Successful treatment of eosinophilic otitis media associated with severe bronchial asthma with an anti-IL-5 monoclonal antibody,mepolizumab

Eosinophilic otitis media (EOM), which is characterized by the accumulation of eosinophils in middle ear effusion and the middle ear mucosa, is a refractory type of otitis media that is often associated with asthma. Although an early diagnosis and appropriate treatment are necessary to prevent the progression of hearing loss in patients with EOM, there are currently no well-established treatments for this condition. We treated a 60-year-old male patient with asthma and EOM. The patient’s asthma was poorly controlled, despite the use of high-dose inhaled corticosteroids, long-acting beta-agonist treatment, and the regular use of systemic corticosteroids. Mepolizumab, an anti-IL-5 monoclonal antibody, was started to treat the patient’s refractory asthma. At 4 months after the initiation of mepolizumab treatment, the patient’s asthma, hearing, and middle ear effusion improved. The present case suggests that mepolizumab therapy can control EOM and asthma.     

糠酸氟替卡松/维兰特罗复方剂治疗哮喘疗效与耐受性的Meta分析

目的 比较糠酸氟替卡松/维兰特罗复方剂（FF/VI）与吸入型糖皮质激素单药或联合长效β₂受体激动剂治疗哮喘患者的疗效与耐受性差异。方法 计算机检索CNKI、PubMed、Embase、Cochrane Library等数据库,纳入随机对照试验,采用Cochrane系统评价方法进行评价。结果 共纳入10个研究,共9 811例患者。在疗效上,FF/VI组与对照组相比,提高患者的1秒用力呼气量谷值[WMD=0.09,95% CI（0.05,0.13）,P=0.000]和哮喘控制测试评分[WMD=0.63,95% CI（0.24,1.03）,P=0.002]。在耐受性方面,FF/VI组与对照组相比不增加患者发生与治疗相关不良反应事件风险[RR=1.15,95% CI（0.98,1.36）,P=0.000]。结论 用FF/VI治疗哮喘在疗效方面具有优势,且具有良好的耐受性。其每日1次的用药频次可提高患者依从性,值得推荐使用。     

Efficacy and safety of benralizumab in Japanese patients with severe,uncontrolled eosinophilic asthma

Background

In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial.

Aclidinium bromide/formoterol fumarate fixed-dose combination for the treatment of chronic obstructive pulmonary disease

Introduction: Hospital-acquired pneumonia is the most common life-threatening hospital-acquired infection, and the majority of cases are associated with mechanical ventilation. Once pneumonia develops, the appropriateness of the initial antibiotic regimen is a vital determinant of outcome. The slow rate of development of newer antimicrobials has led to the rediscovery of the 'old' and 'forgotten' antibiotic ‘Colistin’, and it is increasingly being used as salvage therapy in patients with multidrug-resistant gram-negative bacteria infections.

Areas covered: This article covers medical literature published in any language since 1990 until November 2011, on 'hospital pneumonia', identified using PubMed, MEDLINE and clinicaltrial.gov. The search terms used were ‘ventilator associated pneumonia’, ‘management’ and ‘new antibiotics’.

Expert opinion: Many controversies still remain in the management of hospital-acquired pneumonia. A continuous evaluation of the antimicrobial therapeutic options, along with their pharmacodynamic and pharmacokinetic profiles, is mandatory to optimize therapy and reduce hospital pneumonia-related mortality.     

Non-corticosteroid therapy for the long-term control of asthma

The non-corticosteroids approved for the maintenance therapy of persistent asthma include the long-acting inhaled β₂ agonists (LABAs), leukotriene modifiers, chromones, theophylline and omalizumab. This review assesses the benefits and risks of each in relation to the inhaled corticosteroids and each other. Neither the LABAs nor omalizumab should be used as monotherapy for persistent asthma. There is no evidence of clinically significant differences in efficacy between the chromones, theophylline and leukotriene modifiers as monotherapy in mild-moderate persistent asthma; thus the choice of one therapy over the other is a clinical decision based upon differences in safety, acceptability to the patient and ease of use. Although there is significant variability in response to various therapies, non response to one therapy is not predictive of response to another. Neither studies of phenotypes nor genotypes have provided acceptable determinants of response as yet. As adjunctive therapy to the inhaled corticosteroids for moderate-severe persistent asthma, the LABAs provide superior improvement in lung function and reduction in exacerbations relative to higher doses of inhaled corticosteroids and the other noncorticosteroids used as adjunctive therapy. Thus, LABAs remain the adjunctive therapy of choice in patients not adequately controlled on low-medium dose inhaled corticosteroids. Omalizumab has not been compared with the other adjunctive therapies, so its relative efficacy is unknown. However, it is the only adjunctive therapy added to the combination of an inhaled corticosteroid plus LABA to demonstrate further improvement in a controlled clinical trial.     

Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma

Abstract

Objective:

To investigate the clinical benefits of ‘add-on’ therapy with GSK2190915 in combination with the inhaled corticosteroid (ICS) fluticasone propionate (FP) and the ICS/long-acting beta 2 agonist (LABA) combination FP/salmeterol in asthmatic subjects.     

Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA

Objective: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β₂ agonist (ICS/LABA). Methods: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks. Primary endpoint was change from baseline in evening trough forced expiratory volume in 1 second (FEV₁). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed. Results: The intent-to-treat (ITT) population included 1504 randomized and treated patients (504 FF/VI; 501 FP/SAL; 499 FP); mean age 43.5 years, 64% female. FF/VI demonstrated non-inferiority (using a margin of ?100 mL) to FP/SAL for evening trough FEV₁ at Week 24 (ITT: 19 mL [95% confidence interval (CI) ?11 to 49]; per protocol population [N = 1336]: 6 mL [95% CI ?27 to 40]). Improvement in evening trough FEV₁ at Week 24 for both FF/VI (123 mL; p < 0.001) and FP/SAL (104 mL; p < 0.001) was greater than FP. FF/VI increased rescue-/symptom-free 24-hour periods by 1.2%/1.2% compared with FP/SAL. All treatments were well tolerated. On-treatment adverse event (AE) rates were 43% to 45% across arms; there were no drug-related serious AEs. Conclusions: FF/VI was non-inferior to FP/SAL for evening trough FEV₁ at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.     

Long-acting beta-agonists in adult asthma: Evidence that these drugs are safe.

If asthma is not controlled with low-dose inhaled corticosteroids (ICS), by far the best next step is the addition of a long-acting, inhaled beta-agonist (LABA). Questions regarding the safety of this class of drug have been raised. However, careful examination of the reports which have caused concern in this regard does not reveal any evidence of an increased risk associated with the appropriate use (i.e. in combination with an inhaled ICS) of LABAs in asthma. There is much to suggest that the adverse outcomes associated with LABA monotherapy have been due to "masking of inflammation" rather than a toxic effect of the drugs. In some instances, this has likely allowed worsening asthma to be overlooked - with dire consequences. Studies in subjects receiving combination therapy with LABAs plus ICSs suggest that, if anything, there is an enhanced anti-inflammatory action with the LABA/ICS combination superior to that achieved with ICS alone at the same dose.