Trends and Characteristics of Global Initiative for Chronic Obstructive Lung Disease Guidelines-Discordant Prescribing of Triple Therapy Among Patients with COPD.

BACKGROUND: Triple therapy (long-acting muscarinic antagonist [LAMA] plus long-acting beta2-agonist [LABA] plus inhaled corticosteroid [ICS]) is recommended by the Global initiative for chronic Obstructive Lung Disease (GOLD) for moderate-to-severe chronic obstructive pulmonary disease (COPD) with a history of frequent and/or severe exacerbation(s) and dyspnea while using dual bronchodilators. However, many patients receive triple therapy contrary to these recommendations. This study describes factors associated with GOLD-discordant triple therapy initiation. METHODS: This retrospective analysis included patients aged 40 and above, with ≥1 COPD diagnosis, who initiated triple therapy (initiation=index date) during the period January 1, 2014 to December 31, 2018 and had ≥12 months pre-index continuous enrollment (baseline). Triple therapy comprised ≥30 days of overlapping LAMA, LABA, and ICS treatments (open triple therapy), or single-inhaler fluticasone furoate/umeclidinium/vilanterol (closed triple therapy). Cohorts were defined based on the absence of baseline maintenance medication use ("maintenance-naïve"), and/or exacerbations ("exacerbation-discordant"), or "dual-discordant" (discordant on both measures). All triple therapy initiators, overall and for each cohort, were described, and predictors of GOLD-discordant triple therapy initiation were identified. RESULTS: Among 21,711 triple therapy initiators, 34.4% were maintenance-naïve, 61.9% exacerbation-discordant, and 22.2% dual-discordant. Triple therapy initiation appeared to increase during the period 2016 to 2018. In 2018 alone, 31.9% and 58.3% of open triple therapy patients were maintenance-naïve and exacerbation-discordant, respectively, versus 37.6% and 64.4% of closed triple therapy patients. Closed triple therapy initiators had 1.65 times greater risk of dual discordance than open triple therapy initiators. Exacerbation-discordant patients initiating closed triple therapy were 1.61 times more likely to be maintenance-naïve than those initiating open triple therapy. CONCLUSION: A substantial proportion of COPD patients initiating triple therapy do not meet GOLD recommendations regarding exacerbation history and/or prior maintenance therapy. Compared with open triple therapy, closed triple therapy initiators were more likely to be dual discordant.

Treatment Transitions in Chronic Obstructive Pulmonary Disease: Retrospective Analyses of US and UK Healthcare Databases.

INTRODUCTION: Previous studies have reported that more patients receive inhaled corticosteroid (ICS)-containing therapies than would be expected based on exacerbation history, suggesting overprescribing. We aimed to describe patterns of treatment switching from first (1MT) to second maintenance therapy (2MT) among COPD patients in the US and UK. METHODS: We used healthcare data from the US IBM® MarketScan® and UK Clinical Practice Research Datalink databases (2015 - 2018) to assess transitions between 1MT and 2MT among COPD patients. Patients with a recorded asthma diagnosis prior to 1MT were excluded. We assessed whether prescribed treatments (long-acting muscarinic antagonists [LAMA], long-acting ß2-agonists [LABA], inhaled corticosteroids [ICS], as monotherapy or in combination) were consistent with global and national recommendations for COPD, identified patient characteristics associated with treatment transitions, and evaluated treatment duration. RESULTS: Overall, 7028 patients in the US and 2461 in the UK initiated 2MT within a median (IQR) 160.0 (76.0; 335.0) and 218.0 (86.0; 428.0) days after 1MT, respectively. In the US, 33.6% of patients initiating 2MT had no recorded exacerbations in the previous year, whereas 23.1% had one and 43.3% had ≥ 2. In the UK, 54.9% of patients had no recorded exacerbations in the previous year, whereas 20.9% had one and 24.2% had ≥ 2. At 2MT, most patients switched to LAMA/LABA/ICS (26.1%) or LABA/ICS (25.8%) in the US, and LAMA/LABA (39.4%) or LAMA/LABA/ICS (27.8%) in the UK; 62.2% (US) and 47.5% of patients (UK) were prescribed ICS-containing regimens. The most common treatment transition from 1MT to 2MT was LABA/ICS to LAMA/LABA/ICS (13.0%) in the US; and LAMA to LAMA/LABA (32.5%) and LAMA to LAMA/LABA/ICS (14.3%) in the UK. CONCLUSIONS: At 2MT, the proportion of patients on LAMA/LABA/ICS was similar between the US and UK, but treatment pathways were different.

