Use Of Maintenance Medication Research Articles

Dual Phosphodiesterase 3 and 4 Inhibitor Ensifentrine Reduces Exacerbation Rate and Risk in Patients With Moderate to Severe COPD

IntroductionExacerbations in chronic obstructive pulmonary disease (COPD) can be life-threatening and lead to irreversible declines in lung function and quality of life. Medications that reduce exacerbation burden are an unmet need, as exacerbations put patients at risk for more exacerbations and decrease quality of life. Ensifentrine is a novel, first-in-class, selective, dual inhibitor of phosphodiesterase 3/4 with demonstrated nonsteroidal anti-inflammatory activity and bronchodilatory effects. Research QuestionDoes ensifentrine reduce the rate and/or risk of COPD exacerbations? Study Design and MethodsA prespecified, pooled analysis of the phase 3 clinical trials ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) was conducted to assess the effect of ensifentrine on exacerbation rate and risk (time to first exacerbation). The trials included symptomatic patients aged 40-80 years with moderate-to-severe COPD who received 3 mg twice-daily ensifentrine over 24 weeks or placebo. Subgroup analyses and frequent exacerbator transition risk were conducted post-hoc. ResultsIn total, 975 ensifentrine-treated and 574 placebo-treated patients were included in the pooled analysis, including 62% on concomitant LAMA or LABA therapy and 18% on concomitant inhaled corticosteroid therapy. Ensifentrine was associated with significant reductions in the rate (rate ratio, 0.59; 95% CI, 0.43-0.80; P < 0.001) and risk (hazard ratio, 0.59; 95% CI, 0.44-0.81; P < 0.001) of moderate/severe exacerbations compared with placebo. Reductions in the rate and risk of exacerbations were generally consistent across patient subgroups, including age, sex, race, background maintenance medication use, chronic bronchitis, eosinophil count, COPD severity, and exacerbation history. Ensifentrine was associated with a numerical delay in transitioning from an infrequent exacerbator (GOLD B) to a frequent exacerbator (GOLD E) compared with placebo. ConclusionEnsifentrine reduced the rate of exacerbations and increased the time to first exacerbation among patients with COPD across a broad range of clinically relevant subgroups.

Use of cystic fibrosis inhaled medication before and after elexacaftor/tezacaftor/ivacaftor initiation

Elexacator/tezacaftor/ivacaftor (ETI) has improved cystic fibrosis (CF) outcomes. A reduction in use of maintenance medication after its initiation has been reported. Seventy-one adult people with CF (PwCF) who are followed in three CF centers and completed one year of treatment with ETI were included in this study. Their use of inhaled dornase-α, colistin, tobramycin, aztreonam and levofloxacin during this period was compared with the corresponding use during one year without ETI, using the Medication Possession Ratio (MPR). MPR was significantly decreased after ETI initiation for dornase-α (67±35% vs 48±40%, p<0.001) and for all four inhaled antibiotics together (62±33% vs 41±37%, p<0.001). The findings of this multi-center, retrospective, study suggest that the initiation of ETI significantly leads to decrease in use of standard inhaled medication in PwCF. The significance of this finding in the course of the disease is yet to be investigated by larger prospective clinical trials.

Clinical factors linked to the type of respiratory medication in COPD: results from the COSYCONET cohort.

The use of maintenance medication in patients with chronic obstructive pulmonary disease (COPD) in real life is known to deviate from recommendations in guidelines, which are largely based on randomized controlled trials and selected populations. We used the COSYCONET (COPD and Systemic Consequences - Comorbidities Network) cohort to analyze factors linked to the use of COPD drugs under non-interventional circumstances. COSYCONET is an ongoing, multi-center, non-interventional cohort of patients with COPD. Patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades 0-4 participating in visits 1-5 were included. Data covered the period from 2010 to 2018. Generalized linear models were used to examine the relation of COPD characteristics to different types of respiratory medication. A total of 1043 patients were included. The duration of observation was 4.5 years. Use of respiratory medication depended on GOLD grades 0-4 and groups A-D. Long-acting muscarinic antagonist therapy increased over time, and was associated with low carbon monoxide (CO) diffusing capacity, while inhaled corticosteroid (ICS) use decreased. Active smoking was associated with less maintenance therapy in general, and female sex with less ICS use. From the eight items of the COPD Assessment Test, only hill and stair climbing were consistently linked to treatment. Using data from a large, close to real-life observational cohort, we identified factors linked to the use of various types of respiratory COPD medication. Overall, use was consistent with GOLD recommendations. Beyond this, we identified other correlates of medication use that may help us to understand and improve therapy decisions in clinical practice. ClinicalTrials.gov NCT01245933.

