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• Only 27% patients with Non-Alcoholic Fatty Liver Disease (NFALD) received statins. • Statin therapy was not associated with elevated liver enzyme levels. • ALT, total cholesterol, and LDL were significantly lower in statin users. • Findings demonstrate statin use in patients with NAFLD can reduce CVD risks. • Findings were generalized to the US population. Non-alcoholic fatty liver disease (NAFLD) is an independent risk factor for cardiovascular disease (CVD). Statins are recommended for treatment of dyslipidemia to reduce the overall cardiovascular risk in patients with NAFLD. However, statin treatment was underutilized and the effect of statins on liver enzymes remained unclear in this patient population. This study aimed to provide real-world evidence of the safety and effect of statin use in patients with NAFLD. We conducted a cross-sectional survey study of adults with NAFLD using pooled data from the US NHANES database 2009–2018. NAFLD was defined by Fatty Liver Index (FLI) ≥ 60 and United States Fatty Liver Index (USFLI) ≥ 30. Multivariate regression analyses adjusted for baseline clinical and demographic characteristics were performed to compare the liver enzymes and lipid profile between statin and non-statin users. The study included 2,533 adults with NAFLD, representing 22.6 million individuals in the US, with 27% receiving statin treatment between 2009 and 2018. The mean differences of liver enzymes for AST, ALT, ALP, and GGT between statin and non-statin users were -0.86 (p=0.539), -3.49 (p=0.042), -0.25 (p=0.913), and 0.57 (p=0.901), respectively. In individuals with NAFLD and dyslipidemia, total cholesterol and LDL levels were significantly lower in statin users compared to non-statin users (mean difference, -28.9; p<0.001 and -27.7; p<0.001). The use of statins was not associated with elevated liver enzymes in patients with NAFLD. Significantly lower levels of ALT, total cholesterol, and LDL were observed in statin users compared to non-statin users. [ABSTRACT FROM AUTHOR]

Background: Statins are part of long‐term medical regimens for many older adults. Whether frailty modifies the protective relationship between statins, mortality, and major adverse cardiovascular events (MACE) is unknown. Methods: This was a retrospective study of US Veterans ≥65, without CVD or prior statin use seen in 2002–2012, followed through 2017. A 31‐item frailty index was used. The co‐primary endpoint was all‐cause mortality or MACE (MI, stroke/TIA, revascularization, or cardiovascular death). Cox proportional hazards models were developed to evaluate the association of statin use with outcomes; propensity score overlap weighting accounted for confounding by indication. Results: We identified 710,313 Veterans (mean age (SD) 75.3(6.5), 98% male, 89% white); 86,327 (12.1%) were frail. Over mean follow‐up of 8 (5) years, there were 48.6 and 72.6 deaths per 1000 person‐years (PY) among non‐frail statin‐users vs nonusers (weighted Incidence Rate Difference (wIRD)/1000 person years (PY), −24.0[95% CI, −24.5 to −23.6]), and 90.4 and 130.4 deaths per 1000PY among frail statin‐users vs nonusers (wIRD/1000PY, −40.0[95% CI, −41.8 to −38.2]). There were 51.7 and 60.8 MACE per 1000PY among non‐frail statin‐users vs nonusers (wIRD/1000PY, −9.1[95% CI, −9.7 to −8.5]), and 88.2 and 102.0 MACE per 1000PY among frail statin‐users vs nonusers (wIRD/1000PY, −13.8[95% CI, −16.2 to −11.4]). There were no significant interactions by frailty for statin users vs non‐users by either mortality or MACE outcomes, p‐interaction 0.770 and 0.319, respectively. Statin use was associated with lower risk of all‐cause mortality (HR, 0.61 (0.60–0.61)) and MACE (HR 0.86 (0.85–0.87)). Conclusions: New statin use is associated with a lower risk of mortality and MACE, independent of frailty. These findings should be confirmed in a randomized clinical trial. See related editorial by Aliberti et al. in this issue. [ABSTRACT FROM AUTHOR]

