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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2013/07/23 10:38:40」(JST)

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Indacaterol (INN) is an ultra-long-acting beta-adrenoceptor agonist^[1] developed by Novartis. It was approved by the European Medicines Agency (EMA) under the trade name Onbrez on November 30, 2009,^[2] and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011.^[3] It needs to be taken only once a day,^[4] unlike the currently available formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler.

Clinical trials[edit]

A Phase III trial published in March 2010 examined the efficacy and safety of indacaterol in COPD patients.^[5] This study, conducted in the U.S., New Zealand, and Belgium, compared indacaterol dry-powder inhaler to placebo in 416 COPD patients, mostly moderate to severe (mean FEV₁ of 1.5 L). Indacaterol produced statistically improved FEV₁ (both trough and AUC) and decreased use of rescue medication compared to placebo, but with safety and tolerability similar to those of placebo.

A year-long, placebo-controlled trial published in July 2010 suggests indacaterol may be significantly more effective than twice-daily formoterol in improving FEV₁. There were some reductions in the need for rescue medication, but these were not significantly different; nor was there any difference in the rate of exacerbation between the 2 active treatments.^[6]

A study published in October, 2011 in the European Respiratory Journal compared indacaterol with tiotropium over the study period of 12 weeks. The study found no statistical difference between the effects of the two drugs on FEV₁. Indacaterol yielded greater improvements in transition dyspnoea index (TDI) total score and St. George’s Respiratory Questionnaire (SGRQ) total score.^[7]

References[edit]

^ Cazzola M, Matera MG, Lötvall J (July 2005). "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs 14 (7): 775–83. doi:10.1517/13543784.14.7.775. PMID 16022567.
^ European Public Assessment Report for Onbrez Breezhaler
^ "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Retrieved 2011-07-02. [1]
^ Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A (May 2007). "Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma". Eur. Respir. J. 29 (5): 871–8. doi:10.1183/09031936.00060006. PMID 17251236.
^ Feldman, G; Siler, T; Prasad, N; Jack, D; Piggott, S; Owen, R; Higgins, M; Kramer, B et al. (2010). "Efficacy and safety of indacaterol 150 mcg once-daily in COPD: a double-blind, randomised, 12-week study.". BMC pulmonary medicine 10: 11. doi:10.1186/1471-2466-10-11. PMC 2848004. PMID 20211002. |displayauthors= suggested (help)
^ Dahl R, Chung KF, Buhl R, et al. (June 2010). "Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD". Thorax 65 (6): 473–9. doi:10.1136/thx.2009.125435. PMID 20522841.
^ R. Buhl, L.J. Dunn, C. Disdier, et al. (October 2011). "Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD". European Respiratory Journal 38 (4): 797–803. PMID 21622587.

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UpToDate Contents

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1. 安定した慢性閉塞性肺疾患（COPD）のマネージメント management of stable chronic obstructive pulmonary disease
2. 成人における吸入剤の到達 delivery of inhaled medication in adults
3. 喘息におけるβ刺激剤：長期使用に関する議論 beta agonists in asthma controversy regarding chronic use
4. β-2アドレナリン受容体機能不全および喘息の多型性 beta 2 adrenergic receptor dysfunction and polymorphism in asthma
5. 患者情報：慢性閉塞性肺疾患（COPD）の治療（詳細） chronic obstructive pulmonary disease copd treatments beyond the basics

English Journal

Update on ultra-long-acting β agonists in chronic obstructive pulmonary disease.

Zafar MA1, Droege C, Foertsch M, Panos RJ.
Expert opinion on investigational drugs.Expert Opin Investig Drugs.2014 Dec;23(12):1687-701. doi: 10.1517/13543784.2014.942730. Epub 2014 Aug 19.
INTRODUCTION: For the last two decades, long-acting β agonists (LABAs) have been a cornerstone in the management of chronic obstructive pulmonary disease (COPD). They relax airway smooth muscle and augment expiratory airflow, which reduces hyperinflation and improves dyspnea, functional capacity an
PMID 25139313

Indacaterol for the treatment of chronic obstructive pulmonary disease.

Matera MG1, Rogliani P, Cazzola M.
Expert opinion on pharmacotherapy.Expert Opin Pharmacother.2014 Nov 24:1-9. [Epub ahead of print]
Introduction: The need for a rapid onset of action and a long duration of the broncholytic effect is the likely reason for the development of new long-acting β2-agonists (LABAs) that are fast acting and have true 24 h duration of action. Indacaterol is the archetype of once-daily LABAs and already
PMID 25418284

INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.

