Asthma-related health care resource use among patients starting fluticasone or montelukast therapy

STUDY OBJECTIVES: To compare patterns of asthma-related health care resource use among patients prescribed fluticasone or montelukast as singlecontroller therapy for asthma, and to confirm patterns previously observed in retrospective analyses examining outcomes among patients receiving fluticasone or montelukast for asthma. DESIGN: Retrospective cohort study. DATA SOURCE: Administrative claims data drawn from United States health insurers in 35 states, covering 17 million privately insured patients. PATIENTS; A total of 4758 patients aged 2-55 years with asthma who were prescribed either fluticasone or montelukast from July 1, 1998-June 30, 1999, were continuously enrolled for at least 24 months, had no evidence of controller therapy for 6 months before the start of drug therapy, and had no evidence of chronic obstructive pulmonary disease or other respiratory illness. MEASUREMENTS AND MAIN RESULTS: Patients were identified using an algorithm based on medical and pharmacy insurance claims. Patients were matched between groups based on a propensity score of clinical characteristics and age; this resulted in 1512 patients/treatment group. Asthma-related health care claims incurred for 12 months before and after the start of controller therapy were analyzed. After adjustment, the fluticasone-treated group had greater risk than the montelukast-treated group of requiring therapy with a short-acting beta-agonist in the follow-up period (relative risk 1.12, 95% confidence interval [CI] 1.03-1.20). Odds were similar across treatment groups for needing an emergency department visit and/or hospitalization (odds ratio 1.08, 95% CI 0.74-1.58) and for needing therapy with an oral corticosteroid (odds ratio 1.02, 95% CI 0.84-1.26). CONCLUSION: The start of therapy with either fluticasone or montelukast as a single-controller for asthma was associated with similar asthma-related health care resource use in this matched population.     

Inhaled salmeterol/fluticasone propionate combination: a pharmacoeconomic review of its use in the management of asthma

Asthma guidelines recommend an inhaled corticosteroid plus a long-acting inhaled beta(2)-agonist (beta(2)-adrenoceptor agonist) as the preferred maintenance therapy for moderate and severe persistent asthma. Advair/Seretide Diskus also registered as Accuhaler is fixed-dose salmeterol (a long-acting inhaled beta(2)-agonist) and fluticasone propionate (a corticosteroid) administered via a single powder inhalation device. The clinical effectiveness of salmeterol/fluticasone propionate in patients with persistent asthma symptoms has been established in comparative clinical trials. Pharmacoeconomic analyses, based on data from these clinical trials, have been conducted from a healthcare payer perspective in various countries. In patients with asthma not controlled with inhaled corticosteroids, salmeterol/fluticasone propionate was associated with more favourable (lower) cost-effectiveness ratios than fluticasone propionate monotherapy, oral montelukast plus inhaled fluticasone propionate, inhaled budesonide, and inhaled formoterol plus budesonide. As the initial maintenance therapy in patients with persistent asthma symptoms while receiving short-acting beta(2)-agonists alone, salmeterol/fluticasone propionate was cost effective relative to montelukast monotherapy. Although the total cost of asthma management tended to be slightly higher with salmeterol/fluticasone propionate than with fluticasone propionate or montelukast monotherapy, salmeterol/fluticasone propionate consistently had a more favourable cost-effectiveness ratio in terms of per successfully treated week or symptom-free day and/or was associated with small incremental costs to achieve significant additional clinical benefits. In clinical practice, salmeterol plus fluticasone propionate was associated with lower asthma-related costs than treatment with other maintenance therapies.In patients with asthma symptoms despite treatment with inhaled corticosteroids, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall Asthma Quality of Life Questionnaire (AQLQ) scores relative to salmeterol or placebo monotherapy, in emotional function domain scores relative to fluticasone propionate or budesonide, and in asthma symptoms domain scores relative to budesonide. In patients with persistent asthma symptoms while receiving short-acting beta(2)-agonists alone, salmeterol/fluticasone propionate produced clinically meaningful improvements in overall AQLQ scores compared with fluticasone propionate or montelukast. CONCLUSIONS: Pharmacoeconomic analyses indicate that salmeterol/fluticasone propionate administered via a single inhaler represents a cost-effective treatment option (relative to fluticasone propionate at the same nominal dosage, budesonide, formoterol plus budesonide and montelukast plus fluticasone propionate) in patients with asthma not controlled with inhaled corticosteroid therapy. In patients with asthma not controlled with short-acting beta(2)-agonists alone, salmeterol/fluticasone propionate is a cost effective treatment relative to monotherapy with montelukast. Importantly, salmeterol/fluticasone propionate is also associated with improvements in health-related quality of life.     

