The Impact study showed that inhaled steroids reduced the incidence of COPD exacerbation, in contrast to previous studies which suggested that LABA/LAMA combinations (Anoro, Stiolto, Bevespi) reduced exacerbations similar or greater degree. However the study’s findings are not without controversy. Should you prescribe a triple inhaler (Trelegy), or stick with dual LABA/LAMA, or dual LAMA/ICS like Breo, advair? I discuss these issues in our first Pulmonary, Critical Care (PulmCC) Podcast and how Trelegy might fit into the treatment of people with COPD.
“B” is for Bias!
Pity inhaled steroids. Once a favored drug in the treatment of COPD, they were initially advocated to be used in combination LABA’s (long acting beta agonists) to have a “protective” effect against the harms of LABA’s which were,, back in the day, proposed to have existed in the SMART trial. Things of course have change quite a bit since then. The black box warning for combination inhalers has since been dropped. Ironically it’s now the inhaled steroids that we worry about in the treatment of COPD, as mounting evidence implicates inhaled steroids as increasing the risk of pneumonia.
In the most recent GOLD update, steroids have been relegated as add on therapy to LABA for patients with an exacerbation. However GOLD recommends LABA/LAMA combination as preferred due to evidence that the combination reduces exacerbations better than LABA/ICS, as demonstrated in the FLAME trial. In fact ICS is recommended only as add-on therapy to LABA/LAMA in patients who are highly symptomatic and at high risk of exacerbations.
The Impact trial may be changing that. It compared a single inhaler triple therapy LABA/LAMA/ICS to dual combinations of LABA/LAMA and LABA/ICS. Interestingly, and also quite confusingly, the triple therapy group had reduced exacerbations and reduced COPD related hospitalizations. These results are of course in conflict with the results of the Wisdom Trial, which saw no significant difference in the rate of exacerbations between LABA/LAMA combination vs. triple therapy with LAMA/LAMA/ICS. GSK, of course, has wasted no time telling us this, touting the results of their newest inhaler far and wide.
The accompanying editorial of the study does provide some useful insight. In it the authors point out that patients who had a history of asthma were not excluded. Though this likely diluted the study population, I personally have no problem with this fact, as it likely provided a real world picture of what we see in clinical practice, — many patients do in fact have a history of asthma (real or otherwise). In addition, the authors point out that most of the exacerbations in the LAMA/LAMA group occurred in the first month of the study, after they were abruptly taken off steroids. This enrollment process is a marked change from the Wisdom study, where patients were weaned off their inhaled steroids in a stepwise fashion over a course of 18 weeks. Yes, 18 weeks!. Over the subsequent 11 months in IMPACT, the exacerbation rate was similar in the LABA/LAMA vs. the triple therapy groups. They end the editorial with a rather bold “keep moving along, nothing to see here”- type statement, and recommend that nobody change their approach to COPD based on this study.
The authors of the study, of course take quite a different view. They argue that the Flame trial is the one that’s biased, as patients who had to withdraw from ICS and had an exacerbation during the run-in period would not have participated in the trial. In addition, they say, nay ALLEGE, that there were probably patients enrolled in Flame who were not able to tolerate coming off the their ICS during the run in period and therefore intentionally not enrolled.
So it would seem that everyone is pointing their fingers at everyone else and shouting the “B” word. (it’s Bias, the “B” word is Bias).
Looking at the data, it would seem that the editorialists have a point. There does seem to be quite a lot of asthma going on for a COPD study. 18% of patient had significant reversibility seen on pulmonary function testing, and 57% had blood eosinophil levels of greater than 150 cells/microliter. The authors state that reductions in exacerbations were seen at all eosiniphil levels but were greatest for those with eos of more than 150. Detractors of this study will likely state that this study was not a pure COPD population. But perhaps we’re splitting hairs here. Perhaps alot of our COPD patients do have an element of undiagnosed asthma. Or perhaps we just don’t know enough about COPD yet to say whether the thing we called ACOS may be more of a spectrum than a definable condition. For me, I would probably be more careful about withdrawing ICS in stable patients, and at least consider tapering rather than an abrupt withdrawal to make sure that it is tolerated. I would also be checking eosinophil counts more routinely in my COPD patients to see if there is something I might be missing.