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.

IntroductionSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT).MethodsThis was a retrospective study using the Optum Clinformatics® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting β2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT.ResultsThe study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA.ConclusionIn this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.

Exacerbation history, severity of dyspnoea and maintenance treatment predicts risk of future exacerbations in patients with COPD in the general population

BackgroundWhether risk of exacerbations of chronic obstructive pulmonary disease (COPD) is influenced by severity of symptoms and maintenance treatment is unclear. ObjectiveWe hypothesized that in addition to history of exacerbations of COPD, the severity of dyspnoea and use of maintenance medications are associated with risk of future exacerbations. MethodsWe included 96,462 adults from the Copenhagen General Population Study and assessed risk of moderate and severe exacerbations from 2003 to 2013 according to exacerbation history, dyspnoea score (mMRC), and presence/absence of maintenance treatment with inhaled long-acting bronchodilators and/or inhaled corticosteroids. FindingsAmong 13,380 individuals with COPD, we observed 1543 moderate and 348 severe exacerbations. In treatment naïve individuals and in those on maintenance treatment, history of previous exacerbations and to a smaller degree also dyspnoea were associated with a higher risk of future exacerbations; 32% of the treatment naïve individuals with mMRC≥2 and a single moderate exacerbation in the previous year experienced a moderate exacerbation during the following year compared with only 3% in the individuals with similar severity of dyspnoea but no exacerbations in the previous year yielding an adjusted hazard ratio of 6.26 (95% confidence interval, 3.70–10.58). InterpretationThis observational study of the general population suggests that in addition to exacerbation history also the severity of dyspnoea predicts the risk of future COPD exacerbations. In subjects with severe dyspnoea, a history of a single moderate exacerbation is associated with a high risk of future exacerbations, suggesting that this subgroup needs special attention in order to prevent these events.

CROSS-SECTIONAL SURVEY TO ASSESS COPD MEDICATION USE BY UNITED STATES PHYSICIANS

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Little information is available on the reasoning behind prescribing behaviors for specific COPD medications and classes by US primary care physicians (PCPs) and pulmonologists (Pulms). There is also a lack of information on how well these prescribers align with COPD treatment strategies, including those from the Global Initiative for Obstructive Lung Disease (GOLD) and the COPD Foundation. This study aimed to better understand COPD maintenance medication use by US physicians. METHODS: This was a retrospective analysis of Adelphi Respiratory Disease Specific Programme™ data, which surveyed physicians from July-December 2019. Physicians were presented with four COPD patient types and asked which treatment class they would use for each: 1) Maintenance-naïve, symptomatic COPD, significant exacerbation risk; 2) Maintenance-naïve, symptomatic COPD, recent exacerbation history; 3) Symptomatic COPD, no exacerbations in the past year, moderate dyspnea; 4) Symptomatic COPD, no exacerbations in the past year, severe dyspnea. The information was collected via completed questionnaires on disease management and case reports. All results were reported descriptively and no statistical testing was performed. RESULTS: There were 43 PCPs and 32 Pulms surveyed, covering a total of 800 COPD patients (408 PCP and 392 Pulms). Overall, PCPs used ICS/LABA at a higher rate than Pulms (50.4% vs 39.6%), as well as LAMA (33.2% vs 31.5%). LAMA/LABA (18.4% vs 13.5%) and ICS/LABA/LAMA (14.8% vs 7.9%) were used more by Pulms than PCPs. Patient 1, PCPs chose ICS/LABA (53.5%), LAMA (32.6%), and LAMA/LABA (18.6%); Pulms reported ICS/LABA/LAMA (37.5%), ICS/LABA (28.1%), and LAMA (15.6%) or LAMA/LABA (15.6%). Patient 2, PCPs chose ICS/LABA (55.8%), LABA/LAMA (44.2%), and LAMA (37.2%); Pulms reported LABA/LAMA (40.6%), ICS/LABA/LAMA (28.1%), and ICS/LABA (28.1%). Patient 3, PCPs chose ICS/LABA (39.5%), LAMA (30.2%), and LABA/LAMA (23.3%); Pulms chose ICS/LABA (37.5%), LABA/LAMA (34.4%), and LAMA (31.3%). Patient 4, PCPs chose ICS/LABA (55.8%), LAMA (30.2%), and ICS/LABA/LAMA (23.3%); Pulms chose LABA/LAMA (43.8%), ICS/LABA (28.1%), and LAMA (18.8%). Overall, 79.1% of PCPs and 71.9% of Pulms reported that they refer to clinical strategies when making treatment decisions. The majority reported adhering to GOLD strategies (PCPs 79.4%, Pulms 91.3%). CONCLUSIONS: This real-world data indicates that PCPs and Pulms utilize treatments for COPD at very different rates. Pulms were more likely to utilize dual bronchodilation than PCPs. PCPs were more likely to suggest ICS/LABA than Pulms. When presented with patient profiles, choices differed markedly between provider type. Most of the providers reported referring to clinical strategies. CLINICAL IMPLICATIONS: A better understanding of patient types that benefit from each treatment option could help to optimize patient care in COPD. DISCLOSURES: Employee relationship with GlaxoSmithKline Please note: >$100000 Added 03/03/2020 by Michael Bogart, source=Web Response, value=Salary No relevant relationships by Adam Haq, source=Web Response Employee relationship with GlaxoSmithKline Please note: >$100000 Added 04/30/2020 by David Mannino, source=Web Response, value=Salary No relevant relationships by James Siddall, source=Web Response No relevant relationships by Mark Small, source=Web Response

