Indacaterol: in chronic obstructive pulmonary disease

Indacaterol is a long-acting β?-adrenoceptor agonist that is available in the EU for the maintenance treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Indacaterol has a 24-hour bronchodilatory effect, which allows for once-daily administration. The onset of bronchodilation after inhalation of indacaterol is fast, with significant improvements versus placebo seen 5 minutes after inhalation. In four large (n?>?400), randomized, double-blind, placebo-controlled, multicentre phase III trials, patients with COPD who received indacaterol 150 or 300?μg once daily had a significantly higher mean trough forced expiratory volume in 1 second (FEV?) than placebo recipients after 12 weeks. Trough FEV? differences between indacaterol and placebo recipients were 130-180?mL and exceeded the clinically relevant threshold of 120?mL in all trials. Furthermore, indacaterol recipients had significantly higher mean trough FEV? values after 12 weeks than patients who received formoterol, salmeterol or open-label tiotropium. COPD exacerbations and symptoms, and health-related quality of life were also significantly improved for indacaterol versus placebo recipients in some studies. Indacaterol was generally well tolerated by adults with moderate to severe COPD.     

Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease

The anticholinergic agent tiotropium bromide (Spiriva?) is a long-acting bronchodilator that is indicated for the treatment of chronic obstructive pulmonary disease (COPD). This article reviews the clinical efficacy and tolerability of tiotropium bromide inhalation powder, administered using the HandiHaler? device, in patients with COPD, as well as reviewing its pharmacological properties and the results of pharmacoeconomic analyses. Shorter-term placebo-controlled trials in patients with COPD demonstrated significantly higher trough forced expiratory volume in 1 second (FEV(1)) responses with tiotropium bromide than with placebo, confirming it has a duration of action of ≥24 hours and is suitable for once-daily administration. Lung function improved to a greater extent with tiotropium bromide than with ipratropium bromide or, in most instances, salmeterol. Indacaterol was shown to be noninferior to tiotropium bromide in terms of the trough FEV(1) response. The large, 4-year UPLIFT? trial did not show a significant reduction in the annual rate of decline in FEV(1) with tiotropium bromide versus placebo in patients with COPD, although subgroup analyses demonstrated a significantly lower rate of decline with tiotropium bromide than with placebo in some patient groups (e.g. patients with moderate COPD, patients aged ≥50 years, patients not receiving maintenance therapy at baseline). Tiotropium bromide prevented exacerbations in patients with COPD, with a significantly lower exacerbation rate and a significantly longer time to first exacerbation seen with tiotropium bromide than with placebo or salmeterol. Exacerbation rates did not significantly differ between patients receiving tiotropium bromide and those receiving salmeterol/fluticasone propionate. Tiotropium bromide also had beneficial effects on health-related quality of life (HR-QOL) and other endpoints, such as dyspnoea and rescue medication use. Combination therapy with tiotropium bromide plus formoterol with or without budesonide improved lung function to a significantly greater extent than tiotropium bromide alone in patients with COPD. In addition, exacerbation rates were lower and HR-QOL was improved with tiotropium bromide plus budesonide/formoterol versus tiotropium bromide alone. Although the addition of salmeterol/fluticasone propionate to tiotropium bromide did not reduce the COPD exacerbation rate, it did improve lung function and HR-QOL. Tiotropium bromide inhalation powder is generally well tolerated in patients with COPD, with anticholinergic adverse events (e.g. dry mouth, constipation, gastrointestinal obstruction, dysuria) among the most commonly reported adverse events. The UPLIFT? trial showed no significant difference between tiotropium bromide and placebo recipients in the risk of stroke, and the risk of serious cardiac adverse events (including congestive heart failure and myocardial infarction) was significantly lower with tiotropium bromide than with placebo. The absence of a detrimental effect on cardiovascular outcomes was supported by the results of a meta-analysis and pooled analyses. In addition, on-treatment mortality was lower with tiotropium bromide than with placebo in the UPLIFT? trial. Pooled analyses showed significantly lower cardiovascular mortality with tiotropium bromide than with placebo, with a meta-analysis demonstrating no significant difference between patients receiving tiotropium bromide and controls in cardiovascular mortality. Results of modelled pharmacoeconomic analyses conducted from a healthcare payer perspective in several developed countries suggest that tiotropium bromide is a cost-effective option in patients with COPD. In conclusion, tiotropium bromide inhalation powder is a useful option for the maintenance treatment of patients with COPD.     

