Characteristics of patients with at least one lipoprotein(a) [Lp(a)] assessment and those with Lp(a) levels equal to or greater than 70 mg/dL: a real-world study in the US

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Laguna ◽  
R Lahoz ◽  
A.F Fonseca ◽  
D.T Amari ◽  
P Ferber ◽  
...  
Keyword(s):  
Total Cholesterol ◽  
Real World ◽  
Beta Blockers ◽  
Density Lipoprotein ◽  
The United States ◽  
Funding Source ◽  
Private Company ◽  
Lipoprotein A ◽  
Increased Risk ◽  
The Us

Abstract Background and purpose Elevated lipoprotein(a) [Lp(a)] has been associated with increased risk of cardiovascular disease (CVD). The objective of this real-world study was to characterize the patients in the United States (US) that have an Lp(a) assessment and those with Lp(a) levels ≥70 mg/dL. Methods This is a descriptive, non-interventional, retrospective cohort study of patients with at least one Lp(a) assessment and one-year continuous enrollment prior to index date (first Lp(a) assessment in the identification period i.e. 1/1/2008–30/6/2019) using the Optum® de-identified Electronic Health Record (EHR) dataset (2007–2019) in the US. Optum's longitudinal EHR repository include more than 700 Hospitals and 7000 Clinics; treating more than 95 million patients receiving care in the US. Results 26,997 patients (50.8% females) with ≥1 Lp(a) assessment having a mean (SD) age of 52.6 (14.1) years were evaluated. Patient distribution across Lp(a) levels ≥30, ≥50, ≥70, and ≥90 mg/dL were 32.4%, 20.2%, 12.3%, and 6.6%, respectively. Patients with Lp(a) ≥70 mg/dL (N=3,314) had a mean (SD) age of 54.7 (13.2) years and 55.2% were female. The overall population that gets tested for Lp(a) and the subgroup of patients with Lp(a) ≥70 mg/dL had prior myocardial infarction (4.8% and 6.2%), prior ischemic stroke (2.2% and 2.5%), peripheral artery disease (6.7% and 8.4%), dyslipidaemia (72.6% and 80.9%), hypertension (53.0% and 60.9%), diabetes mellitus (23.5% and 26.8%) and chronic ischemic heart disease (19.6% and 24.6%) at index. The use of baseline medications included statins (37.3% and 49.1%), ACEi/ARBs (28.2% and 34.0%) and beta-blockers (19.0% and 23.6%) for the overall population and those patients with Lp(a) ≥70 mg/dL, respectively. The mean (SD) low-density lipoprotein cholesterol, triglycerides and total cholesterol levels were 109.8 (39.8) mg/dL [n=7,371], 138.3 (119.3) mg/dL [n=8,179] and 190.5 (46.8) mg/dL [n=8,181], respectively for overall population and 114.8 (41.5) mg/dL [n=980], 129.6 (80.5) mg/dL [n=1,063] and 195.9 (47.6) mg/dL [n=1,056] for patients with Lp(a) ≥70 mg/dL. Conclusions Of patients with an Lp(a) assessment in the US, more than 10% had Lp(a) levels ≥70 mg/dL. These patients were frequently diagnosed with dyslipidaemia and when reported showed elevated LDL-C and total cholesterol values. Further analyses are required to better understand any differences in patient characteristics and treatment of patients across Lp(a) levels. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG

scholarly journals RV Pacing Percentage

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y.M Cha ◽  
M.D Metzl ◽  
R.C Canby ◽  
E.M Fruechte ◽  
M Duggal ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Funding Source ◽  
Private Company ◽  
Risk Of Death ◽  
Kaplan Meier ◽  
Increased Risk ◽  
Rv Pacing ◽  
First 90 Days ◽  
The Relationship

