Mometasone/formoterol inhalation aerosol: in asthma uncontrolled on medium- or high-dose inhaled corticosteroids

The corticosteroid mometasone and the long-acting β(2)-selective adrenoreceptor agonist formoterol have been combined in a single pressurized metered-dose inhaler for use in patients aged ≥12 years with asthma. In a 26-week well designed trial in patients with persistent asthma uncontrolled on medium-dose inhaled corticosteroids (ICS), mometasone/formoterol 200?μg/10?μg twice daily (bid) was more effective than placebo or the same nominal dosage of formoterol alone in reducing the incidence of asthma deteriorations, as well as in improving lung function, asthma control, asthma symptoms and asthma-related quality-of-life outcomes. The combination was also more effective than the same nominal dosage of mometasone alone in improving lung function and asthma control. Similarly, in a 12-week well designed trial in patients with persistent asthma uncontrolled on high-dose ICS, mometasone/formoterol 400?μg/10?μg bid was more effective than the same nominal dosage of mometasone alone in improving lung function, asthma control and asthma symptoms. Treatment with a lower dosage of the combination (200?μg/10?μg bid) yielded similar results and, moreover, significantly reduced the incidence of asthma deteriorations compared with mometasone alone. Mometasone/formoterol was generally well tolerated in clinical trials of 12-52 weeks' duration. The adverse event profile of the combination was consistent with that of its individual components; no new or unexpected safety signals were detected.     

Treatment options for initial maintenance therapy of persistent asthma: a review of inhaled corticosteroids and leukotriene receptor antagonists

Inhaled corticosteroids (ICSs) are recognized as the cornerstone of asthma therapy. They are considered to be the most effective anti-inflammatory medication currently available for the treatment of persistent asthma, regardless of its severity. Leukotriene receptor antagonists (LTRAs) are also used as initial maintenance therapy in patients whose asthma is uncontrolled by bronchodilators alone. There are now sufficient data available to allow a comparison of the relative effectiveness and cost-effectiveness of LTRAs and ICSs as initial maintenance therapy. The consensus from the studies reviewed in this article demonstrates that ICSs are more effective than LTRAs as initial maintenance therapy. In particular, studies on fluticasone propionate have shown that it was more effective than LTRAs in clinical outcomes: producing greater improvements in lung function and asthma control; as measured by either forced expiratory volume in 1 second (FEV1) or peak expiratory flow (PEF); by a greater reduction in daytime and night-time asthma symptoms; and short-acting beta2-agonist use. This superiority was also seen when patients were switched from an LTRA to fluticasone propionate. Similar findings have been demonstrated with beclomethasone dipropionate (BDP), showing that, in adults, this inhaled steroid also had a greater effect on pulmonary function and symptom scores than did LTRAs. Quality of life assessments showed that fluticasone propionate achieved improvements that were deemed to be clinically meaningful; these changes were significantly greater than those achieved with LTRAs. However, questionnaire-based patient preference studies comparing BDP with LTRAs showed that children and adolescents generally preferred an LTRA to BDP. A number of comparative analyses showed that inhaled fluticasone propionate is more cost-effective than either montelukast or zafirlukast; these analyses used cost per symptom-free day and cost per successfully treated patient as outcome measures, from the perspective of a third-party payer. In general, these results were supported by resource utilisation studies in real-world settings. Asthma treatment guidelines (e.g. GINA, 2002) recommend combination therapy with ICSs and a long-acting beta2-agonist as initial maintenance therapy if the disease is of sufficient severity. Studies that assessed the effectiveness, cost-effectiveness, and quality of life achieved with a salmeterol fluticasone propionate combination as initial maintenance therapy also showed it to be superior to LTRAs. In conclusion, in terms of efficacy and quality of life, fluticasone propionate is more effective than LTRAs as initial maintenance therapy and is associated with significantly lower healthcare costs and less frequent use of healthcare resources than LTRAs. There is also evidence to suggest that initial maintenance therapy with the combination of an inhaled steroid plus a long-acting beta-agonist bronchodilator may be a more effective option for the management of persistent asthma than treatment with a single-controller agent alone (ICS or LTRA).     