Cost-effectiveness comparison of salmeterol/fluticasone propionate versus montelukast in the treatment of adults with persistent asthma

OBJECTIVE: To compare the relative cost effectiveness of salmeterol (50 microg)/ fluticasone propionate (100 microg) with that of oral montelukast (10mg) as initial maintenance therapy in patients with persistent asthma uncontrolled on short-acting beta2-agonist therapy alone. STUDY DESIGN: A cost-effectiveness analysis was performed based on effectiveness and resource utilisation data that was prospectively collected from a randomised, double-blind, double-dummy, 12-week trial. PATIENTS AND METHODS: Patients (>15 years of age) who had asthma for at least 6 months. Effectiveness measurements in this analysis included improvement in forced expiratory volume in 1 second (FEV(1)) and symptom-free days (SFDs). Cost of asthma drug treatment as well as costs related to an asthma exacerbation were used in the cost analysis. The study assumed a payer's perspective. All costs are in 2001 US dollars. RESULTS: Of the 423 patients eligible for the study, 211 were randomised to salmeterol/fluticasone propionate and 212 to montelukast. Treatment with salmeterol/fluticasone propionate resulted in a significantly higher proportion of patients who achieved a 12% increase in FEV(1) (successful treatment) [salmeterol/fluticasone propionate: 71% vs montelukast: 39%; p < 0.001] and percentage of SFDs (salmeterol/fluticasone propionate: 46.8% vs montelukast: 21.5%; p < 0.001) compared with montelukast. The mean daily costs per successfully treated patient were lower in the salmeterol/fluticasone propionate group (US dollars 5.03, 95% CI US dollars 4.61 to US dollars 5.50) compared with the montelukast group (US dollars 8.25, 95% CI US dollars 6.98 to US dollars 9.93). Furthermore, per patient mean daily cost per SFD was lower with salmeterol/fluticasone propionate (US dollars 7.63, 95% CI US dollars 6.90 to US dollars 8.50) compared with montelukast (US dollars 14.89, 95% CI US dollars 12.36 to US dollars 17.98). Incremental cost-effectiveness ratios (ICERs) showed that the additional costs to achieve these benefits with salmeterol/fluticasone propionate were minimal. With regards to improvement in lung function, the ICER was US dollars 1.33 (95% CI US dollars 0.80 to US dollars 2.02) and with regards to SFD, the ICER was US dollars 1.69 (95% CI US dollars 1.01 to US dollars 2.48). Sensitivity analysis demonstrated the stability of the results over a range of assumptions. CONCLUSIONS: From a third-party payer perspective, this analysis shows that based on increased efficacy and only a slight increase in cost, twice-daily treatment with salmeterol/fluticasone propionate is more cost effective than once-daily treatment with montelukast as initial maintenance therapy for persistent asthma. This finding complements the results of the clinical analyses indicating that treatment of both inflammation and bronchoconstriction with products such as salmeterol/ fluticasone propionate may be more cost effective as initial maintenance asthma therapy than the use of leukotriene modifiers such as montelukast.     