Budesonide/formoterol Turbuhaler®: a review of its use in chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a highly heterogeneous, progressive inflammatory disease that imposes considerable economic and healthcare burdens on society, with the disease predicted to remain a leading cause of morbidity and mortality worldwide in the future. Current pharmacological treatment can improve symptoms of the disease, but not progression. Global Initiative for Chronic Obstructive Lung Disease guidelines recommend that patients with moderate COPD should use one or more long-acting bronchodilators (e.g. a long-acting β(2)-agonist) as required and, for those with severe and very severe disease who are experiencing repeated COPD exacerbations, an inhaled corticosteroid should be added as required. Budesonide/formoterol Turbuhaler? (Symbicort? Turbuhaler?) is a dry powder inhaler (DPI) that combines these two classes of drugs in a single inhaler, thereby making administration easier and more convenient. Budesonide/formoterol Turbuhaler? (delivered dose 320?μg/9?μg) is recommended for the symptomatic treatment of adult patients with severe COPD (forced expiratory volume in 1 second <50% of predicted value) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. This article reviews the pharmacological properties and clinical use of budesonide/formoterol Turbuhaler? in adult patients with moderate to severe COPD. Budesonide/formoterol Turbuhaler? (320?μg/9?μg twice daily) was effective and well tolerated in adult patients with moderate to severe COPD participating in large, multicentre trials of up to 12 months' duration. Budesonide/formoterol Turbuhaler? improved lung function, exacerbation rates, COPD symptom scores and health status from baseline to a significantly greater extent than placebo and, in general, than the individual monotherapies in these trials. Moreover, as reflected in the faster onset of action of formoterol than salmeterol, budesonide/formoterol Turbuhaler? was more effective than salmeterol/fluticasone propionate DPI at improving the patient's ability to perform morning activities in a short-term study. In the 12-week CLIMB trial, adding budesonide/formoterol Turbuhaler? to inhaled tiotropium bromide therapy was significantly more effective than adding placebo to tiotropium bromide therapy. Thus, inhaled budesonide/formoterol, either alone or as add-on therapy to other medications, continues to be a useful option for the management of COPD.     

Indacaterol. A long-acting beta-2 agonist, no advantages in COPD

In patients with chronic obstructive pulmonary disease (COPD), bronchodilator drugs have only modest symptomatic efficacy. There is no evidence that they slow disease progression. A short-acting beta-2 agonist such as salbutamol is the first-choice treatment, used either on demand or on a regular basis. Long-acting beta2 agonists are an option for patients with nocturnal symptoms. Indacaterol is a long-acting beta-2 agonist that is inhaled once a day. Indacaterol has not been compared with a short-acting beta-2 agonist. Clinical evaluation is based on 4 double-blind randomised placebo-controlled trials, 3 of which also included a group treated with another long-acting bronchodilator (formoterol, salmeterol or tiotropium. The symptomatic efficacy of indacaterol was only modest, and similar to that of other long-acting bronchodilators. Indacaterol has the known adverse effect profile of beta-2 agonists. Some adverse effects seem to be more frequent than with other long-acting bronchodilators, including post-inhalation cough, hyperglycaemia, respiratory tract infections, and possibly cardiac disorders. There is no evidence that once-daily inhalation has any advantages over twice-daily inhalation, even in terms of convenience. In addition, as efficacy is limited, there is a risk that patients will use the drug more frequently, resulting in additional adverse effects. The nebulizer used to inhale the powder in the capsules is similar to the one provided with Foradil (formoterol. In practice, indacaterol offers no therapeutic advantage over existing treatments for patients with COPD. It is better to use the best-documented drugs and, if necessary, to add non-drug measures. Eliminating exposure to toxic agents, especially tobacco smoke, remains the only treatment with a proven benefit on the course of COPD.     

