Trelegy Ellipta: Is There Any Downside To Taking All Three Medications Together?

Is There Any Downside to Taking Trelegy Ellipta?

Dear Dr. Mahler:

I read your recent post and have heard of Ellipta, though now Trelegy may be one step newer…
Is there any downside to taking all these helpers at once?
I was thinking, although it is more to do in a day, that keeping them separate might be a good thing.  More effect from each on their own?
Maybe not!
Thanks.

Katherine from Greensboro, NC

Dear Katherine:

Thanks for commenting on my recent post about a new 3-in-1 approved inhaler by the Food and Drug Administration (FDA) for those with COPD on September 18.

Please note that this single inhaler contains three different medications for treatment of those with COPD. These medications are already combined together and are available. These are Anoro Ellipta (different bronchodilators – vilanterol and umeclidinium) and Breo Ellipta (a bronchodilator – vilanterol – and an inhaled corticosteroid – fluticasone). So, the pharmaceutical company, GlaxoSmithKline, combined all three medications together in a dry powder inhaler called Trelegy Ellipta. They performed various studies (called randomized clinical trials) as required by the Food and Drug Administration. The company then submitted the results to the FDA for review and consideration of approval.

Although it may seem confusing, the different Ellipta inhalers along with numerous other inhalers developed by other pharmaceutical companies provide many options for health care providers to hopefully make it easier for you to breathe with activities and to reduce the chances of having a flare-up (called exacerbation). These treatment strategies are provided by the a group of experts in COPD called the GOLD committee.

You asked about a downside to taking all three medications together. Please note that current recommendations for the use of inhaled corticosteroids in treating those with COPD is for those individuals who have had 2 flare-ups (exacerbations) in the past one year OR one flare-up that was “bad enough” to require hospitalization. The reason for this recommendation is that inhaled corticosteroids can have side effects. The most concerning is an increased risk of pneumonia. Other possible side effects include a yeast infection in the throat, bruising of the skin, and thinning of the bones (called osteoporosis).

As with all medications, your health care provider should consider the likely benefits of the medications along with possible side effects. Some people call this “weighing the balance.”

A scale to weigh the benefits and risks of Trelegy Ellipta

A scale represents weighing the benefits and risks of a medication

 

I hope that this information is helpful. I encourage you to discuss the available inhalers with your health care professional.

Best wishes,

Donald A. Mahler, M.D.

What is Triple Therapy? My Doctor has Mentioned This to Me

Triple Therapy: What Is It? What are the Benefits?

Dear Dr. Mahler:

I am curious about “triple therapy.” My doctor suggested this to me at my last visit, but said that he wanted to read more about the results of studies.

 My doctor has told me that my COPD is severe. Last winter I had a flare-up and had to be hospitalized.  I am doing fine now, taking Spiriva HandiHaler and Serevent Diskus. What are your thoughts?

Jeff from Wilmington, NY 

Dear Jeff,

“Triple therapy” refers to three different inhaled medications to treat COPD. Two are bronchodilators, and the other is an inhaled corticosteroid.

You state that you are currently taking a long-acting beta agonist – Serevent Diskus – twice a day – and a long-acting muscarinic antagonist – Spiriva HandiHaler – once a day in the morning. These dry powder bronchodilators act in different ways to open the breathing tubes by relaxing the muscle that wraps around the airways.

Serevent is one component of triple therapy

Serevent Diskus dry powder inhaler

Spiriva is one component of triple therapy

Spiriva HandiHaler dry powder inhaler

 

 

 

 

 

 

Inhaled corticosteroids are a different type of medication used to treat COPD. It is anti-inflammatory – that means it reduces redness and swelling inside of the breathing tubes.

At the present time, two different inhalers need to be used to provide “triple therapy.” According to an international group of experts in COPD called GOLD, triple therapy should be used in those patients who are short of breath with walking on the level and have had 2 or more flare-ups (called exacerbations) or one requiring hospitalization in the past year.

Pharmaceutical companies are working on putting all three types of medications – beta-agonist bronchodilator, muscarinic antagonist bronchodilator, and corticosteroid – into one inhaler. This is also called “closed triple therapy” because all medication are “closed” within one device.

Currently, the Food and Drug Administration (FDA) is reviewing a proposed “closed triple therapy” inhaler for us in the US. At the present, “triple therapy” requires use of two different inhalers.

David Lipson, MD, is first author of article on Triple therapy

David A. Lipson, M.D., of Perelman School of Medicine in Philadelphia

In the August 15, 2017, issue of the American Journal of Respiratory and Critical Care Medicine (volume 196; pages 438-446), Dr. Lipson and colleagues published one of the first reports of triple therapy in one inhaler. It is called the FULFIL study. The 3-in-1 inhaler was compared with twice daily beta-agonist and inhaled corticosteroid for 24 weeks in a total of 1,810 patients with COPD. Triple therapy showed greater improvements in breathing tests and in quality of life scores along with a 35% reduction in flare-ups compared with dual therapy. The safety was similar between the two inhaled medications.