Inhaled salmeterol/fluticasone propionate: a review of its use in asthma

Salmeterol/fluticasone propionate, administered twice daily via a multidose dry powder inhaler (Seretide/Advair Diskus), Seretide Accuhaler or metered-dose hydrofluoroalkane (chlorofluorocarbon-free) inhaler (Seretide Evohaler), is a combination of the long-acting beta(2)-adrenoceptor agonist (beta(2)-agonist) [LABA] salmeterol and the corticosteroid fluticasone propionate.Maintenance therapy with combined salmeterol/fluticasone propionate is at least as effective in improving lung function and symptoms and is as well tolerated in patients with asthma as concurrent salmeterol plus fluticasone propionate. In patients previously receiving as-required short-acting beta(2)-agonists (SABAs) or inhaled corticosteroids, salmeterol/fluticasone propionate was significantly more effective in providing asthma control than fluticasone propionate and in improving lung function and asthma symptoms than inhaled corticosteroids (at equivalent or higher dosages), salmeterol or montelukast (as monotherapy or in combination with fluticasone propionate). Salmeterol/fluticasone propionate was more effective in improving asthma symptoms than adjusted-dose budesonide/formoterol in patients with uncontrolled asthma despite treatment with inhaled corticosteroids with or without a LABA in a well designed 1-year study. In pharmacoeconomic analyses, salmeterol/fluticasone propionate compared favourably with inhaled corticosteroids and mono- or combination therapy with oral montelukast. Salmeterol/fluticasone propionate is, therefore, an effective, well tolerated and cost-effective option for the maintenance treatment of patients with asthma.     

Economic impact of asthma therapy with fluticasone propionate, montelukast, or zafirlukast in a managed care population

STUDY OBJECTIVE: To compare asthma-related health care expenditures among patients newly prescribed fluticasone propionate 44 or 110 microg, montelukast 5 or 10 mg, or zafirlukast 20 mg. DESIGN: Retrospective cohort analysis of medical and pharmacy claims. SETTING: University-affiliated health outcomes research center. PATIENTS: Seven hundred eighty-one patients (aged > or = 4 yrs) with asthma treated with controller therapy for 9 months (postindex period), with no claim for an inhaled corticosteroid or leukotriene modifier in the previous 9 months (preindex period). INTERVENTION: Asthma-related medical and pharmacy data from insurance claims of four managed care plans (two Northeastern, one Midwestern, and one Western) were tabulated over the pre- and postindex periods. MEASUREMENTS AND MAIN RESULTS: Numbers of patients identified were 284 beginning fluticasone propionate; 302, montelukast; and 195, zafirlukast. Fluticasone propionate treatment was associated with significantly (p<0.001) lower risk-adjusted asthma-related charges compared with montelukast and zafirlukast treatment: $528, $967, and $1359, respectively In this cohort, fluticasone propionate also was associated with fewer hospitalizations, less need for additional controller agents, and longer maintenance on the index drug compared with montelukast and zafirlukast. CONCLUSIONS: Based on these real-world data, as well as established national and international asthma guidelines, consideration should be given to inhaled corticosteroid therapy, particularly fluticasone propionate, for first-line, long-term effective management of asthma.     

Inhaled salmeterol/fluticasone propionate combination: a review of its use in persistent asthma

The long-acting beta2-agonist salmeterol and the corticosteroid fluticasone propionate are available as a combination inhalation device for the treatment of persistent asthma. Well designed studies in adults, adolescents and children aged > or =4 years, demonstrate that combined salmetero/fluticasone propionate 50/100, 50/250 and 50/500 microg administered via a dry powder inhaler (DPI) is clinically equivalent to concurrent delivery of the same dosages of the 2 drugs via separate DPIs. In adults and adolescents, combined salmeterol/fluticasone 50/100 and 50/250 microg twice daily produced rapid improvements in lung function that were consistently greater than those in patients receiving monotherapy twice daily salmeterol 50 microg, fluticasone propionate 100 or 250 microg or placebo in 2 well designed studies. Recipients of the combination had a significantly greater probability of completing 12 weeks of treatment than patients receiving monotherapy or placebo. The combination also produced significant improvements between baseline and end-point in all secondary outcome variables (morning and evening peak expiratory flow, daytime symptom scores, days and nights without asthma symptoms and requirements for as-needed beta-agonists) and health-related quality of life (QOL). Combination therapy was superior to monotherapy with salmeterol and placebo for all outcomes in both studies, and was superior to fluticasone propionate 100 microg for all but 1 outcome (nights without awakenings) in 1 study. Similar results were obtained in patients who had previously been using short acting beta2-agonists alone. Combined twice daily salmeterolfluticasone propionate 50/100 and 50/250 microg produced greater improvements in lung function than inhaled budesonide at higher dosages than fluticasone propionate in the combination. Combined salmeterol/fluticasone propionate 50/250 microg produced similar improvements in lung function to concurrent budesonide 800 microg plus formoterol 12 microg when given twice daily for 12 weeks. In another 12-week trial, combined salmeterol/fluticasone propionate 50/100 microg was more effective than oral montelukast 10 mg/day plus fluticasone propionate 100 microg twice daily in patients with suboptimally controlled asthma. Salmeterol/fluticasone is more cost effective than monotherapy with fluticasone propionate or budesonide. The most frequent adverse events associated with salmeterol/fluticasone propionate are headache, throat irritation, hoarseness and candidiasis. CONCLUSION: Combined salmeterol/fluticasone propionate is as effective as the 2 drugs given concurrently via separate inhalers and significantly more effective than either drug given alone at the same nominal dosage. The combination is also significantly more effective than montelukast plus fluticasone propionate or monotherapy with inhaled budesonide. Furthermore, the combination is more cost effective than inhaled corticosteroid monotherapy.     