Indacaterol maleate for the treatment of chronic obstructive pulmonary disease

Importance of the field: Chronic obstructive pulmonary disease (COPD) is a partially reversible, progressive obstructive disorder. Bronchodilators are the mainstay of treatment since they improve lung function and patient-reported outcomes and reduce acute exacerbations. Long-acting inhaled bronchodilators (at present including the once-daily antimuscarinic tiotropium, and the twice-daily β₂-agonists formoterol and salmeterol) are recommended as first-line treatment for patients with persistent symptoms. Indacaterol maleate has been developed as a new once-daily inhaled β₂-selective agonist.

Areas covered in this review: This article reviews the published literature on the pharmacologic properties and the Phase II and III trials that have evaluated the safety and efficacy of this new agent.

What the reader will gain: The reader will obtain an appreciation of the safety and efficacy of indacaterol and the role that it might play in the future management of COPD of varying severity.

Take home message: Indacaterol is a new, once-daily β₂-agonist with an onset of action within 5 min and a duration of bronchodilation of at least 24 h. In doses of 150 and 300 μg, it has sustained benefits over 6 – 12 months with respect to both bronchodilation and patient-reported outcomes and is well-tolerated with an acceptable safety profile.     

Tiotropium bromide

Tiotropium bromide is an anticholinergic bronchodilator that antagonises muscarinic M(1), M(2) and M(3) receptors. It dissociates more slowly from M(1) receptors and, importantly, from M(3) receptors (which are located in bronchial smooth muscle) than from M(2) receptors and subsequently has a long duration of action permitting once-daily administration. In patients with chronic obstructive pulmonary disease (COPD), tiotropium 18microg once daily significantly improved lung function compared with placebo and ipratropium 40microg four times daily in 1-year trials or salmeterol 50microg twice daily in a 6-month study. The incidence of COPD exacerbations decreased and use of rescue medication was lower with tiotropium compared with placebo or ipratropium. There was no evidence of tachyphylaxis during 1-year treatment with tiotropium. Compared with placebo, salmeterol and ipratropium, tiotropium produced significant improvements in patients' perception of dyspnoea and health-related quality of life. Tiotropium is generally well tolerated; dry mouth is the most common drug-related adverse event, occurring in about 10 to 16% of patients in clinical trials.     

24-hour bronchodilator efficacy of single doses of indacaterol in subjects with COPD: comparison with placebo and formoterol

ABSTRACT

Objective: To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled β₂-agonist bronchodilator, in patients with chronic obstructive pulmonary disease (COPD).

Methods: This crossover, double-blind, double-dummy study was conducted to evaluate the 24-h bronchodilator effect of a range of single doses of indacaterol (150?µg, 300?µg and 600?µg), given in the morning via single-dose dry powder inhaler (SDDPI) in subjects with COPD, compared with placebo and with the daily therapeutic dose of formoterol (two 12?µg doses 12?h apart, via an SDDPI). Tolerability and safety were also assessed.

Results: Fifty-one subjects with moderate-to-severe COPD received each of the five treatments on separate study days in randomised sequence. The 24-h trough FEV₁ (primary endpoint; mean [95%?CI]) was 1.46 (1.43, 1.49)?L with indacaterol 600?µg (p?<?0.001 vs. placebo, p?<?0.01 vs. formoterol, p?<?0.05 vs. indacaterol 150?µg), 1.45 (1.42, 1.48)?L with indacaterol 300?µg (p?<?0.001 vs. placebo, p?<?0.05 vs. formoterol), 1.42 (1.39, 1.45)?L with indacaterol 150?µg (p?<?0.001 vs. placebo), 1.41 (1.38, 1.43)?L with formoterol (p?<?0.001 vs. placebo) and 1.28 (1.25, 1.31)?L with placebo. All treatments were well tolerated and there was little effect on serum potassium, blood glucose or QTc interval.

Conclusion: All doses of indacaterol were effective in providing 24-h bronchodilation and were well-tolerated in subjects with COPD. The bronchodilator efficacy of indacaterol (150, 300 and 600?μg) at 24?h post-dose was at least as efficacious as formoterol 12?µg twice daily.     