Validation and Assessment of the COPD Treatment Ratio as a Predictor of Severe Exacerbations.

Population-based risk assessments are needed to identify individuals who may benefit from chronic obstructive pulmonary disease (COPD) management programs for preventing exacerbations. This study compared the validated COPD treatment ratio (CTR) versus other COPD exacerbation predictors: prior exacerbation and rescue and maintenance medication use. A retrospective observational study using medical and pharmacy claims data among Medicare Advantage with Part D beneficiaries with COPD (January 2011-August 2016). Unadjusted and adjusted logistic regression models tested the predictive performance (C-statistic) of potential exacerbation predictors for future severe exacerbations. The unadjusted association between exacerbation predictors and severe exacerbation was examined in 60,776 patients: baseline severe exacerbation had the highest C-statistic (0.668), then number of rescue units dispensed (0.651), CTR (0.619), and number of controller units dispensed (0.562). During the at-risk period, baseline CTR was inversely associated with severe exacerbation (odds ratio, <1.0); other predictors were positively associated with a severe exacerbation (odds ratio, >1.0). Adjusting for age, geographic region, chronic oxygen, and nebulizer use, the severe exacerbation odds were 0.90 (95% confidence interval [CI], 0.89-0.91) lower per 0.10 change in CTR (C-statistic, 0.710). The C-statistic was 0.734 when baseline exacerbation was added to the model. The CTR is an effective tool for identifying patients diagnosed with COPD who are at increased risk of severe exacerbation. Although CTR does not predict future exacerbation as well as prior severe exacerbation history, it has the advantage of being applicable in predicting future exacerbations in patients without an exacerbation history, or in databases limited to pharmacy claims only. In addition, the significant reduction in risk has been observed with incremental increases in the ratio: the ratio can be monitored to assess COPD health improvements over time.

Predicting factors for chronic colonization of Pseudomonas aeruginosa in bronchiectasis

About 25% of the patients with bronchiectasis are likely to develop a chronic colonization with Pseudomonas aeruginosa. A better understanding of predictors of acquiring Pseudomonas within the patient population may facilitate future focused research. The aim of this retrospective observational study was to investigate predicting factors for P. aeruginosa colonization in patients with bronchiectasis. This was a single-center retrospective cohort study using a bronchiectasis database which consisted of 211 patients with bronchiectasis. Data were collected for demographic details, etiology, spirometry, microbiology data, maintenance medication use, exacerbation frequency, hospital admission rate, and FACED and Bronchiectasis Severity Index (BSI) score. Two hundred eleven patients were identified from our bronchiectasis database. Overall, 25% of the patients (n = 53) had a chronic colonization with P. aeruginosa. Seventeen patients (8%) died in a 5-year follow-up period of whom 7 (41%) had a chronic P. aeruginosa colonization (p > 0.05). After multiple regression analysis, P. aeruginosa-positive patients were significantly associated with an older age (> 55 years) (p = 0.004), the use of hypertonic saline (0.042), and inhalation antibiotics (< 0.001). Furthermore, the presence of PCD (p < 0.001) and post-infectious etiology (p < 0.001) as underlying causes were significantly associated with P. aeruginosa colonization. We observed that independent predictors for P. aeruginosa colonization were age > 55 years, hypertonic saline, and PCD, and post-infectious etiology as underlying causes of bronchiectasis. Since prevention of P. aeruginosa colonization is an important aim in the treatment of bronchiectasis, more attention could be directed to these groups at risk for Pseudomonas colonization.

