Introduction

The fixed-dose combination of umeclidinium and vilanterol (trade name: Anoro) has been approved in Germany since May 2014 for the treatment of chronic obstructive pulmonary disease (COPD) in adults. Both drugs act to widen the airways in different ways.

COPD causes permanent damage to the lungs and narrows the airways (bronchi). This makes breathing difficult. Typical symptoms include coughing, sputum and breathing noises such as wheezing or rattling, as well as breathing difficulties during physical activity.

Drugs that widen the airways can relieve these symptoms. These medications are called “bronchodilators.” There are long-acting bronchodilators for long-term use and short-acting bronchodilators to relieve acute breathing attacks. Umeclidinium and vilanterol are long-acting bronchodilators. The drugs have been approved for long-term therapy of COPD in adults.

Application

This drug combination is available as a powder containing 55 micrograms of umeclidinium and 22 micrograms of vilanterol. It is used once a day with a powder inhaler.

Other treatments

For adults, conventional long-term treatment options will depend on COPD severity:

  • For moderate COPD (stage II), treatment with long-acting beta2 agonists (formoterol, salmeterol) and/or the long-acting anticholinergic tiotropium is recommended. These drugs are also options for people with severe or very severe COPD (stage III and IV) provided they have fewer than two exacerbations (flare-ups) a year. During these episodes symptoms such as breathing difficulties, coughing or sputum, as well as fatigue, exhaustion, and fever, worsen significantly.
  • In case of severe or very severe COPD with more than one exacerbation a year, inhalative steroids are an additional option.

Assessment

In 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) examined what advantages and disadvantages the drug combination umeclidinium and vilanterol offers in comparison with conventional therapies.

The manufacturer did not provide sufficient data for people with severe or very severe COPD and more than one exacerbation a year. For these people the question whether umeclidinium / vilanterol provides any added benefit in comparison with standard therapies cannot be answered.

Data from the following groups was made available for analysis:

  • People with moderate COPD
  • People with severe or very severe COPD who had fewer than two acute illness episodes a year

Where was there no difference?

  • Breathlessness: There was no difference between umeclidinium / vilanterol and tiotropium when used to relieve breathing difficulties like shortness of breath during physical activity.
  • Quality of life: There was no real difference between treatments in terms of their effect on quality of life.

What remains unanswered?

  • Life expectancy: The manufacturer did not provide enough data to answer the question of whether umclidinium / vilanterol would have any added benefit compared with conventional therapy.
  • Symptoms: There was also no useable data on any differences to conventional therapy in terms of frequency of exacerbations or symptoms such as coughing, chest tightness, or sputum, and their impact on daily life.
  • Side effects: Because of lack of data it is still not clear whether umeclidinium / vilanterol treatment causes fewer or more side effects than conventional treatment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of the fixed-dose combination umeclidinium / vilanterol (Anoro).