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Hypertrophic cardiomyopathy (HC) is a common genetic heart disease. However, the number of gene mutation carriers who develop HC and manifest clinical symptoms is not well established. Our objective was to estimate annual prevalence and incidence rates of clinically diagnosed HC in the United States. Data from the HealthCore Integrated Research Database (HIRD) were interrogated for years 2013-2019 to identify patients with ≥1 claim of HC International Classification of Diseases, Clinical Modification Ninth and Tenth Revision diagnosis codes. In 2013, among 16,243,109 patients, 8,526 were identified with HC, yielding an estimated prevalence of clinically diagnosed HC of 0.052% (0.035% for obstructive [oHC], 0.017% for nonobstructive [nHC]). This prevalence yielded an estimated 164,403 patients with clinical diagnosis of HC. For the same year, the incidence of new HC diagnoses was 0.030% (0.020% for oHC, 0.010% for nHC). Over the following 6 years, prevalence and incidence of HC increased by 0.005%/year (p

Background Contemporary trials of patients with heart failure with reduced ejection fraction (HFrEF) required a recent worsening heart failure (WHF) event for inclusion. We aimed to describe characteristics and outcomes of patients with HFrEF and a recent WHF event at a large tertiary referral center. Methods and Results We identified adult patients with chronic symptomatic HFrEF (ejection fraction ≤35%) treated at Duke University between January 1, 2009, and December 31, 2018, and applied a set of exclusion criteria to generate a cohort similar to those enrolled in contemporary heart failure trials. Patients were stratified by presence or absence of a recent WHF event, defined as an emergency department visit for heart failure or hospitalization for heart failure in the prior 12 months. Characteristics and outcomes including death and hospitalization were assessed. Of 3867 patients with HFrEF meeting study criteria, 2823 (73.0%) had a WHF event in the prior 12 months. Compared with patients without a WHF event, those with a WHF event were more likely to be under‐represented racial and ethnic groups and had lower ejection fraction, a greater burden of comorbidities, and more echocardiographic evidence of cardiac dysfunction. Despite higher use of guideline‐directed therapies, patients with a WHF event had higher rates of death (hazard ratio, 2.30; 95% CI, 2.01–2.63), all‐cause hospitalization (hazard ratio, 1.56; 95% CI, 1.42–1.71), and heart failure hospitalization (hazard ratio, 1.59; 95% CI, 1.44–1.75) through 5 years compared with those without a recent WHF event. Conclusions WHF events are common in patients with HFrEF and are associated with more advanced disease. Patients with recent WHF have high rates of death and hospitalization, underscoring the need for novel therapies in this large subgroup of patients with HFrEF.

Background: Obstructive hypertrophic cardiomyopathy (oHCM) has mostly been studied in patients treated in advanced comprehensive Centers of Excellence (COE). Understanding the true prevalence of patients with oHCM in the general US population may improve the screening, identification, and treatment outside of COEs. Objectives: To describe the demographics and clinical characteristics of patients with oHCM. Methods: This is a retrospective cohort study to assess patient-level data from the IBM Explorys database (observational period: January 1, 2010 to December 31, 2018). The Explorys database amassed electronic medical records from 39 Integrated Delivery Networks (IDN) from ~12,982,704 patients. We identified adult patients (>18 years old) with oHCM and report their demographics and clinical characteristics from index date to the end of study period. Results: Of 8,792 patients, 53.0% were female, and 81.2% Caucasian (mean index age: 61.8 years). Primary insurance type was private (58.9%); 54.9% of patients lived in the Midwest. Mean BMI at index was 30.4; 30.9% were nondrinkers. The mean Quan-Charlson Comorbidity Index was 6.35% with the most common comorbidities being congestive heart failure (31.9%), chronic pulmonary disease (20.1%), and diabetes without chronic complications (16.9%). CV drug rates included β-blockers (80.5%), CCBs (46.0%), ACE inhibitors (27.7%), ARBs (18.8%), disopyramide (2.4%) and amiodarone (13.0%). Surgical procedure rates included septal myectomy (22%), ablation (19.8%), implantable cardioverter defibrillator (11.2%), and heart transplantation (0.3%). Major residual side effects subsequent to surgical procedures included atrial fibrillation (31.4%) and reintervention (15.6%). Common reintervention procedures included ablation and septal myectomy. Conclusions: This is the first study to examine a national sample of oHCM patients using clinical data from more than 39 IDNs. Leveraging the Explorys database allowed us to analyze a larger, more diverse cohort of oHCM patients across the entire broader US. The results from this analysis may be used to compare the characteristics of patients with oHCM in the general population with those treated in COE.