Background: The prevalence of cardiovascular events is increasing. There are many new lipids lowering therapies available in recent years. Increased evidence through literature and guidelines suggests that the use of lipid lowering therapy (LLT) benefits patients who are at risk for cardiovascular events. Objective: The objective of this study was to describe the current LLT use as well as patterns of treatment modification among adults ≥ 65 years. Methods: A retrospective analysis of administrative claims data between January 2016 and May 2018 was conducted. Patients with a LLT refill and continuous enrollment during 1-year prior and 1-year follow-up were identified. The treatment episodes captured were interruption of therapy, intensity changes, dose changes, treatment augmentation, switching, and discontinuation. An analysis of treatment patterns among patients ≥75 years was also performed. Results: The study included 14,360 patients with a LLT of which 99% of patients were on statins as monotherapy or combination. Overall non-statin therapy use either as monotherapy or combination was 2.1%. There were significant differences among new initiators and existing users of therapy. Among prevalent users 57.4% had no changes in the follow-up period, 13.6% interrupted therapy, and 6.6% discontinued. Among new users, 47.9% patients had interrupted therapy, 25% had no changes, and 21.9% discontinued therapy. Conclusion: Most patients were on monotherapy and statins with low non-statin use. The new users among them were more likely to discontinue and interrupt therapy, highlighting the limitations and issues that older patients face that need to increase adherence. [ABSTRACT FROM AUTHOR]

Background: The contemporary uptake of lipid‐lowering therapies (LLT), including more intensive treatment with high‐intensity statins and non‐statin LLT, among U.S. older adults (≥75 years old) with ASCVD is unknown. Methods: In this multicenter retrospective cohort study of a large geographically diverse sample of commercially insured U.S. older adults with ASCVD, we assessed treatment with LLT. Secondary measures included LDL‐C above target ≥70 mg/dl, persistence and adherence to therapy. Results: Treatment with statins, high‐intensity statins, ezetimibe, and PCSK9 inhibitors was assessed in 194,503 older adults (49.9% female) with known ASCVD on January 31st, 2019. 49.3% of older adults with ASCVD were on any statin, with 16.6% receiving a high‐intensity statin and 32.7% on low‐or moderate‐intensity statins. Treatment with ezetimibe (2.4%) or PCSK9 inhibitors (0.24%) was rare and 62.6% of the overall cohort had an LDL‐C above target at ≥70 mg/dl. Patients on high‐intensity statins were more frequently male, had a diagnosis of coronary artery disease, and were more frequently seen by a cardiologist compared with those on low‐or moderate‐intensity statins and untreated individuals (p < 0.0001). The majority of older adults on high‐intensity statins remained on therapy at 12 months (91.9%) and 85.7% had ≥75% adherence to treatment. Conclusions: Less than half of eligible older adults with ASCVD are on statins and only a minority of patients are receiving more intensive lipid‐lowering to improve outcomes. [ABSTRACT FROM AUTHOR]

• National metrics do not include LDL-C measurement as a necessary performance metric. • This clinical perspective reviews history of LDL-C as a quality/performance metric. • Lipid monitoring is essential for assessing lipid-lowering pharmacotherapy. • Evidence favors LDL-C measurement to improve population-wide lipid control. Despite the established role of low-density lipoprotein cholesterol (LDL-C) as a major risk factor for cardiovascular disease (CVD), and the persistence of CVD as the leading cause of morbidity and mortality in the United States, national quality assurance metrics no longer include LDL-C measurement as a required performance metric. This clinical perspective reviews the history of LDL-C as a quality and performance metric and the events that led to its replacement. It also presents patient, healthcare provider, and health system rationales for re-establishing LDL-C measurement as a performance measure to improve cholesterol control in high-risk groups and to stem the rising tide of CVD morbidity and mortality, cardiovascular care disparities, and related healthcare costs. [ABSTRACT FROM AUTHOR]