Medication management patterns among Medicare beneficiaries with chronic obstructive pulmonary disease who initiate nebulized arformoterol treatment.

Purpose: Global evidence-based treatment strategies for chronic obstructive pulmonary disease (COPD) recommend using long-acting bronchodilators (LABDs) as maintenance therapy. However, COPD patients are often undertreated. We examined COPD treatment patterns among Medicare beneficiaries who initiated arformoterol tartrate, a nebulized long-acting beta2 agonist (LABA), and identified the predictors of initiation.Methods: Using a 100% sample of Medicare administrative data, we identified beneficiaries with a COPD diagnosis (ICD-9 490–492.xx, 494.xx, 496.xx) between 2010 and 2014 who had ≥1 year of continuous enrollment in Parts A, B, and D, and ≥2 COPD-related outpatient visits within 30 days or ≥1 hospitalization(s). After applying inclusion/exclusion criteria, three cohorts were identified: (1) study group beneficiaries who received nebulized arformoterol (n=11,886), (2) a subset of the study group with no LABD use 90 days prior to initiating arformoterol (n=5,542), and (3) control group beneficiaries with no nebulized LABA use (n=220,429). Logistic regression was used to evaluate predictors of arformoterol initiation. Odds ratios (ORs), 95% confidence intervals (CIs), and p values were computed.Results: Among arformoterol users, 47% (n=5,542) had received no LABDs 90 days prior to initiating arformoterol. These beneficiaries were being treated with a nebulized (50%) or inhaled (37%) short-acting bronchodilator or a systemic corticosteroid (46%), and many received antibiotics (37%). Compared to controls, beneficiaries who initiated arformoterol were significantly more likely to have had an exacerbation, a COPD-related hospitalization, and a pulmonologist or respiratory therapist visit prior to initiation (all p<0.05). Beneficiaries with moderate/severe psychiatric comorbidity or dual-eligible status were significantly less likely to initiate arformoterol, as compared to controls (all p<0.05).Conclusion: Medicare beneficiaries who initiated nebulized arformoterol therapy had more exacerbations and hospitalizations than controls 90 days prior to initiation. Findings revealed inadequate use of maintenance medications, suggesting a lack of compliance with evidence-based treatment guidelines.

Pattern and Adherence to Maintenance Medication Use in Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease: 2008-2013.

Background: Maintenance medications provide symptomatic relief, improve lung function and reduce the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Despite their proven benefits, limited information exists on maintenance medication use and adherence among users. Objective: We examined the patterns and factors associated with the receipt of and adherence to maintenance medication in individuals with COPD. Methods: A retrospective cross-sectional study of 5% of Medicare beneficiaries enrolled in Parts A, B and D with COPD who received maintenance medication from 2008 to 2013 was conducted. Maintenance medication includes: inhaled corticosteroids (ICSs), long-acting beta2- agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) alone or in combination. We examined the proportion of beneficiaries with COPD who had at least one prescription filled for maintenance medication. Among users of maintenance medications, we also examined adherence, defined as proportion of days covered (PDC) ≥80% over the year from the first maintenance medication prescription fill date. Results: Overall, maintenance medication (LAMAs, LABAs, ICSs and/or LABA/ICS) use increased from 67.8% in 2008 to 72.1% in 2013. The increase is related to increases in use of LABA/ICS, which rose from 41.1% in 2008 to 49.6% in 2013. Factors associated with receipt of maintenance medication include female gender, recent COPD hospitalization (odds ratio [OR] 1.63; 95% confidence interval [CI] 1.54-1.73), oxygen therapy (OR 1.74 95% CI, 1.68-1.81), dual eligibility status (OR 1.45; 95% CI 1.39-1.51), higher education level and evaluation by a pulmonary provider (OR 1.88; 95% CI 1.81-1.96). The overall adherence among maintenance medication users remained flat. The most important factor associated with adherence was dual eligibility status (OR, 1.67; 95% CI: 1.59-1.75). Conclusions: Receipt of maintenance medications increased during the study period and was higher in those with dual eligibility. Overall, adherence to maintenance medications was suboptimal and remained unchanged.

