The drug umeclidinium (trade name: Incruse) has been approved in Germany since November 2015 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.
In COPD, the lungs become permanently damaged and the airways (bronchi) are constantly narrowed. This makes it difficult to breathe. Typical symptoms include coughing, coughed-up phlegm and wheezing, 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 problems. Umeclidinium is a long-acting bronchodilator.
It inhibits one of the body’s chemical messengers, acetylcholine, which narrows the airways. By doing this, umeclidinium can widen the airways.
Umeclidinium is inhaled once a day using a dry powder inhaler (trade name: Ellipta). One inhaled dose contains 55 micrograms of umeclidinium.
The recommended treatments for moderate COPD (stage II) are long-acting beta2-agonists (formoterol or salmeterol) and/or the long-acting anticholinergic tiotropium. These drugs are also options for people with severe or very severe COPD (stage III and IV) provided they have no more than one exacerbation (flare-up) per year. During flare-ups, symptoms such as breathing difficulties, coughing or coughed-up phlegm, as well as fatigue, exhaustion and fever, worsen significantly.
Inhaled steroids are an additional option for people who have severe or very severe COPD (stage III and IV) with more than one flare-up a year.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether umeclidinium has any advantages or disadvantages compared with the standard therapy for people with COPD.
The manufacturer did not provide sufficient data for people with stage III or IV COPD and more than one flare-up a year. So it is not possible to tell whether umeclidinium has any advantages or disadvantages compared with the standard therapies for this group of people.
The manufacturer provided one study involving 78 people with stage II or III COPD who have no more than one flare-up a year. Half of the participants took the drug umeclidinium, while the other half had treatment with tiotropium. After 6 months there was no difference between the two groups in terms of the following factors:
- Life expectancy: None of the 78 patients died during the 6 month study.
- Acute severe flare-ups: Up to two people in each group had a severe flare-up.
- Symptoms: Symptoms like coughing, chest tightness or coughed-up phlegm were equally common.
- Severe side effects and termination of treatment due to side effects: One person in each group stopped the treatment due to side effects.
- Health-related quality of life: No difference was found.
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 the review and the hearings received, the G-BA passed a resolution on the added benefit of umeclidinium (Incruse).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Umeclidinium – Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-02. Cologne: IQWiG. March 28, 2016.
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