Background: Preclinical evidence suggests improved breast cancer survival associated with statin use, but findings from observational studies are conflicting and remain inconclusive. The objective of this study was to assess the association between statin use after cancer diagnosis and cancer outcomes among breast cancer patients., Methods: In this retrospective cohort study, 38,858 women aged ≥66 years who were diagnosed with localized and regional stage breast cancer from 2008 through 2017 were identified from the linked Surveillance, Epidemiology, and End Results Medicare database. Statin use was ascertained from Medicare Part D pharmacy claims data. Multivariable Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the association between post-diagnosis statin use and risks of breast cancer recurrence and breast cancer-specific mortality., Results: Over a median follow-up of 2.9 years for recurrence and 3.7 years for mortality, 1446 women experienced a recurrence, and 2215 died from breast cancer. The mean duration of post-diagnosis statin use was 2.2 years. Statin use post-diagnosis was not associated with recurrence risk (HR, 1.05; 95% CI, 0.91-1.21), but was associated with a reduced risk of cancer-specific mortality (HR, 0.85; 95% CI, 0.75-0.96). The reduction was more pronounced in women with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR, 0.71; 95% CI, 0.57-0.88)., Conclusions: These findings suggest that post-diagnosis statin use is associated with improved cancer-specific survival in women with breast cancer and should be confirmed in randomized trials of statin therapy in breast cancer patients., (© 2024 American Cancer Society.)

Background: Preventive therapy among patients with established atherosclerotic cardiovascular disease (ASCVD) is generally underused. Whether new guideline recommendations and a focus on implementation have improved the use of high-intensity statins is unknown.Objectives: This study sought to evaluate the patterns and predictors of statin use among patients with ASCVD.Methods: In this retrospective cohort study, pharmacy and medical claims data from a commercial health plan were queried for patients with established ASCVD between January 31, 2018, and January 31, 2019. Statin use on an index date of January 31, 2019, was evaluated, as was 12-month adherence and discontinuation. Multivariable logistic regression was used to determine independent associations with statin use of varying intensities.Results: Of the 601,934 patients with established ASCVD, 41.7% were female, and the mean age was 67.5 ± 13.3 years. Overall, 22.5% of the cohort were on a high-intensity statin, 27.6% were on a low- or moderate-intensity statin, and 49.9% were not on any statin. In multivariable analysis, younger patients, female patients, and those with higher Charlson comorbidity score were less likely to be prescribed any statin. Among statin users, female patients, older patients, and those with peripheral artery disease were less likely to be on a high-intensity formulation, whereas a cardiology encounter in the prior year increased the odds. The majority of high-intensity stain users achieved high levels of adherence.Conclusions: Substantial underuse of statins persists in a large, insured, and contemporary cohort of patients with ASCVD from the United States. In particular, concerning gaps in appropriate statin use remain among younger patients, women, and those with noncoronary ASCVD. [ABSTRACT FROM AUTHOR]

