Dalbavancin Effective for Bacterial Skin Infections in Patients With Obesity
The lipoglycopeptide dalbavancin is safe, effective, and well-tolerated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in patients with overweight or obesity, according to a recent analysis.
Findings from the study were presented at ID Week 2017, which is taking place from October 4 to 8, 2017, in San Diego, California.
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Dalbavancin, which has been approved by the US Food and Drug Administration (FDA) as a single- or 2-dose regimen, is known for its activity against gram-positive pathogens that cause ABSSSI, including methicillin-resistant Staphylococcus aureus (MRSA).
For their analysis, the researchers assessed 698 patients with ABSSSI who had been enrolled in a previously published randomized, double-blind, phase 3 trial. A total of 237 patients had normal weight (body mass index [BMI] less than 25 kg/m2), 221 had overweight (BMI of 25 to 30 kg/m2), and 240 had obesity (119 with BMI of 30 to less than 35 kg/m2; 60 with BMI of 35 to less than 40 kg/m2; and 61 with BMI of 40 kg/m2 or higher). During the trial, patients had been randomly assigned to receive either a single 1500 mg dose of intravenous dalbavancin, or a 1000 mg dose on day 1 and 500 mg dose on day 8.
ABSSSI was defined as a major abscess, cellulitis, or traumatic wound/surgical site infection and an area of erythema measuring 75 cm2 or more. The primary outcome was clinical response within 48 to 72 hours, which was defined as a 20% or greater reduction in infection-related erythema. The researchers assessed safety at every visit and clinical success, or the resolution of all signs and symptoms with no further antibiotic treatment needed, at day 14 and day 28.
Results indicated that the incidence of diabetes, hypertension, systemic inflammatory response syndrome, and cellulitis had been higher in patients with obesity vs those with overweight or normal weight. The researchers observed similar clinical success rates across groups at end-of-treatment visits and final visits.
Treatment-emergent adverse events related to the study drug occurred in 7.2% of patients with normal weight, 4.6% with overweight, and among patients with obesity: 7.6% with a BMI of 30 to 35 kg/m2, 11.7% with a BMI of 35 to 40 kg/m2, and 13.1% with a BMI of 40 kg/m2 or higher. The rates of serious treatment-emergent adverse events were similar across BMI groups, ranging from 0% to 3.3%. The researchers noted that these rates were similar to those reported in previous phase 3 trials.
“Dalbavancin is effective and well tolerated in overweight and obese patients,” the researchers concluded.
—Christina Vogt
Reference:
Georgiades B, Rappo U, Gonzales PL, McGregor JS, Chen J, McCarthy M. Efficacy and safety of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the obese population. Paper presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. https://idsa.confex.com/idsa/2017/viewsessionpdf.cgi.