Background: Heart failure (HF) is one of the costliest conditions in the US with immense public health interest to examine and improve the value of care. We sought to characterize current payments spanning the index hospitalization through 30-days post-discharge for Medicare beneficiaries with HF. Methods: Using Medicare fee-for-service administrative claims data, we identified patients hospitalized with HF from 2016-2018 with the following primary discharge diagnoses (ICD-10 codes): systolic HF (50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease (HHD) with HF (I11), and HHD with HF and chronic kidney disease (CKD) (I13). Coding patterns over time across these four groups, mean 30-day episode of care spending overall, and proportion of total costs allocated to the index hospitalization and post-acute care were analyzed. Results: The study sample included 174,539 patients hospitalized with systolic HF; 163,071 diastolic HF; 221,820 HHD with HF; and 359,950 HHD with HF and CKD. Over time, there was a substantial increase in the use of the HHD with HF +/- CKD codes, accounting for 52% of HF hospitalizations in 2018 (Figure). We found substantial spending on 30-day episode for HF with nearly 2-fold variation across mean spending. Overall, 30-day episode spending was significantly higher for HHD with HF and CKD as compared to other diagnoses. Across all codes, the index hospitalization accounts for 70% of total episode spending while 30% is accounted for by post-acute care spending (Table). Conclusions: This patient episode-level analysis of contemporary Medicare beneficiaries suggests several areas to improve the value of HF care. The 30-day episode of care spending for heart failure hospitalizations is substantial with more than 2-fold variation. The impact of alternative payment models on HF outcomes and spending remains an important area for ongoing investigation.

Background: Several recent heart failure trials enrolled patients with heart failure with reduced ejection fraction (HFrEF) who had a worsening heart failure (WHF) event. Aim: To describe the characteristics and outcomes of patients with HFrEF and a WHF event at a large tertiary medical center. Methods: We identified patients 18-85 years of age with chronic symptomatic HFrEF (EF ≤35% and ≥2 HF encounters in the prior 18 months) treated at Duke University between Jan 2009-Dec 2018 through the Duke Echo Lab Database. A WHF event was defined as either a hospitalization or ED visit for HF in the prior 12 mos. A set of exclusion criteria [e.g., renal dysfunction, left ventricular assist device (LVAD), heart transplant] were applied to patients with a WHF event to generate a patient cohort similar to those enrolled in contemporary HF trials. We did not restrict the cohort based on BP or BNP levels since these vary over time. Baseline characteristics and outcomes including death and hospitalization were assessed. Results: Of 4846 unique patients with HFrEF, 3668 (76%) had a WHF event in the year prior to index echo. Sequentially, patients with GFR 2 (n=458), LVAD (n=291), or heart transplant (n=95) were excluded; 2824/4846 (58%) remained in the WHF study population. HFrEF patients with WHF were typically men (68%) with median age of 65 years (IQR 54, 73) and low EF (EF Conclusions: In patients with chronic HFrEF at Duke University, 76% had a WHF event in the past year and 58% met several of the key eligibility criteria of contemporary HF trials. Patients with recent WHF had a high burden of comorbidities and very high event rates.