People with chronic obstructive pulmonary disease (COPD) take inhaled medication to control symptoms such as breathlessness and cough. There are two types of inhaler: 'reliever' inhalers for immediate symptom relief, and 'maintenance' inhalers for long-term disease control. Maintenance inhalers can be used on their own or together, and treatment is often escalated based on the persistence of symptoms or exacerbations (flare-ups), for which inhaled corticosteroids (ICS) are often prescribed. We wanted to see whether doctors' prescribing habits are in line with clinical guidelines, so we looked at data from COPD patients who switched from their first maintenance therapy (1MT) to a second, different maintenance therapy (2MT) between 2015 and 2018. Our data sources were a US health claims database (~ 7000 patients) and a UK general practice database (~ 2500 patients). We excluded people with a diagnosis of both COPD and asthma, as similar inhalers are used to treat these two conditions, although the clinical decisions for when to prescribe them differ. On average, the time between 1MT and 2MT was 160 days (US) and 218 days (UK). Overall, 50% (UK) and 60% of patients (US) were prescribed ICS as part of their treatment regimen at 2MT, and ICS use in both countries was higher than expected based on the guidelines, which recommend ICS only for patients with severe COPD who meet certain criteria. This means that some patients are being given medication without a known clinical benefit, which puts them at risk of side effects, possibly increasing unnecessary healthcare costs.

First Maintenance Therapy for Chronic Obstructive Pulmonary Disease: Retrospective Analyses of US and UK Healthcare Databases.

INTRODUCTION: Inhaled corticosteroids (ICS) are often prescribed inappropriately alongside long-acting bronchodilators for chronic obstructive pulmonary disease (COPD). We aimed to investigate if prescribing habits in the US and UK differ from recommendations for initiation of COPD maintenance therapy. METHODS: We used healthcare data from the US IBM® MarketScan® and UK Clinical Practice Research Datalink databases to assess exacerbations and comorbidities in patients with COPD initiating first maintenance therapy (1MT) between 2015 and 2018. Patients with a recorded asthma diagnosis prior to initiation of 1MT were excluded. We evaluated time from recorded diagnosis of COPD until initiation of 1MT, and treatment regimen at 1MT (long-acting muscarinic antagonist [LAMA], long-acting ß2-agonist [LABA], ICS, as monotherapy or in combination). RESULTS: In the US and UK, median (IQR) time between recorded COPD diagnosis and 1MT was 158 (12; 839) and 29 (1; 521) days, respectively. Among the 53,473 US patients and 8786 UK patients who initiated 1MT, 50.9% and 32.4% had ≥ 1 exacerbation in the previous year. In the US, 20% of patients initiated LAMA, 1% LABA, 13% LAMA/LABA, and 66% an ICS-containing regimen (49% LABA/ICS, 13% ICS, and 4% LAMA/LABA/ICS). In the UK, 53% of patients initiated LAMA, 4% LABA, 16% LAMA/LABA, and 27% an ICS-containing regimen (14% LABA/ICS, 9% ICS, and 4% LAMA/LABA/ICS). CONCLUSIONS: At 1MT, two-thirds of patients in the US received ICS-containing therapies, with almost half on LABA/ICS. In contrast, less than one-third received ICS-containing therapy in the UK and more than half of patients received LAMA. In both countries, more patients received ICS-containing therapies at initiation of 1MT than would be expected based on their exacerbation history, suggesting overprescribing.

Chronic obstructive pulmonary disease (COPD), a smoking-related lung disease, restricts airflow in the lungs, causing symptoms such as breathlessness and coughing. To control symptoms, patients use one or more types of inhaled 'maintenance' medication, which can be prescribed alone or together. When patients have a short-term worsening of symptoms, doctors often prescribe inhaled corticosteroids (ICS). We wanted to see whether doctors' prescribing habits for maintenance inhalers are in line with clinical guidelines, so we analyzed data from a US health insurance database (~ 50,000 patients) and UK primary care medical records (~ 8000 patients). We focused on patients with a diagnosis of COPD who were prescribed their first maintenance therapy (1MT) between 2015 and 2018. We excluded people with a diagnosis of both COPD and asthma, as similar inhalers are used to treat these conditions, although the clinical decisions for when to prescribe them differ. The average time between COPD diagnosis and 1MT was longer in the US (158 days) than in the UK (29 days). A higher percentage of patients in the US (~ 65%) versus UK (~ 25%) were prescribed ICS as part of their treatment, and ICS use in both countries was higher than expected based on the guidelines, which recommend ICS only for patients with severe COPD who meet certain criteria. Our findings suggest overprescribing of ICS in both countries (particularly the US), meaning that some patients are being given medication without a known clinical benefit, which puts them at risk of side effects, possibly increasing unnecessary healthcare costs.

