Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study

Background Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population. Objectives This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013‐30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score‐matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB. Results Amongst NVAF patients, 34% (N = 150 487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55–0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72–0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57–0.66) and dabigatran (HR: 0.79, 95% CI: 0.70–0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08–1.21) was associated with a higher risk vs warfarin. Conclusion Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real‐world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population

Using the Technology Acceptance Model to conceptualise experiences of the usability and acceptability of a self-management app (COPD.Pal®) for Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a long-term progressive inflammatory lung disease causing chronic breathlessness and many hospital admissions. It affects up to 1.2 million people in the UK. To help people with COPD self-manage their condition we developed, in partnership with healthcare users, a digital mobile phone app called COPD.Pal®. We report the first user feedback of COPD.Pal®, applying the Technology Acceptance Model (TAM) theoretical framework. 11 participants engaged with a click dummy version of COPD.Pal® before being asked questions relating to their experiences. A deductive, semantic, reflexive thematic analysis was conducted to analyse their individual and collective experiences. The study was registered at Clinical Trials.gov (NCT04142957). Two overarching themes resulted: Ease of Use and Perceived Usefulness. Within the former, participants discussed how they wanted flexibility and choice in how they engaged with the app; including how often they used it. Additionally, they discussed how the app layout should make it straightforward to use, whilst unanimously agreeing that COPD.Pal® provided this. Within Perceived Usefulness, participants discussed how they wanted the information they entered into the app to be useful, in addition to the app providing resources regarding COPD. Lastly, there was disagreement regarding preferences for further app development. We found that COPD.Pal® was usable and acceptable by people with COPD and TAM provided a useful theoretical framework for both structuring discussions with users and analysing their comments

Association between adherence to medications for COPD and medications for other chronic conditions in COPD patients

Amol D Dhamane,1 Phil Schwab,2 Sari Hopson,2 Chad Moretz,2 Srinivas Annavarapu,2 Kate Burslem,1 Andrew Renda,3 Shuchita Kaila1 1Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, 2Comprehensive Health Insights Inc, Louisville, 3Humana Inc, Louisville, KY, USA Background: Patients with COPD often have multiple comorbidities requiring use of multiple medications, and adherence rates for maintenance COPD (mCOPD) medications are already known to be suboptimal. Presence of comorbidities in COPD patients, and use of medications used to treat those comorbidities (non-COPD medications), may have an adverse impact on adherence to mCOPD medications. Objective: The objective of the study was to evaluate the association between non-adherence to mCOPD medications and non-COPD medications in COPD patients. Methods: COPD patients were identified using a large administrative claims database. Selected patients were 40–89 years old and continuously enrolled for 12 months prior to and 24 months after the first identified COPD diagnosis (index date) during January 1, 2009 to December 31, 2010. Patients were required to have ≥1 prescription for a mCOPD medication within 365 days of the index date and ≥1 prescription for one of 12 non-COPD medication classes within ±30 days of the first COPD prescription. Adherence (proportion of days covered [PDC]) was measured during 365 days following the first COPD prescription. The association between non-adherence (PDC <0.8) to mCOPD and non-adherence to non-COPD medications was determined using logistic regression, controlling for baseline patient characteristics. Results: A total of 14,117 patients, with a mean age of 69.9 years, met study criteria. Of these, 40.9% were males and 79.2% were non-adherent to mCOPD medications with a mean PDC of 0.47. Non-adherence to mCOPD medications was associated with non-adherence to 10 of 12 non-COPD medication classes (odds ratio 1.38–1.78, all P<0.01). Conclusion: Adherence to mCOPD medications is low. Non-adherence (or adherence) to mCOPD medications is positively related to non-adherence (or adherence) to non-COPD medications, implying that the need to take medications prescribed for comorbid conditions does not adversely impact adherence to mCOPD medications. Keywords: COPD, comorbidities, adherence, PDC, database, Medicar

COPD exacerbation frequency and its association with health care resource utilization and costs

