Real-world comparative effectiveness of sotorasib versus docetaxel in second line and beyond among patients with advanced non-small cell lung cancer (NSCLC).

Objectives: To evaluate the comparative effectiveness of sotorasib monotherapy versus docetaxel as monotherapy or combination therapy in patients with pretreated KRAS G12C-mutated advanced NSCLC in the real-world.

Methods: A US-based electronic health record-derived de-identified database was used in this study. Patients with pretreated KRAS G12C-mutated advanced NSCLC who initiated sotorasib between May 28, 2021, and September 30, 2022, and docetaxel between January 1, 2019, and September 30, 2022 (to enhance sample size), were included, with a minimum of 12-month opportunity for follow-up.

Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data.

Purpose: We describe constructs designed to protect the integrity of the results from comparative analyses using real-world data (RWD): staging and clean room.

Methods: Staging involves performing sequential preliminary analyses and evaluating the population size available and potential bias before conducting comparative analyses. A clean room involves restricted access to data and preliminary results, policies governing exploratory analyses and protocol deviations, and audit trail.

Ancestral diversity in lipoprotein(a) studies helps address evidence gaps.

Introduction: The independent and causal cardiovascular disease risk factor lipoprotein(a) (Lp(a)) is elevated in >1.5 billion individuals worldwide, but studies have prioritised European populations.

Methods: Here, we examined how ancestrally diverse studies could clarify Lp(a)'s genetic architecture, inform efforts examining application of Lp(a) polygenic risk scores (PRS), enable causal inference and identify unexpected Lp(a) phenotypic effects using data from African (n=25 208), East Asian (n=2895), European (n=362 558), South Asian (n=8192) and Hispanic/Latino (n=8946) populations.

Lipoprotein(a) and the Risk for Recurrent Atherosclerotic Cardiovascular Events Among Adults With CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study.

Rationale & Objective: Many adults with chronic kidney disease (CKD) and atherosclerotic cardiovascular disease (ASCVD) have high lipoprotein(a) levels. It is unclear whether high lipoprotein(a) levels confer an increased risk for recurrent ASCVD events in this population. We estimated the risk for recurrent ASCVD events associated with lipoprotein(a) in adults with CKD and prevalent ASCVD.

Incident CHD and ischemic stroke associated with lipoprotein(a) by levels of Factor VIII and inflammation.

Background: Inflammation and coagulation may contribute to the increased risk for atherosclerotic cardiovascular disease (ASCVD) associated with high lipoprotein(a). The association of lipoprotein(a) with ASCVD is stronger in individuals with high versus low high-sensitivity C-reactive protein (hs-CRP), a marker of inflammation.

Objectives: Determine the association of lipoprotein(a) with incident ASCVD by levels of coagulation Factor VIII controlling for hs-CRP.

Heterogeneity of Lipoprotein(a) Levels Among Hispanic or Latino Individuals Residing in the US.

Importance: Lipoprotein(a) (Lp[a]) is a genetically determined risk-enhancing factor for atherosclerotic cardiovascular disease (ASCVD). The Lp(a) distribution among the diverse Hispanic or Latino community residing in the US has not been previously described, to the authors' knowledge.

Objective: To determine the distribution of Lp(a) levels across a large cohort of diverse Hispanic or Latino adults living in the US and by key demographic groups.

Contemporary patterns of lipoprotein(a) testing and associated clinical care and outcomes.

Objective: Elevated lipoprotein(a) [Lp(a)] is associated with atherosclerotic cardiovascular disease, yet little is known about Lp(a) testing patterns in real-world practice. The objective of this analysis was to determine how Lp(a) testing is used in clinical practice in comparison with low density lipoprotein cholesterol (LDL-C) testing alone, and to determine whether elevated Lp(a) level is associated with subsequent initiation of lipid-lowering therapy (LLT) and incident cardiovascular (CV) events.

Methods: This is an observational cohort study, based on lab tests administered between Jan 1, 2015 and Dec 31, 2019.

Lipoprotein(a) and the Risk for Coronary Heart Disease and Ischemic Stroke Events Among Black and White Adults With Cardiovascular Disease.

