Triple Therapy – Trelegy Ellipta – Inhaler Approved for COPD

FDA Approves Trelegy Ellipta Dry Powder Inhaler

Background: Over the past several years, the United States Food and Drug Administration has approved numerous combination inhalers – two medications in a single inhaler for patients with COPD. These combinations include short-acting bronchodilators, four different long-acting bronchodilators, and three different long-acting bronchodilators along with an inhaled corticosteroid.

Combination inhalers are more convenient for patients than using two different inhalers. Also, there is only one co-pay with a single combination inhaler compared to two separate inhalers.

Announcement: On September 18, 2017, the FDA announced approval of a once-daily single inhaler triple therapy – three medicines in one – the brand name is Trelegy Ellipta.

FDA approves triple therapy - Trelegy Ellipta

Trelegy Ellipta dry powder inahler

This triple therapy inhaler consists of three medications that are approved in two different inhalers: 1. umeclidinium – muscarinic antagonist bronchodilator (brand name: Incruse); and 2. vilanterol (a beta2 agonist bronchodilator) combined with fluticasone furoate (an inhaled corticosteroid) (brand name: Breo).  

Indications: The press release states that the FDA approves triple therapy inhaler – Trelegy Ellipta – for the “long-term, once-daily, maintenance treatment of patients with COPD” who are: 1. already taking vilanterol and fluticasone furoate (Breo Ellipta) in whom additional bronchodilation is desired; OR 2. Those currently taking both Incruse and Breo Ellipta inhalers.

Trelegy Ellipta is not indicated for the treatment of those with asthma.

The press release also stated that the medication “will be available in the US shortly.”

European Medicines Agency (EMA): On September 15, 2017, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for Trelegy Ellipta – the same triple therapy inhaler approved by the FDA. 

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Frailty in Elderly with COPD is Related to Shortness of Breath and Frequent Flare-ups

Frailty in Elderly with COPD is Common (10%)   

Background: Those with COPD often have other medical conditions (called co-morbidities) that include heart disease, muscle weakness and wasting, weight loss, arthritis, and low red blood cells (anemia). Both COPD and these other conditions can contribute to a frail status – defined as a generalized loss of physical abilities. The five important features are nutritional status, physical activity, mobility, strength, and energy.

Frailty is common in the general elderly population, but is unknown in the elderly with COPD.

Study: Dr. Lahousse and colleagues working at the Ghent University Hospital examined residents living in Rotterdam, The Netherlands, who agreed to be tested every 3-5 years. Frailty was defined as someone meeting 3 or more of the following 5 conditions: weight loss of more 5% compared with previous visit; low physical activity (less than 383 kcal per week for men and less than 270 kcal per week for women); slow walking pace; reduced grip strength; and self-reported exhaustion “frequently” or “mostly.” The study results were published in the Journals of Gerontology, Series A, Biological Sciences and Medical Sciences, 2016, volume 71, pages 689-695.

Results: There were 2,142 subjects 65 years of age or older. 100 of these were considered frail and was more common in those with COPD (10%) compared to those without COPD (3%). It was greatest in those who had severe obstruction on breathing tests, more shortness of breath, and frequent flare-ups (exacerbations). Subjects with COPD who were frail had worse survival.

Frailty in COPD

Results of Frailty and Non-frailty Based on Severity of COPD

Conclusions: COPD is associated with frailty even after adjusting for various risk factors.

My Comments: Treatment of those who are frail requires a multidisciplinary approach to deal with many factors including possible associated anxiety and depression. Whenever possible, physical therapy and/or pulmonary rehabilitation should be offered to the individual.

Reduction in Opioids for Pain: Could This Make My Breathing Worse?

Reduction in Opioids and Breathing is Worse

Dear Dr. Mahler:

I have COPD-my Dr. has taken me completely off the Fentanyl patch which I used for years – I have several issues that cause me a lot of pain. I have also been on Vicodin – 8 each day. They are now cutting back on it.
My problem is my breathing has worsened and I have had increased breathing exacerbations with these cut backs. Do you think there could be a connection?
Do you have any suggestions for me? Between the pain and breathing issues my quality of life is bad and I am depressed that I can’t do the things I used to. I use the Stiolto Respimat and Albulterol when I have a bad breathing situation.
Would really appreciate if you would have any suggestions for me. THANK YOU.