Rossi A1, van der Molen T2, Olmo RD3, Papi A4, Wehbe L5, Quinn M6, Lu C6, Young D7, Cameron R7, Bucchioni E8, Altman P6.
The European respiratory journal.Eur Respir J.2014 Dec;44(6):1548-56. doi: 10.1183/09031936.00126814. Epub 2014 Oct 30.
The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled cortico
PMID 25359348

Japanese Journal

慢性閉塞性肺疾患に対するチオトロピウムとインダカテロールの併用療法からグリコピロニウム/インダカテロール配合剤への切り替えの検討 : 単施設での自己対照比較研究

呼吸器内科 = Respiratory medicine 28(3), 256-262, 2015-09
NAID 40020599206

臨床新薬レビューグリコピロニウム臭化物/インダカテロールマレイン酸塩 Glycopyrronium Bromide/Indacaterol Maleate ウルティブロ吸入用カプセルノバルティスファーマ

MD : medical doctor : 明日を創る医療総合誌 11(6), 27-29, 2014-06
NAID 40020113738

COPDの吸入治療の第一選択は吸入抗コリン薬(LAMA)か吸入β刺激薬(LABA)か? (特集 COPD治療の新時代 : 21世紀の「社会的」生活習慣病) -- (COPD治療のコントラバシー)

内科 113(2), 265-269, 2014-02
NAID 40019954889

Related Pictures

Indacaterol Structural Formulae.svg ARCAPTA NEOHALER (Indacaterol ) dosage Indacaterol inhaler for COPD relief File:Indacaterol.png - Wikipedia, the free Neumología » Indacaterol, un nuevo Indacaterol – nový lék pro pacienty s Go Back > Gallery For > Indacaterol

★リンクテーブル★

リンク元	「インダカテロール」

「インダカテロール」

Indacaterol
Systematic (IUPAC) name
	(R)-5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one
Clinical data
Trade names	Onbrez, Arcapta
AHFS/Drugs.com	International Drug Names
Licence data	EMA:Link, US FDA:link
Pregnancy cat.	C (US)
Legal status	POM (UK) ℞-only (US)
Routes	Inhalation
Identifiers
CAS number	312753-06-3
ATC code	R03AC18
PubChem	CID 6433117
ChemSpider	5293751
UNII	8OR09251MQ
KEGG	D09318
ChEBI	CHEBI:68575
ChEMBL	CHEMBL1095777
Chemical data
Formula	C24H28N2O3
Mol. mass	392.490 g/mol
	SMILES O=C4/C=C\c1c(c(O)ccc1[C@@H](O)CNC3Cc2cc(c(cc2C3)CC)CC)N4;
	InChI InChI=1S/C24H28N2O3/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29)/t22-/m0/s1 ; Key:QZZUEBNBZAPZLX-QFIPXVFZSA-N ;
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　　[★]

英: indacaterol
同: インダカテロールマレイン酸塩 indacaterol maleate
商: オンブレス
関: 気管支拡張剤

[pmid16022567-1] Cazzola M, Matera MG, Lötvall J (July 2005). "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs 14 (7): 775–83. doi:10.1517/13543784.14.7.775. PMID 16022567.

[2] European Public Assessment Report for Onbrez Breezhaler

[3] "FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease" (Press release). U.S. Food and Drug Administration. 2011-07-01. Retrieved 2011-07-02. [1]

[pmid17251236-4] Beeh KM, Derom E, Kanniess F, Cameron R, Higgins M, van As A (May 2007). "Indacaterol, a novel inhaled beta2-agonist, provides sustained 24-h bronchodilation in asthma". Eur. Respir. J. 29 (5): 871–8. doi:10.1183/09031936.00060006. PMID 17251236.

[5] Feldman, G; Siler, T; Prasad, N; Jack, D; Piggott, S; Owen, R; Higgins, M; Kramer, B et al. (2010). "Efficacy and safety of indacaterol 150 mcg once-daily in COPD: a double-blind, randomised, 12-week study.". BMC pulmonary medicine 10: 11. doi:10.1186/1471-2466-10-11. PMC 2848004. PMID 20211002. |displayauthors= suggested (help)

[Dahl2010-6] Dahl R, Chung KF, Buhl R, et al. (June 2010). "Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD". Thorax 65 (6): 473–9. doi:10.1136/thx.2009.125435. PMID 20522841.

[Buhl2011-7] R. Buhl, L.J. Dunn, C. Disdier, et al. (October 2011). "Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD". European Respiratory Journal 38 (4): 797–803. PMID 21622587.

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