Background It is unclear whether lipoprotein(a) is associated with coronary heart disease (CHD) and ischemic stroke events in White and Black adults with atherosclerotic cardiovascular disease (ASCVD). Methods and Results We conducted a case-cohort analysis, including Black and White REGARDS (Reasons for Geographic and Racial Differences in Stroke) study participants ≥45 years of age with prevalent ASCVD (ie, CHD or stroke) at baseline between 2003 and 2007. Baseline lipoprotein(a) molar concentration was measured in participants with ASCVD who experienced a CHD event by December 2017 (n=1166) or an ischemic stroke by September 2019 (n=492) and in a random subcohort of participants with prevalent ASCVD (n=1948).

Cost and Utilization Impacts of a Medicaid Managed Care Organization's Behavioral Health Wraparound Program.

Wraparound programs that provide comprehensive evidence-based outpatient treatment, transportation, social services, and housing supports have shown promise for improving clinical behavioral health-related outcomes to reduce the need for institutionalized care; however, the majority of evidence is based on wraparound programs for children. This study examined the impact of a wraparound program for adult Medicaid managed care organization members with serious mental health or substance use disorders on health care costs and utilization. This retrospective observational study used 2013-2018 claims data collected from a large Medicaid managed care organization operating in multiple states.

Lipoprotein(a) Testing Patterns in a Large Health System.

Lipoprotein (a) [Lp(a)] is associated with increased risk of atherosclerotic cardiovascular disease (ASCVD). As directed therapy for Lp(a) emerges, it is important to understand patterns of Lp(a) testing in routine clinical practice. We set out to characterize Lp(a) testing across a large academic health system.

Antihypertensive Medication Nonpersistence and Low Adherence for Adults <65 Years Initiating Treatment in 2007-2014.

Previous evidence suggests modest improvements in antihypertensive medication adherence occurred from 2007 to 2012 among US adults ≥65 years of age. Whether adherence improved over time among adults <65 years of age is unknown. We assessed trends in antihypertensive medication nonpersistence and low adherence among 379 658 commercially insured adults <65 years of age initiating treatment in 2007-2014 using MarketScan claims.

Healthcare resource use and costs associated with chronic kidney disease in US private insurance patients with multiple myeloma.

Objectives: Within a median 1.2 years after patients have an initial diagnosis with multiple myeloma, up to 61% were diagnosed with renal impairment and 50% were diagnosed with chronic kidney disease. This study estimated economic burden associated with chronic kidney disease in multiple myeloma patients in the US.

Is Rheumatoid Arthritis a Cardiovascular Risk-Equivalent to Diabetes Mellitus?

Objective: The 2013 American College of Cardiology/American Heart Association cholesterol treatment guidelines recommend statins for patients with diabetes mellitus ages 40-75 years due to their elevated cardiovascular disease (CVD) risk. We compared the incidence of hospitalized acute myocardial infarction (MI), stroke, and coronary revascularization according to whether patients had diabetes mellitus, rheumatoid arthritis (RA), both, or neither.

Methods: Using 2006-2010 private and public health plan claims, we identified 4 mutually exclusive retrospective cohorts ages >40 years: patients with RA and diabetes mellitus, RA only, diabetes mellitus only, or neither condition.

Loss-of-Function Variants, Low-Density Lipoprotein Cholesterol, and Risk of Coronary Heart Disease and Stroke: Data From 9 Studies of Blacks and Whites.

Background: loss-of-function (LOF) variants allow for the examination of the effects of lifetime reduced low-density lipoprotein cholesterol (LDL-C) on cardiovascular events. We examined the association of LOF variants with LDL-C and incident coronary heart disease and stroke through a meta-analysis of data from 8 observational cohorts and 1 randomized trial of statin therapy.

Methods And Results: These 9 studies together included 17 459 blacks with 403 (2.

Race and sex differences in ambulatory blood pressure measures among HIV+ adults.

