schemes were developed for both FDAapproved daptomycin dosing regimens (4 mg/kg i.v. q24h and 6 mg/kg i.v. q24h) and for the two interdialytic periods (48 and 72 h). For efficacy, the primary exposure target was the area under the curve (AUC). Animal model data suggest that daptomycin is a concentration-dependent antibiotic, and the AUC/ MIC ratio is the pharmacodynamic (PD) parameter that best describes its activity (3,5,9,11). However, the AUC/MIC ratio associated with maximal effect has varied (3,5,9,11). Given the lack of a definitive AUC/MIC threshold, especially for patients with bloodstream infections, the ...

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Section: Discussioncontrasting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Use of Pharmacokinetic and Pharmacodynamic Principles To Determine Optimal Administration of Daptomycin in Patients Receiving Standardized Thrice-Weekly Hemodialysis

Patel

Cardone

Grabe

et al. 2011

Antimicrob Agents Chemother

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“…Mean volume in the peritoneal space was 2.6 L, roughly the amount of fluid administered during each exchange. Clearance was approximately 0.3 L/h, close to previous approximations for patients with minimal kidney function (8,(23)(24)(25). Finally, a physiologic amount of residual drug (approximately 0.5 mg) was estimated to remain in the peritoneal cavity after drainage.…”

Section: Discussionsupporting

confidence: 76%

Pharmacokinetics and Pharmacodynamics of Intravenous Daptomycin during Continuous Ambulatory Peritoneal Dialysis

Cardone

Lodise²,

Patel³

et al. 2011

Clinical Journal of the American Society of Nephrology

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Summary Background and objectives This study sought to (1) characterize the pharmacokinetic (PK) profile of intravenous (IV) daptomycin among patients receiving continuous ambulatory peritoneal dialysis (CAPD); (2) identify optimal IV CAPD dosing schemes; and (3) determine extent of daptomycin penetration into the peritoneal space after IV administration. Design, setting, participants, & measurements A PK study was conducted among eight CAPD patients. Population PK modeling and Monte Carlo simulation (MCS) were used to identify CAPD dosing schemes providing efficacy and toxicity plasma profiles comparable with those obtained from MCS using the daptomycin population PK model derived from patients in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) study. The primary efficacy exposure target was the area under the curve (AUC). For toxicity, the goal was to identify CAPD dosing schemes that minimized plasma trough concentrations in excess of 24.3 mg/L. Finally, peritoneal cavity penetration was determined. Results Administration of IV daptomycin 4 or 6 mg/kg, depending on indication, every 48 h was identified as the optimal CAPD dosing scheme. This regimen provided cumulative (AUC0–48) and daily partitioned (AUC0–24h and AUC24–48h) plasma AUC values similar to the SAB-IE or “typical patient” simulations. In addition, the proportion of patients likely to experience an elevated trough concentration in excess of 24.3 mg/L was similar between every 48 h CAPD dosing and the referent group. Penetration into the peritoneal cavity was 6% of plasma. Conclusions Daptomycin 4 or 6 mg/kg, on the basis of indication, IV every 48 h was found to be the optimal IV CAPD dosing scheme.

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Nephrology practice and research network opinion paper: Pharmacists' perspectives on the Advancing American Kidney Health initiative

Meaney

Manley²,

Pai

et al. 2020

J Am Coll Clin Pharm

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Patients with chronic kidney disease (CKD) are at high risk for clinically significant medication therapy problems (MTPs) due primarily to the complex pharmacotherapy prescribed by numerous providers, and the significant changes in pharmacokinetic and pharmacodynamic properties of many medications due to their kidney disease. While MTPs are well recognized, pharmacists are not routinely involved in the health care teams that provide care for patients with CKD. The Advancing American Kidney Health initiative was announced in July 2019 and is poised to shift models of care in nephrology toward value‐based payment. This represents an opportunity for pharmacists to integrate into teams to improve quality of care and outcomes for patients with CKD. Pharmacists should engage in medication reconciliation, transitions of care, and medication‐focused kidney disease education programs within a comprehensive medication management (CMM) framework to optimize pharmacotherapy outcomes. To implement these services, pharmacists need to utilize certified pharmacy technicians, telehealth, interprofessional skills, and other tools in innovative ways. Current models of successful practice from Canada can serve as a template for United States‐based nephrology pharmacy practice. In this opinion paper, we characterize the current state of nephrology practice and identify significant opportunities for advancement. We propose metrics to evaluate pharmacy services and a framework for key stakeholder engagement which will be critical to advance the profession of pharmacy within nephrology. The Advancing American Kidney Health initiative offers a distinct opportunity to demonstrate the value of CMM provided by pharmacists in the nephrology arena to optimize patient care.

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Intradialytic Administration of Daptomycin in End Stage Renal Disease Patients on Hemodialysis

Cited by 41 publications

References 10 publications

Use of Pharmacokinetic and Pharmacodynamic Principles To Determine Optimal Administration of Daptomycin in Patients Receiving Standardized Thrice-Weekly Hemodialysis

Use of Pharmacokinetic and Pharmacodynamic Principles To Determine Optimal Administration of Daptomycin in Patients Receiving Standardized Thrice-Weekly Hemodialysis

Pharmacokinetics and Pharmacodynamics of Intravenous Daptomycin during Continuous Ambulatory Peritoneal Dialysis

Nephrology practice and research network opinion paper: Pharmacists' perspectives on the Advancing American Kidney Health initiative

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