Factors Associated with Indacaterol Response in Tuberculosis-Destroyed Lung with Airflow Limitation / 결핵및호흡기질환

BACKGROUND: Pulmonary tuberculosis can result in anatomical sequelae, and cause airflow limitation. However, there are no treatment guidelines for patients with a tuberculosis-destroyed lung. Recently, indacaterol effectiveness in chronic obstructive pulmonary disease (COPD) patients with Tuberculosis history (INFINITY) study revealed indacaterol provided bronchodilation and symptom improvement in COPD patients with a tuberculosis-destroyed lung. METHODS: We conducted a post-hoc subgroup analysis of the randomized controlled trial, the INFINITY study, to determine factors associated with indacaterol response in a tuberculosis-destroyed lung with airflow limitation. Data from 68 patients treated with inhaled indacaterol, were extracted and analyzed. Factors associated with the response of forced expiratory volume in one second (FEV1) to indacaterol treatment, were determined using linear regression analysis. RESULTS: Of 62 patients included, 68% were male, and 52% had history of cigarette smoking. Patients revealed mean FEV1 of 50.5% of predicted value with mean improvement of 81.3 mL in FEV1 after indacaterol treatment for 8 weeks. Linear regression analysis revealed factors associated with response of FEV1 to indacaterol included a short duration of smoking history, and high short-acting bronchodilator response. When patients with history of smoking were excluded, factors associated with response of FEV1 to indacaterol included high short-acting bronchodilator response, and poor healthrelated quality of life score as measured by St. George's Respiratory Questionnaire for COPD. CONCLUSION: In a tuberculosis-destroyed lung with airflow limitation, short-acting bronchodilator response and smoking history can play a critical role in predicting outcomes of indacaterol treatment.

Cost-effectiveness of indacaterol/glycopyrronium in comparison with salmeterol/fluticasone combination for patients with moderate-to-severe chronic obstructive pulmonary disease: a LANTERN population analysis from Singapore

<p><b>INTRODUCTION</b>In light of the growing evidence base for better clinical results with the use of the dual bronchodilator indacaterol/glycopyrronium (IND/GLY) over inhaled corticosteroid-containing salmeterol/fluticasone combination (SFC), this study aimed to evaluate the cost-effectiveness of IND/GLY over SFC in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are at low risk of exacerbations, in the Singapore healthcare setting.</p><p><b>METHODS</b>A previously published patient-level simulation model was adapted for use in Singapore by applying local unit costs. The model was populated with clinical data from the LANTERN and ECLIPSE studies. Both costs and health outcomes were predicted for the lifetime horizon from a payer's perspective and were discounted at 3% per annum. Costs were expressed in 2015 USD exchange rates. Uncertainty was assessed through probabilistic sensitivity analysis.</p><p><b>RESULTS</b>Compared to SFC, use of IND/GLY increased mean life expectancy by 0.316 years and mean quality-adjusted life years (QALYs) by 0.246 years, and decreased mean total treatment costs (drug costs and management of associated events) by USD 1,474 over the entire lifetime horizon. IND/GLY was considered to be 100% cost-effective at a threshold of 1 × gross domestic product per capita. The cost-effectiveness acceptability curve showed that IND/GLY was 100% cost-effective at a willingness-to-pay threshold of USD 0 (additional cost) when compared to SFC.</p><p><b>CONCLUSION</b>IND/GLY was estimated to be highly cost-effective compared to SFC in patients with moderate-to-severe COPD who are not at high risk of exacerbations in the Singapore healthcare setting.</p>

Safety and Effectiveness of Indacaterol in Chronic Obstructive Pulmonary Disease Patients in South Korea / 결핵및호흡기질환

BACKGROUND: Inhaled indacaterol (Onbrez Breezhaler), a long-acting β₂-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. METHODS: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or 300 µg), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. RESULTS: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. CONCLUSION: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

O uso da combinação LABA/LAMA em pacientes com DPOC / LABA/LAMA combination in COPD

Neste artigo de atualização discutiremos, à luz dos mais recentes e relevantes trabalhos, a terapia dupla com broncodilatadores de longa ação para os pacientes com Doença Pulmonar Obstrutiva Crônica (DPOC) no período estável, destacando sua proteção quanto a exacerbações, dispneia, qualidade de vida, utilizando como orientador de sua oportunidade de uso a recomendação mais recente do Iniciativa Global para Doenças Pulmonares (GOLD) da sigla em língua inglesa.

In this update article we will discuss the light of the most recent and relevant studies on dual therapy with long acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD) in the stable period, highlighting their protection against exacerbations, dyspnea, quality of life, Using the most recent recommendation of the Global Initiative for Lung Disease (GOLD) as the guideline of their opportunity to use the English acronym.

