952
Gregory M. Schrank et al
Table 3. Multivariate Logistic Regression Model of Adverse Drug Events Leading to a Change or Early Discontinuation of Antibiotic Therapy Covariate
Adjusted OR
OPAT antibiotic Daptomycin Vancomycin
Age
Baseline eGFR, mL/min/1.73m2 >90
60–90 <60
Charlson comorbidity index
Location of OPAT treatment Home
Long-term acute-care or skilled nursing facility OPAT combination therapy
Safety labs not available weekly 95% CI ……
3.71 1.00
1.64–8.40 0.98–1.02
……
0.75 1.52 0.81
0.38–1.48 0.74–3.13 0.66–0.99
……
0.53 1.10 0.99
0.29–0.95 0.48–2.55 0.51–1.92
NOTE. OR, odds ratio; CI, confidence interval; eGFR, estimated glomerular filtration rate; OPAT, outpatient parenteral antibiotic therapy; OR, odds ratio. aBold values indicate statistical significance.
of patients in our cohort received vancomycin empirically without a confirmed microbiologic diagnosis of a resistant organism (23.4%). This treatment decision was driven in part by cases in which patients did not have a microbiologic culture obtained in the setting of an infectious process often caused by methicillin- resistant Staphylococcus aureus (MRSA) or coagulase-negative Staphylococci, such as skin and soft-tissue infections (5.8%), bone and joint infections (24.3%), and hardware-associated infections (37.8%). Careful consideration of MRSA risk is important before committing patients to a prolonged course of vancomycin. If microbiology results are not conclusive, alternative means of MRSA risk stratification, such as MRSA nasal screening, may be useful to tailor decision making. Negative nasal screening has a high negative predictive value and is useful in many instances for narrowing antimicrobial coverage.29 The IDSA OPAT guidelines recommend weekly safety
Fig. 3. Cumulative incidence (with 95% confidence intervals) for adverse drug events among recipients of vancomycin and daptomycin as part of their OPAT regimen. Patients were censored at completion of OPAT treatment, discontinuation of vancomycin or daptomycin, or after loss to follow-up.
hypersensitivity syndromes, organ dysfunction, and cytopenias were observed in the vancomycin group. Notably, 3 of 7 dapto- mycin patients who developed a skeletal muscle ADE were also taking a statin at the time of discharge. Some cases of skeletal muscle toxicity may have been reduced through a robust dis- charge medication reconciliation process. However, in some high- risk patients, discontinuing the statin may have outweighed any potential benefits. This high-risk population is also at increased risk of kidney injury, further complicating the clinical decision- making process. The toxicity of intravenous antibiotics, particularly vancomy-
cin, necessitates a careful review of the clinical indication for the expanded-spectrum gram-positive coverage. A significant number
laboratory monitoring for patients receiving home infusions of vancomycin and daptomycin. These guidelines were last updated in 2004, however, and logistical challenges result in significant variation in real-world clinical practice.8,30,31 Availability of OPAT laboratory testing is associated with a lower risk of hospital readmission and higher OPAT success.1,28 We did not find a significant association between frequency of safety laboratory monitoring and reduced risk of adverse events; however, our study had limited power to detect a difference in this outcome between the 2 exposures groups. These findings are limited in several ways. First, there is potential
for residual confounding present in all observational designs. This may explain our finding that receipt of therapy at a long-term acute- care or skilled nursing facility was associated with a lower risk of medication change due to ADE. A higher burden of comorbidities was noted among patients at facilities (Supplementary Table 1). In a sensitivity analysis including patients who died, the association between receipt of therapy at a long-term acute-care or skilled
P Valuea …
<.01 .90
…
.40 .25 .04
…
.03 .82 .97
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