Improving asthma control in patients suboptimally controlled on inhaled steroids and long-acting beta2-agonists: addition of montelukast in an open-label pilot study

BACKGROUND: Airway inflammation and symptoms often persist in asthma patients despite treatment with inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA). It is hypothesized that the leukotriene receptor antagonist montelukast, treating a pathway of inflammation distinct from that of ICS, might confer additional benefit. OBJECTIVE: To evaluate the efficacy of montelukast in improving asthma control in patients symptomatic on a fixed-association (FA) medium dose of ICS and LABA. METHODS: A 2-month, open-label, real-life observational study was undertaken by 131 Belgian pulmonologists. Patients (> or = 15 years old) suffering from persistent asthma (pre-bronchodilator FEV1 > or = 60% of predicted value) and insufficiently controlled on a FA therapy of fluticasone/salmeterol or budesonide/formoterol were given montelukast 10 mg daily as add-on therapy. Asthma control was assessed by the standardized Juniper asthma control questionnaire (ACQ) at baseline and after a 2-month treatment with montelukast. Global evaluation of therapy was made both by the patients and physicians. RESULTS: A total of 313 patients were eligible for analysis. Forty-nine per cent received inhaled fluticasone/salmeterol and the rest budesonide/formoterol. Mean ACQ score decreased significantly on montelukast (13.9 +/- 5.1 at baseline versus 7.4 +/- 4.7 on montelukast, p < 0.001), with a significant improvement in all individual symptom scores (p < 0.001) and in pre-bronchodilator FEV1 score (from 2.2 +/- 1.5 to 1.6 +/- 1.4; p < 0.001). Parallel to these results, 78.6% of the patients reported a global improvement of their asthma. The same proportion of improvement was observed in the global evaluation made by the physicians (kappa = 0.66). CONCLUSION: This pilot study suggests that addition of montelukast in patients symptomatic on a FA of ICS and LABA may result in significant improvements in asthma control. A randomised, placebo-controlled clinical trial seems warranted.     

Inhaled salmeterol/fluticasone propionate combination. A pharmacoeconomic review of its use in the management of asthma