Abstract Introduction Chronic right ventricular pacing (RVP) has been associated with dyssynchrony, leading to increased mortality. However, there have been discrepancies in previous reports in the effect of RVP levels. Objective To sub-stratify mortality risk by age for different RVP level groups within a large real-world ICD cohort. Methods Optum® de-identified electronic health records were linked to the Medtronic Carelink data to identify dual chamber ICD recipients (2007–2017). RVP level was based on median daily pacing during the first 90 days post-implant and categorized either into groups with a cutoff of 40%, or with groups of 0–9%, 10–19%, 20–29%, 30–39%, 40–49%, and 50–100%. The endpoint was death more than 90 days post-implant. Kaplan-Meier survival curves, log-rank tests, and Cox regression were used to analyze the relationship between RVP and risk of death. Results Among 14,832 ICD patients (median age 67; 74.0% male), there were 2,602 deaths within 10 years after implant. In unadjusted comparisons, high RVP (>40%) increased the risk of death relative to low RVP (≤40%) (p<0.001). This effect remained significant in older cohort (≥67 years old at implant) (p<0.001), but not in younger cohort (<67 years old) (p=0.955) (Figure). After controlling for age, gender, pacing mode, MI, SCA, HF hospitalization, diabetes, and renal dysfunction, similar or increased risk was associated with higher pacing groups relative to the 0–9% pacing group in the older cohort, but not in the younger cohort. Conclusions Our data from a large contemporaneous real-world source suggests that older age or characteristics associated with age make patients more sensitive to chronic RVP effects. These results help reconcile differences observed in prior studies. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic, Inc.

A real-world assessment of the distribution of lipid levels across increasing lipoprotein(a) levels in patients with established cardiovascular disease in the United States

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A.F Fonseca ◽  
R Lahoz ◽  
P Ferber ◽  
A Laguna ◽  
D.T Amari ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Ischemic Stroke ◽  
Total Cholesterol ◽  
Real World ◽  
Lipid Lowering ◽  
Funding Source ◽  
Lipid Levels ◽  
Lipoprotein A ◽  
The Mean ◽  
One Year

Abstract Background and purpose Measurements of lipid levels are frequently used to assess the risk of developing cardiovascular disease (CVD), including future myocardium infarction (MI) and ischemic stroke. Lipoprotein(a) [Lp(a)] has been established as an independent risk factor for developing CVD, however it is not widely measured. This real-world study assessed the distribution of lipid (Total Cholesterol [TC], low-density cholesterol [LDL-C], high-density cholesterol [HDL-C] and Triglycerides [TGs]) levels across different Lp(a) strata of patients with established CVD and at least one Lp(a) assessment. Methods This was a descriptive, non-interventional, retrospective cohort study of patients with established CVD and at least one Lp(a) assessment in the Optum® de-identified Electronic Health Record dataset (2007–2019). The index date was defined as the date of the first established CVD (MI, ischemic stroke or peripheral artery disease diagnosis) in the identification period (1/1/2008–30/6/2018) following one-year continuous enrollment. Patients were followed for up to one year, until death or transfer out of the dataset, whichever occurred first. Results 5,434 patients (55.5% males) with established CVD and at least one Lp(a) assessment having a mean (SD) age of 62.5 (12.6) years were evaluated. During the 12 months pre-index period, 49.9%, 46.1%, 48.1% and 49.8% of these patients had a measurement of TC, LDL-C, HDL-C and TGs, respectively. Overall, the mean (SD) TC, LDL-C, HDL-C and TGs levels were 182.1 (47.0) mg/dL [n=2,712], 102.6 (40.1) mg/dL [n=2,503], 52.7 (16.7) mg/dL [n=2,614], and 140.3 (108.8) mg/dL [n=2,707], respectively. More than half of these patients were treated with at least one lipid lowering drug (includes statins, ezetimibe, fibrates, niacin or PCSK9is) during the pre-index period. The mean (SD) levels of TC, LDL-C, HDL-C and TG in patients with Lp(a) <30 mg/dL, 30–50] mg/dL, 50–70 mg/dL, 70–90 mg/dL and ≥90 mg/dL are presented in Figure 1. Conclusions Overall, no trends in the levels of total cholesterol, LDL-C, HDL-C or triglycerides were observed across increasing levels of lipoprotein(a). These findings suggest the measurement of lipoprotein(a) is required to ensure a complete characterization of a patient lipid profile. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG

A real-world assessment of the burden associated with hospitalizations in US patients with heart failure and left ventricular ejection fraction (LVEF) greater than 40%

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Lahoz ◽  
R Studer ◽  
G Farries ◽  
C Proudfoot ◽  
S Suminska ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Disease ◽  
The United States ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Funding Source ◽  
Private Company ◽  
Ventricular Ejection Fraction ◽  
Hospitalization Rates ◽  
The Us

Abstract Background and purpose Heart failure (HF) is one of the leading causes of hospitalization among older adults and is associated with a large burden of disease for the individual, the patient's family, healthcare systems, and society. This study assessed the burden of hospitalizations in patients with HF with LVEF >40% in the United States (US). Methods This retrospective, non-interventional study identified adult patients with incident or prevalent HF in Optum® de-identified Electronic Health Record (EHR) dataset (2007–2018) between 01/01/2013 and 31/12/2017. Optum's longitudinal EHR repository is derived from dozens of healthcare provider organizations in the US, that include more than 700 Hospitals and 7000 Clinics; treating >95 million patients receiving care in the US. Patients were followed for up to 1 year or until last active date whichever occurred first. Comorbidities, all-cause hospitalizations (AcH) and primary cause HF hospitalizations (HFH) were analysed. Results 120,606 patients with HF and LVEF >40% (54% female) with a mean (SD) age of 71 (13) yrs were included, representing 80,324.74 patient-yrs follow-up (days). Common comorbidities were hypertension (91.8%), ischemic heart disease (IHD, 71.4%), atrial fibrillation (AF, 54.8%), renal disease (54.1%), type 2 diabetes (T2D, 50.7%), obesity (44.6%) and anemia (39%). Comorbidities including IHD (72.9% vs. 68.4%), AF (56.4% vs. 51.6%) and T2D (51.1% vs. 49.9%) were more often recorded in patients with LVEF >40-≤60% than >60% cohort while hypertension (91.6% vs. 92.2%), renal disease (53.8% vs. 54.6%), obesity (43.9% vs. 46.1%) and anemia (38.1% vs. 40.9%) had significantly higher frequency in the LVEF >60% cohort. The annualized AcH rate for patients with LVEF>40% was 1.44 and annualized HFH rate was 0.24 with a median length of stay of 3 and 4 days, respectively. Annualized hospitalization rates were significantly higher for women than men (both AcH and HFH). AcH rates were significantly higher and HFH rates were significantly lower for patients with LVEF>60% compared with LVEF >40-≤60. Conclusions This study demonstrates that patients with HF and LVEF >40% experience significant burden from comorbidities and hospitalizations from any-cause and for HF. The hospitalization rates are higher in women (both AcH and HFH) or patients with LVEF >60% (AcH only). Further focus on reduction of hospitalizations and interdisciplinary management of patients with HF should be warranted. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG

scholarly journals Long-Term Physical Health Outcomes of Resettled Refugee Populations in the United States: A Scoping Review

2021 ◽  
Author(s):  
Gayathri S. Kumar ◽  
Jenna A. Beeler ◽  
Emma E. Seagle ◽  
Emily S. Jentes
Keyword(s):  
Health Outcomes ◽  
Physical Health ◽  
Public Health Practice ◽  
The United States ◽  
Inclusion Criteria ◽  
Physical Health Outcomes ◽  
Increased Risk ◽  
The Us ◽  
Bhutanese Refugee

AbstractSeveral studies describe the health of recently resettled refugee populations in the US beyond the first 8 months after arrival. This review summarizes the results of these studies. Scientific articles from five databases published from January 2008 to March 2019 were reviewed. Articles were included if study subjects included any of the top five US resettlement populations during 2008–2018 and if data described long-term physical health outcomes beyond the first 8 months after arrival in the US. Thirty-three studies met the inclusion criteria (1.5%). Refugee adults had higher odds of having a chronic disease compared with non-refugee immigrant adults, and an increased risk for diabetes compared with US-born controls. The most commonly reported chronic diseases among Iraqi, Somali, and Bhutanese refugee adults included diabetes and hypertension. Clinicians should consider screening and evaluating for chronic conditions in the early resettlement period. Further evaluations can build a more comprehensive, long-term health profile of resettled refugees to inform public health practice.