The association of antidepressant treatment with COPD maintenance medication use and adherence in a comorbid Medicare population: A longitudinal cohort study.

Using 2006-2012 Medicare data, this retrospective cohort study identified patients with newly diagnosed COPD and new-onset major depression. Two exposures-antidepressant use (versus non-use) and adherence measured by proportion of days covered (PDC) (PDC ≥0.8 versus <0.8)-were assessed quarterly. We used marginal structural models to estimate the effects of prior antidepressant use and adherence on subsequent COPD maintenance inhaler use and adherence outcomes, accounting for time-varying confounders. A total of 25458 COPD-depression patients, 82% with antidepressant treatment, were followed for a median of 2.5years. Nearly half (48%) used at least 1 COPD maintenance inhaler in any given quarter; among users, 3 in 5 (61%) had a PDC of <0.8. Compared to patients with no antidepressant treatment, those with antidepressant use were more likely to use (relative ratio [RR]=1.15, 95% confidence interval [CI]=1.12-1.17) and adhere to (RR=1.08, 95%=1.03-1.14) their COPD maintenance inhalers. Patients who adhered to antidepressant treatment were more likely to use and adhere to COPD maintenance inhalers. Regularly treated depression may increase use of and adherence to necessary maintenance medications for COPD. Antidepressant treatment may be a key determinant to improving medication-taking behaviors among COPD patients comorbid with depression.

Pilot study of a culturally adapted psychoeducation (CaPE) intervention for bipolar disorder in Pakistan

BackgroundDespite the use of maintenance medication, recurrence rates in bipolar affective disorder (BPAD) are high. To date, there are no clinical trials that have investigated the use of psychological interventions in bipolar disorder in Pakistan.AimThe purpose of the study was to assess the feasibility and acceptability of a culturally adapted bipolar psychoeducation programme (CaPE) in Pakistan.MethodsThirty-four euthymic bipolar I and II outpatients were randomized to either 12 weekly sessions of individual psychoeducation plus Treatment As Usual (Intervention) or Treatment As Usual (TAU) (Control). Outcomes were assessed using the Young Mania Rating Scale (YMRS), Beck Depression Inventory (BDI), EuroQoL (EQ-5D), Bipolar Knowledge and Attitudes and Questionnaire (BKAQ), and a self-reported measure of medication adherence (Morisky Medication Adherence Scale-4 items, MMAS-4). Effect sizes were derived from baseline adjusted standardized regression coefficients.ResultsRetention in the study was good, 80% of patients in the TAU follow-up assessment and 100% of patients in the CaPE group attended all 12 sessions. Patient satisfaction was higher in the CaPE group relative to control (ES = 1.41). Further, there were large effect sizes shown for CaPE versus TAU for medication adherence (MMAS-4: ES = 0.81), knowledge and attitudes towards bipolar (BKAQ: ES = 0.68), mania (YMRS: ES = 1.18), depression (BDI: ES = 1.17) and quality of life measures (EQ-5D: ES ⇒ 0.88).ConclusionsCulturally adapted psychoeducation intervention is acceptable and feasible, and can be effective in improving mood symptoms and knowledge and attitudes to BPAD when compared with TAU. Larger scale studies are needed to confirm our findings.Trial registration. Clinicaltrials.gov identifier NCT02210390

Predictors of Appropriate Pharmacotherapy Management of COPD Exacerbations and Impact on 6-Month Readmission.