Effect of Indacaterol on Cough and Phlegm in Chronic Obstructive Pulmonary Disease Patients: A Meta-Analysis of Five Randomized Controlled Trials

We investigated the effects of indacaterol on cough and phlegm in patients with stable chronic obstructive pulmonary disease (COPD). We performed a meta-analysis with five randomized controlled trials (RCTs) of indacaterol in stable COPD patients. The symptom severity was defined using the St. George's Respiratory Questionnaire (SGRQ). We analyzed patients treated with 150 microg (n = 945) and 300 microg (n = 832) out of 3,325 patients who completed the SGRQ from five RCTs. After a 12-week treatment of 150 microg indacaterol, cough improvement was reported in 36.5% (316/866) of patients treated with indacaterol vs. 32.2% (259/804) patients treated with placebo (Relative Ratio [RR], 1.13; 95% confidence interval [CI], 0.99-1.29). Phlegm improvement was reported in 31.0% (247/798) of patients treated with indacaterol vs. 30.6% (225/736) of patients treated with placebo (RR, 1.01; 95% CI, 0.87-1.18). Dyspnea improvement was reported in 39.5% (324/820) of patients treated with indacaterol vs. 31.5% (237/753) patients treated with placebo (RR, 1.33; 95% CI, 1.03-1.71; P = 0.001, I2 = 55.1%). Only dyspnea improvement was significant compared to placebo even at the 300 microg indacaterol dose. Compared to placebo, a 12-week treatment of the long-acting beta-agonist, indacaterol might not have a significant effect on cough or phlegm in stable COPD.

Meta-analysis of the treatment of chronic obstructive pulmonary diseases with indacaterol maleate / 中国药学杂志

OBJECTIVE: To evaluate the efficacy and safety of indacaterol in the treatment of chronic obstructive pulmonary diseases (COPD). METHODS: The randomized controlled trials (RCTs) about indacaterol, placebo, salmeterol, tiotropium and formeterol in the treatment of CDPD were collected from Pubmed, Embase, CNKI, Wangfang database, VIP and CBM. The quality of the trials was evaluated and selected, and the results of the studies were reviewed and analyzed using Rev Man 5.1 software. RESULT: Eourteen RCTs were included, involving 8594 patients. Meta-analysis showed that effective rate of improving trough forced expiratory volume in one second was higher than that of placebo[mean OR=0.16, 95% CI (0.15, 0.18), P<0.01], salmeterol [MD=0.08, 95%CI (0.08, 0.09), P<0.01], formeterol [MD=0.10, 95% CI (0.08, 0.12), P<0.01] and tiotropium [MD=0.02, 95%CI (0.01, 0.04), P<0.01] in the treatment of COPD. In terms of ADR, indacaterol showed no statistical difference with control group. Main ADR include COPD worsening, nasopharyngitis, cough and headache. CONCLUSION: Indacaterol is more effective and safer than other bronchodilators in the treatment of COPD.

Eficacia del indacaterol como broncodilatador en un grupo de pacientes asmáticos / Effectiveness of Indacaterol as bronchodilator in a group of asthmatic patients

La búsqueda de nuevas opciones terapéuticas para tratar las enfermedades obstructivas bronquiales representa un reto permanente y los broncodilatadores constituyen unos de los fármacos más empleados para la atención de estos pacientes. En los últimos años han ido ganando fuerza los broncodilatadores de acción prolongada, pero el mayor efecto alcanzado era 12 h, superado por un broncodilatador nuevo salido al mercado en el año 2011, denominado indacaterol, del grupo de los beta agonistas, se diferencia de estos por la duración de su efecto que llega a alcanzar 24 h. Se realizó un estudio prospectivo, a ciego, tipo ensayo clínico, aleatorizado, con 90 pacientes asmáticos, entre 18 y 59 años de edad, que acudieron al departamento de pruebas funcionales respiratorias para estudiarles la función pulmonar. Todos recibieron de manera aleatoria indacaterol, salbutamol o placebo, y se les repitió la espirometría a los 15 min y a las 24 h de aplicado cada medicamento. Se evidenció que la respuesta broncodilatadora obtenida en los que usaron indacaterol, a las 24 h, fue muy superior a la respuesta de los que usaron otros fármacos. Se muestra además un discreto aumento de la frecuencia cardiaca y de la tensión arterial en los que usaron indacaterol y salbutamol, principalmente a los 15 min de empleados dichos medicamentos, pero dentro de los límites considerados como normales. No se evidenciaron efectos adversos

The search for new therapeutic options to treat bronchial obstructive diseases represents a permanent challenge and bronchodilators constitute one of the most used drugs in the treatment of these patients. In recent years, long acting bronchodilators have grown importance, but the greatest effect has been 12 h, superseded by a new bronchodilator that came on to the market in the year 2011 named Indacaterol, which belongs to the group of ß2-agonists and differentiates from the rest for its effect on the duration which lasts 24 hours. A randomized, essay-type, blind, prospective study was performed in 90 asthmatic patients, ranging from 18 to 59 years of age that presented to the department of respiratory functional tests for a study of their pulmonary functions. All the patients randomly received Indacaterol, Salbutamol or Placebo and spirometry was repeated 15 minutes and 24 hours after treatment. It was evidenced that the bronchodilator response obtained at the 24 hours in those patients that used Indacaterol, was higher than the response in the patients that used other drugs. The patients that used Indacterol and Salbutamol also showed a discrete increase of the cardiac frequency and blood pressure, mainly 15 minutes after receiving such drugs, but this increase is considered within the normal limits. Adverse effects were not evidenced