A comprehensive telehealth program delivered to rural patients with poorly controlled type 2 diabetes (T2D) resulted in a reduction in A1c levels at 6 months, according to research presented at the American Diabetes Association’s 80th Virtual Scientific Sessions

The improvement—a 1.36% reduction in A1c—was maintained up to 18 months after the program initiation.

Diabetes management in rural areas is problematic because of limited access to specialists as well as to self-management programs. Under an award form the Veterans Administration (VA) Office of Rural Health--Iowa City, researchers designed an intensive diabetes management program called the 

Advanced Comprehensive Diabetes Care (ACDC)

The program was specifically designed for delivery using the existing Veterans Health Administration’s Home Telehealth (VHA HT) infrastructure and clinical staff.

The 6-month telehealth intervention combines telemonitoring with module-based self-management support and medication management.

Existing clinical staff with VHA HT delivered ACDC through bi-monthly half-hour calls. In an 

, researchers found that ACDC improved A1c, blood pressure, and diabetes self-care in the initial 50 veterans who participated. Since 2017, ACDC has been implemented in clinical practice at 7 VHA sites around the country that serve rural veterans.

The most recent analysis examined 125 patients receiving ACDC at 5 sites. Across all locations, patients’ average A1c levels improved from 9.25% at baseline to 7.89% at 6 months, a benefit that largely persisted 18 months after the start of the study. On qualitative analyses, ACDC enhanced patient engagement and awareness of diabetes control.

“We are pleased to see that the intervention was well-suited for delivery in clinical practice and that it remained effective in real-world settings,” said Elizabeth Kobe, a study investigator and MD candidate at Duke University Medical School.

“When telehealth interventions are designed to leverage existing resources, they can greatly improve diabetes care in underserved rural populations. We also believe this design-minded approach can extend to other chronic diseases.”

Articles

ADA 2020. Improvement in glycemic control among US veterans was seen across 5 study sites and was sustained at 18 months after study initiation, says study reported at the ADA 80th Virtual Scientific Sessions. 

Intensive Telehealth Program Improves A1c In Rural Patients with Type 2 Diabetes 

A novel once-weekly basal insulin analog demonstrated comparable efficacy and safety vs once-daily insulin glargine U100 (IGlar U100) in insulin-naïve type 2 diabetes (T2D) poorly controlled on oral antidiabetes drugs (OADs), according to 

 on Sunday, June 14, 2020, at the 80th Annual American Diabetes Association Virtual Scientific Sessions

In the 26-week, randomized, double-blind, double-dummy, treat-to-target, phase 2 trial, participants (n = 247) were randomized 1:1 to the investigational insulin icodec (icodec; n = 125) or to IGlar U100 (n = 122). At baseline, patients were inadequately controlled (A1c 7.0-9.5%) with metformin with or without a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Starting doses were icodec 70 U weekly and IGlar U100 10 U daily, with weekly titration to a pre-breakfast self-monitored blood glucose (SMBG) target of 70-108 mg/dL. 

Baseline characteristics appeared similar in both groups; mean age was 59.6 years, diabetes duration 9.7 years, BMI 31.3 kg/m2 and fasting plasma glucose (FPG) 181 mg/dL. Mean baseline A1C was 8.1% for the icodec group and 8.0% for the IGlar U100 group.

The primary endpoint was change in A1c from baseline to week 26 and secondary endpoints included change in FPG from baseline to week 26 and hypoglycemic episodes.

At week 26, estimated mean A1c was 6.69% for icodec and 6.87% for IGlar U100 (estimated mean change from baseline: -1.33% and -1.15%-points, respectively).

There was no statistically significant treatment difference for change in A1c from baseline to week 26 (-0.18%, 95% CI, -0.38; 0.02).

Estimated mean FPG at week 26 was 123 mg/dL (icodec) and 127 mg/dL (IGlar U100).

Observed rates of level 2 (<54 mg/dL) + 3 (severe) hypoglycemia were low (60.55 and 52.36 events per 100 patient years of exposure for icodec and IGlar U100, respectively) and were comparable (

There were no unexpected safety findings.

Insulin icodec is the first once-weekly insulin with similar glucose-lowering effects and safety profile to once-daily IGlar U100. Study authors note that icodec could improve treatment acceptance and facilitate T2D management in patients needing basal insulin.