Hypertriglyceridemia (HTG) is a common cardiovascular risk factor characterized by elevated triglyceride (TG) levels. Researchers have assessed the genetic factors that influence HTG in studies focused predominantly on individuals of European ancestry. However, relatively little is known about the contribution of genetic variation of HTG in people of African ancestry (AA), potentially constraining research and treatment opportunities. Our objective was to characterize genetic profiles among individuals of AA with mild-to-moderate HTG and severe HTG versus those with normal TGs by leveraging whole-genome sequencing data and longitudinal electronic health records available in the All of Us program. We compared the enrichment of functional variants within five canonical TG metabolism genes, an AA-specific polygenic risk score for TGs, and frequencies of 145 known potentially causal TG variants between HTG patients and normal TG among a cohort of AA patients (N = 15,373). Those with mild-to-moderate HTG (N = 342) and severe HTG (N ≤ 20) were more likely to carry APOA5 p.S19W (odds ratio = 1.94, 95% confidence interval = [1.48-2.54], P = 1.63 × 10 -6 and OR = 3.65, 95% confidence interval: [1.22-10.93], P = 0.02, respectively) than those with normal TG. They were also more likely to have an elevated (top 10%) polygenic risk score, elevated carriage of potentially causal variant alleles, and carry any genetic risk factor. Alternative definitions of HTG yielded comparable results. In conclusion, individuals of AA with HTG were enriched for genetic risk factors compared to individuals with normal TGs., Competing Interests: Conflict of interest The authors declare that they have no conflicts of interest with the contents of this article., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Despite using identical evidence to support practice guidelines for lipid-lowering treatment in primary prevention of cardiovascular disease (CVD), it is unclear to what extent the 2018 American Heart Association/American College of Cardiology/Multisociety, 2016 US Preventive Services Task Force (USPSTF), 2020 Department of Veterans Affairs/Department of Defense, 2021 Canadian Cardiovascular Society, and 2019 European Society of Cardiology/European Atherosclerosis Society guidelines differ in grading and assigning levels of evidence and classes of recommendations (LOE/class) at a population level.Methods: We included 7262 participants, aged 45 to 75 years, without history of CVD from the prospective population-based Rotterdam Study. Per guideline, proportions of the population recommended statin therapy by LOE/class, sensitivity and specificity for CVD events, and numbers needed to treat at 10 years were calculated.Results: Mean age was 61.1 (SD 6.9) years; 58.2% were women. American Heart Association/American College of Cardiology/Multisociety, USPSTF, Department of Veterans Affairs/Department of Defense, Canadian Cardiovascular Society, and European Society of Cardiology/European Atherosclerosis Society strongly recommended statin initiation in respective 59.4%, 40.2%, 45.2%, 73.7%, and 42.1% of the eligible population based on high-quality evidence. Sensitivity for CVD events for treatment recommendations supported with strong LOE/class was 86.3% for American Heart Association/American College of Cardiology/Multisociety (IA or IB), 69.4% for USPSTF (USPSTF-B), 74.5% for Department of Veterans Affairs/Department of Defense (strong for), 93.3% for Canadian Cardiovascular Society (strong), and 66.6% for European Society of Cardiology/European Atherosclerosis Society (IA). Specificity was highest for the USPSTF at 45.3% and lowest for European Society of Cardiology/European Atherosclerosis Society at 10.0%. Estimated numbers needed to treat at 10 years for those with the strongest LOE/class were ranging from 20 to 26 for moderate-intensity and 12 to 16 for high-intensity statins.Conclusions: Sensitivity, specificity, and numbers needed to treat at 10 years for assigned LOE/class varied greatly among 5 CVD prevention guidelines. The level of variability seems to be driven by differences in how the evidence is graded and translated into LOE/class underlying the treatment recommendations by different professional societies. Efforts towards harmonizing evidence grading systems for clinical guidelines in primary prevention of CVD may reduce ambiguity and reinforce updated evidence-based recommendations. [ABSTRACT FROM AUTHOR]