Amol D Dhamane,1 Chad Moretz,2 Yunping Zhou,2 Kate Burslem,1 Kim Saverno,2 Gagan Jain,1 Andrew Renda,3 Shuchita Kaila1 1Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA; 2Comprehensive Health Insights Inc., Louisville, KY, USA; 3Humana Inc., Louisville, KY, USA Background: Chronic obstructive pulmonary disease (COPD) exacerbations account for a substantial proportion of COPD-related costs.Objective: To describe COPD exacerbation patterns and assess the association between exacerbation frequency and health care resource utilization (HCRU) and costs in patients with COPD in a Medicare population.Methods: A retrospective cohort study utilizing data from a large US national health plan was conducted including patients with a COPD diagnosis during January 1, 2007 to December 31, 2012, aged 40–89 years and continuously enrolled in a Medicare Advantage Prescription Drug plan. Exacerbation frequency, HCRU, and costs were assessed during a 24-month period following the first COPD diagnosis (follow-up period). Four cohorts were created based on exacerbation frequency (zero, one, two, and ≥three). HCRU and costs were compared among the four cohorts using chi-square tests and analysis of variance, respectively. A trend analysis was performed to assess the association between exacerbation frequency and costs using generalized linear models.Results: Of the included 52,459 patients, 44.3% had at least one exacerbation; 26.3%, 9.5%, and 8.5% had one, two, and ≥three exacerbations in the 24-month follow-up period, respectively. HCRU was significantly different among cohorts (all P<0.001). In patients with zero, one, two, and ≥three exacerbations, the percentages of patients experiencing all-cause hospitalizations were 49.7%, 66.4%, 69.7%, and 77.8%, respectively, and those experiencing COPD-related hospitalizations were 0%, 40.4%, 48.1%, and 60.5%, respectively. Mean all-cause total costs (medical and pharmacy) were more than twofold greater in patients with ≥three exacerbations compared to patients with zero exacerbations ($27,133 vs$56,033; P<0.001), whereas a greater than sevenfold difference was observed in mean COPD-related total costs ($1,605 vs$12,257; P<0.001). Conclusion: COPD patients frequently experience exacerbations. Increasing exacerbation frequency is associated with a multiplicative increase in all-cause and COPD-related costs. This underscores the importance of identifying COPD patients at risk of having frequent exacerbations for appropriate disease management. Keywords: COPD, exacerbations, frequency, cost

Impact of comorbid conditions in COPD patients on health care resource utilization and costs in a predominantly Medicare population

Phil Schwab,1 Amol D Dhamane,2 Sari D Hopson,1 Chad Moretz,1 Srinivas Annavarapu,1 Kate Burslem,2 Andrew Renda,3 Shuchita Kaila2 1Comprehensive Health Insights Inc., Louisville, KY, 2Health Economics and Outcomes Research, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 3Humana Inc., Louisville, KY, USA Background: Patients with chronic obstructive pulmonary disease (COPD) often have multiple underlying comorbidities, which may lead to increased health care resource utilization (HCRU) and costs.Objective: To describe the comorbidity profiles of COPD patients and examine the associations between the presence of comorbidities and HCRU or health care costs.Methods: A retrospective cohort study utilizing data from a large US national health plan with a predominantly Medicare population was conducted. COPD patients aged 40–89 years and continuously enrolled for 12 months prior to and 24 months after the first COPD diagnosis during the period of January 01, 2009, through December 31, 2010, were selected. Eleven comorbidities of interest were identified 12 months prior through 12 months after COPD diagnosis. All-cause and COPD-related hospitalizations and costs were assessed 24 months after diagnosis, and the associations with comorbidities were determined using multivariate statistical models.Results: Ninety-two percent of 52,643 COPD patients identified had at least one of the 11 comorbidities. Congestive heart failure (CHF), coronary artery disease, and cerebrovascular disease (CVA) had the strongest associations with all-cause hospitalizations (mean ratio: 1.56, 1.32, and 1.30, respectively; P<0.0001); other comorbidities examined had moderate associations. CHF, anxiety, and sleep apnea had the strongest associations with COPD-related hospitalizations (mean ratio: 2.01, 1.32, and 1.21, respectively; P<0.0001); other comorbidities examined (except chronic kidney disease [CKD], obesity, and osteoarthritis) had moderate associations. All comorbidities assessed (except obesity and CKD) were associated with higher all-cause costs (mean ratio range: 1.07–1.54, P<0.0001). CHF, sleep apnea, anxiety, and osteoporosis were associated with higher COPD-related costs (mean ratio range: 1.08–1.67, P<0.0001), while CVA, CKD, obesity, osteoarthritis, and type 2 diabetes were associated with lower COPD-related costs.Conclusion: This study confirms that specific comorbidities among COPD patients add significant burden with higher HCRU and costs compared to patients without these comorbidities. Payers may use this information to develop tailored therapeutic interventions for improved management of patients with specific comorbidities. Keywords: COPD, comorbidities, utilization, cost, database, Medicar