Real-world use and accuracy of stress echocardiography: preliminary insights from the EVAREST study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W Woodward ◽  
A McCourt ◽  
C Dockerill ◽  
L Ayres ◽  
D Augustine ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Stress Echocardiography ◽  
Significant Coronary Artery Disease ◽  
Phone Call ◽  
Funding Source ◽  
Private Company ◽  
Coronary Syndrome ◽  
Stress Echo ◽  
Cardiac Outcome

Abstract Background Stress echocardiography is a widely used, non-invasive imaging modality used to identify prognostically significant coronary artery disease. High levels of accuracy have been reported, however this is highly dependent on operator training and image quality. There are currently limited data available on the accuracy of stress echo in every day clinical practice. Purpose The EVAREST study links stress echo clinics in 30 NHS Hospital Trusts in England and therefore provides data to evaluate the performance and diagnostic accuracy of stress echo in “real-world” clinical practice. Methods Analysis was performed on the first 7415 patients recruited prospectively between 2015 and January 2020. Participants are included if they have undergone stress echo to investigate for ischaemic heart disease. Data is collected on medical history and stress echo performance. Participants are followed up for 12 months through health records and patient phone call, with all outcomes undergoing expert adjudication. A positive cardiac outcome is defined as initiation of anti-anginal medications, ≥70% stenosis on coronary angiography, revascularisation, confirmed acute coronary syndrome or cardiac-related death. Results Mean age of patients undergoing stress echo is 65±12.3 years and 56% are male. Average BMI is 28.9±5.6 kg/m2. 71.4% undergo dobutamine stress (DSE) and 28.4% exercise with <1% having a pacemaker-mediated stress. Contrast was used in 71.4% of studies. Stress echos were interpreted at time of clinic visit as positive for inducible ischaemia in 18.2% of patients. One-year outcome data is currently available for 1892 participants. Sensitivity and specificity for clinician prediction of a positive cardiac outcome was 88.7% and 94.4%, respectively. Positive and negative predictive value of stress echo was 76.4% and 97.6%, respectively. Conclusion EVAREST provides unprecedented, large-scale information on the “real world” use and accuracy of stress echo across different healthcare settings in the UK, demonstrating performance consistent with best practice. Ongoing data collection will be used to evaluate sources of heterogeneity in the predictive accuracy of stress echo and identify optimal approaches to further improve performance. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Ultromics Ltd., Lantheus Ltd.

scholarly journals Extremely elevated lipoprotein (a) as an independent risk factor for peripheral arterial disease in large patient cohort

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M.R Poudel ◽  
S Kirana ◽  
D Stoyanova ◽  
K.P Mellwig ◽  
D Hinse ◽  
...  
Keyword(s):  
Peripheral Arterial Disease ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Arterial Disease ◽  
P Value ◽  
Lipoprotein A ◽  
Large Patient ◽  
Increased Risk ◽  
Revascularization Therapy ◽  
Peripheral Arterial