Cost estimates from developed countries indicate that asthma accounts for up to 2% of the economic cost of all diseases. A large proportion of asthma-related costs are attributable to poor asthma control. Treatment strategies which improve clinical outcomes in patients with asthma, therefore, have the potential for significant economic benefits, and it is important to evaluate new asthma therapies for cost effectiveness. Several studies have established that salmeterol and fluticasone propionate combined in a single dry powder inhalation device are at least as effective as a combination of the 2 drugs administered via separate dry powder inhalers and more effective than monotherapy with fluticasone propionate or budesonide. Importantly, pharmacoeconomic analysis of several of these studies show that the salmeterol/fluticasone propionate combination is cost effective relative to monotherapy with fluticasone propionate or budesonide. Although the total cost of asthma management tended to be slightly higher with salmeterol/fluticasone propionate than with inhaled corticosteroid monotherapy, in most cases mean cost-effectiveness ratios were lower (i.e. more favourable) for salmeterol/fluticasone propionate than either fluticasone propionate or budesonide. Cost effectiveness was assessed according to 3 end-points: successfully treated weeks, symptom-free days and episode-free days. Mean cost-effectiveness ratios consistently favoured salmeterol/fluticasone propionate over the comparator drug for the end-point successfully treated weeks, and in most cases the other 2 end-points also favoured the combination product over the comparator. In a further study, salmeterol/fluticasone was also less costly than therapy with formoterol and budesonide administered via 2 separate inhalers. Studies of health-related quality of life (HR-QOL) using the Asthma Quality of Life Questionnaire indicate that salmeterol/fluticasone propionate produces clinically meaningful improvements in overall HR-QOL relative to salmeterol monotherapy or placebo. Improvements in overall HR-QOL were statistically significantly greater for salmeterol/fluticasone propionate than with fluticasone propionate or budesonide alone, although the differences between treatments did not exceed the threshold for clinical significance. In conclusion, short term cost-effectiveness data show that salmeterol/fluticasone propionate is more cost effective than the inhaled corticosteroids budesonide and fluticasone propionate alone. The combination product also appears to improve HR-QOL relative to placebo or salmeterol alone.     

沙美特罗丙酸氟替卡松联合孟鲁司特钠治疗咳嗽变异型哮喘的疗效观察

目的 观察沙美特罗丙酸氟替卡松联合孟鲁司特钠治疗成人咳嗽变异型哮喘的疗效.方法 采用完全随机对照试验方法将93例咳嗽变异型哮喘患者分为3组各31例,观察组吸入沙美特罗/丙酸氟替卡松(50 μg/250 μg)1吸,早晚各1次,孟鲁司特钠10 mg/次,顿服,共8周.沙美特罗/丙酸氟替卡松组吸入沙美特罗/丙酸氟替卡松(50 μg/250μg)1吸,早晚各1次,共8周.孟鲁司特钠组服用孟鲁司特钠10 mg/次,顿服,共8周.比较3组患者症状改善和肺功能变化情况.结果 治疗后症状积分均较治疗前低,差异有统计学意义(P＜0.05),3组组间差异有统计学意义(P＜0.05).8周治疗后观察组、沙美特罗/丙酸氟替卡松组和孟鲁司特钠组第1秒用力呼气容积(FEV1)、FEV1占预计值的百分比(FEV1％)、呼气峰流速(PEF)与治疗前比较差异均有统计学意义(均P＜0.05);治疗后观察组FEV1、FEV1％、PEF高于沙美特罗/丙酸氟替卡松组及孟鲁司特钠组,差异均有统计学意义[ FEV1:(1.65±0.52)L比(1.52±0.63)L,(1.46±0.53)L;FEV1％:(64.41±10.31)％比(62.81±11.03)％,(59.02±11.19)％; PEF:(5.24±1.15) L/min比(6.10±1.28) L/min,(6.62±1.00) L/min,均P＜0.05].结论 沙美特罗/丙酸氟替卡松与孟鲁司特钠联合应用治疗咳嗽变异型哮喘疗效优于单用沙美特罗/丙酸氟替卡松或孟鲁司特钠.     

孟鲁司特钠联合氟替卡松治疗儿童哮喘疗效的Meta分析

]目的：评价孟鲁司特钠联合氟替卡松治疗儿童哮喘的疗效和安全性。方法：检索the Cochrance Library, PubMed、EMBase、CBM、Science Direct, 中国知网、万方及维普数据库,纳入孟鲁司特钠联合氟替卡松治疗儿童哮喘的随机对照试验,观察组采用孟鲁司特钠氟替卡松吸入治疗,对照组单用氟替卡松吸入治疗,提取符合纳入标准的临床研究文献信息,采用RevMan5.3软件对纳入文献进行质量评价和Meta分析。结果：共纳入13篇中文文献,包括1 440例受试者。Meta分析结果显示,观察组总有效率及肺功能指标第一秒用力呼气容积（FEV1）、用力肺活量（FVC）高于对照组（P<0.01）;观察组复发率低于对照组（P<0.01）。结论：孟鲁司特钠联合氟替卡松吸入治疗儿童哮喘临床治疗效果显著。     

Healthcare utilisation and costs associated with adding montelukast to current therapy in patients with mild to moderate asthma and co-morbid allergic rhinitis: PRAACTICAL study