Once-daily glycopyrronium via the Breezhaler® device for the treatment of COPD: pharmacological and clinical profile

In the management of chronic obstructive pulmonary disease (COPD), there is an unmet medical need for effective bronchodilator treatments that not only have a fast onset of action, but also a long duration of action and are delivered using a simple, easy-to-use device. Long-acting muscarinic antagonists such as glycopyrronium and tiotropium, along with long-acting beta-2 agonists such as indacaterol, formoterol and salmeterol are the pillars of pharmacological therapy for the long-term management of patients with COPD. Glycopyrronium, the quaternary ammonium ion of glycopyrronium bromide, acts as a competitive antagonist by selectively binding to the muscarinic receptors in the bronchial smooth musculature, thus inhibiting acetylcholine-mediated bronchoconstriction. Glycopyrronium is an inhaled once-daily long-acting muscarinic antagonist recently approved for the maintenance treatment of patients with COPD. Glycopyrronium is administered by a single-dose, dry-powder inhaler, the Breezhaler® device, designed specifically to have a low internal resistance, be easy to use and confirm efficient drug delivery in patients with a wide range of COPD severities, irrespective of the age. Glycopyrronium has been shown to provide rapid and sustained improvements in lung function, dyspnea, health status, exercise endurance and exacerbation risk and an acceptable safety and tolerability profile.     

联合应用噻托溴铵与沙美特罗／氟替卡松治疗中重度COPD稳定期的临床观察

目的观察联合应用噻托溴铵与沙美特罗／氟替卡松治疗中重度慢性阻塞性肺疾病（COPD）稳定期的临床疗效。方法选取中重度COPD稳定期患者97例,随机分为A、B、C3组：在常规家庭氧疗及祛痰等治疗基础上,A组给予吸入噻托溴铵干粉剂（18μg,每日1次）与沙美特罗／氟替卡松（50／500μg,每日2次）;B组给予吸入噻托溴铵干粉剂（18μg,每日1次）;C组给予吸入沙美特罗／氟替卡松（50／500μg,每日2次）,治疗3个月后观察3组患者的血气、肺功能改善情况。结果经3个月的治疗后,A组肺功能及血气改善率明显高于B、C两组,差异有统计学意义（P〈0．05）。结论联合应用噻托溴铵与沙美特罗／氟替卡松对COPD患者具有更强的扩张支气管作用,能够显著改善COPD患者的肺功能,有重要的临床意义。     

Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease

Salmeterol/fluticasone propionate (Seretide, Advair, Viani) administered using a multidose dry powder inhaler (Diskus, Accuhaler) is approved for use in the treatment of chronic obstructive pulmonary disease (COPD) in numerous countries.Salmeterol/fluticasone propionate administered twice daily via dry powder inhaler is effective and generally well tolerated in patients with COPD. Although not associated with a statistically significant reduction in mortality versus placebo in the TORCH study (p = 0.052), salmeterol/fluticasone propionate reduced the rate of decline in lung function over the 3 years of the trial and was associated with lower exacerbation rates than the component monotherapies or placebo; other trials revealed clinically significant improvements in health status and dyspnoea scores with salmeterol/fluticasone propionate. Results of the INSPIRE trial suggest that salmeterol/fluticasone propionate is associated with a significantly lower mortality rate than tiotropium bromide monotherapy in patients with COPD; the two treatments had similar effects in terms of exacerbation rates and lung function. Thus, salmeterol/fluticasone propionate is an important option in the treatment of patients with COPD who are appropriate candidates for combination therapy with a long-acting bronchodilator and an inhaled corticosteroid.     

A benefit-risk assessment of inhaled long-acting beta2-agonists in the management of obstructive pulmonary disease.