May lay in a hospital bed, her wrinkled and mottled skin covered with leads, and sensors that monitored her every breath and heartbeat. A camera that was mounted on the wall allowed a doctor to zoom in closely enough to count her tattered eyelashes. Her husband sat at her bedside, gently stroking her withering gray hair as her chest moved slowly up and down accompanied by the soft whoosh-whoosh of the ventilator that breathed for her. He stared expectantly at her face as if at any moment she would rise and free herself from the myriad tubes that sustained her. Her adult daughters sat and stared blankly at the floor, waiting for something, anything. The streams of data transmitted from her body were monitored closely both by a team in a remote electronic-ICU bunker 50 miles away and her ICU nurse 15 feet away. Yet what May could not have realized was that despite her family’s presence at her bedside and the twenty-four hour care she received, she had been abandoned. She was alone.
Several weeks earlier, May came to the hospital from her nursing home, “yet another pneumonia”, the note in her chart said. “She seems to get one of these every few months” said her husband “can’t we give her something for that?”. The Emergency Room physician explained that she had aspiration, essentially choking on her own food and spit. She would continue to get pneumonia, until she eventually passed away. This wasn’t the first time he had heard this. “They told me before to let her die, but I didn’t listen to them, I told them to treat her anyway, and she made it through. I didn’t give up on her then and I’m not going to now”, adding “she’s a fighter”. Her husband Daniels countenance was such that the Emergency physician admitting May to the hospital didn’t bother asking whether his wife should be resuscitated in the event her heart or lungs stopped working and she needed to be put on life support. May was admitted to the general medical ward, and was started on antibiotics, but she eventually got worse. Sometime in the middle of the night a nurse found her ashen and struggling to breathe, and called a “code blue”. May’s breathing had gotten so bad that she needed life support, she had a tube put down her trachea and was taken to the ICU where she was put on a ventilator.
Doctors worked on her for more than a week, treating her pneumonia with powerful antibiotics. But even as her pneumonia cleared, her body withered. Her skin hung from her bones as her muscles wasted away, her eyes hollowed, and the skin of her arms filled with bruises as nurses struggled to find a place from which to draw blood. On the second Sunday of her ICU stay, the doctors tried a “trial extubation”. As the family understood it, her lungs had improved to the point that she might be able to be taken off the ventilator, but her body was now so weak, they did not know whether she would actually be able to breathe on her own. If she had to be put back on the ventilator, the doctors told them, she would require a tracheostomy that would allow her to live on the ventilator long term. The social worker would then seek placement in a long term facility for patients on long term ventilators, essentially a hybrid hospital, rehab, and nursing home in one. Her breathing failed within minutes of being taken off the ventilator, and she was immediately put back on life support.
It was the following day, Monday morning, that I met with May’s family to discuss what had happened the day before, it was the beginning of my ICU week. For May and her family it was the beginning of their third week in the ICU, and it showed. Her husband, Daniel looked unkept, his thick shock of gray hair was whirled and tangled, his flannel shirt partly tucked into ripped and stained jeans. He gave the impression of someone who had not been taking care of himself, let alone someone who could take care of his chronically ill wife. His visage upon seeing me betrayed both surprise and regret as he recognized me from four months earlier. I was the doctor who told him that May was going to die. Continue reading “Not Dead but Not Alive; The terminally unhealed languish in America’s hospitals.”
Study Shows That Bariatric Surgery Reduced COPD Exacerbations by More Than Half
I often tell my patients with COPD that quitting smoking can have a greater effect on their respiratory health than any inhaler that I could prescribe them. Should I now also extend that advice to include weight loss for obese patients with COPD? In this journal CHEST® study, researchers used registry data to look at COPD exacerbations for patients both before and after bariatric surgery. In the year before bariatric surgery, risk of COPD exacerbations was 31%. Looking at the rate of COPD exacerbations during the year after bariatric surgery, that rate dropped to 12%, an astounding change.
The accompanying editorial proposes mechanisms explaining why this might be so and postulates whether obesity could be a modifiable risk factor in COPD. While these results are certainly exciting, we look forward to future investigation into whether bariatric surgery, or other weight loss means, could further help reduce risk of COPD exacerbation.
Pneumonia: If You Can’t See It, Does It Still Exist?