Suboptimal treatment of exacerbations is a major concern in management of chronic obstructive pulmonary disease (COPD). The Pharmacotherapy Management of COPD Exacerbation (PCE) Healthcare Effectiveness Data and Information Set (HEDIS) measure is a quality measure included by the National Committee for Quality Assurance that focuses on appropriate use of steroids and bronchodilators during an acute COPD exacerbation. There is limited evidence evaluating predictors of this quality measure, as well as its association with hospital readmission and cost outcomes. To (a) describe characteristics of patients hospitalized for COPD, (b) evaluate factors associated with appropriate receipt of pharmacotherapy upon discharge, and (c) evaluate factors associated with the rate of readmission. In this retrospective, observational, event-based study of COPD-related hospital and ED visits, events were identified between 2007 and 2013 from a Central Texas health plan using administrative claims data. The index date was defined as the date of admission. Subjects were included if they were aged ≥ 40 years and had a medical claim with a primary diagnosis for COPD or a pharmacy claim for a COPD maintenance medication during the 1-year pre-index period. Study groups were identified based on the receipt of PCE within the time frame specified by HEDIS: (a) a systemic corticosteroid within 14 days of discharge (PCE-C) or (b) a bronchodilator within 30 days of discharge (PCE-D). Bivariate analyses of potential factors associated with the receipt of PCE were performed using t-tests for continuous data and chi-square tests for categorical data. Generalized estimating equations, including significant predictors from the bivariate analyses, were used to determine factors associated with receipt of PCE-C and/or PCE-D, as well association with COPD-related and all-cause readmission within 6 months of discharge. Of 375 identified index admissions, 254 (68%) patients received PCE-C; 299 (80%) received PCE-D; and 229 (61%) received both. Patients were more likely to receive PCE with an index inpatient visit as compared with an ED visit (PCE-C: RR = 2.25, 95% CI = 1.21-4.17, P = 0.010; PCE-D: RR = 1.90, 95% CI = 1.01-3.58, P = 0.048). Those with previous use of rescue medication were also more likely to receive PCE (PCE-C: RR = 1.88, 95% CI = 1.12-3.17, P = 0.018; PCE-D: RR = 2.11, 95% CI = 1.16-3.83, P = 0.014). Patients with greater adherence (proportion of days covered [PDC] ≥ 75%) to COPD maintenance medication before admission (RR = 8.67, 95% CI = 1.60-46.78, P = 0.012) were also more likely to receive PCE-D. Older patients were more likely to have a COPD-related readmission (RR = 1.07, 95% CI = 1.01-1.13, P = 0.028), while use of maintenance medication before admission was associated with lower risk of an all-cause readmission (RR = 0.49, 95% CI = 0.30-0.79, P = 0.004). In addition, patients with higher medical and pharmacy costs before the index event were more likely to have all-cause readmission (RR = 1.01, 95% CI = 1.00-1.02, P = 0.013). Receipt of PCE was not shown to be a significant predictor of all-cause or COPD-related readmission. The use of bronchodilators and systemic corticosteroids after a COPD-related inpatient or ED visit may be related to the severity of the index COPD exacerbation or patients' previous pattern of bronchodilator use. However, the use of maintenance medication before the index event was associated with a significant reduction in all-cause readmission, so proper treatment of the underlying disease may be an effective strategy in reducing readmission. Funding for this study was provided by GlaxoSmithKline (HO-14-15081). Tran was a Fellow at Scott & White Health Plan (SWHP) during year 1 of this study and a Fellow at Novartis during year 2 of this study. Novartis did not have any input in this study nor did it contribute any funding or support for this research. Tran, Xiang, Godley, and Stock were employed by SWHP at the time of this study. Rascati is employed by the University of Texas at Austin and also by the Journal of Managed Care & Specialty Pharmacy and has received consulting fees from GlaxoSmithKline. Coleman, Bogart, and Stanford are GlaxoSmithKline employees and shareholders. Study design was created by Rascati, Tran, and Godley, with assistance from Stock, Coleman, Bogart, and Stanford. Tran and Xiang collected the data, with data analysis and interpretation performed by Stock and Rascati. The manuscript was written by Tran, Rascati, and Xiang and revised by Godley, Stock, Coleman, Bogart, and Stanford.

The effects of a palliative care program on antidepressant use and continuing maintenance medications in near end-of-life oncology patients (the HEALED study)

The use of antidepressants and maintenance medications for cancer patients in a palliative care setting is controversial. The effectiveness of antidepressants and consequences of discontinuing maintenance medications are unknown in this population. Compare the quality of life of patients taking and not taking antidepressants at entry to a palliative care clinic, and to observe maintenance medication use in this population, along with consequences of stopping them. Prospective, monthly review of medications, quality of life, and hospitalizations were recorded from oncology patients that attended a palliative care clinic. In addition, a retrospective chart review of medications and hospitalizations of oncology patients that did and did not attend a palliative care clinic was performed. Forty-three prospective patients were enrolled. Patients had similar quality of life whether or not they were taking antidepressants (p = 0.52). Number of maintenance medications at entry and at final evaluation did not change (p = 0.45). No hospitalizations were caused by discontinuation of maintenance medications. QOL of patients did not decline after coming to the clinic based on the baseline and second FACT-G questionnaires (p = 0.84). Fifty-six patients were included in the retrospective portion of this study. The non-palliative care patients had higher proportions of maintenance medications and rates of hospitalizations when compared to the palliative care patients. Quality of life is essentially the same between palliative care patients, whether they are receiving antidepressants or not.