The two inhaled long-acting beta2-adrenoceptor agonists, salmeterol and formoterol, have been studied extensively since their introduction in the early 1990s. In this review we consider the evidence for their efficacy and safety in adults with asthma and chronic obstructive pulmonary disease (COPD), by reviewing long-term prospective studies in which these drugs have been compared with placebo or an alternative bronchodilator. We have also assessed safety, including data from postmarketing surveillance studies and case-control studies using large databases. In patients with asthma, salmeterol and formoterol increase lung function, reduce asthmatic symptoms and improve quality of life when compared with placebo. Both drugs protect against exercise-induced asthma, although some tolerance develops with regular use. Tolerance to the bronchodilator effects of formoterol has also been seen, although this is small and most of the beneficial effects are maintained long-term. Both drugs have been shown to reduce asthma exacerbations but only in studies in which most patients were taking an inhaled corticosteroid. Adding a long-acting beta2-agonist provided better control than increasing the dose of inhaled corticosteroid in several studies. Long-acting beta2-agonists also provide better asthma control than use of regular short-acting beta2-agonists and theophylline. Their relative efficacy compared with leukotriene antagonists is uncertain as yet. Formoterol appears to be at least as safe and effective as a short-acting beta2-agonist when used on an 'as required' basis. In patients with COPD, both salmeterol and formoterol offer improved lung function and reduced COPD symptoms compared with placebo, and quality of life has been improved in some studies. Some tolerance to the bronchodilating effect of salmeterol was seen in one study. Most studies have not found a significant reduction in exacerbations in COPD. Both drugs have provided greater benefit than ipratropium bromide or theophylline; there are limited data on tiotropium bromide. The long-acting beta2-agonists cause predictable adverse effects including headache, tremor, palpitations, muscle cramps and a fall in serum potassium concentration. Salmeterol can also cause paradoxical bronchospasm. There is some evidence that serious adverse events including dysrhythmias and life-threatening asthma episodes can occur; however, the incidence of such events is very low but may be increased in patients not taking an inhaled corticosteroid. Salmeterol 50 microg twice daily and formoterol 12 microg twice daily are effective and safe in treating patients with asthma and COPD. Higher doses cause more adverse effects, although serious adverse events are rare.     

Tiotropium bromide, a new, once-daily inhaled anticholinergic bronchodilator for chronic-obstructive pulmonary disease

Tiotropium bromide is a quaternary ammonium compound structurally related to ipratropium and has recently been approved in the US for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic-obstructive pulmonary disease (COPD). It is available in a dry powder form, where 18 microg [corrected] of the drug is inhaled once-daily through a device, the HandiHaler). The potency and long duration of effect of this anticholinergic bronchodilator result primarily from a prolonged blockade of the M1 and M3 muscarinic receptors in the airways and a relatively more rapid dissociation from the M2 receptor (which provides inhibitory feedback). Multiple studies of up to a duration of 1 year have demonstrated its effectiveness as a bronchodilator for COPD, with a trough increase (measured approximately 24 h after administration of the drug) in forced expiratory volume in 1 s of approximately 0.12 l and a peak increase of approximately 0.25 l. Tiotropium inhalation also leads to a significant reduction in static lung volumes in hyperinflated patients with COPD; this probably contributes to the reduction in dyspnoea that is associated with long-term use of this maintenance bronchodilator. Regular use of the drug was associated with clinically meaningful increases in the Transitional Dyspnoea Index, which indicate reductions in dyspnoea associated with daily activities. Improvement in the respiratory-specific health status questionnaire, the St George's Respiratory Questionnaire component and total scores was also documented. Finally, pooled data from two 1-year studies and two 6-month studies documented 20 and 28% reductions in the number of exacerbations per patient per year. Side effects have been relatively minimal, with dry mouth the most common symptom, ranging 6 - 16% of patients and rarely leading to discontinuation of the study drug. Limited comparisons of efficacy with other bronchodilators are available. Once-daily tiotropium has been demonstrated to be clearly superior to ipratropium four times daily as a bronchodilator for COPD. Combined results from two studies comparing once-daily tiotropium to twice-daily inhalation of standard doses of salmeterol, indicate a magnitude of the bronchodilator response similar in the two drugs early in the study. However, by 6 months, the bronchodilator effect of tiotropium was somewhat greater than that of the long-acting beta-agonist. Preliminary data suggest that combining tiotropium with long-acting beta-agonists may produce additional bronchodilator action in COPD.     

