Tedizolid and Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections of the Lower Extremity versus Non–Lower-Extremity Infections

Joseph, Warren S.; Culshaw, Darren; Anuskiewicz, Steven; Anda, Carisa De; Prokocimer, Philippe

doi:10.7547/15-218

Cited by 8 publications

(12 citation statements)

References 29 publications

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“…This non-inferiority between tedizolid and linezolid remained the same in the sensitivity analysis. This finding was consistent with previous post-hoc analyses [15,16,17] of two phase 3 studies in which the non-inferiority of tedizolid to linezolid in terms of early responses remained consistent across various populations, including body mass index ≥30 kg/m 2 , diabetes, intravenous drug users, elderly patients of age ≥65 years, patients with renal impairment and different disease severity/sites. Second, the clinical responses at test and PTE among the ITT and CE population were similar between the tedizolid and linezolid groups.…”

Section: Discussionsupporting

confidence: 91%

Tedizolid Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis

Lan

Lin

Chang³

et al. 2019

Antibiotics

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This meta-analysis aims to assess the efficacy and safety of tedizolid, compared to linezolid, in the treatment of acute bacterial skin and skin structure infection (ABSSSI). PubMed, Web of Science, EBSCO (Elton B. Stephens Co.), Cochrane Library, Ovid Medline and Embase databases were accessed until 18 July 2019. Only randomized controlled trials (RCTs) comparing the efficacy of tedizolid with linezolid for adult patients with ABSSSIs were included. The outcomes included the clinical response, microbiological response, and risk of adverse events (AEs). A total of four RCTs involving 2056 adult patients with ABSSSI were enrolled. The early clinical response rate was 79.6% and 80.5% for patients receiving tedizolid and linezolid, respectively. The pooled analysis showed that tedizolid had a non-inferior early clinical response rate to linezolid (odds ratio (OR) = 0.96, 95% confidence interval (CI) = 0.77–1.19, I2 = 0%). The early response rate was similar between tedizolid and linezolid among patients with cellulitis/erysipelas (75.1% vs. 77.1%; OR = 0.90, 95% CI = 0.64–1.27, I2 = 25%), major cutaneous abscess (85.1% vs. 86.8%; OR = 0.93, 95% CI = 0.42–2.03, I2 = 37%) and wound infection (85.9% vs. 82.6%; OR = 1.29, 95% CI = 0.66–2.51, I2 = 45%). For methicillin-resistant Staphylococcus aureus patients, tedizolid had a favorable microbiological response rate of 95.2% which was comparable to linezolid (94%) (OR = 1.19, 95% CI = 0.49–2.90, I2 = 0%). In addition to the similar risk of treatment-emergent AEs (a serious event, the discontinuation of the study drug due to AEs and mortality between tedizolid and linezolid), tedizolid was associated with a lower risk of nausea, vomiting and abnormal neutrophil count than linezolid. In conclusion, once-daily tedizolid (200 mg for six days) compared to linezolid (600 mg twice-daily for 10 days) was non-inferior in efficacy in the treatment of ABSSSI. Besides, tedizolid was generally as well tolerated as linezolid, and had a lower incidence of gastrointestinal AEs and bone marrow suppression than linezolid.

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Section: Discussionsupporting

confidence: 91%

Tedizolid Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis

Lan

Lin

Chang³

et al. 2019

Antibiotics

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“…Rates of clinical response were also similar in patients of non-Latino origin: 82.2% (396 of 482) for tedizolid and 78.5% (391 of 498) for linezolid (difference 3.64%, 95% CI −1.37% to 8.55%) 43. Finally, similar rates of early clinical response between tedizolid-treated and linezolid-treated patients were observed in different subgroups according to various severity measures, as well as in the subgroups of patients with and without lower-extremity infections 44,45…”

