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This pooled analysis of two studies (Lefamulin Evaluation Against Pneumonia [LEAP] trials) examined lefamulin's overall safety and efficacy in individuals having comorbidities typical in the management of CABP.
Lefamulin may be a
promising empiric monotherapy option for people with community-acquired
bacterial pneumonia (CABP), including people at risk for poor outcomes due to
age or several comorbidities.
This pooled analysis of two studies (Lefamulin Evaluation
Against Pneumonia [LEAP] trials) examined lefamulin's overall safety and
efficacy in individuals having comorbidities typical in the management of CABP.
In one study (LEAP 1), patients with CABP were given intravenous (IV) lefamulin (first-in-class pleuromutilin antibiotic) 150 mg (once every 12 hours) for 5 to 7 days or; moxifloxacin 400 mg (once a day) for a week, with optional IV-to-oral change if predefined improvement criteria were not fulfilled. In the second study (LEAP 2), CABP people received oral administration of 600 mg lefamulin (once every 12 hours) for five days or 400 mg moxifloxacin (once a day) for a week.
The early clinical response (ECR) at 96 ± 24 hours after the first study drug
dose was assessed. The investigator’s assessment of clinical response (IACR) of
the patient at 5 to 10 days after the final dose was also evaluated. A 10%
non-inferiority margin was used for pooled analyses of the total population.
Out of the total, 646 patients were in the lefamulin group and 643 in the moxifloxacin group. Lefamulin was non-inferior to moxifloxacin for ECR, as shown in Figure 1:
High IACR rates of success at 5 to 10 days after the
last dose were observed. Patient subgroups, incorporating people with older age, diabetes, a
history of cardiovascular diseases (for example, high blood pressure,
congestive heart failure, or irregular heartbeat) or chronic lung diseases (for
example, chronic obstructive pulmonary disease or asthma), raised liver
enzymes, or kidney dysfunction (mild-to-moderate) demonstrated high efficacy with both
lefamulin and moxifloxacin. There
were no new safety signals.
Lefamulin may be a significant IV or oral therapy that
can be used as a substitute to fluoroquinolones or macrolides for CABP
management and in patients with higher age or comorbidities. The antibiotic was
well-tolerated irrespective of the route of administration (oral or IV).
BMC Pulmonary Medicine
Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities
Thomas M. File Jr. et al.
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