Can Bariatric Surgery be Performed Safely in Patients with Severe Treatment-Resistant Asthma?

Obesity-associated severe asthma is a distinct phenotype characterised by resistance to standard asthma therapies. Bariatric surgery appears to be a viable alternative for those who have failed trials of traditional weight loss methods. However, anaesthetic and surgical risks are potential barriers. We describe three patients with treatment-resistant obesity-associated severe asthma who underwent bariatric surgery without complications due to the multidisciplinary perioperative planning and care involved in these complex cases. All three patients showed improvements in asthma control and reduction in maintenance medication use post-surgery.

Should Medicare rely on high drug spending as a criterion for medication therapy management programmes?

Abstract Objectives The goal of Medicare Part D medication therapy management programmes (MTMPs) is to optimize medication use by beneficiaries. The Centers for Medicare &amp; Medicaid Services require prescription drug plans (PDPs) to consider numbers of chronic medications and conditions, and total Part D spending when targeting beneficiaries for MTMPs. However, there is no explicit evidence base establishing these criteria. The objectives were to examine the associations of Part D spending with medication use and adherence among Medicare beneficiaries with chronic obstructive pulmonary disease (COPD). Methods This retrospective cross-sectional study used a 5% random sample of Medicare beneficiaries with COPD enrolled in stand-alone PDPs and Medicare Parts A and B in 2006–2007 (n = 72 912). Maintenance medication use and adherence for COPD were measured in three domains: discontinuation, duration of therapy and proportion of days covered. Key findings Proportions of beneficiaries using COPD maintenance medications increased with Part D spending, from 33.4% (quintile 1) to 60.5% (quintile 5), after covariant adjustment. Among maintenance medication users, the adjusted proportions of beneficiaries exhibiting better adherence also increased with spending, with the top 20% of spenders having the highest proportion of beneficiaries exhibiting good adherence. Adjusted proportions of beneficiaries discontinuing medications decreased with increased Part D spending. Conclusions The Part D MTMP spending criterion (US$4000 in 2007; US$3000 in 2010) may be an inappropriate target for identifying Medicare beneficiaries in need of adherence counselling. Findings suggest higher spenders may have learned healthy adherence behaviours, whereas lower spenders may be prone to discontinue medication and/or demonstrate poor adherence behaviours.

Clinical predictors of frequent exacerbations in subjects with severe chronic obstructive pulmonary disease (COPD)

Acute exacerbations are a significant source of morbidity and mortality associated with chronic obstructive pulmonary disease. Among individuals with COPD, some patients suffer an inordinate number of exacerbations while others remain relatively protected. We undertook a study to determine the clinical factors associated with "frequent exacerbator" status within a population of subjects with severe COPD. Case-control cohort recruited from two Boston-area practices. All subjects had GOLD stage 3 or 4 (FEV(1) ≤ 50% predicted) COPD. "Frequent exacerbators" (n = 192) had an average of ≥2 moderate-to-severe exacerbations per year while "non-exacerbators" (n = 153) had no exacerbations in the preceding 12 months. Multivariate logistic regression was performed to determine the significant clinical predictors of "frequent exacerbator" status. Physician-diagnosed asthma was a significant predictor of frequent exacerbations. Within a subset of our cohort, the modified Medical Research Council dyspnea score and FEF (25-75%) predicted were also significant clinical predictors of frequent exacerbator status (p < 0.05). Differences in exacerbation frequency were not found to be due to increased current tobacco use or decreased rates of maintenance medication use. Within our severe COPD cohort, a history of physician-diagnosed asthma was found to be a significant clinical predictor of frequent exacerbations. Although traditional risk factors such as decreased FEV(1)% predicted were not significantly associated with frequent exacerbator status, lower mid-expiratory flow rates, as assessed by FEF (25-75%) predicted, were significantly associated with frequent exacerbations in a subset of our cohort.