Tiotropium bromide as add-on therapy to inhaled corticosteroids for treating asthma

Introduction: Bronchial asthma is becoming increasingly prevalent worldwide. Although first-line therapy with inhaled corticosteroids (ICS) with or without long-acting β2 agonists (LABA) has significantly improved the clinical outcomes of asthma, they cannot provide all asthmatics with good control and thus alternatives or add-on drugs are required. Tiotropium is a long-acting muscarinic antagonist that has been used to treat chronic obstructive pulmonary disease and it has been approved for treating asthma in some countries. This agent has similar bronchodilatory effects to those of LABA and might also have anti-inflammatory and anti-remodeling effects.

Areas covered: Some pivotal clinical trials have found tiotropium effective as an add-on medication for low-to-medium doses of ICS for treating symptomatic asthma and asthma that remains uncontrolled despite ICS plus LABA therapy.

Expert opinion: Whether or not tiotropium has anti-inflammatory and anti-remodeling effects in humans with asthma is an important issue. Predictors that would identify patients who would derive the maximal potential benefit from treatment with tiotropium in addition to their current therapy are also needed. Although the cardiovascular toxicity of tiotropium is less remarkable in asthma than in chronic obstructive pulmonary disease, longer and larger studies are still needed to confirm the safety of tiotropium for treating asthma.     

Comparison of combination inhalers vs inhaled corticosteroids alone in moderate persistent asthma

AIMS: Inhalers combining long acting beta2-adrenoceptor agonists (LABA) and corticosteroids (ICS) are indicated at Step 3 of current asthma guidelines. We evaluated the relative effects of LABA + ICS combination vs ICS alone on pulmonary function, bronchoprotection, acute salbutamol recovery following methacholine bronchial challenge, and surrogate inflammatory markers in patients with moderate persistent asthma. METHODS: Twenty-nine patients with mean FEV1 (+/- SEM) of 78 +/- 3% predicted completed a randomized, double-blind, double-dummy, cross-over study. Patients received either 4 weeks of budesonide 400 microg + formoterol 12 microg (BUD + FM) combination twice daily followed by 1 week of BUD 400 microg alone twice daily, or 4 weeks of fluticasone propionate 250 microg + salmeterol 50 microg (FP + SM) combination twice daily followed by 1 week of FP 250 microg alone twice daily. Measurements were made at baseline and following each randomized treatment. RESULTS: FEV1 increase from pretreatment baseline as mean (+/- SEM) % predicted was significantly higher (P < 0.05) for BUD + FM (8 +/- 1%) vs BUD (2 +/- 1%), and for FP + SM (8 +/- 1%) vs FP (2 +/- 1%). The fall in FEV1 following methacholine challenge as percentage change from prechallenge baseline FEV1 was not significantly different in all four groups; BUD + FM (22 +/- 1%), BUD (24 +/- 1%), FP + SM (23 +/- 1%) and FP (23 +/- 1%). Salbutamol recovery over 30 min following methacholine challenge as area under curve (AUC %.min) was significantly blunted (P < 0.05) with BUD + FM (486.7 +/- 35.5) vs BUD (281.1 +/- 52.8), and with FP + SM (553.1 +/- 34.1) vs FP (368.3 +/- 46.7). There were no significant differences between respective combination inhalers or between respective ICS alone. Decreases in exhaled nitric oxide (NO) and serum eosinophilic cationic protein (ECP) from baseline were not significantly different between treatments. CONCLUSIONS: Combination inhalers improve pulmonary function without potentiating anti-inflammatory effects on exhaled NO and serum ECP as compared with ICS alone, but delay acute salbutamol recovery after bronchoconstriction.     

Long-acting beta2-agonists or leukotriene receptor antagonists as add-on therapy to inhaled corticosteroids for the treatment of persistent asthma