____________________________________________________________

Dapagliflozin Reduces Incident T2D in Patients with HFrEF

Next Generation "Artificial Pancreas" Improves Glycemic Control, A1c in T1D

SGLT-2 Inhitibor Delays Insulin Initiation, Intensification in T2D with CVD

ADA 2020. An investigational once-weekly insulin proved comparable in safety and efficacy to traditional once-daily insulin glargine in findings presented at the ADA 80th Annual Virtual Scientific Sessions.  

Novel Once-weekly Basal Insulin Found Comparable to QD Insulin Glargine

— The SGLT2 inhibitor dapagliflozin prevented incident type 2 diabetes (T2D) in patients with heart failure (HF), according to results of the study titled “Effect o

f dapagliflozin on the incidence of diabetes: A prespecified exploratory analysis from DAPA-HF,"

 presented today at the American Diabetes Association’s80th Virtual Scientific Sessions.

 was a phase 3 placebo-controlled international study of dapagliflozin (Farxiga, AstraZeneca) in people with chronic heart failure and a reduced ejection fraction (HFrEF). The trial enrolled people both with and without T2D. The 4,774 study participants, average age 66 years, were randomly assigned to take either 10 mg of dapagliflozin or a placebo once daily and were followed for 18.2 months. 


The study found the risk of worsening HF or death from cardiovascular causes was lower among patients treated with dapagliflozin than those who received the placebo, regardless of the presence or absence of T2D.

The current planned analysis assessed whether dapagliflozin reduced the incidence of T2D in the 2,605 trial participants who did not have T2D when the study began.

Of the participants without T2D, 1,298 had been assigned to the dapagliflozin group, and 1,307 to the placebo group. New-onset T2D was defined as A1c ≥ 6.5% on two consecutive study visits throughout the median 18.2-month follow-up.

A total of 157 participants developed T2D, 150 of whom had prediabetes (A1c 5.7-6.4%) at the beginning of the study.


The people who developed T2D had higher average A1c levels, greater body mass index and lower eGFR at the beginning of the study than those who did not develop diabetes. 


Cox proportional hazards model data showed dapagliflozin reduced new-onset diabetes by 32%, with 4.9% of dapagliflozin patients (64 of 1,298) developing T2D, compared to 7.1% (93 of 1,307) in the placebo group.

In an additional exploratory analysis, those patients who did develop diabetes during the trial experienced a 70% increase in mortality, after adjustments for baseline features.


“Our sub-study within the DAPA-HF trial demonstrates that diabetes prevention could be considered an additional benefit of dapagliflozin, whose main effect, of course is to reduce cardiovascular mortality and worsening heart failure in patients with heart failure and reduced ejection fraction,” said Silvio Inzucchi, MD, lead investigator and professor of medicine at the Yale University School of Medicine.

“The 32% relative risk reduction compares favorably with the 31% reduction with metformin, as reported in the Diabetes Prevention Program. We will need to do more studies to see if this effect extends to patients without heart failure and reduced ejection fraction and to evaluate how durable the benefit might be and how long diabetes prevention persists after the discontinuation of therapy.”

ADA 2020. Dapagliflozin reduced new onset type 2 diabetes in patients with heart failure with reduced ejection fraction, according to a study released today at the ADA 80th Virtual Scientific Sessions. 

Empagliflozin significantly and durably reduces the need for insulin initiation and the need for large dose increases in current insulin users with type 2 diabetes (T2D), according to 

 Friday, June 12, 2020 at the American Diabetes Association’s® Virtual 80th Scientific Sessions.

Delay to initiation of insulin was longer among those recently diagnosed.

Insulin use in treatment of T2D is associated with weight gain and hypoglycemia, requires training and education, can be costly, and increases daily disease management burden, state Muthiah Vaduganathan, MD, MPH, and colleagues in the study abstract. They note that "reducing insulin need is attractive to both patients and practitioners."

, 7020 patients with type 2 diabetes at high cardiovascular risk were treated with the sodium-glucose co-transporter-2 inhibitor empagliflozin 10, 25 mg, or placebo against a background of standard care. Median follow-up was 3.1 years.

After the first 12 weeks, changes in background glucose-lowering therapy were permitted.

Researchers assessed treatment effects of pooled empagliflozin vs placebo on time to new initiation of insulin among insulin-naïve patients and time to total daily insulin dose increase by >20% among insulin-treated patients.

