Very expensive lefamulin is no worse than moxifloxacin for community-acquired pneumonia

Reference

Alexander E, Goldberg L, Das AF, et al. Oral lefamulin vs moxifloxacin for early clinical response among adults with community-acquired bacterial pneumonia. The LEAP 2 randomized clinical trial. JAMA 2019;322(17):1661-1671.

Synopsis

Lefamulin is the first pleuromutilin antibiotic approved for use in humans and with activity against most common community-acquired bacterial pneumonia-causing pathogens. These investigators identified 738 hospitalized adults, 18 years or older (mean age 57.5 years) with lower respiratory symptoms, abnormal vital signs, and radiographically confirmed pneumonia. Almost all patients met the criteria for Pneumonia Outcomes Research Team risk class II (50.4%), class III (37.7%), or class IV (11.1%). Common comorbid conditions included hypertension, asthma, chronic obstructive respiratory disease, and diabetes. Eligible patients randomly received (concealed allocation assignment) 600 mg oral lefamulin every 12 hours for 5 days or 400 mg oral moxifloxacin every 24 hours for 7 days. Each group also received matching oral placebo to maintain masked treatment group assignment and outcome assessments. Complete data were available for 95.8% of patients at 30 days. Using intention-to-treat analysis, no significant group differences occurred in the likelihood of early clinical response or overall clinical response at the end of therapy. Differences in response rates were in the range of 1% to 2% for most outcomes and remained similar across all severity indices. Serious adverse events occurred similarly between groups. Patients who received lefamulin were more likely to report gastrointestinal adverse events (17.9% vs 7.6%), but the discontinuation rates were also similar.