Background: Regularity and continuity of general practitioner (GP) contacts are associated with reduced hospitalisation. Opportunities for improved medication management are cited as a potential cause.Objective: Determine associations between continuity and regularity of primary care and statin use amongst individuals at risk of cardiovascular disease (CVD) outcomes.Design: Observational cohort study using self-report and administrative data from 267,153 participants of the Sax Institute's 45 and Up Study conducted in New South Wales, Australia. from 2006 to 2009. Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data, from Services Australia, were linked to survey, hospital and death data by the NSW Centre for Health Record Linkage.Participants: The 45 and Up Study participants at risk of CVD outcomes based on self-report and administrative data, divided into existing users and potential users based on dispensing records through the exposure period.Main Measures: The Continuity of Care index (COC), measuring whether patients see the same GP, and an index assessing whether GP visits are on a regular basis, measured from July 2011 to June 2012. Amongst potential users, statin initiation from July 2012 to June 2013 was assessed using logistic regression; amongst existing users, adherence was assessed from July 2012 to June 2015 using Cox regression (non-adherence being 30 days without statins).Key Results: Amongst 29,420 potential users, the most regular quintile had 1.22 times the odds of initiating statin (95%CI 1.11-1.34), while the high continuity group had an odds ratio of 1.12 (95%CI 1.02-1.24). Amongst 30,408 existing users, the most regular quintile had 0.82 the hazard of non-adherence (95%CI 0.78-0.87); the high continuity group had a hazard ratio of 0.89 (95%CI 0.84-0.94).Conclusions: Regularity and continuity of care impact on medication management. It is possible that this mediates impacts on hospitalisation. Where there is a risk of unobserved confounding, potential causal pathways should be investigated. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). American cardiovascular societies consider CKD a risk-enhancing factor that supports statin therapy in intermediate-risk patients aged 40–75 years. In contrast, European cardiovascular societies recommend statins for all middle-aged adults with CKD. The Kidney Disease: Improving Global Outcomes lipid management guideline for CKD recommends statin therapy for all patients with CKD >50 years. Clinical implications for these differences have not been examined. This study examines CKD prevalence and statin eligibility in non-ASCVD adults, representative of the US population, at 3 levels of 10-year risk of ASCVD estimated by pooled cohort equations. National Health and Nutrition Examination Surveys 1999–2016 weighted data were evaluated for CKD defined as estimated glomerular filtration rate < 60 mL/min/1.73 m2. Overall prevalence of low, intermediate, and high 10-year risk for ASCVD was determined. A total of 92.5% of all participants had estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2; 7.5% (confidence interval 6.9%, 8.1%) had CKD. Among participants with CKD, 46.3% had 10-year risk for ASCVD <7.5% (low risk); 31.7% had intermediate risk (7.5-< 20%), and 22.0% had high risk (≥20%). In participants with CKD, 62.5% were women. A total of 19.6% of all participants with CKD had diabetes. A total of 46.3% of participants with CKD at intermediate or high risk reported taking cholesterol-lowering drugs. A total of 46.3% of patients with CKD aged 40–75 years had 10-year risk <7.5% (low risk) and hence were statin eligible by European and Kidney Disease: Improving Global Outcomes (>50 years) guidelines. US cardiovascular guidelines limit statin eligibility to intermediate- and high-risk CKD. Statin eligibility in lower-risk patients may be best determined by measuring coronary artery calcium. • Chronic kidney disease (CKD) is an independent cardiovascular disease (CVD) risk factor, and 7.5% of USA population has CKD. • A total of 46.3% of participants with CKD have low 10-year CVD risk; 31.7% have intermediate risk. • A total of 45.8% report cholesterol-lowering treatment. • Guidelines for statin eligibility vary widely. [ABSTRACT FROM AUTHOR]

Background: Statins, previously rated as pregnancy category X agents, were contraindicated during pregnancy due to the teratogenic effects observed in animal studies. However, it is still controversial whether statins have detrimental impact on pregnant women or not, and some studies even suggest a potential benefit of statin use against pregnancy complications. The aim of this study was to explore whether maternal exposure to statins is associated with increased rates of pregnancy-related adverse events (AEs), including abortion, abortion spontaneous, preterm birth, low birth weight, stillbirth/fetal death, and fetal complications., Research Design and Methods: Data from 1 January 2004 to 30 June 2022 were extracted through the U.S. FDA Adverse Event Reporting System (FAERS) database, to conduct disproportionality analysis and Bayesian analysis by reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) algorithms. To identify the potential risks of pregnancy-related AEs, each statin was compared to all the other drugs, all the other statins, and the reference drugs (fenofibrate and evolocumab)., Results: A total of 477 cases involving pregnancy-related AEs associated with stains were submitted to the FAERS database by healthcare professionals. No obvious disproportionate association of abortion, abortion spontaneous, or stillbirth/fetal death was identified for all statins during gestation. In comparison with all the other drugs, lovastatin showed an increased risk of fetal complications (ROR = 2.45, 95% CI, 1.22-4.95; IC 025  = 0.63), and pravastatin demonstrated increased risks of preterm birth (ROR = 4.89, 95% CI, 3.65-6.54; IC 025  = 1.69) and low birth weight (ROR = 9.60, 95% CI, 5.56-16.56; IC 025  = 1.88). Similar results were found when compared lovastatin or pravastatin with fenofibrate. Furthermore, statins were associated with higher proportion of fetal complications and preterm birth when comparing with evolocumab., Conclusions: Statins did not increase the risk of pregnancy-related AEs, including abortion, abortion spontaneous, or stillbirth/fetal death. However, we did find significant disproportionality signals for preterm birth and low birth weight associated with pravastatin, and lovastatin was related to a higher proportion of fetal complications. The results in this study may provide evidence on the safety of statins during pregnancy, which need to be verified in further investigations.