It is well accepted that the combination of inhaled corticosteroids (ICSs) and long-acting beta2-agonists (LABAs) is effective in achieving asthma control, as it treats both components of asthma pathophysiology, namely inflammation and smooth muscle dysfunction of the airways. Leukotriene receptor antagonists (LTRAs) can also be used as add-ons to ICS therapy in patients whose asthma is not controlled by ICSs alone. The purpose of this review is to compare the effectiveness of ICSs plus LABAs with that of ICSs plus LTRAs for the treatment of persistent asthma that is not controlled by ICSs alone. Several studies have shown that, in comparison with an ICS plus an LTRA, the addition of an LABA to ICS therapy provides greater improvements in pulmonary function and overall control of asthma as measured by use of rescue medication and the number of exacerbations of the asthma, symptom-free days and symptom-free nights. The greater improvements in pulmonary function observed with an ICS plus the LABA, salmeterol, occurred within the first week of treatment (at first treatment assessment), and remained significantly greater than those achieved with an ICS plus an LTRA over the duration of the treatment. Moreover, the salmeterol-fluticasone propionate combination (SFC) produces consistently greater improvements in pulmonary lung function and control of asthma than does the addition of an LTRA to fluticasone propionate. In addition, SFC is a more cost-effective treatment option than fluticasone propionate plus montelukast for patients with asthma that is uncontrolled by ICSs alone. Important cost savings can be made with SFC in clinical practice compared with other combinations of ICSs plus salmeterol or ICSs plus LTRAs.     

Once-daily inhaled corticosteroids in children with asthma: nebulisation

Current guidelines on the management of childhood asthma have emphasised the important preventive role of inhaled corticosteroids, which should be used at the lowest possible doses that are compatible with good disease control. However, some children do not respond to inhaled corticosteroids, the most common reasons for which are inability to use conventional hand-held inhalers (plus spacers and face masks) effectively or lack of cooperation with them, particularly among infants and young children. In these patients, nebulisers have proved effective in administering corticosteroids, and this form of delivery is often preferred by both the children and their parents, despite their longer administration times (commonly around 10 minutes). Compliance with these devices may therefore be better than with a conventional pressurised metered-dose inhaler plus spacer and face mask. Recent studies with nebulised budesonide have demonstrated that once-daily administration is as effective in maintaining control of asthma symptoms in children as the usual twice-daily administration. In children with moderately severe persistent asthma, the improvement provided by once-daily nebulised doses of 1.0 mg budesonide has been found to be equivalent to that with twice-daily doses of 0.25 or 0.5 mg, indicating that once-daily therapy is an effective option that can be considered in many patients. In view of the time-consuming nature of nebuliser administration, reduction of the frequency of corticosteroid administration from twice to once daily may be useful in simplifying the treatment programme and improving compliance with it. This may be beneficial in reducing under-utilisation of inhaled corticosteroids in children with asthma and improving long term control of the disease.     

Combination therapy with inhaled long-acting beta2-agonists and inhaled corticosteroids: a paradigm shift in asthma management

Long-acting inhaled beta2-agonists and inhaled corticosteroids are classes of drugs with different mechanisms of action that are commonly used to provide effective long-term control of persistent asthma. Scientific and clinical data support the complementary mechanisms of action of the inhaled corticosteroids and the long-acting beta2-agonists in achieving a superior level of asthma control. In addition, evidence supports significant reductions in exacerbations and effective control of airway inflammation with an inhaled corticosteroid and a long-acting beta2-agonist versus higher dosages of inhaled corticosteroids or combinations of other therapeutic agents with an inhaled corticosteroid. Finally, there are distinct economic advantages to combining an inhaled corticosteroid and a long-acting beta2-agonist in the treatment of asthma relative to other treatment regimens.     