OBJECTIVE: To evaluate the healthcare resource use and costs associated with adding montelukast to therapy in patients with mild to moderate persistent asthma and co-morbid seasonal allergic rhinitis whose asthma is inadequately controlled by their current asthma therapy. METHODS: A multicentre, pre-post retrospective cohort study was conducted in three European countries (Italy, Poland and Spain). Consecutive patients who were receiving inhaled corticosteroid therapy (monotherapy or combination therapy with long-acting beta(2)-adrenoceptor agonists) and who started concomitant treatment with montelukast between January 1999 and December 2002 were identified from clinical charts. Asthma/seasonal allergic rhinitis-related concomitant medications and asthma-related outpatient care, ED visits and hospitalisations for the periods 12 months before and 12 months after montelukast initiation were recorded from patient charts and combined with country-specific published unit costs (adjusted to 2004 values). The analysis was performed from a third-party-payer perspective and thus direct healthcare resource utilisation due to asthma/seasonal allergic rhinitis and associated costs for each country were estimated. RESULTS: A total of 98 physicians provided data for 696 asthmatic patients with seasonal allergic rhinitis (Italy: n = 158; Poland: n = 334; and Spain: n = 204). The mean age of patients was 32.7 years, 57.5% were female and patients had asthma that was considered either mild-persistent (54.5%) or moderate-persistent (45.5%) according to the Global Initiative for Asthma classifications. The introduction of montelukast (10 mg/day daily cost range euro0.8-1.68) was associated with increases in the total annual mean healthcare cost per patient of 11.9%, 60.4% and 5.5% for Italy, Poland and Spain, respectively. However, mean annual costs for asthma-related outpatient care, ED visits and hospitalisations dropped significantly in all three countries (Italy: from euro805.00 to euro281.60 [p < 0.01]; Poland: from euro127.10 to euro99.00 [p < 0.01]; and Spain: from euro463.40 to euro119.70 [p < 0.01]). CONCLUSIONS: The addition of montelukast to therapy in patients with mild to moderate asthma and concomitant seasonal allergic rhinitis whose asthma was inadequately controlled by current asthma therapy significantly reduced the use of concomitant asthma-allergy medications, ED visits, outpatient care visits and hospitalisation. The total direct healthcare cost obtained after the addition of montelukast increased only as a result of the montelukast treatment cost.     

Add-on therapy with montelukast or formoterol in patients with the glycine-16 beta2-receptor genotype

AIMS: We assessed whether montelukast or formoterol provides additive effects to asthmatics not controlled on inhaled corticosteroids, by studying patients who were considered to be genetically susceptible to beta2-receptor down regulation and subsensitivity, and who expressed the homozygous glycine-16 beta2-receptor genotype. METHODS: Fifteen corticosteroid-treated, mild to moderate persistent asthmatics received montelukast 10 mg once daily or formoterol 9 micro g twice daily for 2 weeks, separated by a 2-week placebo run-in and washout, in a double-blind, double-dummy, randomized crossover design. Bronchoprotection against adenosine monophosphate (AMP) challenge (primary endpoint), spirometry and blood eosinophils were measured at trough after placebo, first and last doses. RESULTS: For AMP PC20vs placebo, there were sustained significant (P < 0.05) doubling dilution improvements following first (1.1; 95% CI 0.4, 1.9) and last (1.0; 95% CI 0.3, 1.8) doses of montelukast, and following first (1.3; 95% CI 0.1, 2.6) but not last (0.3; 95% CI -0.9, 1.6) doses of formoterol. Blood eosinophils (x 10(6) l(-1)) were significantly (P < 0.05) suppressed after the last dose of montelukast (-71; 95% CI -3, -140) compared with placebo, while formoterol exhibited a nonsignificant rise (20; 95% CI -92, 132). Neither treatment significantly improved FEV1, FEF25-75 or PEF after 2 weeks. CONCLUSIONS: In genetically susceptible patients with the homozygous glycine-16 genotype, montelukast, but not formoterol, conferred sustained anti-inflammatory properties in addition to inhaled corticosteroid, which were dissociated from changes in lung function after 2 weeks. Thus, assessing lung function may miss potentially beneficial anti-inflammatory effects of montelukast when used as add-on therapy.     

