Featured Research

from universities, journals, and other organizations

Minor added benefit of indacaterol/glycopyrronium in COPD

Date:
February 19, 2014
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Adults with COPD of moderate or severe severity grade with no more than 2 flare-ups per year have fewer breathing difficulties when treated with the drug combination. According to the findings, the drug combination is better at relieving breathing difficulties (dyspnoea) than a combination treatment with tiotropium and formoterol. However, this only applies to patients who do not yet need inhaled corticosteroids because they have no more than 2 acute flare-ups (exacerbations) per year. Furthermore, there is an indication that the severity of the disease may influence the treatment result, and hence is a so-called "effect modifier." Hence overall, there is only a hint of a minor added benefit for patients with COPD grade 2. In contrast, there is an indication of a minor added benefit for patients with COPD grade 3 and no more than 2 exacerbations per year.

The drug combination indacaterol/glycopyrronium (trade name: Ultibro Breezhaler, Xoterna Breezhaler) has been approved since September 2013 for adults with chronic obstructive pulmonary disease (COPD). In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this drug combination offers an added benefit over the appropriate comparator therapy.

Related Articles


According to the findings, the drug combination is better at relieving breathing difficulties (dyspnoea) than a combination treatment with tiotropium and formoterol. However, this only applies to patients who do not yet need inhaled corticosteroids because they have no more than 2 acute flare-ups (exacerbations) per year. Furthermore, there is an indication that the severity of the disease may influence the treatment result, and hence is a so-called "effect modifier." Hence overall, there is only a hint of a minor added benefit for patients with COPD grade 2. In contrast, there is an indication of a minor added benefit for patients with COPD grade 3 and no more than 2 exacerbations per year.

Due to a lack of relevant data, an added benefit of indacaterol/glycopyrronium is not proven for adults with symptoms at later stages of disease (COPD grades 4 and 3/4 with more than 2 exacerbations per year).

Tiotropium with formoterol as comparator therapy

In COPD, the lungs are permanently damaged, and the airways (bronchi) are continuously narrowed. This makes breathing more difficult. The symptoms can be relieved by drugs called bronchodilators, which widen the airways. Long-acting bronchodilators like indacaterol and glycopyrronium are used on a long-term basis (with a dry powder inhaler) and relieve symptoms like dyspnoea in various ways.

The appropriate comparator therapy specified by the Federal Joint Committee (G-BA) takes into account the graded scheme of the most recently effective German National Care Guideline COPD: From grade 2, long-acting beta-2 sympathomimetics (formoterol, salmeterol) and/or long-acting anticholinergics (tiotropium bromide) should be used; from grade 3/4 with more than 2 exacerbations per year, inhaled corticosteroids (ICS) should be used in addition.

The drug manufacturer chose formoterol in combination with tiotropium bromide (tiotropium for short) as appropriate comparator therapy. In its dossier however, it did not consider the conditions specified by the G-BA for the use of ICS for the inclusion of studies.

Added benefit not proven in most severe symptoms

The manufacturer used a randomized controlled trial (QUANTIFY -- QVA149ADE01) for the direct comparison of indacaterol/glycopyrronium with the comparator therapy: 934 adults with COPD were included in the 6-month study.

Patients who had already received ICS treatment before enrolment continued this treatment. However, apart from a few exceptions, the study participants did not receive this treatment according to the specifications for the appropriate comparator therapy. 41% of the study participants therefore had to be excluded from the assessment. Hence relevant data were only available for a part of the therapeutic indication of indacaterol/glycopyrronium.

No differences in most outcomes

There were no significant differences between the treatment groups with regards to mortality, side effects and quality of life. Hence an added benefit is not proven for these patient-relevant outcomes.

The assessment of COPD symptoms and the associated impairments in daily life conducted on the basis of a questionnaire (COPD Assessment Test, CAT) showed only marginal differences between the 2 study groups. No added benefit of the drug combination can be derived from this.

The proportion of moderate and severe exacerbations in the study participants did not differ between the treatment groups. Adults with COPD grade 3 who were treated with indacaterol/glycopyrronium had marginally fewer moderate exacerbations, but the same number of severe exacerbations as the comparator group. There were no relevant differences between the study groups in COPD grade 2. Hence an added benefit is also not proven for these outcomes.

Fewer breathing difficulties

The Transition Dyspnoea Index (TDI) uses a questionnaire to measure the severity of dyspnoea, the main symptom of COPD. The patient's TDI score at the start of the study served as comparison.

According to the TDI, adults with COPD grade 2 and grade 3 with no more than 2 exacerbations per year who were treated with indacaterol/glycopyrronium had fewer breathing difficulties than patients under treatment with tiotropium and formoterol. A minor added benefit of the new drug combination can be derived from this.

However, the severity of the disease is an effect modifier and may influence the treatment result. Hence overall, in the treatment with indacaterol/glycopyrronium, there is a hint of a minor added benefit for adults with COPD grade 2. For adults with COPD grade 3 with no more than 2 exacerbations per year, there is an indication of a minor added benefit.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Minor added benefit of indacaterol/glycopyrronium in COPD." ScienceDaily. ScienceDaily, 19 February 2014. <www.sciencedaily.com/releases/2014/02/140219102321.htm>.
Institute for Quality and Efficiency in Health Care. (2014, February 19). Minor added benefit of indacaterol/glycopyrronium in COPD. ScienceDaily. Retrieved December 21, 2014 from www.sciencedaily.com/releases/2014/02/140219102321.htm
Institute for Quality and Efficiency in Health Care. "Minor added benefit of indacaterol/glycopyrronium in COPD." ScienceDaily. www.sciencedaily.com/releases/2014/02/140219102321.htm (accessed December 21, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Sunday, December 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
The Best Protein-Filled Foods to Energize You for the New Year

The Best Protein-Filled Foods to Energize You for the New Year

Buzz60 (Dec. 19, 2014) The new year is coming and nothing will energize you more for 2015 than protein-filled foods. Fitness and nutrition expert John Basedow (@JohnBasedow) gives his favorite high protein foods that will help you build muscle, lose fat and have endless energy. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins