만성폐쇄성폐질환 환자에서 흡입제 Indacaterol과Tiotropium의 효과 평가
Comparison of Clinical Efficacy and Safety Between Indacaterol and Tiotropium for COPD
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According to current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy, longacting inhaled bronchodilators for treating stable chronic obstructive pulmonary disease (COPD) use two classes of pharmacological agents: long-acting β2-agonist (LABA; eg, Indacaterol) and long-acting muscarinic antagonists (LAMA; eg, Tiotropium). The objective of this study was to assess the long-term effect of Indacaterol, including its efficacy on exacerbations and adverse events for patients with severe COPD compared to Tiotropium. Data were retrospectively collected from COPD patients who visited a respiratory medicine clinic of Seoul St. Mary's Hospital from April 2013 to August 2015 when Indacaterol was introduced. They used LABA (Indacaterol) or LAMA (Tiotropium) alone for more than one year. After 52 weeks of treatment, lung function (forced expiratory volume in 1 second; FEV1), incidence of COPD worsening (add antibiotics or steroids, hospitalization), and adverse events were measured as outcomes. Between April 2013 and August 2015, 136 patients were collected (75 with Indacaterol and 61 with Tiotropium). At week 52, estimated least squares mean trough FEV1 in both groups were increased (Indacaterol: 0.11 L, p 0.0001; Tiotropium: 0.19 L, p 0.0001), showing no significant difference between the two groups. Sub-analysis results on Exsmokers revealed that FEV1 was increased significantly in both groups. However, in smokers, the increase of FEV1 was not statistically significant. Indacaterol did not show non-inferiority in terms of annualized exacerbation rates: 0.35 (Indacaterol) versus 0.46 (Tiotropium); relative ratio of 0.76. Regarding safety results, the incidence of adverse events was higher in the Tiotropium group than that in the Indacaterol group (50.00% vs. 27.78%, p=0.0023). The most common adverse event was cough in the Indacaterol group, while dry mouth and BPH symptoms were the most common in the Tiotropium group. There was no superiority or inferiority in therapeutic effect between the two drugs after long-term use. Therefore, clinical pharmacists should consider side effects of the drug and encourage smoking cessation. Continuous monitoring is required for patients with COPD.
Abstract
According to current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy, longacting inhaled bronchodilators for treating stable chronic obstructive pulmonary disease (COPD) use two classes of pharmacological agents: long-acting β2-agonist (LABA; eg, Indacaterol) and long-acting muscarinic antagonists (LAMA; eg, Tiotropium). The objective of this study was to assess the long-term effect of Indacaterol, including its efficacy on exacerbations and adverse events for patients with severe COPD compared to Tiotropium. Data were retrospectively collected from COPD patients who visited a respiratory medicine clinic of Seoul St. Mary's Hospital from April 2013 to August 2015 when Indacaterol was introduced. They used LABA (Indacaterol) or LAMA (Tiotropium) alone for more than one year. After 52 weeks of treatment, lung function (forced expiratory volume in 1 second; FEV1), incidence of COPD worsening (add antibiotics or steroids, hospitalization), and adverse events were measured as outcomes. Between April 2013 and August 2015, 136 patients were collected (75 with Indacaterol and 61 with Tiotropium). At week 52, estimated least squares mean trough FEV1 in both groups were increased (Indacaterol: 0.11 L, p 0.0001; Tiotropium: 0.19 L, p 0.0001), showing no significant difference between the two groups. Sub-analysis results on Exsmokers revealed that FEV1 was increased significantly in both groups. However, in smokers, the increase of FEV1 was not statistically significant. Indacaterol did not show non-inferiority in terms of annualized exacerbation rates: 0.35 (Indacaterol) versus 0.46 (Tiotropium); relative ratio of 0.76. Regarding safety results, the incidence of adverse events was higher in the Tiotropium group than that in the Indacaterol group (50.00% vs. 27.78%, p=0.0023). The most common adverse event was cough in the Indacaterol group, while dry mouth and BPH symptoms were the most common in the Tiotropium group. There was no superiority or inferiority in therapeutic effect between the two drugs after long-term use. Therefore, clinical pharmacists should consider side effects of the drug and encourage smoking cessation. Continuous monitoring is required for patients with COPD.
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