Clinical characteristics and treatment patterns in patients with atherosclerotic cardiovascular disease with hypercholesterolemia: a retrospective analysis of a large US real-world database cohort.

OBJECTIVE: Guidelines developed by the American College of Cardiology/American Heart Association (ACC/AHA) recommend lipid-lowering therapies (LLTs) to reduce low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD) risk. This study described LLT utilization patterns and LDL-C goal achievement (to <70 mg/dL) among patients with ASCVD in the United States. METHODS: This retrospective study was conducted using Optum's de-identified Clinformatics Data Mart Database (CDM). Patients with their first ASCVD diagnosis (index date) in the CDM database between July 1, 2015, and December 31, 2018, were followed for ≥12 months to assess LLT utilization patterns and change in LDL-C. LLTs included were statins and non-statin LLTs (ezetimibe, fibrates, and proprotein convertase subtilisin/kexin type 9 inhibitors). Adherence was measured as the proportion of days covered (PDC), defined as the number of days with drug on-hand (or number of days exposed to drug) divided by the 12-month follow-up period. Patients with PDC ≥0.8 were considered adherent. RESULTS: Among the patients with ASCVD (N = 1,424,893) included in this study, only 621,978 (43.7%) had at least one LDL-C measurement at baseline (6 months prior to and 3 months after the index date). The mean age was 71.5 years, and almost half of the patients were female. Patients were followed for a mean (standard deviation [SD]) duration of 30.6 (11.4) months (median of 29.9 months). During the follow-up, about one-quarter of the patients did not receive any LLT. Among treated patients, 89.5% received statins and 10.5% received non-statin LLT. Less than half (47.6%) of the patients were adherent to the index treatment during the 12-month follow-up. Even in patients receiving combination therapy (statin + non-statin LLT), a sizable proportion (35.8%) showed an increase in LDL-C over the follow-up period. CONCLUSIONS: This retrospective study highlighted limited LDL-C monitoring in patients with ASCVD, and unmet need in terms of suboptimal utilization of non-stain LLTs, limited adherence to LLTs, and inadequate lipid control after treatment (among those with LDL-C measurements during the follow-up period) need to be addressed to improve outcomes in this patient cohort.

International societies of cardiologists recommend use of medications to lower the "bad" cholesterol, and its risk of cardiovascular diseases like stroke. We aimed to describe how those medications are being used and to what extent patients with cardiovascular diseases in the United States have their "bad" cholesterol under control. Results of this study indicate that cholesterol check-up among the patients was limited. Among recommended medications, statins were mostly used, whereas use of other recently approved medications was minimal. One-quarter of patients were not prescribed medications to control their cholesterol. Moreover, patients were not taking the medications as frequently as prescribed.

Cost Effectiveness of Inclisiran in Atherosclerotic Cardiovascular Patients with Elevated Low-Density Lipoprotein Cholesterol Despite Statin Use: A Threshold Analysis.

BACKGROUND: Inclisiran is a novel, cholesterol-lowering therapy, with a long duration of effect, administered every 6 months (subcutaneously by a healthcare professional). In the ORION-10 trial in US patients with atherosclerotic cardiovascular disease (ASCVD) in addition to maximum tolerated statins, with or without ezetimibe, inclisiran demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 51%. This is the first peer-reviewed publication to investigate the price at which inclisiran is cost effective in the US. OBJECTIVE: The aim of this study was to determine the maximum price at which inclisiran is cost effective in addition to standard of care, in US patients with ASCVD, versus standard of care alone, at different willingness-to-pay thresholds. DESIGN, SETTING AND PARTICIPANTS: A lifetime Markov model from the US health system perspective, including 15 health states, was used to evaluate the cost effectiveness of inclisiran. The following states were separated by time from a previous cardiovascular event (0-1 years, 1-2 years, 2+ years ['stable']): initial, unstable angina, myocardial infarction, and stroke. Additional states included revascularization and death (cardiovascular or non-cardiovascular causes). Baseline risk of cardivoascular events were from US database sources or published literature. Reductions in LDL-C from inclisiran were from the ORION-10 trial. LDL-C reduction was used to adjust baseline risk of cardiovascular events, based on established relationships between 1 mmol/L reduction in LDL-C and decreases in cardiovascular events, from the Cholesterol Treatment Trialists studies. The population included adults with a history of ASCVD, and LDL-C ≥ 70 mg/dL, despite maximum tolerated doses of statin therapy. INTERVENTIONS: Inclisiran as an adjunct to standard of care, compared with standard of care alone. MAIN OUTCOMES AND MEASURES: The threshold price of inclisiran. RESULTS: Inclisiran as an adjunct to standard of care resulted in threshold annual inclisiran prices of $6383, $9973, and $13,563 at willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per quality-adjusted life-year, respectively. Probabilistic sensitivity analysis showed that at a threshold of $100,000 per QALY, inclisiran had a 100% probability of being cost effective, with an annual price below $9000. At the publicly available price of $3250 per dose, inclisiran was found to have an incremental cost-effectiveness ratio just above the $50,000 per QALY threshold, of $51,686. CONCLUSIONS AND RELEVANCE: This study identified the price at which inclisiran is cost effective for the US health system, at generally accepted willingness-to-pay thresholds.

Physician-Patient Concordance in the Assessment of Asthma Control.