联合应用沙美特罗替卡松与噻托溴铵对慢性阻塞性肺疾病肺功能的疗效

目的：联合应用沙美特罗替卡松与噻托溴铵治疗慢性阻塞性肺疾病（COPD）,并观察其疗效。方法：将88例中重度COPD患者随机分为3组,联合治疗组给予吸入沙美特罗替卡松50/500μg,每日2次与噻托溴铵干粉剂18μg,每日1次;噻托溴铵组给予吸入噻托溴铵干粉剂18μg,每日1次;沙美特罗替卡松组给予吸入沙美特罗替卡松50/500μg,每日2次,在治疗前及治疗后测定肺功能。结果：与同组治疗前相比,治疗后噻托溴铵组、沙美特罗替卡松组、联合治疗组第1秒用力呼气量（FEV1）显著提高（P〈0.05）,第1秒用力呼气容积/用力肺活量、第1秒用力呼气容积/预计值均较治疗前改善（P〈0.05）;联合治疗组第1秒用力呼气容积、第1秒用力呼气容积/用力肺活量（FEV1/FVC）、第1秒用力呼气容积/预计值改善优于沙美特罗替卡松组、噻托溴铵组,差异有统计学意义（P〈0.05）。结论：沙美特罗替卡松粉吸入剂联合噻托溴铵粉吸入剂治疗慢性阻塞性肺疾病疗效肯定,优于单用一种药物治疗,值得临床进一步推广应用及探讨。     

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma

ABSTRACT

Objective: This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses.

Research design and methods: This was a randomised, open-label crossover study in adult subjects with asthma (forced expiratory volume in 1 second [FEV₁] ≥?60% predicted). In part A, patients (n = 20) received single doses of indacaterol 200?µg, salbutamol 200?µg, salmeterol 50?µg and placebo. In part B, patients (n = 19) received single doses of indacaterol 1000?µg, salbutamol 1000?µg, salmeterol 250?µg and placebo.

Main outcomes measures; Results: For the primary endpoint, FEV₁ area under the effect curve during 0–24?h, indacaterol 200?µg was statistically superior to placebo and salbutamol. Indacaterol 200?µg FEV₁ was higher than placebo (5?min to 24?h), salbutamol 200?µg (4–24?h), and salmeterol 50?µg (5 and 15?min and 22 and 24?h). Few adverse events were reported; all were mild or moderate in severity. Initial changes were observed in glucose, potassium, heart rate and QTc interval, but all values remained within normal ranges. Values matched placebo levels after a shorter time for indacaterol 1000?µg than for salmeterol 250?µg.

Conclusions: In this single-dose, open-label study, indacaterol 200?µg provided effective 24‐h bronchodilation, with a longer duration than salmeterol 50?µg and a good overall safety profile. The sustained bronchodilation of indacaterol 1000?µg was not associated with sustained systemic adverse effects.     

Indacaterol: a new long-acting β2-agonist in the management of chronic obstructive pulmonary disease

INTRODUCTION: Bronchodilators represent the mainstay of symptomatic treatment for chronic obstructive pulmonary disease (COPD). The principal bronchodilator agents are β(2)-agonists, anticholinergics and methylxanthines, used singly or in combination. Indacaterol is a novel long-acting β(2)-agonist for maintenance bronchodilator treatment of airflow obstruction in patients with COPD, approved in December 2009 by the European Medicines Association, and recently by the US Food and Drug Administration. It is administered once daily and is delivered by means of a single-dose dry powder inhaler (SDDPI). In Europe, the recommended dose is 150 μg and the maximum dose is 300 μg, while in the US the recommended dose is 75 μg. Indacaterol shows evidence of a rapid onset of bronchodilation, and its bronchodilatory duration is sustained. AREAS COVERED: Numerous clinical studies have assessed the therapeutic effects of indacaterol in various physiologic parameters, as well as symptoms, disease progression, exacerbation rates, quality of life, safety and tolerability. This review summarises published evidence regarding the efficacy, tolerability and safety of indacaterol in regard to lung function and symptoms of COPD patients. EXPERT OPINION: Indacaterol, the novel once-daily β(2)-agonist, has rapid and sustained bronchodilatory effect, showing excellent efficacy, tolerability and safety, as shown by all clinical trials so far.     