In 3633 (52%) insulin-naïve patients, empagliflozin reduced the need for insulin use vs placebo by 54% (11.1% vs. 22.3%; HR 0.46 [0.39-0.54]), adjusted for key covariates (baseline A1c, time since T2D diagnosis, BMI, eGFR, geographic region and treatment status) .

In 3387 (48%) patients using insulin at baseline, empagliflozin reduced need for a >20% increase in insulin dose by 57% (19.1% vs. 36.8%; HR 0.43 [0.37-0.49]).

Reduction in incident insulin use was most pronounced in patients within 5 years of T2D diagnosis (HR 0.31 [0.21-0.45]) vs T2D duration of >5-10 yrs (0.42 [0.31-0.59]) or >10 yrs (0.56 [0.44-0.71); P interaction=0.03. 

In patients with T2D and CVD, empagliflozin markedly and durably delays the need for insulin initiation, more so in those recently diagnosed, and reduces need for large dose increases in those already using insulin.

EMPA-REG OUTCOME was an FDA-mandated trial to assess the cardiovascular safety of all new diabetes drugs. Results of the trial, first reported in November 2015, indicated that empagliflozin was superior to placebo in improving glycemic control and reducing CV events in patients with T2D and established CVD.

ADA2020: Empagliflozin significantly, durably delays need for insulin and for large dose increases, in patients with type 2 diabetes and cardiovascular disease, finds study presented at ADA 80th Scientific Sessions. 

ADA2020: SGLT-2 Inhibitor Delays Insulin Initiation, Intensification in T2D with CVD

CHICAGO (June 12, 2020)—A “next generation” automatic insulin delivery system (AID) improved daytime blood sugar control and improved A1c levels among adolescents and young adults with type 1 diabetes (T1D) without an increase hypoglycemia, according to research presented today at the American Diabetes Association’s® (ADA’s) 80th Scientific Sessions.

The results of this first comparison of a next generation AID system to a currently approved one were shared during the presentation, “FLAIR—An NIDDK-sponsored international, multi-site randomized crossover trial of AHCL vs 670G.”

Despite the use of multiple daily injections or insulin pumps and continuous glucose monitoring (CGM), many individuals with T1D require additional glycemic control—but without increasing the daily burden of living with diabetes.

Youth with T1D in particular often have difficulty achieving optimal glycemic control, which is essential to help reduce the risk for diabetes complications

AID systems—sometimes referred to as artificial pancreas—are rapidly becoming a standard of care in the management of T1D. The 

 (Fuzzy Logic Automated Insulin Regulation) study compared the efficacy and safety of 2 systems manufactured by Medtronic—the new Advanced Hybrid Closed-Loop (AHCL) and the 670GHybrid Closed-Loop (HCL). The latter is one of 2 FDA-approved AID systems

FLAIR enrolled 113 patients with T1D at 7 international diabetes centers. The participants, aged 14 to 29 years, used each AID system for 3 months in a randomized crossover trial.

Standardized pump training, including how to account for meals and exercise, was provided to all participants and their diabetes care partners.

Focusing on the biggest challenge for AID systems--how effective they are at preventing high blood glucose levels during the day--the researchers compared the 2 systems and evaluated how participants adjusted to the daily use of the technology.

•  Percentage of time in range (TIR) over 24 hours (ie, blood sugar levels from 70-180 mg/dL) was superior with AHCL vs HCL. TIR went from 57% at baseline to 67% (AHCL) and 63% (HCL).

•  The number of individuals achieving the international TIR consensus target of > 70% TIR increased nearly 3-fold from baseline when using AHCL vs increasing almost 2-fold with HCL.

•  Baseline average A1c levels were 7.9% and A1c decreased to 7.4% with AHCL vs 7.6% with HCL.

•  Both systems were safe when evaluating events of level 3 hypoglycemia or diabetic ketoacidosis.

•  Responses to a user satisfaction survey showed patients preferred the AHCL over the HCL system.

“This age group has traditionally been the most difficult group in which to optimize glucose management and the FLAIR study shows that individuals using any type of therapy, even insulin injections without a pump or CGM system, can benefit from the next generation AHCL AID therapy,” said Richard Bergenstal, MD, co-primary investigator of FLAIR, executive director of the International Diabetes Center at HealthPartners, and past ADA President of Medicine & Science, in an ADA press release.

“There is much interest in the future of advanced technology to treat type 1 diabetes," he added, "and the AHCL system is a significant step forward for adolescents or young adults who have a hard time managing their glucose levels.”