BACKGROUND: Discordance between physicians' and patients' perceptions of asthma control may negatively impact symptom control, treatment, and outcomes. OBJECTIVE: To evaluate concordance between physicians' and patients' perceptions of overall asthma control and the association between perceived overall control and individual components of control. METHODS: U.S. survey data (Dec 2015-Feb 2016; Apr-Aug 2018) from the Respiratory Disease Specific Programme were analyzed. Physicians recorded patient disease characteristics and their perception of patients' asthma control. Patients' perception of control was assessed using the Asthma Control Test; responses were compared with level of symptom control per the Global Initiative for Asthma criteria and Work Productivity and Impairment questionnaire responses. Agreement and association were assessed by weighted kappa (κ) and Spearman rho (ρ), respectively. RESULTS: The study included 1,288 patients. Concordance between physician-perceived and patient-perceived asthma control in the prior 4 weeks was moderate (κ = 0.4951). Association between physicians' overall perception of asthma control and patients' overall Asthma Control Test score was also moderate (ρ = 0.5450). However, 61.5% of patients with self-reported, well-controlled asthma had shortness of breath 1 to 2 times/wk, 45.6% had 1 to 2 night-time awakenings/wk, and patients reported a mean (SD) daily activity impairment of 17.5% (16.2%). Only 21.8% of patients with self-reported, well-controlled asthma were classified as such by Global Initiative for Asthma symptom criteria. CONCLUSIONS: Patients' self-assessment of overall control does not accurately characterize the true level of control; thus, patients and physicians may benefit from working together to assess the individual components of asthma control to achieve better disease management, treatment decisions, and improved outcomes.

Burden of relapsing-remitting multiple sclerosis on workers in the US: a cross-sectional analysis of survey data.

BACKGROUND: Multiple sclerosis (MS) is prevalent among working age individuals (20-60 years), leading to high burden on work productivity. Few data are available about the absenteeism and presenteeism in employed individuals with MS in comparison to non-MS personnel. This study aimed to quantify the burden of illness of employed US adults with relapsing-remitting multiple sclerosis (RRMS) and examine burden by levels of work impairment. METHODS: A retrospective cross-sectional analysis was conducted using patient-reported responses from the US National Health and Wellness Survey (NHWS). Data from NHWS 2015-2016 were analyzed from 196 employed RRMS respondents who were matched 1:4 to employed respondents without MS based on demographic and general health characteristics. Demographic and general health characteristics for employed RRMS individuals were analyzed by levels of work impairment (none, 1-30%; 31-68%; 69-100%). Work productivity (absenteeism, presenteeism, and work impairment), decrements in health-related quality of life (HRQoL) (short form-36, EQ-5D), and healthcare resource utilization (HCRU) were compared to determine the burden of RRMS. RESULTS: After propensity score matching, the levels of absenteeism and presenteeism were 2 and 1.8 times higher in the employed RRMS population than the employed non-MS population, respectively (P < 0.001 for both). HRQoL was significantly lower in employed respondents with RRMS than those without MS (P < 0.001 for all). Employed respondents with RRMS had significantly more HCRU over 6 months compared to those without MS (P < 0.001). Furthermore, among employed RRMS respondents, greater levels of impairment were associated with increasing disease severity, greater healthcare resource use, fatigue, and cognitive impairment and inversely associated with mental and physical HRQoL (P < 0.0001 for all). CONCLUSIONS: Among employed individuals, respondents with RRMS had lower, work productivity, HRQoL, and higher HCRU as compared with those without MS. Given the large impact RRMS has on work impairment, a need exists to manage individuals on therapies that improve HRQoL, reduce symptoms, and improve their ability to perform in the workforce.

Effectiveness of a Pharmacist-Physician Team-Based Collaboration to Improve Long-Term Blood Pressure Control at an Inner-City Safety-Net Clinic.

PURPOSE: To evaluate the effectiveness of a pharmacist-physician collaborative practice model (PPCPM) to improve long-term blood pressure (BP) control rates in a primarily African-American underserved urban population. PRACTICE INNOVATION: Volunteer physicians established initial diagnoses, whereas pharmacists provided most (more than 70%) of the medication management. During each scheduled visit, the pharmacist reconciled the medication list, completed a clinical interview, conducted a focused physical examination, developed and implemented a treatment plan, and provided documentation in a shared medical record. EVALUATION: A retrospective chart review was performed to collect data for a longitudinal cohort of patients managed by the PPCPM from 2010-2013. RESULTS: Of 385 patients with at least two pharmacist visits during 2009, 172 patients received continuous care over the study period. At baseline, the mean age of the cohort was 51.3 years, 62% were female, and 76% were African-American. Approximately 65% were obese (body mass index 30 kg/m(2) or higher), and 39% were cigarette smokers. Mean baseline BP was 156/98 mm Hg, with only 17% of the cohort at their BP goal of lower than 140/90 mm Hg. The BP control rate improved to 66% during the first year and persisted throughout the study period, with 68% of patients at goal in 2013 (p<0.05 compared with baseline). CONCLUSION: The PPCPM BP control rate ranks in the 90th percentile of National Committee for Quality Assurance benchmarks and was superior even to the 2013 reported mean for commercial insurers. The PPCPM effectively improved hypertension control in an uninsured, primarily African-American, urban population despite significant health barriers. Key elements of this asynchronous care model included access to a common medical record, optimization of distinct interprofessional roles, frequent follow-up with evaluation, and collaborative practice agreement with sufficient scope of practice to implement medication changes at the time of the visit.