联合吸入舒利迭和思力华治疗稳定期慢性阻塞性肺疾病的疗效观察

目的分析研究舒利迭联合思力华吸入治疗稳定期慢性阻塞性肺疾病的临床疗效和安全性。方法将82例稳定期COPD患者随机分成两组,治疗组41例,吸入舒利迭50μg/250μg,每日2次,间隔12 h。吸入思力华18μg,每日1次。对照组仅吸入舒利迭50μg/250μg,每日2次,间隔12 h。治疗12周后判定疗效。结果共有77例患者完成本实验,治疗组在临床症状体征改善、动脉血气改善及肺功能的改善方面明显优于对照组(P<0.05),用药过程中未出现严重不良反应。结论联合吸入舒利迭和思力华治疗稳定期COPD患者,效果优于单用舒利迭,可以明显改善临床症状及肺功能。     

噻托溴铵联合福莫特罗吸入治疗慢性阻塞性肺疾病

目的观察噻托溴铵联合福莫特罗吸入治疗慢性阻塞性肺疾病(COPD)的效果及安全性。方法46例COPD患者随机分为2组,对照组23例,常规给予福莫特罗治疗;治疗组23例,噻托溴铵联合福莫特罗吸入治疗,疗程4周。观察治疗前、后的临床症状及肺功能变化。结果治疗组对FEV1的改善显著高于对照组(P<0.05)。治疗组减轻日常症状的效果优于对照组。各组均未出现明显不良反应。结论吸入噻托溴铵与福莫特罗联合治疗COPD,疗效优于单药治疗。     

茚达特罗/格隆溴铵治疗慢性阻塞性肺疾病的 成本-效果分析

目的 评估茚达特罗/格隆溴铵与沙美特罗/氟替卡松治疗中度至极重度慢性阻塞性肺疾病(COPD)的成本-效果,为临床用药决策提供依据.方法 利用Markov模型队列模拟分析法预估两种药物治疗COPD的远期效果和费用.结果 茚达特罗/格隆溴铵和沙美特罗/氟替卡松治疗每例COPD患者的平均费用分别为86393.01元和8153...     

▾Indacaterol for COPD

?Indacaterol powder for inhalation (Onbrez Breezhaler - Novartis) is a long-acting beta(2) agonist, licensed for once-daily use as maintenance bronchodilator therapy for chronic obstructive pulmonary disease (COPD). In this article, we consider the evidence for indacaterol and how its use fits with current management strategies for COPD.     

Tiotropium bromide,a new,once-daily inhaled anticholinergic bronchodilator for chronic-obstructive pulmonary disease

Tiotropium bromide is a quaternary ammonium compound structurally related to ipratropium and has recently been approved in the US for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic-obstructive pulmonary disease (COPD). It is available in a dry powder form, where 18 mg of the drug is inhaled once-daily through a device, the HandiHaler^®. The potency and long duration of effect of this anticholinergic bronchodilator result primarily from a prolonged blockade of the M₁ and M₃ muscarinic receptors in the airways and a relatively more rapid dissociation from the M₂ receptor (which provides inhibitory feedback). Multiple studies of up to a duration of 1 year have demonstrated its effectiveness as a bronchodilator for COPD, with a trough increase (measured ～ 24 h after administration of the drug) in forced expiratory volume in 1 s of ～ 0.12 l and a peak increase of ～ 0.25 l. Tiotropium inhalation also leads to a significant reduction in static lung volumes in hyperinflated patients with COPD; this probably contributes to the reduction in dyspnoea that is associated with long-term use of this maintenance bronchodilator. Regular use of the drug was associated with clinically meaningful increases in the Transitional Dyspnoea Index, which indicate reductions in dyspnoea associated with daily activities. Improvement in the respiratory-specific health status questionnaire, the St George’s Respiratory Questionnaire component and total scores was also documented. Finally, pooled data from two 1-year studies and two 6-month studies documented 20 and 28% reductions in the number of exacerbations per patient per year. Side effects have been relatively minimal, with dry mouth the most common symptom, ranging 6 – 16% of patients and rarely leading to discontinuation of the study drug. Limited comparisons of efficacy with other bronchodilators are available. Once-daily tiotropium has been demonstrated to be clearly superior to ipratropium four times daily as a bronchodilator for COPD. Combined results from two studies comparing once-daily tiotropium to twice-daily inhalation of standard doses of salmeterol, indicate a magnitude of the bronchodilator response similar in the two drugs early in the study. However, by 6 months, the bronchodilator effect of tiotropium was somewhat greater than that of the long-acting β-agonist. Preliminary data suggest that combining tiotropium with long-acting β-agonists may produce additional bronchodilator action in COPD.