ADA 2020: A new automatic insulin delivery system improves glycemic control in young people with type 1 diabetes, according to research presented at the American Diabetes Association Virtual Scientific Sessions. 

ADA: Next Generation “Artificial Pancreas” Improves Glycemic Control, A1c in T1D

The American Diabetes Association took advantage of the time between April 3, 2020, when it cancelled the live 

, originally scheduled for Chicago's McCormick Place, and the meeting's opening day which was--and still is--Friday, June 12, 2020.

The Virtual 80th Scientific Sessions will feature the entire program planned before the COVID-19 pandemic. Nearly all of the in-person presentations are still part of the virtual meeting, according to Jose C. Florez, MD, PhD, chair of the 80th Scientific Sessions Meeting Planning Committee. 

of scientific and educational sessions available, with an eye toward the clinical needs of primary care clinicians. Start here:

Slideshows

The American Diabetes Association kicks off its Virtual 80th Scientific Sessions on Friday, June 12, 2020. Here is our guide to top sessions. 

10 Essential Symposia for Primary Care at ADA 2020

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States, and pulmonary rehabilitation has been shown to improve outcomes and reduce hospital readmissions among these patients. However, studies have shown that only a fraction of patients who need pulmonary rehabilitation actually receive it.

Disparities in access and the emergence of telehealth as a modality to more conveniently deliver pulmonary rehabilitation received significant attention during a session titled “Pulmonary Rehabilitation 2019” at the American Thoracic Society Meeting 2019 held May 17 – 22, 2019, in Dallas, Texas. Several studies were presented that revealed new insights into both areas of research. 

Carolyn Rochester, MD, Medical Director of the Yale COPD Program, Yale School of Medicine in New Haven, Connecticut, highlighted top research in pulmonary rehabilitation for 2018-2019. One 

 of particular interest highlighted significant problems with geographic access to hospital outpatient pulmonary rehabilitation programs, with a focus on rural areas. Published in the journal

 in April 2019, the study found that there were 1,776 counties in the United States lacking a hospital outpatient pulmonary rehabilitation program in a short-term acute care general medical or surgical hospital. The regions with the greatest disparities to access were in the South (for which only 39% of hospitals had a program) and West (for which only 35.5% had a program).

presented during the session that explored whether geographic variation in access to pulmonary rehabilitation could explain why rates of use are lower among African-American patients compared to whites.

Is geographic variation in access a factor?

 Using the hospital-referral region as a measure of geographic location, study researchers found that a median of 2% of Medicare beneficiaries (range, 0.5% – 7.1%) included in the analysis received pulmonary rehabilitation after hospital discharge for COPD exacerbation. This rate varied across hospital-referral region, with higher rates in the Midwest and hospital-referral regions with greater pulmonary rehabilitation program density.

However, the median rate of pulmonary rehabilitation was lower among African-Americans (1.2%; IQR, 1.1 – 1.2) compared to whites (2.1%; IQR, 1.5 – 2.9). Furthermore, while program density was associated with higher rates of pulmonary rehabilitation among white Medicare beneficiaries (P<.0001), no such association was seen among African-Americans. These findings suggest that the lower rates of pulmonary rehabilitation receipt among African-Americans cannot be explained by geographic differences.

“We need to add more [pulmonary rehabilitation] programs definitely, but adding more programs is not going to solve this disparity that we’re seeing,” said study presenter Kerry Spitzer, PhD, MPA, Institute for Healthcare Delivery and Population Science, Baystate Health, in Springfield, Massachusetts.
	 

Telehealth for pulmonary rehabilitation. 

Pulmonary rehabilitation not only has low uptake but also high dropout rates, and telehealth has emerged as a modality to help counteract this problem. In fact, Yale's Dr Rocheter highlighted a recently 

 showing pulmonary rehabilitation delivered via video-based telehealth could reduce 30-day hospital readmissions among patients with COPD.

Specifically, the all-cause remission rate was significantly lower among telehealth group participants compared to those in the standard of care group (6.2% vs 18.1%; P<.013). The acute exacerbation COPD readmission rate was also lower among the telehealth group (3.8% vs 11.9%; P=0.040).

 of a multicenter, randomized controlled trial conducted to determine if telehealth could deliver outcomes superior to conventional pulmonary rehabilitation among patients with advanced COPD. 