Baixo grau de percepção da dispneia após teste de broncoprovocação induzida por metacolina em pacientes com asma

To determine the proportion of asthma patients with a poor perception of dyspnea, correlating the level of that perception with the severity of acute bronchoconstriction, bronchial hyperresponsiveness, use of maintenance medication, and asthma control. Uncontrolled clinical trial involving asthma patients treated at the Pulmonology Outpatient Clinic of the São Lucas Hospital, in Porto Alegre , Brazil. Methacholine challenge testing was performed using a five-breath dosimeter protocol. The perception of dyspnea after each breath was determined using the Borg scale. Data concerning asthma control, medication in use, and use of rescue short-acting bronchodilators were recorded. Of the 65 patients included in the study, 53 completed the evaluation. Of those, 32 (60.5%) showed adequate perception of dyspnea after the methacholine challenge test, whereas 21 (39.5%) did not perceive any changes in the degree of dyspnea even after a 20% fall in FEV1. There were no significant differences between the two groups regarding baseline FEV1, percentage fall in FEV1, and the dose of methacholine causing a 20% fall in FEV1. The perception of dyspnea was not significantly associated with age (p = 0.247); gender (p = 0.329); use of maintenance medication (p = 0.152); asthma control (p = 0.562), bronchial hyperresponsiveness (p = 0.082); or severity of acute bronchoconstriction (p = 0.749). A significant proportion of asthma patients have a poor perception of dyspnea. The factors related to the inability of these patients to identify changes in pulmonary function have not yet been well defined. In order to reduce asthma-related morbidity and mortality, it is essential that this group of patients be identified and counseled.

Intermittent Therapy for Flare Prevention and Long-term Disease Control in Stabilized Atopic Dermatitis: A Randomized Comparison of 3-Times-Weekly Applications of Tacrolimus Ointment Versus Vehicle

Breneman D, Fleisher AB, Abramovitis A, et al. J Am Acad Dermatol . 2008;58(6):990–999 PURPOSE OF THE STUDY. To examine the usefulness of regular intermittent therapy instead of treating flares for the approach of atopic dermatitis (AD). STUDY POPULATION. A total of 383 patients were randomly assigned to the stabilization phase, and 288 patients were controlled on tacrolimus ointment. There were 68 children (aged 2–16 years) and 57 adults (>16 years) in the tacrolimus arm and 37 children and 35 adults in the vehicle arm. Eighty-five percent had moderate AD, and 15% had severe AD. METHODS. Adult and pediatric patients with moderate-to-severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomly assigned in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days. Relapses were treated with open-labeled tacrolimus. RESULTS. There were 288 patients who entered the randomization phase. The largest reasons for not finishing the stabilization phase were voluntary patient withdrawal for 95 patients and loss to follow-up for 55 patients. Only 16 (4.2%) patients were withdrawn for lack of efficacy. A total of 125 patients were randomly assigned to tacrolimus, and 72 patients were assigned to vehicle. The mean number of flare-free treatment days was 177 for the tacrolimus group and 134 for the vehicle group ( P = .003). Median time to first relapse was 169 days for the tacrolimus group and 43 for the vehicle group ( P = .037). CONCLUSIONS. Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle and a significantly longer time until first disease relapse. REVIEWER COMMENTS. This article examined the possibility of proactive treatment of AD instead of reacting to flares. The principle is similar to the use of maintenance medication for asthma. Similar results were seen with topical fluticasone propionate (Berth-Jones J, Damstra RJ, Golsch S, et al. BMJ . 2003;326[7403]:1367). One significant limitation is that the study only included patients who responded to topical tacrolimus. The question now is whether it can be generalized to all patients with AD or patients not controlled with daily topical therapies.

Use of inhaled corticosteroids decreases hospital admissions for asthma in young children

An active use of inhaled corticosteroids for asthma has been associated with less asthma exacerbations and hospital admissions in children aged more than 2 years. The present study aimed to investigate hospital admission rates in young children from two populations in relation to the age-specific use of maintenance medication for asthma. Annual data on children aged less than 24 months treated for asthma, including data on the use of maintenance medication based on the purchases of prescribed medications, and annual numbers of admissions to hospital and proportions of readmissions, were collected from 1995 to 1999 in two provinces of Finland. The inclusion criteria, three or more doctor-diagnosed wheezing episodes, were individually checked by the authors in each case. The mean number of children aged less than 24 months during the years of the study was 5490 in Kuopio and 9914 in Oulu area. In the Kuopio area, during the years of the study, 16.5/1000 children aged less than 24 months were on maintenance medication for asthma, and 90% of them were receiving inhaled corticosteroids. In the Oulu area, the respective figures were 13.5/1000 (P<0.001) and 99%. The average admission rate was 7.9/1000 in the Kuopio area and 8.7/1000 in the Oulu area (P<0.05). The readmissions indicated the higher admission rates in the Oulu (40% of all admissions) than in the Kuopio (28%) area (P<0.01). Active use of maintenance therapy by inhaled corticosteroids was associated with a decreased need of hospital treatment in young children <24 months old with asthma, mainly because of less readmissions.