The prevalence of irritable bowel syndrome with constipation (IBS-C) is estimated to be between 4.3% and 5.2% among adults in the United States. Little is known about the health care resource utilization and costs associated with IBS-C.To (a) evaluate the annual total all-cause, gastrointestinal (GI)-related, and IBS-C-related health care costs among IBS-C patients seeking medical care in a commercially insured population and (b) estimate the incremental all-cause health care costs among IBS-C patients relative to matched controls.Patients aged ≥ 18 years with continuous medical and pharmacy benefit eligibility in 2010 were identified from the HealthCore Integrated Research Database, which consists of administrative claims from 14 geographically dispersed U.S. health plans representing 45 million lives. IBS-C patients were defined as those with ≥ 1 medical claim with an ICD-9-CM diagnosis code in any position for IBS (ICD-9-CM 564.1x) and either ≥ 2 medical claims for constipation (ICD-9-CM 564.0x) on different service dates or ≥ 1 medical claim for constipation plus ≥ 1 pharmacy claim for a constipation-related prescription on different dates of service during the study period. Controls were defined as patients without any medical claims for IBS, constipation, abdominal pain, or bloating or pharmacy claims for constipation-related prescriptions. Controls were randomly selected and matched with IBS-C patients in a 1:1 ratio based on age (± 4 years), gender, health plan region, and health plan type. Patients with diagnoses or prescriptions suggesting mixed IBS, IBS with diarrhea, chronic diarrhea, or drug-induced constipation were excluded. Total health care costs in 2010 U.S. dollars were defined as the sum of health plan and patient paid costs for prescriptions and medical services, including inpatient visits, emergency room (ER) visits, physician office visits, and other outpatient services. The total cost approach was used to assess total all-cause or disease-specific health care costs for patients with IBS-C, while the incremental cost approach was used to examine the excess all-cause costs of IBS-C by comparing IBS-C patients with matched controls. Generalized linear models with bootstrapping were used to assess the incremental all-cause costs attributable solely to IBS-C after adjusting for demographics, Elixhauser Comorbidity Index (ECI) score, and other general and GI-related comorbidities not included in the ECI score.A total of 7,652 patients (n = 3,826 each in the IBS-C and control cohorts) were included in the analysis. The mean (± SD) age was 48 (± 17) years, and 83.6% were female. The mean annual all-cause health care costs for IBS-C patients were $11,182, with over half (53.7%) of the costs attributable to outpatient services, including physician office visits and other outpatient services (13.1% and 40.6%, respectively). Remaining total all-cause costs were attributable to hospitalizations (21.8%), prescriptions (19.1%), and ER visits (5.4%). GI-related costs ($4,456) comprised 39.8% of total all-cause costs, while IBS-C-related costs ($1,335) accounted for 11.9% and were primarily driven by costs of other outpatient services (50.3%). After adjusting for demographics and comorbidities, the incremental annual all-cause health care costs associated with IBS-C were $3,856 ($8,621 for IBS-C patients vs. $4,765 for controls, P less than 0.01) per patient per year, of which 78.1% of the incremental costs were due to medical services, and 21.9% were due to prescription fills.IBS-C imposes a substantial economic burden in terms of direct health care costs in a commercially insured population. Compared with matched controls, IBS-C patients incurred significantly higher total annual all-cause health care costs even after controlling for general and GI-related comorbidities. Incremental all-cause costs associated with IBS-C were mainly driven by costs related to more frequent use of medical services as opposed to prescriptions.

To evaluate total annual all-cause, gastrointestinal-related, and symptom-related healthcare costs among chronic constipation (CC) patients and estimate incremental all-cause healthcare costs of CC patients relative to matched controls.Patients aged ≥18 years with continuous medical and pharmacy benefit eligibility in 2010 were identified from the HealthCore Integrated Research Database. CC patients had ≥2 medical claims for constipation (ICD-9-CM code 564.0x) ≥90 days apart or ≥1 medical claim for constipation plus ≥1 constipation-related pharmacy claim ≥90 days apart, and no medical claims for irritable bowel syndrome (IBS). Sub-groups with and without abdominal symptoms were classified according to the presence/absence of abdominal pain (ICD-9-CM code 789.0x) and bloating (ICD-9-CM code 787.3x). Controls without claims for constipation, abdominal pain, bloating, or IBS or constipation-related prescriptions were randomly selected and matched 1:1 with CC patients on age, gender, health plan region, and plan type. Generalized linear models with bootstrapping evaluated incremental all-cause costs attributable to CC, adjusting for demographics and comorbidities.Overall, 14,854 patients (n = 7427 each in CC and control groups) were identified (mean age = 59 years; 75.4% female). Mean annual all-cause costs for CC patients were $11,991 (2010 USD), with nearly half (44.8%) attributable to outpatient services, including physician office visits and other outpatient services (10.0% and 34.8%, respectively). GI-related costs comprised 33.7% of total all-cause costs. Symptom-related costs accounted for 10.5%, primarily driven by costs of other outpatient services (50.6%). Adjusted incremental all-cause costs associated with CC were $3508 per patient per year ($4446 for CC with abdominal symptoms; $2783 for CC without abdominal symptoms), of which 81.0% were from medical services. Incremental cost estimates may be over- or under-estimated due to classification based on claims.CC imposes a substantial burden in direct healthcare costs in a commercially insured population, mainly attributable to greater use of medical services.