The trial enrolled 134 patients with severe and very severe COPD and randomly assigned them to either pulmonary tele-rehabilitation (n=67) or conventional pulmonary rehabilitation (n=67). The tele-rehabilitation intervention consisted of 60 minutes 3 times per week for 10 weeks, and the conventional pulmonary rehabilitation program consisted of 90 minutes 2 times a week for 10 weeks. The primary outcome was difference in 6-minute walk distance.

The study failed to showed superior 6-minute walk distance among patients in the tele-rehabilitation group or higher adherence rates compared to the conventional program group, but did show higher completion rates in the former (odds ratio=3.18; 95% CI, 1.37 – 7.35; P<.01).

Study authors note that tele-rehabilitation could potentially provide an equally effective alternative to conventional pulmonary rehabilitation but implementation would require evidence from a randomized controlled trial designed to explore noninferiority.

DALLAS--In a session at the American Thoracic Society meeting this week study authors reported on gaps in post-discharge care for COPD and on tele-rehabilitation as possible bridge. 

Can Telehealth Bridge Disparities in Access to Pulmonary Rehab? 

At the American Thoracic Society Meeting 2019 held May 17 – 22, 2019, in Dallas, Texas, several studies presented during a thematic poster session titled “Idiopathic Interstitial Pneumonia: Natural History” reported characteristics that could be used to help predict outcomes among patients with interstitial lung disease (ILD), including certain factors during mechanical ventilation, white blood cell (WBC) count, and weight loss.

Factors predict mortality during mechanical ventilation

Mechanical ventilation has been shown to be associated with high mortality rates among patients with fibrotic ILD (f-ILD) but there is a dearth of information on patient characteristics at hospital admission and procedural strategies that could improve outcomes. A retrospective study of patients intubated for acute respiratory failure (ARF) identified several factors during mechanical ventilation that predicted mortality in this patient population.

The study included 111 patients (38 with idiopathic pulmonary fibrosis [IPF] and 73 with non-IPF), for whom there were 114 admissions for ARF and placement on mechanical ventilation. Most patients (75%) died while in the hospital. Of the 25% of patients who survived to hospital discharge, 4.5% died within 30 days of discharge and 9% died within one year, leaving 11% who survived past 1 year.

An adjusted analysis revealed several statistically significant predictors of mortality, including P/F ratios within 3 and 48 hours of mechanical ventilation, initial fraction of inspired oxygen, initial mean airway pressure, and higher net volume status. The strongest predictors were vasopressor use (odds ratio [OR]=8.05; P=0.0001) and paralytic use (OR=17.9; P<.001) in the first 24 hours of mechanical ventilation.

White blood cell count associated with survival. 

In the abstract for this study, the authors note that inpatient status and elevated white blood cell count (WBC) have both been associated in the past with negative outcomes in IPF. Results of their single-center study of patients hospitalized with IPF found that increased WBC count, vs a low count, was associated with reduced survival. 

The study cohort included 56 IPF patients who were hospitalized at Inova Fairfax Hospital between 2009 and 2018. The cohort had a median WBC count of 11.2 X 10

 cells/L at hospital admission (range, 4.4 – 30.0 X 10

 cells/L), and this median was used to stratify patients as having a “low” (<11.2 X 10

 cells per liter) WBC count or a “high” (>11.2 X 10

A high WBC count was associated with a >20-month shorter transplant-free survival compared with a low WBC count (0.5 vs 21.5 months; P=0.005). The reason why high WBC is associated with worse survival is unclear. The study authors propose that an elevated white count could be a surrogate for infection and other inflammatory stressors that affect the disease course in patients with IPF.

The significance of weight loss in patients with ILD has not been studied. Authors of a single-center study presented during this poster session reported that weight loss was associated with decreased survival and pulmonary function among patients with ILD.

The study cohort had 224 patients with ILD, including subtypes such as IPF, connective tissue disease-associated-ILD, and chronic hypersensitivity pneumonitis. Only patients who had 2 or more pulmonary function tests conducted more than 90 days apart were included. Average body mass index (BMI) among patients was 28.2 and average annual decline in BMI, 0.1 kg/m

In an adjusted analysis, for each annual decline in BMI of 1%, there was a statistically significant increased risk of death (risk ratio [RR]=1.04; 95% CI, 1.01 - 1.08; P=0.005), but no increased risk of ≥10% decline in forced vital capacity (FVC) (RR=1.02; 95% CI, 0.99 - 1.05; P=0.16). Furthermore, the largest effect was seen in patients with at least a 5% annual decline in BMI where increased risk of death was more than 2-fold (RR=2.18; 95% CI, 1.23 - 3.89; P=0.008) and risk of FVC decline nearly 2-fold (RR=1.91; 95% CI, 1.15 - 3.16; P=0.012).

