Early Symptom Response in Patients With Uncomplicated Urinary Tract Infection Treated With Gepotidacin or Nitrofurantoin: Pooled Analysis From Two Pivotal Phase 3 Studies

Resumo original em inglês

O que aconteceu

Uncomplicated urinary tract infections (uUTIs) can cause distressing symptoms seriously impacting daily activities. Early symptom relief during treatment, though fundamental to patients, is often overlooked in clinical trials. Gepotidacin, a new antibacterial agent, was noninferior to the first-line treatment nitrofurantoin in two randomized controlled trials (EAGLE-2 [NCT04020341] and EAGLE-3 [NCT04187144]). The current analysis utilized pooled data from these two trials to evaluate symptom responses during and after treatment in participants with uUTI.

Participants were aged ≥12 years with at least two uUTI symptoms, urinary nitrite and/or pyuria, and no complicating factors. Participants were randomized 1:1 to oral gepotidacin (1500 mg) or nitrofurantoin (100 mg), both taken twice daily for 5 days. At baseline (Day 1), on-therapy (OT; Days 2-4), and test-of-cure (TOC; Days 10-13) visits, urinary symptoms were assessed (0-3; none-severe) from which a total score (0-12) was derived.

O que encontraram

Overall, 3136 participants were randomized (1572 gepotidacin, 1564 nitrofurantoin). Mean (median) baseline symptom scores for gepotidacin and nitrofurantoin arms were 7.1 (7.0) and 7.2 (7.0), respectively; at OT, this decreased to 3.6 (3.0) for both arms. At the OT visit, >80% of participants had clinical improvement/resolution. Among those with baseline symptoms affecting everyday activities (moderate or severe), 53.2% (728/1369) assigned gepotidacin and 53.6% (738/1377) assigned nitrofurantoin reported at OT that symptoms no longer affected everyday activities (mild or absent); at TOC, these percentages were 93.8% (1232/1313) and 93.3% (1254/1344), respectively.

Por que isso importa

Gepotidacin and nitrofurantoin provide meaningful and similar early relief from uUTI symptoms.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.