To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide vs lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1) a ≥ 14-point increase from baseline in IBS-Quality-of-Life (IBS-QoL) questionnaire overall score at week 12 or (2) one of the top two responses (moderately/significantly relieved) on a 7-point IBS symptom relief question in ≥ 2 of 3 months. Patients who do not respond to therapy are assumed to fail therapy and accrue costs associated with a treatment failure. Model time horizon is aligned with clinical trial duration of 12 weeks. Model outputs include number of responders, quality-adjusted life-years (QALYs), and total costs (including direct and indirect). Both one-way and probabilistic sensitivity analyses were conducted.Treatment for IBS-C with linaclotide produced more responders than lubiprostone for both response definitions (19.3% vs 13.0% and 61.8% vs 57.2% for IBS-QoL and symptom relief, respectively), lower per-patient costs ($803 vs $911 and $977 vs $1056), and higher QALYs (0.1921 vs 0.1917 and 0.1909 vs 0.1894) over the 12-week time horizon. Results were similar for most one-way sensitivity analyses. In probabilistic sensitivity analyses, the majority of simulations resulted in linaclotide having higher treatment response rates and lower per-patient costs.There are no available head-to-head trials that compare linaclotide with lubiprostone; therefore, placebo-adjusted estimates of relative efficacy were derived for model inputs. The time horizon for this model is relatively short, as it was limited to the duration of available clinical trial data.Linaclotide was found to be a less costly option vs lubiprostone for the treatment of adult patients with IBS-C.

Background: Irritable bowel syndrome with constipation (IBS-C) is a chronic functional gastrointestinal disorder characterized by abdominal pain or discomfort with bowel symptoms of constipation. IBS-C has been shown to decrease work productivity and increase activity impairment, resulting in a substantial economic burden for patients and employers. Linaclotide is an investigational minimally absorbed guanylate cyclase-C receptor agonist shown to significantly improve abdominal and bowel symptoms in 2 Phase 3 IBS-C trials. Aim: To evaluate the impact of linaclotide treatment on work productivity and activity impairment in IBS-C patients. Methods: Adult patients meeting modified Rome II criteria for IBS-C were randomized to oral once-daily 290-μg linaclotide or placebo for 12 weeks in 2 Phase 3 trials. The Work Productivity and Activity Impairment questionnaire for IBS-C (WPAI:IBSC), a self-administered questionnaire consisting of 6 items, was used to measure absenteeism (work hours missed due to IBS-C), presenteeism (degree IBS-C symptoms affected productivity while at work), overall work productivity loss (absenteeism + presenteeism due to IBSC), and daily activity impairment (degree IBS-C symptoms affected regular daily activities, including housework, shopping, childcare, exercising, studying) over the previous 7 days. Based on pooled Phase 3 trial data, changes from baseline to weeks 4, 8, and 12 for all 4 WPAI scores were assessed using an analysis of covariance (ANCOVA) model. Scores are represented as percentages, with higher percentages indicating greater work productivity loss and activity impairment. Results: A total of 1602 patients were randomized in the 2 Phase 3 trials. Patients included in this analysis had both baseline and at least 1 postbaseline WPAI:IBS-C assessment. Daily activity impairment was computed for all patients. Summary measures for absenteeism, presenteeism, and overall work productivity included employed patients only. Compared to placebo, linaclotide significantly reduced presenteeism, overall work productivity loss, and daily activity impairment at weeks 4, 8, and 12. A greater decrease in absenteesim was also observed for linaclotide compared to placebo at weeks 4, 8, and 12. Differences versus placebo in change from baseline to week 12 were 5.6% (p