Section: Methodsmentioning

confidence: 66%

<p>Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy</p>

Bassetti¹,

Castaldo²,

Carnelutti³

et al. 2019

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Introduction Tedizolid phosphate is an oxazolidinone approved for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) and active against methicillin-resistant Staphylococcus aureus . Aims The objective of this article was to review the evidence for the efficacy and safety of tedizolid phosphate for the treatment of ABSSSI. Evidence review Approval of tedizolid phosphate for the treatment of ABSSSI was based on the results of two phase III randomized controlled trials, ESTABLISH-1 (NCT01170221) and ESTABLISH-2 (NCT01421511), comparing 6-day once-daily tedizolid vs 10-day twice-daily linezolid. In ESTABLISH-1, noninferiority was met with early clinical response rates of 79.5% and 79.4% in tedizolid and linezolid groups, respectively (difference 0.1%, 95% CI –6.1% to 6.2%, with a 10% noninferiority margin). In ESTABLISH-2, noninferiority was met with 85% and 83% rates of early clinical response in tedizolid and linezolid groups, respectively (difference 2.6%, 95% CI –3.0% to 8.2%). Pooled data from ESTABLISH-1 and ESTABLISH-2 indicated a lower frequency of thrombocytopenia in tedizolid-treated than in linezolid-treated patients. Conclusion Tedizolid offers the option of an intravenous to oral switch, allows once-daily administration, and presents lower risk of myelotoxicity when a 6-day course is used for the treatment of ABSSSI. Greater economic cost associated with this antibiotic could be offset by its shorter treatment duration and possibility of oral administration in routine clinical practice, although either sponsored or nonsponsored postmarketing observational experience remains essential for ultimately confirming the effectiveness and tolerability of tedizolid outside clinical trials.

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“…15 By contrast, Leman and Mukherjee identified no adverse effects for benzylpenicillin. 13 RoB was high for three of these studies, 13,15,16 and there were some concerns about RoB in the fourth 14 ( Fig. 2).…”

Section: Resultsmentioning

confidence: 85%

“…15,16 Two studies specified LLC severity and excluded patients with mild disease. 14,16 No studies compared the same antibiotic regimen, hence I 2 and meta-analysis was inappropriate.…”

Section: Resultsmentioning

confidence: 99%

“…16 This raises the possibility that in some patients lower doses of ciprofloxacin could potentially be used with no reduction in clinical response. 16 Joseph et al 14 performed a pooled analysis of the ESTABLISH 1 and 2 trials. 17,18 In the tedizolid group 114 of 162 patients (70.4%) achieved early clinical response compared with 115 of 158 (72.8%) in the linezolid group (RR = 0.97, 95% CI 0.84-1.1).…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Clinical response to antibiotic regimens in lower limb cellulitis: a systematic review

Mistry

Sharma

Patel

et al. 2020

Clin Experimental Derm

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There is variation in the treatment of lower limb cellulitis (LLC) with no agreement on the most effective antibiotic regimen. Many patients with cellulitis fail to respond to first-line antibiotics. This can negatively affect patient care and result in unnecessary hospital admissions. The aim of this systematic review was to determine the clinical response and safety of antibiotic regimens for the management of LLC. A systematic review for randomized controlled trials (RCTs) was conducted using OVID MEDLINE, Ovid Embase and Cochrane Central Register of Controlled Trials in January 2019. Outcomes of interest included the clinical response to antibiotic regimens (type, dose, route, duration) and the safety of antibiotics in LLC. Trial quality was identified using the Cochrane Risk of Bias tool. Four RCTs were included. All included studies showed no significant differences between the clinical response to different antibiotic type, administration route, treatment duration or dose. LLC may be overtreated and shorter courses of oral antibiotics, possibly with lower doses, may be more suitable. There is a lack of published data on the clinical response and safety of antibiotics in LLC. Three studies were high risk for bias overall. Further high-quality studies may help determine whether less intensive antibiotic regimens can effectively treat LLC.

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Tedizolid and Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections of the Lower Extremity versus Non–Lower-Extremity Infections

Cited by 8 publications

References 29 publications

Tedizolid Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis

Tedizolid Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection: A Systematic Review and Meta-Analysis

<p>Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy</p>

Clinical response to antibiotic regimens in lower limb cellulitis: a systematic review

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