Efficacy of 1.5% levofloxacin otic solution in treating acute otitis externa: A post hoc analysis of ENT103-3001, a multicenter randomized double-blind parallel-group placebo-controlled phase III study in otitis media with persistent otorrhea

IF 1.6 4区 医学 Q2 OTORHINOLARYNGOLOGY Auris Nasus Larynx Pub Date : 2024-10-30 DOI:10.1016/j.anl.2024.10.015
Han Matsuda , Masafumi Sawada , Kayo Suzuki , Haruo Takahashi , Tetsuo Ikezono
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Abstract

Objective

In this post hoc analysis, we aimed to evaluate the efficacy of 1.5% levofloxacin (LVFX) otic solution for the treatment of acute otitis externa (AOE) in patients with nonintact tympanic membrane (NTM) accompanied by chronic suppurative and acute otitis media.

Methods

Digital endoscopic images of the tympanic membrane and cavity were evaluated. In addition, the full analysis set from the original ENT103-3001 study was analyzed to determine the efficacy of the 1.5% LVFX otic solution in treating patients with otitis media with persistent otorrhea. AOE was diagnosed by a study-specific blinded independent review committee (BIRC) in the present study, which reviewed the presence of inflammatory findings, such as edema, erosion, and/or erythema (redness), in the external ear canal on the digital endoscopic images acquired at screening. The improvement in the inflammatory findings in each diseased ear was evaluated by examining the digital endoscopic images acquired at the end of treatment (EOT; including study discontinuation) and follow-up (F/U) visits. Data regarding residual purulent otorrhea at EOT and F/U visits were assessed by the BIRC of the ENT103-3001 study. Similarly, otological symptoms at EOT were recorded in the patients’ diaries, and the bacterial eradication rates were used from the ENT103-3001 study. Improvement was defined as the resolution of the inflammatory findings and purulent otorrhea.

Results

Among the 201 patients with otitis media, 161 patients had AOE (LVFX group, 82; placebo group, 79). The difference (95% confidence interval) between the groups at EOT was 27.3% (12.7, 40.3), and the proportion of patients showing improvement in all inflammatory findings in the external ear canal in the LVFX group (47.6%, 39/82) was significantly higher than that in the placebo group (20.3%, 16/79; Fisher's exact test, p < 0.001). Similarly, the bacterial eradication rate in the LVFX group (94.3%, 66/70) was also significantly higher than that in the placebo group (10.3%, 7/68; Fisher's exact test, p < 0.001).

Conclusion

The use of 1.5% LVFX otic solution resulted in a significantly higher rate of improvement in inflammatory findings in the external ear canal and bacterial eradication rate, indicating its efficacy. Thus, 1.5% LVFX otic solution may be an effective treatment for chronic suppurative otitis media and acute otitis media, as well as AOE with NTM.
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1.5% 左氧氟沙星耳溶液治疗急性外耳道炎的疗效:多中心随机双盲平行组安慰剂对照III期研究ENT103-3001对持续性中耳炎的事后分析。
目的在这项事后分析中,我们旨在评估1.5%左氧氟沙星(LVFX)耳药液治疗非接触性鼓膜(NTM)伴慢性化脓性和急性中耳炎患者急性外耳道炎(AOE)的疗效:方法:对鼓膜和鼓室的数字内窥镜图像进行评估。此外,还分析了ENT103-3001 原始研究的完整分析集,以确定 1.5% LVFX 耳用溶液治疗中耳炎伴持续性流脓患者的疗效。在本研究中,AOE 由研究特定的盲法独立审查委员会 (BIRC) 诊断,该委员会审查了筛查时获得的数字内窥镜图像上外耳道是否存在炎症结果,如水肿、糜烂和/或红斑(发红)。通过检查治疗结束(EOT;包括研究中止)和随访(F/U)时获得的数字内窥镜图像,评估每只病变耳朵炎症症状的改善情况。ENT103-3001研究的BIRC评估了EOT和F/U检查时残留的化脓性耳泻数据。同样,EOT 时的耳科症状也记录在患者的日记中,细菌根除率则采用 ENT103-3001 研究中的数据。病情好转的定义是炎症症状和化脓性耳泻消失:结果:在 201 名中耳炎患者中,有 161 名患者出现了 AOE(LVFX 组,82 人;安慰剂组,79 人)。两组患者在EOT时的差异(95%置信区间)为27.3%(12.7,40.3),LVFX组患者外耳道所有炎症症状均得到改善的比例(47.6%,39/82)明显高于安慰剂组(20.3%,16/79;费雪精确检验,P < 0.001)。同样,LVFX 组的细菌根除率(94.3%,66/70)也明显高于安慰剂组(10.3%,7/68;费雪精确检验,P < 0.001):结论:使用 1.5% LVFX 耳液可明显提高外耳道炎症改善率和细菌根除率,这表明其疗效显著。因此,1.5% LVFX 耳液可有效治疗慢性化脓性中耳炎、急性中耳炎以及伴有 NTM 的 AOE。
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来源期刊
Auris Nasus Larynx
Auris Nasus Larynx 医学-耳鼻喉科学
CiteScore
3.40
自引率
5.90%
发文量
169
审稿时长
30 days
期刊介绍: The international journal Auris Nasus Larynx provides the opportunity for rapid, carefully reviewed publications concerning the fundamental and clinical aspects of otorhinolaryngology and related fields. This includes otology, neurotology, bronchoesophagology, laryngology, rhinology, allergology, head and neck medicine and oncologic surgery, maxillofacial and plastic surgery, audiology, speech science. Original papers, short communications and original case reports can be submitted. Reviews on recent developments are invited regularly and Letters to the Editor commenting on papers or any aspect of Auris Nasus Larynx are welcomed. Founded in 1973 and previously published by the Society for Promotion of International Otorhinolaryngology, the journal is now the official English-language journal of the Oto-Rhino-Laryngological Society of Japan, Inc. The aim of its new international Editorial Board is to make Auris Nasus Larynx an international forum for high quality research and clinical sciences.
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