Abstract Background Elevated lipoprotein (a) [LP (a)] levels are an independent, genetic, and causal factor for cardiovascular disease and associated with myocardial infarction (MI). Although the association between circulating levels of lipoprotein(a) [Lp(a)] and risk of coronary artery disease (CAD) is well established, its role in risk of peripheral arterial disease (PAD) remains unclear. PAD affects over 236 million individuals and follows ischaemic heart disease (IHD) and cerebrovascular disease (CVD) as the third leading cause of atherosclerotic cardiovascular morbidity worldwide. LP (a) is genetically determined, stable throughout life and yet refractory to drug therapy. While 30 mg/dl is considered the upper normal value for LP (a) in central Europe, extremely high LP (a) levels (>150mg/dl) are rare in the general population. The aim of our study was to analyse the correlation between lipoprotein (a) [LP (a)] levels and an incidence of PAD in high-risk patients. Patients and methods We reviewed the LP (a) concentrations of 52.898 consecutive patients admitted to our cardiovascular center between January 2004 and December 2014. Of these, 579 patients had LP (a) levels above 150 mg/dl (mean 181.45±33.1mg/dl). In the control collective LP (a) was <30mg/dl (n=350). Other atherogenic risk factors in this group were HbA1c 6.58±1.65%, low density lipoprotein (LDL) 141.99±43.76 mg/dl, and body mass index 27.81±5.61. 54.40% were male, 26.07% were smokers, 93.2% had hypertension, and 24% had a family history of cardiovascular diseases. More than 82.6% were under statins. The mean glomerular filtration rate (GFR) was 69.13±24.8 ml/min [MDRD (Modification of Diet in Renal Disease)]. Results 45.00% (n=261) of the patients with LP (a) >150mg/dl had PAD. The prevalence of PAD in patients with LP (a) <30mg/dl in our control collective was 15.8%. (P- Value 0.001). Patients with LP (a) >150mg/dl had a significantly increased risk for PAD (Odds ratio 4.36, 95% CI 2.94–6.72, p: 0.001). 19.1% of patients were re-vascularized by percutaneous angioplasty (PTA) and 7.09% of patients had to undergo peripheral vascular bypass (PVB). Mean LP (a) level in patients with PAD was 182.6±31.61. Conclusion Elevated LP (a) levels above 150 mg/dl are associated with a significantly increased risk of PAD in our collective and it confirms our hypothesis. Over one fourth of these patients had severe PAD and requiring revascularization therapy. We need more prospective studies to confirm our findings. Funding Acknowledgement Type of funding source: None

scholarly journals Serum uric acid, influence of sacubitril/valsartan, and cardiovascular outcomes in heart failure with preserved ejection fraction: PARAGON-HF

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Selvaraj ◽  
B.L Claggett ◽  
D.V Veldhuisen ◽  
I.S Anand ◽  
B Pieske ◽  
...  
Keyword(s):  
Heart Failure ◽  
Uric Acid ◽  
Ejection Fraction ◽  
Serum Uric Acid ◽  
Primary Outcome ◽  
Adverse Outcomes ◽  
Funding Source ◽  
Preserved Ejection Fraction ◽  
Private Company ◽  
Increased Risk

Abstract Background Serum uric acid (SUA) is a biomarker of several pathobiologies relevant to the pathogenesis of heart failure with preserved ejection fraction (HFpEF), though by itself may also worsen outcomes. In HF with reduced EF, SUA is independently associated with adverse outcomes and sacubitril/valsartan reduces SUA compared to enalapril. These effects in HFpEF have not been delineated. Purpose To determine the prognostic value of SUA, relationship of change in SUA to quality of life and outcomes, and influence of sacubitril/valsartan on SUA in HFpEF. Methods We analyzed 4,795 participants from the Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction (PARAGON-HF) trial. We related baseline hyperuricemia to the primary outcome (CV death and total HF hospitalization), its components, myocardial infarction or stroke, and a renal composite outcome. At the 4-month visit, the relationship between SUA change and Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) and several biomarkers including N-terminal pro-B-type natriuretic peptide (NT-proBNP) were also assessed. We simultaneously adjusted for baseline and time-updated SUA to determine whether lowering SUA was associated with clinical benefit. Results Average age was 73±8 years and 52% were women. After multivariable adjustment, hyperuricemia was associated with increased risk for most outcomes (primary outcome HR 1.61, 95% CI 1.37, 1.90, Fig 1A). The treatment effect of sacubitril/valsartan for the primary outcome was not modified by baseline SUA (interaction p=0.11). Sacubitril/valsartan reduced SUA −0.38 mg/dL (95% CI: −0.45, −0.31) compared with valsartan (Fig 1B), with greater effect in those with baseline hyperuricemia (−0.50 mg/dL) (interaction p=0.013). Change in SUA was independently and inversely associated with change in KCCQ-OSS (p=0.019) and eGFR (p<0.001), but not NT-proBNP (p=0.52). Time-updated SUA was a stronger predictor of adverse outcomes over baseline SUA. Conclusions SUA independently predicts adverse outcomes in HFpEF. Sacubitril/valsartan significantly reduces SUA compared to valsartan, an effect that was stronger in those with higher baseline SUA, and reducing SUA was associated with improved outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis

scholarly journals Estimating the burden of hyperkalaemia in the UK in high-risk patient populations

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P McEwan ◽  
L Hoskin ◽  
K Badora ◽  
D Sugrue ◽  
G James ◽  
...  
Keyword(s):  
Clinical Practice ◽  
High Risk ◽  
Patient Outcomes ◽  
Real World ◽  
High Risk Patient ◽  
Incidence Rates ◽  
Funding Source ◽  
Eligible Population ◽  
Increased Risk ◽  
The Uk

Abstract Background Patients with chronic kidney disease (CKD), heart failure (HF), resistant hypertension (RHTN) and diabetes are at an increased risk of hyperkalaemia (HK) which can be potentially life-threatening, as a result of cardiac arrhythmias, cardiac arrest leading to sudden death. In these patients, renin-angiotensin-aldosterone system inhibitors (RAASi), are used to manage several cardiovascular and renal conditions, and are associated with an increased risk of HK. Assessing the burden of HK in real-world clinical practice may concentrate relevant care on those patients most in need, potentially improving patient outcomes and efficiency of the healthcare system. Purpose To assess the burden of HK in a real-world population of UK patients with at least one of: RHTN, Type I or II diabetes, CKD stage 3+, dialysis, HF, or in receipt of a prescription for RAASi. Methods Primary and secondary care data for this retrospective study were obtained from the UK Clinical Practice Research Datalink (CPRD) and linked Hospital Episode Statistics (HES). Eligible patients were identified using READ codes defining the relevant diagnosis, receipt of indication-specific medication, or, in the case of CKD, an estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73m2 within the study period (01 January 2008 to 30 June 2018) or in the five-year lookback period (2003–2007). The index date was defined as 01 January 2008 or first diagnosis of an eligible condition or RAASi prescription, whichever occurred latest. HK was defined as K+ ≥5.0 mmol/L; thresholds of ≥5.5 mmol/L and ≥6.0 mmol/L were explored as sensitivity analyses. Incidence rates of HK were calculated with 95% confidence intervals (CI). Results The total eligible population across all cohorts was 931,460 patients. RHTN was the most prevalent comorbidity (n=317,135; 34.0%) and dialysis the least prevalent (n=4,415; 0.5%). The majority of the eligible population were prescribed RAASi during follow-up (n=754,523; 81.0%). At a K+ threshold of ≥5.0 mmol/L, the dialysis cohort had the highest rate of HK (501.0 events per 1,000 patient-years), followed by HF (490.9), CKD (410.9), diabetes (355.0), RHTN (261.4) and the RAASi cohort (211.2) (Figure 1). This pattern was still observed at alternative threshold definitions of HK. Conclusion This large real-world study of UK patients demonstrates the burden of hyperkalaemia in high-risk patient populations from the UK. There is a need for effective prevention and treatment of HK, particularly in patients with CKD, dialysis or HF where increased incidence rates are observed which in turn will improve patient outcomes and healthcare resource usage. Figure 1. Rates of HK by condition Funding Acknowledgement Type of funding source: Private company. Main funding source(s): AstraZeneca

scholarly journals Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniel C. Beachler ◽  
Cynthia de Luise ◽  
Aziza Jamal-Allial ◽  
Ruihua Yin ◽  
Devon H. Taylor ◽  
...  
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Pulmonary Embolism ◽  
Cohort Study ◽  
Real World ◽  
The United States ◽  
Elevated Risk ◽  
Breast Cancer Patients ◽  
Increased Risk ◽  
Serious Infections