Safety of the newer inhaled corticosteroids in childhood asthma

Inhaled corticosteroids (ICS) remain a vital part of the management of persistent asthma, but concerns have been raised about their potential adverse effects in children. This review examines the safety data on three new ICS - fluticasone propionate, mometasone, and extrafine beclomethasone in hydrofluoroalkane (HFA-134a) propellant (QVAR The use of tradenames is for product identification purposes only and does not imply endorsement. formulation) in relation to the older corticosteroids. Topical adverse effects such as thrush and dysphonia are rare, but dental erosion is a possibility with powder forms of ICS because of their low pH. Thus, it is important to stress mouth rinsing after administration and maintaining good dental hygiene to minimize this risk. Biochemical adrenal suppression can be readily demonstrated, particularly with high doses of all ICS. The clinical relevance of this was uncertain in the past, but there have now been >50 reported cases of acute adrenal crises in children receiving ICS, most of whom were on fluticasone propionate. In order to minimize the risk of symptomatic adrenal suppression, it is important to back-titrate the ICS dose and alert families of children receiving high-dose ICS of this potential adverse effect. A pediatric endocrine opinion should be sought if adrenal suppression is suspected. The older ICS cause temporary slowing of growth velocity, but the limited data available do not show any significant compromise of final adult height. The effect on growth of fluticasone propionate may not be as great as with the older ICS, but the studies have been short term and only used low doses of fluticasone propionate. There have been case reports of growth suppression in children receiving high doses of fluticasone propionate. The limited studies performed on the effect of ICS on bone mineral density in children did not show any adverse effects, but there may be an increased risk of fractures. Hydrofluoroalkane beclomethasone (QVAR) is essentially the same drug as chlorofluorocarbon beclomethasone, but with double the lung deposition owing to the smaller particle size. Thus, it could be expected that any adverse effects seen with chlorofluorocarbon beclomethasone would be the same with hydrofluoroalkane beclomethasone. However, some of the published data, particularly in adults, suggest that hydrofluoroalkane beclomethasone may be less systemically active than chlorofluorocarbon beclomethasone, even at equipotent doses. As yet, there are no long-term data on mometasone, but initial studies in adults suggest there may be less suppression of the hypothalamic-pituitary-adrenal axis, although further studies are required, particularly in children.ICS will remain a cornerstone in the management of persistent pediatric asthma, provided that the diagnosis of asthma is secure. It is very important to use ICS appropriately and to ensure the lowest possible doses are used to achieve symptom control, thus minimizing the risk of serious adverse effects.     

Daily versus intermittent corticosteroids for the treatment of mild persistent asthma

Asthma is a chronic disease of the airways in which inflammation causes bronchial hyper-reactivity and attacks of wheezing, dyspnea and chest tightness that are triggered by various agents. It requires both acute treatment of the paroxistical respiratory symptoms with reliever medications and maintenance treatment, which is aimed at achieving an optimal disease control and consists of controller medications with regimens and dosages that are tailored according to disease severity. Inhaled steroids represent the main controller medication and are recommended to be given even in mild asthma on a daily basis in order to improve lung function, reduce asthma exacerbations and symptoms, and improve the quality of life. Intermittent regimens could also be used and the currently discussed study compares these two regimens in terms of clinical efficacy.     

Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids

ABSTRACT

Background: Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing.

Objective: The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 µg qd PM (one 400 g inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo.

Methods: This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 µg qd (once a day, quaque die) PM, 400 µg qd PM as one inhalation from a 400 µg device, 400 µg qd PM as two inhalations from a 200 µg device, 200 µg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time.

Results: Mean changes from baseline at endpoint in FEV₁ (forced expiratory volume in 1 s) were similar for MF-DPI 400 µg qd PM (one inhalation; 0.41 L), MF-DPI 400 g qd PM (2 inhalations; 0.49 L), MF-DPI 200 µg qd PM (0.41 L), and MF-DPI 200 µg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity.

Conclusions: Once-daily evening dosing of MF-DPI at doses of 400 and 200 µg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 µg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 µg qd PM, the lowest dose studied.     

Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids

BACKGROUND: Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing. OBJECTIVE: The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 microg qd PM (one 400 microg inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo. METHODS: This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 microg qd (once a day, quaque die) PM, 400 microg qd PM as one inhalation from a 400 microg device, 400 microg qd PM as two inhalations from a 200 microg device, 200 microg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time. RESULTS: Mean changes from baseline at endpoint in FEV1 (forced expiratory volume in 1 s) were similar for MF-DPI 400 microg qd PM (one inhalation; 0.41 L), MF-DPI 400 microg qd PM (2 inhalations; 0.49 L), MF-DPI 200 microg qd PM (0.41 L), and MF-DPI 200 microg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity. CONCLUSIONS: Once-daily evening dosing of MF-DPI at doses of 400 and 200 microg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 microg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 microg qd PM, the lowest dose studied.     

