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ORIGINAL   DISTORTED  

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v  Vancomycin-resistant Enterococcus (VRE) bacteremia has become a major concern in the nosocomial setting v  Currently, daptomycin and linezolid are two common options to treat VRE bacteremia infections with resistance to ampicillin v  Studies suggest linezolid and standard dose daptomycin (6 mg/kg) have similar clinical outcomes for treatment of VRE bacteremia v  A comparison of high-dose (HD) daptomycin (> 6 mg/kg) to linezolid may provide insight into another treatment option v  To our knowledge, there are currently no published studies that evaluate the efficacy and safety of high-dose daptomycin compared to linezolid for the treatment of VRE bacteremia

BACKGROUND

To compare the efficacy and safety of high-dose daptomycin to linezolid for the treatment of VRE bacteremia

v  This retrospective analysis suggests the clinical response and microbiological clearance rates of high-dose daptomycin were similar to linezolid for the treatment of VRE bacteremias v  A large, randomized, prospective study comparing high-dose daptomycin and linezolid for the treatment of VRE bacteremias would provide additional insight on whether there is a difference between both therapies

James Truong, Pharm.D., Gary Wu, Pharm.D., BCPS (AQ-ID), AAHIVP; Teena Abraham, M.S., Pharm.D., BCPS; Nasser Saad, Pharm.D.

New York Methodist Hospital, Brooklyn, New York

Efficacy and Safety of High-Dose Daptomycin versus Linezolid for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremias: A Retrospective Study

OBJECTIVE

MATERIALS AND METHODS

RESULTS

CONCLUSIONS

DISCLOSURES

MATERIALS AND METHODS

Primary Efficacy Endpoints

Secondary Efficacy Endpoints

Safety Endpoints

Study Design & Data Collection

Inclusion and Exclusion Criteria Inclusion Criteria:

1.  > 18 years old 2.  Received linezolid or high-dose daptomycin for > 48 hours 3.  > 1 documented positive VRE blood culture

Exclusion Criteria:

1.  Concomitant VRE therapy for > 48 hours (except gentamicin) 2.  Non susceptibility to daptomycin for daptomycin-treated patients 3.  Resistance to linezolid for linezolid-treated patients

Table 1. Baseline Demographics

Secondary Endpoints HD Daptomycin

(n = 16) Linezolid (n = 25)

p-value

Overall Mortality 5  (31.3 %)   14  (56 %)   0.19  Infection Related Mortality 3  (18.8 %)   5  (20 %)   1  30-Day Mortality 3  (18.8 %)   9  (36 %)   0.31  30-Day Readmission 4  (25%)   5  (20 %)   0.72  Time to First Negative Culture from Initiation of Targeted Therapy  (days)

5.8  (2 – 16)   7.4  (1 – 22)   0.34  

Length of Hospital Stay from Initiation of Targeted Therapy (days)

29.7  (4 – 130)   21.2  (4 – 130)   0.41  

Overall Length of Hospital Stay (days) 49.5  (7 – 251)   36.5  (5 – 166)   0.41  

Adverse Drug Events† HD Daptomycin (n = 16)

Linezolid (n = 25) p-value

Creatine Phosphokinase Elevation > 5 x ULN > 10 x ULN

0  0  

(0 %)  (0 %)  

0  0  

(0 %)  (0 %)  

1  1  

Myopathy 0  (0 %)   0  (0 %)   1  Hematologic Neutropenia Thrombocytopenia Anemia

0  2  0  

(0 %)  (12.5 %)  (0 %)  

0  6  0  

(0 %)  (24 %)  (0 %)  

1  

0.45  1  

Eosinophilic Pneumonia 0  (0 %)   0  (0 %)   1  Discontinuation due to an Adverse Drug Event 0  (0 %)   3  (12 %)   0.27  

Table 5. Safety Endpoints

Table 3. Microbiology

RESULTS

LIMITATIONS

Baseline Characteristics

HD Daptomycin (n = 16)

Linezolid (n = 25) p-value

Demographics Age (years) 74.4  (32 – 92)   74.1  (38 – 95)   0.95  Gender (males) 5  (31.3 %)   13  (52 %)   0.22  Height (in) 65.4  (61 – 71)   65.1  (55 – 74)   0.79  Weight (kg) 76.2  (49.8 – 133.2)   67.2  (43.6 – 94)   0.15  BMI (kg/m2) 27.43  (19 – 41)   24.9  (17 – 44.3)   0.25  Location Prior to Hospital Admission Home 10  (62.5 %)   16  (64 %)   1  Nursing Home 6  (37.5 %)   8  (32 %)   0.75  LTCF 0  (0%)   1  (4 %)   1  Illness Severity APACHE-II Score 18.7  (6 – 35)   19.6  (0 – 37)   0.72  Charlson Comorbidity Index 7.8  (4 –12)   7.3  (2 – 15)   0.55  

