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DAR No 1. Indacaterol (Onbrez breezhaler®) Maintenance bronchodilator therapy in patients with COPD

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Uncertainty regarding safety


  • Indacaterol is a long-acting beta 2 agonist that is administered once daily and authorized for patients with chronic obstructive pulmonary disease (COPD).
  • It has not been clinically proven that this agent is more effective than tiotropium or the other long-acting beta 2 agonists, salmeterol or formeterol.
  • Clinical trials available are short lasting, less than a year, with few patients and important exclusion criteria. Thus, the safety profile of the agent is not conclusive.
  • The rapid onset of its action could result in inadequate use of the drug as rescue therapy.
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