Ambulatory blood pressure monitoring (ABPM) can identify phenotypes that cannot be measured in the clinic. Determining race and sex disparities in ABPM measures among HIV+ individuals may improve strategies to diagnose and treat hypertension in this high-risk population. We compared ABPM measures between 24 African-American and 25 white HIV+ adults (36 men and 13 women).

Statin Intolerance and Risk of Coronary Heart Events and All-Cause Mortality Following Myocardial Infarction.

Background: Many patients report adverse reactions to, and may not tolerate, statin therapy. These patients may be at increased risk for coronary heart disease (CHD) events and mortality.

Objectives: This study evaluated the risk for recurrent myocardial infarction (MI), CHD events, and all-cause mortality in Medicare beneficiaries with statin intolerance and in those with high adherence to statin therapy.

Trends in Antihypertensive Medication Discontinuation and Low Adherence Among Medicare Beneficiaries Initiating Treatment From 2007 to 2012.

Low antihypertensive medication adherence is common. During recent years, the impact of low medication adherence on increased morbidity and healthcare costs has become more recognized, leading to interventions aimed at improving adherence. We analyzed a 5% sample of Medicare beneficiaries initiating antihypertensive medication between 2007 and 2012 to assess whether reductions occurred in discontinuation and low adherence.

Algorithms to Identify Statin Intolerance in Medicare Administrative Claim Data.

Purpose: To compare characteristics of patients with possible statin intolerance identified using different claims-based algorithms versus patients with high adherence to statins.

Methods: We analyzed 134,863 Medicare beneficiaries initiating statins between 2007 and 2011. Statin intolerance and discontinuation, and high adherence to statins, defined by proportion of days covered ≥80 %, were assessed during the 365 days following statin initiation.

Associations of blood pressure, sunlight, and vitamin D in community-dwelling adults.

Background: Vitamin D deficiency/insufficiency is associated with hypertension. Blood pressure (BP) and circulating vitamin D concentrations vary with the seasons and distance from the equator suggesting BP varies inversely with the sunshine available (insolation) for cutaneous vitamin D photosynthesis.

Methods: To determine if the association between insolation and BP is partly explained by vitamin D, we evaluated 1104 participants in the Reasons for Racial and Geographic Differences in Stroke study whose BP and plasma 25-hydroxyvitamin D [25(OH)D] concentrations were measured.

Ambulatory Blood Pressure Monitoring in Individuals with HIV: A Systematic Review and Meta-Analysis.

Introduction: Abnormal diurnal blood pressure (BP) rhythms may contribute to the high cardiovascular disease risk in HIV-positive (HIV+) individuals. To synthesize the current literature on ambulatory BP monitoring (ABPM) in HIV+ individuals, a systematic literature review and meta-analysis were performed.

Methods: Medical databases were searched through November 11, 2015 for studies that reported ABPM results in HIV+ individuals.

Agreement between Medicare pharmacy claims, self-report, and medication inventory for assessing lipid-lowering medication use.

Background: Medicare claims have been used to study lipid-lowering medication (LLM) use among US adults.

Methods: We analyzed the agreement between Medicare claims for LLM and LLM use indicated by self-report during a telephone interview and, separately, by a medication inventory performed during an in-home study visit upon enrollment into the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. We included REGARDS participants ≥65 years enrolled in 2006-2007 with Medicare pharmacy benefits (Part D) from 120 days before their telephone interview through their medication inventory (n = 899).

Comparative effects of biologics on cardiovascular risk among older patients with rheumatoid arthritis.

Objectives: To compare the coronary heart disease risk among patients with rheumatoid arthritis (RA) initiating common biologic disease-modifying antirheumatic drugs of different mechanisms.

Methods: We conducted a retrospective cohort study of patients with RA enrolled in Medicare, a public health plan covering >90% of US residents 65 years or older, from 2006 to 2012 who (1) initiated a biologic, (2) had complete medical and pharmacy coverage for at least 12 months before biologic initiation and (3) were free of coronary heart disease at the time of initiation. We compared the incidence rates (IRs) of (1) acute myocardial infarction (AMI) and (2) a composite outcome of AMI or coronary revascularisation and used multivariable adjusted Cox regression models to examine the associations between the type of biologic and the two outcomes.