Comorbidities Concurrent BSI 8 (50 %) 7 (28 %) 0.19 Malignancy 5 (31.3 %) 8 (32 %) 1 HIV / AIDS 0 (0 %) 1 (4 %) 1 CKD 7 (43.8 %) 8 (32 %) 0.52 ESRD on HD 4 (25 %) 3 (12 %) 0.4 Echocardiogram Transthoracic 7 (43.8 %) 6 (24 %) 0.3 Transesophageal 3 (18.8 %) 0 (0 %) 0.05 Hematology Neutropenia 0 (0 %) 1 (4 %) 1 Thrombocytopenia 3 (18.8 %) 4 (16 %) 1 Anemia 16 (100 %) 25 (100 %) 1

Microbiology HD Daptomycin (n = 16)

Linezolid (n = 25)

Enterococcus species faecalis faecium both

3

12 1

(18.8 %) (75 %) (6.3 %)

6

19 0

(24 %) (76 %) (0 %)

Susceptibility† S I R S I R Daptomycin (%) 100   (§)   (§)   93.8   (§)   (§)  Linezolid (%) 93.8   6.2 0   96   4   0  Ampicillin (%) 18.8   0   81.2   28   0   72  Quinupristin/Dalfopristin(%)‡ 60   0   40   73.3   6.67   20  Gentamicin Synergy (%) 87.5   0   12.5   60   20   40  

Figure 1. Screening of Enterococcal Bacteremias (Jan 2011 to Mar 2015)

Statistical Analysis

*Categorical data - Number (percentage); Continuous data - Average (range) BMI – Body Mass Index; LTCF – Long Term Care Facility; APACHE-II – Acute Physiology and Chronic Health Evaluation-II; BSI – Blood Stream Infection; HIV / AIDS – Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome; CKD – Chronic Kidney Disease; ESRD on HD – End Stage Renal Disease on Hemodialysis

v  Baseline characteristics and endpoints for both cohorts were analyzed using two-sided t tests for continuous data and Fisher’s exact tests for categorical data

v  Statistical significance was defined as a P-value of less than 0.05

v  Retrospective study v  Small sample size

Authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation:

All authors: Nothing to disclose

Microbiological clearance: At least 1 negative blood culture for VRE after targeted treatment initiation and remains negative while on targeted therapy  

Clinical response (needs to meet all three criteria): v   Resolution or improvement of baseline signs & symptoms v  Blood cultures remain negative at the end of targeted therapy v  No additional anti-VRE antibiotics were given for treatment of VRE bacteremia due to lack of clinical response

30-Day Mortality Infection Related Mortality Overall Mortality 30-Day Readmission Time to First Negative Culture from Initiation of Targeted Therapy Length of Hospital Stay from Initiation of Targeted Therapy Overall Hospital Length of Stay  

Adverse Event Profile v  Anemia (< 13 g/dL for males and < 12 g/dL for females) v  Thrombocytopenia (platelets < 100,000/mm3) v  Neutropenia (absolute neutrophil count [ANC] < 1000) v  Elevated Creatine Phosphokinase (> 120 µg/L) v  Eosinophilic Pneumonia

Discontinuation due to an Adverse Drug Event

v  This is a retrospective health outcomes study utilizing electronic medical chart review of eligible patients admitted to New York Methodist Hospital v  The primary investigator screened microbiology reports containing positive enterococcal blood cultures from January 2011 to March 2015 for potential patients to be included in this analysis v  Pertinent information of patients were obtained from Cerner® including baseline demographics and clinical characteristics

HD Daptomycin (n = 16)  

Linezolid (n = 25)   p-value  

Dose (mg) 551.9  (300 – 800)   600   -  Dose (mg/kg) 7.36  (6.01 – 9.96)   -   -  Duration (days) 12  (2 – 30)   8.6  (3 – 16)   0.14  

†Susceptibilities of enterococcal blood cultures were obtained for VRE bacteremia occurrences ‡Susceptibility for Quinupristin/Dalfopristin was only obtained for E. faecium §The current absence of data on daptomycin-resistant isolates precludes defining any categories other than “Susceptible”

Table 2. Dose and Duration of Therapy

Catheter 8% Intra-

abdominal 8%

Pulmonary 12%

Other 8%

Urinary 20%

Unknown 44%

Catheter 19%

Intra-abdominal

19%

Pulmonary 19%

Other 6%

Unknown 37%

Figure 2. Source of Bacteremia

High-dose Daptomycin (n = 16)   Linezolid (n = 25)  

Table 4. Secondary Efficacy Endpoints

†Based on the microbiologically evaluable population for high-dose daptomycin (n = 12) and linezolid (n= 16)

Figure 3. Primary Efficacy Endpoints HD Daptomycin Linezolid

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Clinical Response Microbiological Clearance†

% o

f Pa

tient

s

12 / 12 (100 %)

15 / 16 (94%)

13 / 25 (52 %)

8 / 16 (50 %)

p  = 1

p  = 1

204 occurrences of enterococcal bacteremia

16 were receiving high-dose daptomycin for VRE treatment

25 were receiving linezolid for VRE treatment

163 occurrences were excluded: 121 (74%) Vancomycin- susceptible 34 (23%) Other 4 (3%) Met > 1 exclusion criteria

STRENGTHS v  Clearly defined endpoints to minimize potential bias v  Examined clinically relevant adverse effects commonly associated with linezolid and daptomycin

†New-onset ADEs after initiation of Targeted Therapy