Once-daily inhaled corticosteroids in children with asthma: dry powder inhalers

The cornerstone of pharmacological management of asthma in childhood is inhaled corticosteroids. These drugs are intended for long term treatment and, consequently, compliance is a major issue. Once-daily administration of maintenance medication would simplify treatment and it is likely that it would lead to better compliance. Moreover, the excellent safety profile of inhaled corticosteroid treatment tailored to disease severity may, theoretically, be further improved with once-daily administration. Studies comparing inhaled corticosteroids given once or twice daily to patients with asthma indicate that unstable asthma is best treated with at least 2 daily doses. On the other hand, it has been demonstrated that, if the asthma is stabilised, most children can be treated with inhaled corticosteroids once daily without loss of efficacy. Thus, the data suggest that newly diagnosed asthma, or asthma after deterioration, should first be reliably controlled with inhaled corticosteroids divided into at least 2 daily doses. Once-daily maintenance treatment should then be tried with the aim of improving compliance and quality of life. A dry powder inhalation device is probably the best choice for children from the age of 5 years.     

顺尔宁联合糖皮质激素吸入和单纯糖皮质激素吸入治疗儿童哮喘的效果对比

目的探讨顺尔宁联合糖皮质激素吸入和单纯糖皮质激素吸入治疗儿童哮喘的临床效果。方法将2014年2月~2016年12月在我院接受治疗的60例儿童哮喘患者作为本次研究对象,将其按照随机数字法平均分为两组,30例采用单纯糖皮质激素吸入治疗(对照组),30例给予顺尔宁联合糖皮质激素吸入治疗(研究组)。将两组患者临床疗效、湿啰音消失时间、哮鸣音消失时间、咳嗽消失时间、住院时间、FEV1、PEF、Eos指标及不良反应发生情况进行比较。结果研究组临床总有效率为86.66%,对照组临床总有效率为63.33%,研究组患者临床总有效率显著高于对照组(P<0.05)。研究组患者湿啰音消失时间、哮鸣音消失时间、咳嗽消失时间及住院时间均显著短于对照组(P<0.05)。干预前两组患者FEV1、PEF、Eos指标比较差异无统计学意义(P>0.05),干预后两组患者FEV1、PEF指标均显著升高,Eos指标均显著降低(P<0.05),且研究组较对照组改善显著(P<0.05)。研究组不良反应发生率为6.66%,对照组不良反应发生率为10.00%。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论在儿童哮喘患者治疗中选择顺尔宁联合糖皮质激素吸入治疗可显著缩短患者临床症状消失时间及住院时间,提高治疗效果,降低患者经济负担,改善患者肺功能,且不良反应低安全有效,值得在临床上推广使用。     

大环内酯类抗生素联用吸入类固醇治疗哮喘的临床研究

目的通过与小剂量茶碱联用吸入类固醇比较,观察罗红霉素联用吸入类固醇治疗支气管哮喘的疗效。方法选择40例中、重度哮喘患者并随机分为两组:20例患者为罗红霉素联用布地奈德干粉吸入剂组(简称A组),另20例患者为小剂量茶碱联用布地奈德干粉吸入剂组(简称B组)。观察指标为1s用力呼气量(FEV1)、晨晚最大呼气流速(PEFR)及其变异率等。结果第1～12周治疗期间,两组治疗后FEV1均明显高于治疗前,治疗第8周时B组FEV1明显高于A组,但第12周时两组差异无统计学意义,治疗12周时两组平均晨晚PEFR及其变异率差异无统计学意义,两组副作用相似。结论罗红霉素联用吸入类固醇能安全有效地控制哮喘,其治疗12周时疗效与小剂量茶碱联用吸入小剂量类固醇相似。     

Advances in asthma and COPD treatment: combination therapy with inhaled corticosteroids and long-acting beta 2-agonists

Asthma treatment guidelines advocate the use of long-acting beta2-agonists (LABA) in addition to inhaled corticosteroids (ICS) in patients whose asthma is uncontrolled by ICS alone, thereby addressing two processes fundamental to asthma: bronchoconstriction and inflammation. Superior control--including a reduction in severe exacerbations--of asthma and COPD by ICS/LABA combination therapy has been demonstrated. Results from clinical studies suggest additive and potentially synergistic effects when the two agents are used in combination. No new safety-related issues have been identified with ICS/LABA compared with the monocomponents. The exact mechanisms for the enhanced efficacy of ICS/LABA combinations are under investigation but likely include drug interactions at the receptor level and interwoven signalling pathways, which may result in improved function of 2- adrenoceptors and steroid receptors. Data from preclinical studies provide evidence of additive, compensatory, complementary and synergistic effects of ICS and LABA in the control of inflammation and airway and lung remodelling. These effects may contribute to the improved efficacy seen when treating asthma and COPD with ICS/LABA combinations in clinical studies. Two ICS/LABA combination products are available: budesonide/formoterol (Symbicort) and salmeterol/fluticasone propionate (SeretideTM). An ICS/LABA combination in a single inhaler represent safe, effective and convenient treatment options for the management of patients with asthma and COPD. Clinical results also suggest that adjustable dosing with budesonide/formoterol provides better asthma control than fixed dosing. Further elucidation of the underlying mechanisms responsible for this superior disease control is needed.     