The diagnosis of pneumonia requires the radiographic presence of infiltrates on imaging. However, with its greater resolution, CT scanning can often demonstrate infiltrates when none are seen on chest roentgenogram. Do we treat these the same as a regular pneumonia? This study sought to quantify differences between patients with pneumonia as seen on a chest radiograph vs CT scanning. The differences between the two groups appeared to be minor, with procalcitonin levels appearing to be lower in the CT group. Otherwise, it would appear that patients with pneumonia seen only on CT scanning should be managed like other groups.
The accompanying editorial raises the question of what to do with patients who are suspected of pneumonia but have negative chest radiographs. Certainly, exposing them all to CT scanning can’t be the right answer. Perhaps we should err on the side of caution and treat these patients for pneumonia when clinical suspicion is high. Conversely, we should consider CT scanning in this group only if suspicion is low and the presence of an infiltrate would change management. Continue reading “Pulmonary Medicine Update: Bariatric surgery for COPD exacerbations & The Mortality Indicator that Won’t Die.”
When you live in Tobacco Road region of North Carolina, the local news tends to focus on 3 things; Duke basketball, UNC basketball, and Duke vs.UNC basketball. So it was a little surprising to see in the front page of my local paper that my own county is joining a lawsuit against three of the nation’s largest opioid distributors.
Perhaps I shouldn’t have been surprised, given the scope of the opioid epidemic. Opioid related deaths have topped 40,000 in recent years. The drug overdose death rate in in my home state of North Carolina jumped by nearly 24.7% from 2015 to 2016 and area hospitals including my own ICU can certainly attest to this.
Multiple state and county governments are joining lawsuits against opioid manufacturers and distributors to recoup costs which they allege were due to the crisis the companies helped create. And in a bit of sweet, sweet irony, even JCAHO (aka Joint Commission) a not-for profit entity responsible for
antagonizing accrediting health care organizations is getting sued. I can tell you that no doctor will shed a tear over that one. Continue reading “Opioid lawsuit: We’ve seen this before, and it didn’t go well.”
Hospitals run short of critical medications after loss of production in Puerto Rico facilities.
“Doc, you mind switching that to an oral preparation?”, our clinical pharmacist inquired during multi-disciplinary rounds as intravenous infusion devices beeped annoyingly in the background. Taking care of ICU patients can be extraordinarily complicated, so doing it as part of a team helps make sure that all bases are covered. ICU’s like ours have a BEEP BEEP BEEP. Excuse me, for a moment, Staci, can you get that thing to stop, please? BEEP, BEEP, BEE– Thanks, Staci!. As I was saying, like many hospitals, ours uses a multidisciplinary model which makes rounds on all patients in the ICU. An ICU nurse, clinical pharmacist, dietitian, social worker, pastoral care, respiratory therapist, each provides important insight and perspective that guides patient care in the right direction.
As a pulmonary, critical care doc, I’m lucky to have a great team, so my ears perked up when I heard the suggestion. This was now the third patient he had made a suggestion to switch a medication to the oral route from the intravenous route. “What gives, Scott?” Over the past few years, we’ve been experiencing alot of spot medication shortages either because of inadequate supply, or because of precipitous price increases; we can usually change to an alternative. But today was different. Today we were switching a number of different medications, all of which were intravenous to oral formulations of the same or similar medicines.
“It’s not the medicines,” he replied, “It’s the bags they’re in”. Continue reading “Devastation in Puerto Rico leads to hospital shortages in U.S.”
If you’re reading this, chances are that you are familiar with EPIC EMR, as well my ongoing love/hate thing with EMR’s since I first started writing about them a few years ago.
If you recall, I called most early EMR systems “overpriced, sub-standard, half-baked systems designed by polytech school dropouts”. Ok, so maybe that was a bit harsh. Continue reading “EMR Review: Epic EMR 2017”
When I worked as a physician in Michigan, I had been recorded by patients several times during their visits. Some of them asked for permission, but in most cases I was only informed by one of my staff after the fact. Continue reading “Can I record my doctor without permission? Not in these 11 states.”
Republicans have been waiting a long time for this moment. They have tried, time and again, (and again and again!) to repeal Obamacare. Now at long last, after sixty previous attempts to overturn the Affordable Care Act, commonly known as Obamacare, their moment has arrived. Continue reading “7 Reasons Why President Trump Can’t Repeal Obamacare.”