“BMI decline over time is prevalent among patients with ILD and is associated with an increased risk of disease progression, as measured by death and pulmonary function decline,” the study authors wrote.

DALLAS-Studies on 3 factors that may help guide intervention for patients with ILD were presented: factors during mechanical ventilation, WBC count, and weight loss.

From ATS 2019: Update on Factors that May Help Predict ILD Outcomes

New research on predicting outcomes in patients with chronic obstructive pulmonary disease (COPD) was presented in a session titled “COPD: Mortality and Risk Prediction” at the American Thoracic Society Meeting 2019 held May 17 – 22, 2019, in Dallas, Texas.

Here we highlight studies on the role of respiratory exacerbations; the predictive accuracy of a new machine learning tool; and, hemoglobin as a biomarker of clinical outcomes. 

Exacerbation frequency predicts mortality

, which included more than 10 000 current and former smokers with or without COPD, revealed possible predictors and causes of mortality in this patient population. Study authors posited that prediction and causality would depend on severity of airflow restriction. 

The most common causes of death among smokers without COPD fell into the miscellaneous category, Other (33%), followed by cardiovascular (25%) and lung cancer (10%). By contrast, the most common causes of death among smokers with GOLD stage 1 or stage 2 COPD were cardiovascular (22%) and respiratory (20%) and most smokers with GOLD stage 3 or stage 4 COPD died from respiratory disease (61%).

In an adjusted analysis, having at least 2 respiratory exacerbations during the past year was predictive of all-cause mortality for GOLD stage 1 or stage 2 COPD (hazard ratio [HR]=1.44; P=0.05) and GOLD stage 3 or 4 COPD (HR=1.61; P<.001), but not for smokers without COPD (HR=0.89; P=0.70).

Chronic bronchitis was predictive of all-cause mortality for smokers without COPD (HR=1.47; P=0.009) and smokers with GOLD stage 3 or stage 4 COPD (HR=1.35; P=0.003), but not for smokers with GOLD stage 1 or stage 2 COPD (HR=1.11; P=0.50).

“We affirmed that reducing the exacerbation rate remains an important clinical and research priority for patients with COPD,” said the study presenter Wassim Walid Labaki, MD, Division of Pulmonary and Critical Care Medicine, University of Michigan.

Results of this new study found that a machine learning algorithm combined with clinical and quantitative CT imaging features predicted mortality among COPD patients better than the traditionally used BODE (Body-mass index, airflow Obstruction, Dyspnea, and Exercise) index and other prognostic indices.

“While the BODE index may have some limitations, despite many people trying, no one has actually successfully outperformed the BODE index consistently,” said the study presenter Matthew Moll, MD, Channing Division of Network Medicine, Brigham and Women’s Hospital, Boston, Massachusetts.

To develop the machine learning model, patients with GOLD 2 to 4 COPD from the COPDGene and the 

 were used. Three-quarters of the COPDGene cohort (n=1,974) were used for the training set and the remaining quarter (n=658) were used for the testing set. The algorithm was then externally validated in the ECLIPSE cohort (n=1,645).

The most important predictors of mortality in the model were 6-minute walk distance, FEV1, and age. The machine learning model outperformed 4 other prognostic indices, including BODE, updated BODE, e-BODE, and ADO (age, dyspnea and FEV1), for both the testing set (P<.05) and externally validated set (P<.05).

“To put this in clinical context, if you use our model compared to BODE, for every 26 patients that you use our model in, 1 additional person would be predicted correctly to die at 5 years,” said Dr. Moll.

Among patients with COPD, anemia was independently associated with worse outcomes, including symptoms, quality of life, and functional performance, according to results of a cross-sectional 

“Because there are new therapies that are available for the treatment of chronic inflammation-related anemia, understanding hemoglobin as a biomarker across its continuous range is pretty important,” said study presenter Aparna Balasubramanian, MD, Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.

The cross-sectional study used data from the COPDGene cohort for which hemoglobin data were available. On the basis of hemoglobin level, patients were categorized as normal, anemic (Hgb <12 g/dL for females and Hgb <13 g/dL for males), or polycythemic (Hgb >16 g/dL for women, Hgb>16.5 g/dL for men).