Abstract Background There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer. Methods We conducted a cohort study of breast cancer patients initiating palbociclib and fulvestrant from February 2015 to September 2017 using the HealthCore Integrated Research Database (HIRD), a longitudinal claims database of commercial health plan members in the United States. The historical comparator cohort comprised patients initiating fulvestrant monotherapy from January 2011 to January 2015. Propensity score matching and Cox regression were used to estimate hazard ratios for various safety events. For acute liver injury (ALI), additional analyses and medical record validation were conducted. Results There were 2445 patients who initiated palbociclib including 566 new users of palbociclib-fulvestrant, and 2316 historical new users of fulvestrant monotherapy. Compared to these historical new users of fulvestrant monotherapy, new users of palbociclib-fulvestrant had a greater than 2-fold elevated risk for neutropenia, leukopenia, thrombocytopenia, stomatitis and mucositis, and ALI. Incidence of anemia and QT prolongation were more weakly associated, and incidences of serious infections and pulmonary embolism were similar between groups after propensity score matching. After adjustment for additional ALI risk factors, the elevated risk of ALI in new users of palbociclib-fulvestrant persisted (e.g. primary ALI algorithm hazard ratio (HR) = 3.0, 95% confidence interval (CI) = 1.1–8.4). Conclusions This real-world study found increased risks of several adverse events identified in clinical trials, including neutropenia, leukopenia, and thrombocytopenia, but no increased risk of serious infections or pulmonary embolism when comparing new users of palbociclib-fulvestrant to fulvestrant monotherapy. We observed an increased risk of ALI, extending clinical trial findings of significant imbalances in grade 3/4 elevations of alanine aminotransferase (ALT).

Abstract P102: Variability In Lipid Levels And Risk For Cardiovascular Disease: An Electronic Health Record-based Population Cohort Study

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Sheila M Manemann ◽  
Suzette J Bielinski ◽  
Ethan D Moser ◽  
Jennifer L St. Sauver ◽  
Paul Y Takahashi ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Electronic Health Record ◽  
Total Cholesterol ◽  
Index Date ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Health Record ◽  
Lipid Levels ◽  
Population Cohort ◽  
Increased Risk

Background: Larger within-patient variability of lipid levels has been associated with an increased risk of cardiovascular disease (CVD). However, measures of lipid variability are not currently used clinically. We investigated the feasibility of calculating lipid variability within a large electronic health record (EHR)-based population cohort and assessed associations with incident CVD. Methods: We identified all individuals ≥40 years of age who resided in Olmsted County, MN on 1/1/2006 (index date) without prior CVD. CVD was defined as myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention or stroke. Patients with ≥3 measurements of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and/or triglycerides during the 5 years before the index date were retained in the analyses. Lipid variability was calculated using variability independent of the mean (VIM). Patients were followed through 9/30/2017 for incident CVD (including CVD death). Cox regression was used to investigate the association between quintiles of lipid VIMs and incident CVD. Results: We identified 18,642 individuals (mean age 60; 55% female) who were free of CVD at baseline and VIM calculated for at least one lipid measurement. After adjustment, those in the highest VIM quintiles of total cholesterol had a 25% increased risk of CVD (Q5 vs. Q1 HR: 1.25, 95% CI: 1.08-1.45; Table). We observed similar results for LDL-C (Q5 vs. Q1 HR: 1.20, 95% CI: 1.04-1.39) and HDL-C (Q5 vs. Q1 HR: 1.25, 95% CI: 1.09-1.43). There was no association between triglyceride variability quintiles and CVD risk. Conclusion: In a large EHR-based population cohort, high variability in total cholesterol, HDL-C and LDL-C was associated with an increased risk of CVD, independently of traditional risk factors, suggesting it may be a target for intervention. Lipid variability can be calculated in the EHR environment but more research is needed to determine its clinical utility.

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