Once again, triple therapy is recommended for those who are symptomatic (short of breath walking on the level) and are at risk for a flare-up (exacerbation) based on 2 episodes in the past year or one leading to hospitalization.

Sincerely,

Donald A. Mahler, M.D.

Bronchiectasis Can Cause Frequent COPD Flare-ups

Bronchiectasis Is Linked to Increased Risk of a COPD Exacerbation

Background: Bronchiectasis is a chronic condition in which the walls of the breathing tubes are thickened from long-term inflammation and scarring. Typically, bronchiectasis is a result of a pneumonia which damages parts of the lung. As a result of the damage, mucus produced by the cells lining the breathing tubes does not drain normally. Mucus build-up can lead to a chronic infection. A cycle of inflammation and infection can develop, leading to loss of lung function over time.

CT scan shows cystic bronchiectasis

A slice of the chest on a high-resolution CT scan in a 62 year old with cystic bronchiectasis. The cysts are seen on the lower portions of both lungs.

Different types of bacteria and mycobacteria can infect the damaged areas of the lung causing:

  1. chronic coughing
  2. coughing up blood
  3. shortness of breath
  4. chest pain
  5. coughing up large amounts of mucus daily
  6. weight loss
  7. fatigue
  8. thickening of the skin under the finger nails and toes (called clubbing)

Poster Presention at CHEST meeting October 25, 2016, in Los Angeles: Dr. Kosmas of the Metropolitan Hospital in Piraeus, Greece, presented findings in 855 individuals with COPD 

42% of the patients were found to have evidence of bronchiectasis on CT scan of the chest. About 20% had experienced more than one flare-up (exacerbation) of COPD in previous year. The investigators also found that the severity of COPD predicted the increased likelihood that a person would have bronchiectasis.

Dr. Kosmas commented at the poster presentation that, “Bronchiectasis is an area in the lung that is destroyed by pneumonia, and bacteria reside there. It results in a low-grade infection, and can then lead to inflammation and an exacerbation.”

My Comments: The symptoms of bronchiectasis usually start off as mild with a persistent cough that produces yellow or green mucus. An antibiotic may help to clear up the mucus, but typically the yellow or green color returns after a few weeks.

A CT scan of the chest is important to diagnose this condition. Then, a fresh sample of the mucus should be obtained to send to the laboratory to identify the specific type of infection (sputum culture). Different blood tests should also be ordered to look for possible medical conditions that may contribute to bronchiectasis (for example, cystic fibrosis, immunodeficiency, HIV infection, alpha-1 antitrypsin deficiency, rheumatoid arthritis, and inflammatory bowed disease).

If you experience frequent chest infections, or continue to cough up yellow-green mucus persistently, ask you health care provider to consider bronchiectasis.

Health Coaching Reduced COPD-related Hospitalizations

Study Shows Benefits of Health Coaching Plus a Written Action Plan

Background: There is considerable attention focused on preventing hospital readmissions for COPD. One factor is that hospitals are penalized by lower reimbursement for services if there is a high readmission rate.

first author of study evaluating health coaching

Dr., Roberto Benzo of the Mayo Clinic.

Study: Dr. Roberto Benzo and colleagues at the Mayo Clinic in Rochester, MN, studied a total of 215 patients hospitalized for a COPD flare-up (called an exacerbation). At discharge from the hospital, one-half were assigned to health coaching and a written action plan for any flare-up OR usual care. 

The health coach met with each patient in the hospital for 2 hours and at least once in person after discharge. At the first visit, the patient was provided with prednisone and an antibiotic to be started if the individual experienced a flare-up. Also, during the visit self-management concepts, goal setting, action planning, and details of the telephone sessions to come were discussed. All subsequent sessions were conducted by telephone.

The study was published in the September 15, 2016, issue of the American Journal of Respiratory and Critical Care Medicine (volume 194; pages 671-680).

Health coach aims for healthy lives.

A health coach can help someone achieve a healthy life.

Results: There was a significant reduction in hospital readmissions at 6 months, but not at one year, in the group who received health coaching compared with usual care. The health coaching group also had better quality of life than the usual care group. 

Conclusions: The authors concluded that their study was the first to show the benefits of “a feasible, innovative, and effective intervention designed to reduce short-term readmissions for those with COPD.”

My Comments: Health coaching is popular in managed care and accountable care organizations (ACOs) in an effort to improve care and to reduce costs. Health coaching is patient-centered, individualized, and aimed at improving health behaviors. For those with COPD, a health coach may assist the individual with quitting smoking, increasing physical activity, and starting early treatment for a flare-up. Whether health coaches will become an integral part of medical practices in the future is unknown.