Systematic review and meta-analysis on the safety of dalbavancin

ABSTRACT

Background

Dalbavancin is a semisynthetic lipoglycopeptide antimicrobial agent with activity against Gram-positive bacteria including anaerobes.

Research design and methods

Meta-analysis of randomized control trials and large case series (more than 20 patients), were identified by searching Pubmed and Cochrane databases through 14 December 2020.

Results

3,073 patients from 6 RCTs met the inclusion criteria. Treatment emergent adverse effects were described in 30.6% dalbavancin patients, and 38.1% patients with other treatments. Our meta-analysis supports favorable results for dalbavancin treatment (OR 0.79; 95%CI 0.66–0.94; p = 0.01). 2.74% dalbavancin patients had to discontinue treatment versus 2.49% patients on other antibiotics. 4.80% dalbavancin patients versus 5.30% patients with other treatments had severe adverse events. 0.31% in the dalbavancin group and 0.95% receiving other antibiotics died. There was no statistically significant difference in severe adverse effects with OR 0.77; 95% CI 0.52–1.14; p = 0.19. Dalbavancin therapy was shown to have statistically significant lower mortality rate (OR 0.26; 95% CI 0.07–0.90; p = 0.03). Observational studies reported few side effects but included a heterogeneous population of patients concerning their diagnosis and the duration of antibiotic treatment.

Conclusions

Dalbavancin has comparable safety profile relative to other antibiotics and is well-tolerated.

KEYWORDS:

• Dalbavancin
• side effect
• safety
• clinical trial
• systematic review

Author contributions

NMM, JSGP, and JJ concepted and designed the study and analyzed and interpreted data. All authors made the drafting of the paper and revised it critically for intellectual content. All authors approved the final version to be published and agree about the journal. All authors agree to be accountable for all aspects of the work.

Abbreviations

• ABSSI: acute bacterial skin and skin-structure infection.

• AE: adverse event

• BMI: body mass index

• CI: confidence interval

• ITT: intention to treat

• NR: not reported

• OR: odds ratio

• OTA: ‘other sites’ infections

• RCT: randomized control trial

• SD: standard deviation

• SOC: standard of care

• SSTI: skin and soft tissue infection

• TEAE: treatment emergent adverse event

Declaration of interest

MF Galindo ́s contract is co-financed by the European Development Fund Regional (Feder) in accordance with the Operational Programme of the Region of Castilla-La Mancha for the programming of Feder 2014- 2020, and for the University’s own Research Plan of Castilla-La Mancha. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.