Trends in the use of inhaled corticosteroids for childhood asthma in New Zealand

Objective To compare the dispensed volumes and prescribed doses for inhaled corticosteroids (ICS) for children in New Zealand.Design Longitudinal analysis of prescribing trends using the Royal New Zealand College of General Practitioners Research Unit database and the Pharm Warehouse database of the New Zealand Health Information System.Setting New Zealand from 1993 to 2001.Subjects Children aged 0–5 years and 6–17 years.Main outcome measures The ratio of potency-adjusted mean daily dose of fluticasone propionate (FP) to beclomethasone (BDP) and dispensed volumes of FP, BDP and budesonide .Results The ratio of potency-adjusted mean daily dose of FP to BDP prescribed to children aged 0–17 years ranged from 1.22 to 1.91. With the introduction of FP, the total amount of ICS dispensed to children aged 0–5 years in New Zealand nearly doubled, when adjusted for potency.Conclusions The introduction of FP into New Zealand corresponds with an increase in the total amount of ICS dispensed and an increase in the adjusted daily dose prescribed.     

A cost-effectiveness analysis of first-line controller therapies for persistent asthma

BACKGROUND: Asthma is one of the most common chronic diseases in the US, and its prevalence continues to increase. Despite the availability of effective asthma controller medications, many patients with asthma are still not meeting therapeutic goals because of poor disease management. The high disease prevalence combined with the high costs associated with the poor management of asthma, make patients with asthma a costly group to treat for managed care organisations (MCOs) and this motivates decision makers in MCOs to consider both the clinical and economic value of asthma therapies. OBJECTIVE: To compare the cost effectiveness of first-line controller asthma therapies in patients with mild-to-moderate persistent asthma from an MCO payer perspective. METHODS: A decision-analysis model was developed to evaluate the cost effectiveness of fluticasone propionate and salmeterol administered in a single inhaler (salmeterol/fluticasone propionate 50/100microg), compared with fluticasone propionate inhaled corticosteroids (FPIC), non-fluticasone propionate inhaled corticosteroids (nFPIC) and leukotriene modifiers. The model estimated costs ($US, year 2005 values) and health outcomes over a 1-year period. Costs and outcomes data were obtained from published clinical trials and observational studies, and model assumptions on the relationship between adherence and effectiveness were evaluated by a panel of experts. Effectiveness measures included symptom-free days and rescue medication-free days. The cost effectiveness of first-line asthma therapies was compared using a step-wise approach, with FPIC as the reference case. Both one-way and probabilistic sensitivity analyses were performed to assess the robustness of results over a range of assumptions. RESULTS: The step-wise comparison found that the additional costs for achieving an incremental effectiveness unit (incremental cost-effectiveness ratio) using single-inhaler salmeterol/fluticasone propionate compared with FPIC was $US9.55 per symptom-free day and $US8.93 per rescue medication-free day. Sensitivity analyses indicated that the model was robust to changes in base-case assumptions. A probabilistic sensitivity analysis showed that, corresponding to a benchmark value of $US14.8 per symptom-free day, the probabilities that single-inhaler salmeterol/fluticasone propionate, n-FPIC and leukotriene modifiers were more cost effective than FPIC were 98%, 30.7% and 2.1%, respectively. CONCLUSION: Based on our decision analysis, the additional costs for achieving incremental effectiveness with single-inhaler salmeterol/fluticasone propionate treatment compared with FPIC and nFPIC may be lower than the commonly accepted benchmark value for cost effectiveness, based on published estimates of the utility losses associated with asthma symptoms. Single-inhaler salmeterol/fluticasone propionate may also be more cost effective than leukotriene modifiers.