Sandra from Little Rock, AK

Dear Sandra:

Your experience is not unusual.

opium poppy is source of natural opiods

Opium poppy

Both fentanyl and vicodin are opioids that act on receptors in the body to relieve pain. Opioids include opiates that found in the resin of the opium poppy (incluidng morphine) as well as medications made in laboratories that are called synthetic drugs. These include fentanyl and vicodin [hydrocodone and acetaminophin (brand name is tylenol)] which you are or were taking.

Opioids are also helpful to relieve shortness of breath. Usually, they are used for those with advanced disease for palliation. It is quite possible that your worsening in breathing is related to the reduction in opioids. Remember that opioids may cause side effects including tiredness, low energy, sleepiness, and constipation.

water exercise may help shortness of breath due to reduction in opioids

Seniors doing Water Aerobics

exercise may help with shortness of breath due to reduction in opioids

Man pedaling stationary cycle being supervised by rehabilitation specialist.

Could the combination of your COPD and use of fentanyl/vicodin led to an inactive life style? If so, is it possible for you to do more activities to improve your breathing, or does your pain limit activity level? Is participation in a pulmonary rehabilitation program a possibility for you? Are water activities possible with your pain problem?

Another question that I have relates to your report of exacerbations with reduction in opioids. Are you experiencing chest congestion and coughing up yellow or green mucus with these episodes? If so, I suggest that you ask your doctor to check for bronchiectasis (see post on April 21, 2017, under COPD News) and acquired immunodeficiency (see post on November 23, 2016, under COPD News). Both of these conditions may lead to frequent flare-ups.

Finally, you may wish to ask your doctor about starting an inhaled corticosteroid medication to help reduce the risk of future flare-ups. Your current use of Stiolto Respimat as a maintenance medication is excellent as it contains two different types of long-acting bronchodilators. The 2017 GOLD recommendations suggest that an inhaled cortiosteroid be added to a medication like Stiolto if you continue to experience exacerbations.

I hope this information is helpful. Best wishes,

Donald A. Mahler, M.D.

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.


Primary Care Providers’ Knowledge and Beliefs about COPD

Survey of 426 Primary Care Providers about COPD

Background: Primary care physicians, nurse practitioners, and physician assistants provide the majority of care for those who have COPD. Thus, it is important to ask these primary care providers about their overall knowledge and beliefs about diagnosis and treatment of COPD.

Dr. Barbara Yawn of the Olmstead Medical Center in Rochester, MN

Dr. Barbara Yawn of the Olmstead Medical Center in Rochester, MN

Study: Barbara Yawn, MD, MSc, and colleagues at the Olmstead Medical Center in Rochester, MN, surveyed 426 primary care providers at 3 different medical meetings in 2013 and 2014. The survey asked questions about perceived barriers to diagnosis of COPD and beliefs concerning the value of available COPD medications. The findings were published in the August 2016 issue of the Journal of the COPD Foundation (volume 3; pages 628-635).

Results: Of the 426 people who answered the questions on the survey, there were 278 medical doctors (MDs) and doctors of osteopathic medicine (DOs) and 148 nurse practioners (NPs) and physician assistants (PAs). 

The two most common barriers to making a diagnosis of COPD were: ♦ patients had many chronic medical conditions, not just COPD; and ♦ patients often failed to recognize and report breathing difficulty. These barriers were similar between MDs/DOs and NPs/PAs.

Woman performing breathing test.

Woman performing breathing test (spirometry).

About one-half of the clinicians said that they had equipment (spirometry) in their office, but less than 2/3 reported using testing to diagnose COPD.

Only 10% of those answering the survey reported ordering blood tests (screening) for alpha-1 antitrypsin deficieny, a hereditary form of emphysema.

About 75% said that there were available treatments to reduce shortness of breath, and 85% answered that medications for COPD could reduce exacerbations (flare-ups) of COPD. Some of these medications are shown below.

Examples of dry-powder inhalers

Examples of dry-powder inhalers

Conclusions: Primary care providers continue to report multiple barriers to diagnose COPD including easy access to testing equipment. However, most respondents noted that effective medications were available to improve breathing difficulty and to reduce the risk of a flare-up.

My Comments: In the past, many primary care providers felt that diagnosing those with COPD was not important because: COPD was self-inflicted by smoking; and treatments for COPD were not generally effective.

This survey shows that knowledge and attitudes among primary care providers have changed. Primary care providers do not need to have testing equipment (spirometers) in their offices, but instead can refer patients for testing at the local hospital.

If you have told that you have COPD and have not had breathing tests, ask your health care provider to order testing. Ask about what treatments are available to “make it easier to breathe.” BE PROACTIVE.