People with obesity are under-represented in randomized clinical trials (RCTs) of drugs used to treat acute bacterial skin and skin structure infections (ABSSSIs) in the United States, according to findings published in Open Forum Infectious Diseases. Ronald Hall, PharmD, MSCS, and colleagues examined the representation of people with obesity in RCTs for skin and skin structure infections, noting that—among other risks—people with obesity are at higher risk for developing ABSSSIs. The analysis included 69 studies. Weight and/or BMI was only reported in an estimated 50% of the RCTs reviewed, and no trials assessed the effect of body size on outcomes in the original publication. Additionally, the average weights or BMIs used in most RCTs were lower than US averages. Only 30% of newly approved drugs for ABSSSIs discussed the inclusion of people with obesity in the prescribing information. “Further ABSSSI studies should include subgroup analyses to determine outcomes in [people with obesity], as this would further stress the need for more evidence-based treatment in this globally rising population,” Dr. Hall and colleagues wrote.