A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India.

BACKGROUND: The primary objective of this study was to intervene with vitamin D supplementation in rural-based women with pre-diabetes (impaired fasting glucose or impaired glucose tolerance) to prevent development of type 2 diabetes (T2DM). METHODS: This was an open-label randomized placebo-controlled trial conducted in rural women with pre-diabetes and vitamin D deficiency (Clinicaltrials.gov NCT02513888). Women aged 20-60 years with pre-diabetes were selected from rural Haryana (north India) and followed up for two years. A semi-structured questionnaire was used to collect information on socio-demographic and behavioral details, like sun exposure, dietary habits, etc., The intervention group received vitamin D supplementation while control group received lactose granules as placebo. Equal doses of calcium carbonate were given to both the groups. RESULTS: A total of 132 participants were recruited in the study (58 each in the intervention and control groups). It was observed that there was no statistical significance in the incidence of diabetes in the control group as compared to the intervention group at the end of 2 years (P = 0.701). CONCLUSION: Though during the first year there was some delay in development of DM in the intervention group but at the end of two years there was no significant effect of vitamin D supplementation in delaying the incidence of diabetes in these women after two years. TRIAL REGISTRATION: (Clinicaltrials.gov NCT02513888).

Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective.

The burden of chronic obstructive pulmonary disease (COPD) in the USA continues to grow. Although progress has been made in the the development of diagnostics, therapeutics, and care guidelines, whether patients' quality of life is improved will ultimately depend on the actual implementation of care and an individual patient's access to that care. In this Commission, we summarise expert opinion from key stakeholders-patients, caregivers, and medical professionals, as well as representatives from health systems, insurance companies, and industry-to understand barriers to care delivery and propose potential solutions. Health care in the USA is delivered through a patchwork of provider networks, with a wide variation in access to care depending on a patient's insurance, geographical location, and socioeconomic status. Furthermore, Medicare's complicated coverage and reimbursement structure pose unique challenges for patients with chronic respiratory disease who might need access to several types of services. Throughout this Commission, recurring themes include poor guideline implementation among health-care providers and poor patient access to key treatments such as affordable maintenance drugs and pulmonary rehabilitation. Although much attention has recently been focused on the reduction of hospital readmissions for COPD exacerbations, health systems in the USA struggle to meet these goals, and methods to reduce readmissions have not been proven. There are no easy solutions, but engaging patients and innovative thinkers in the development of solutions is crucial. Financial incentives might be important in raising engagement of providers and health systems. Lowering co-pays for maintenance drugs could result in improved adherence and, ultimately, decreased overall health-care spending. Given the substantial geographical diversity, health systems will need to find their own solutions to improve care coordination and integration, until better data for interventions that are universally effective become available.

Volitional pursed lips breathing in patients with stable chronic obstructive pulmonary disease improves exercise capacity.

Pursed lips breathing (PLB) is used by a proportion of patients with chronic obstructive pulmonary disease (COPD) to alleviate dyspnea. It is also commonly used in pulmonary rehabilitation. Data to support its use in patients who do not spontaneously adopt PLB are limited. We performed this study to assess the acute effects of PLB on exercise capacity in nonspontaneously PLB patients with stable COPD. We performed a randomized crossover study comparing 6-min walk test (6MWT) at baseline without PLB with 6WMT using volitional PLB. Spirometry, maximal inspiratory and expiratory mouth pressures, and diaphragmatic excursion during tidal and vital capacity breathing using B-mode ultrasonography were measured at baseline and after 10 min of PLB. A Visual Analog Scale (VAS) assessed subjective breathlessness at rest, after 6MWT and after 6MWT with PLB. p ≤ 0.01 was considered significant. Mean ± SD age of patients was 53.1 ± 7.4 years. Forced expiratory volume in 1 second was 1.1 ± 0.4 L/min (38.4 ± 13.2% predicted). Compared with spontaneous breathing, all but one patient with PLB showed a significant increment in 6MW distance (+34.9 ± 26.4 m; p = 0.002). There was a significant reduction in respiratory rate post 6MWT with PLB compared with spontaneous breathing (-4.4 ± 2.8 per minute; p = 0.003). There was no difference in VAS scores. There was a significant correlation between improvement in 6MWT distance and increase in diaphragmatic excursion during forced breathing. The improvement was greater in patients who had poorer baseline exercise performance. PLB has an acute benefit on exercise capacity. Sustained PLB or short bursts of PLB may improve exercise capacity in stable COPD.