In an adjusted analysis, compared with a normal hemoglobin level, anemia was associated with worse scores on St. George's Respiratory Questionnaire (which assesses quality of life), worse scores on the Short Form (36) Health Survey for physical and general function, and decreased distance on the 6-minute walk test, whereas polycythemia was not. Continuous analyses showed that the relationship between hemoglobin and COPD morbidity is likely nonlinear.

DALLAS--Results of 3 studies presented at the American Thoracic Society meeting this week focus on the predictive role of disease exacerbations, machine learning, and Hgb levels in COPD. 

ATS Highlights Advances in the Prediction of COPD Outcomes

In a session titled “Addicting a New Generation: Juuling, Vaping, Heat Not Burn, Flavorings, and the Evidence for Why We Should Be Very Concerned,” at the American Thoracic Society Meeting 2019 held May 17 – 22, 2019, in Dallas, Texas, experts described the alarming growth in the rate of e-cigarette use among teens and emerging data on the safety of the new electronic nicotine delivery systems. 

, 1 in 5 high school students were e-cigarette users in 2018, up from approximately 1 in 100 in 2011. Currently, more than 1 in 4 high school students use any tobacco or nicotine product. “Up until 2010, we had been conquering the tobacco epidemic. Tobacco use among youth in our population had been going down,” said Harold J. Farber, MD, MSPH, ATSF, Texas Children’s Hospital, Houston, Texas. “Now we’re starting to see this rise again.”

Contrary to common belief, the use of e-cigarettes is not necessarily associated with quitting or avoiding smoking tobacco, and may have the opposite effect. A 

and meta-analysis among adolescents and young adults found that e-cigarette users had a more than three times greater risk of starting cigarette smoking than those who had never used e-cigarettes.

There are dozens of e-cigarette brands on the market, but one causing particular alarm is the JUUL, which entered the market in 2015 and by November of 2018 had secured 76% of the e-cigarette market. “[JUUL is] very small, very discrete, and amazingly addictive,” said Dr. Farber. JUUL uses a patented nicotine salt-nicotine benzoate-that increases the rate of nicotine uptake and has less adverse effects than freebase nicotine, often found in traditional tobacco cigarettes. “You find kids saying it gives them a better buzz,” he said.

The US Food and Drug Administration gained the authority to regulate e-cigarettes in 2016, but data about safety of the products is needed in order to decide how best to regulate them.  A primary problem, however, is that these products have only been on the market for a few years and the market is constantly changing, explained Ilona Jaspers, PhD, University of North Carolina at Chapel Hill. “We are always chasing and always behind on the products, in terms of testing their toxicity,” she said.

A feature of e-cigarettes that especially worries Dr. Jaspers when it comes to safety is the flavorings used; while the natural flavors are recognized as safe when used as a food product, that safety cannot be assumed when the route of exposure is changed to inhalation. Of particular concern are the aromatic aldehyde compounds, which include the cinnamon flavor (cinnamaldehyde), almond flavor (benzaldehyde), and vanilla flavor (vanillin and ethyl vanillin). Other aromatic aldehydes, such as formaldehyde, are known to be toxic when inhaled, and cinnamaldehyde 

 to inhibit the function of immune cells, including macrophages, neutrophils, and natural killer cells. “Why do we think that [these flavors] actually could be safe when we inhale them?” she asked rhetorically. 

Studies also have shown that e-cigarettes appear to have different effects on the body than conventional cigarettes. For instance, a mid-2018 

 that airways among e-cigarette users were inflamed whereas the airways of cigarette smokers and nonsmokers were not. 

 found e-cigarette users to have more gene expression changes than combustible cigarette smokers and to have an overall immune suppressive phenotype. 

reported at the American Thoracic Society meeting went a step further and showed a reduced antiviral response within the respiratory tract among e-cigarette users compared with non-users.

Although there is no conclusive evidence to date, Dr. Jaspers speculated that it is possible new diseases may emerge among e-cigarette users. For example, a 2018 

described an 18-year-old female who developed hypersensitivity pneumonitis and acute respiratory distress syndrome after e-cigarette use.

“We may not be seeing [chronic obstructive pulmonary disease], but we may be seeing an uptick in new diseases and new clinical phenotypes,” she said.

DALLAS-At the American Thoracic Society meeting thought leaders cited disturbing trends in e-cigarette use by teens and warned of health dangers, known and unknown.

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