Improving asthma control in patients suboptimally controlled on inhaled steroids and long-acting β2‐agonists: addition of montelukast in an open-label pilot study

ABSTRACT

Background: Airway inflammation and symptoms often persist in asthma patients despite treatment with inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA). It is hypothesized that the leukotriene receptor antagonist montelukast, treating a pathway of inflammation distinct from that of ICS, might confer additional benefit.

Objective: To evaluate the efficacy of montelukast in improving asthma control in patients symptomatic on a fixed-association (FA) medium dose of ICS and LABA.

Methods: A 2-month, open-label, real-life observational study was undertaken by 131 Belgian pulmonologists. Patients (≥ 15 years old) suffering from persistent asthma (pre-bronchodilator FEV₁ ≥ 60% of predicted value) and insufficiently controlled on a FA therapy of fluticasone/salmeterol or budesonide/formoterol were given montelukast 10?mg daily as add-on therapy. Asthma control was assessed by the standardized Juniper asthma control questionnaire (ACQ) at baseline and after a 2-month treatment with montelukast. Global evaluation of therapy was made both by the patients and physicians.

Results: A total of 313 patients were eligible for analysis. Forty-nine per cent received inhaled fluticasone/salmeterol and the rest budesonide/formoterol. Mean ACQ score decreased significantly on montelukast (13.9 ± 5.1 at baseline versus 7.4 ± 4.7 on montelukast, p < 0.001), with a significant improvement in all individual symptom scores (?p < 0.001) and in pre-bronchodilator FEV₁ score (from 2.2 ± 1.5 to 1.6 ± 1.4; p < 0.001). Parallel to these results, 78.6% of the patients reported a global improvement of their asthma. The same proportion of improvement was observed in the global evaluation made by the physicians (κ = 0.66).

Conclusion: This pilot study suggests that addition of montelukast in patients symptomatic on a FA of ICS and LABA may result in significant improvements in asthma control. A randomised, placebo-controlled clinical trial seems warranted.     

沙美特罗氟替卡松联合孟鲁司特钠治疗慢性支气管炎临床观察

目的：对在慢性支气管炎治疗中,运用沙美特罗氟替卡松粉吸入剂与孟鲁司特钠的效果进行观察。方法：通过随机对照研究,对比观察组采用沙美特罗氟替卡松联合孟鲁司特钠治疗,对照组采用沙美特罗氟替卡松治疗的临床效果及肺功能改善情况。结果：观察组总有效率为92.59%,对照组总有效率为70.37%;观察组肺功能各项指标改善效果更加显著。结论：在慢性支气管炎治疗中,采用沙美特罗氟替卡松粉吸入剂与孟鲁司特钠进行联合治疗效果显著。     

Meta-analysis: combination therapy with interferon-alpha 2a/2b and ribavirin for patients with chronic hepatitis C previously non-responsive to interferon

BACKGROUND: The efficacy of interferon-alpha plus ribavirin treatment for patients not responding to interferon monotherapy is not well established. AIM: To assess the efficacy and safety of combination therapy with interferon-alpha 2a/2b plus ribavirin by performing a meta-analysis of randomized clinical trials. METHODS: A systematic search of electronic databases for randomized clinical trials of interferon-alpha 2a/2b plus ribavirin was conducted independently by two investigators. Data abstraction was performed. The primary end-point was a sustained virological response. Estimates of the common odds ratio were calculated using a random effects model. RESULTS: Of the 127 identified studies, 46 were considered for evaluation and 10 were included (1728 patients). The pooled sustained virological response was 12.6% (95% CI, 9.5-16.3%) for combination therapy vs. 2% (95% CI, 0.9-4.0%) for interferon monotherapy, with a common odds ratio of 5.49. Higher doses of interferon, a longer duration of therapy (48 weeks) and genotypes other than 1 and 4 were associated with an improvement in response. More side-effects and discontinuations were observed with combination therapy than with interferon monotherapy. CONCLUSIONS: Non-responders to interferon may benefit from re-treatment with combination therapy, especially from a 48-week regimen.