Context: Cardiovascular disease (CVD) is the leading cause of death in the United States. As such, an unmet need exists in the primary and secondary prevention of adverse cardiovascular events (CVEs). Specifically, identifying drugs that can reduce the progression of CVD and serious adverse events is much needed. Drugs that work by reducing platelet aggregation, blocking cholesterol formation (3-hydroxy-3-methyl-glutaryl-coenzyme A [HMG-CoA] reductase inhibitors), and/or blocking inflammation pathways (mainly interleukin-1b [IL-1b]) have been linked to preventing adverse CVEs, including acetylsalicylic acid (ASA, aspirin), statins, colchicine, and IL-1 inhibitors (interleukin-1 receptor antagonists). This systematic review aims to provide insight into utilizing these four agents for the primary and/or secondary prevention of CVD., Objectives: In this systematic review, we opted to review the efficacy of aspirin, statins, colchicine, and IL-1 inhibitors in the primary and secondary prevention of CVE to provide clinical practitioners with evidence-based practice approaches and determine any unmet needs in their utilization., Methods: Between October 1 and 12, 2021, a search was conducted and completed on five databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, and Biomedical Reference Collection: Comprehensive. A total of 13 researchers (V.A., A.H., S.B., V.G., D.C., C.C., C.B., C.A., S.K., J.H., A.K., S.F., and S.E.) were involved in the search and screening of the articles. Search terms included "aspirin, statins, colchicine, IL-1 inhibitors, and primary, secondary, myocardial infarction (MI)." Inclusion criteria included clinical study design, English language articles, all genders older than 50 years old, and established patient history of CVD, including MI. In addition, articles were excluded if they were animal models, in vitro studies, pharmacokinetic studies, systematic reviews, literature reviews, and studies exploring therapies other than those listed in the inclusion criteria. First, five individuals independently sorted through abstracts or articles based on the inclusion and exclusion criteria. Then, a team of 13 individuals sorted through full-text articles of selected abstracts based on the same criteria. A separate researcher resolved conflicts between the team., Results: A total of 725 articles were identified from all databases, from which 256 duplicated articles were removed. Thus, a total of 469 articles abstracts were screened, of which 425 articles either did not meet the inclusion criteria or met the exclusion criteria. A total of 42 articles were retrieved and assessed for full-text review, from which 15 articles were retrieved for analysis., Conclusions: Statins may prevent primary CVEs based on their role in preventing cholesterol formation. Aspirin, canakinumab, and colchicine may be helpful in the secondary prevention of CVEs due to their blocking of various steps in the inflammation pathway leading to CVD. Future research should primarily focus on the use of canakinumab and colchicine in preventing CVD due to the limited number of studies on these drugs., (© 2023 the author(s), published by De Gruyter, Berlin/Boston.)

Purpose: Low-density lipoprotein cholesterol (LDL-C) recommendations differ between the 2018 American College of Cardiology/American Heart Association (ACC/AHA) and 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for patients with atherosclerotic cardiovascular disease (ASCVD) (< 70 vs. < 55 mg/dl, respectively). In the DA VINCI study, residual cardiovascular risk was predicted in ASCVD patients. The extent to which relative and absolute risk might be lowered by achieving ACC/AHA versus ESC/EAS LDL-C recommended approaches was simulated., Methods: DA VINCI was a cross-sectional observational study of patients prescribed lipid-lowering therapy (LLT) across 18 European countries. Ten-year cardiovascular risk (CVR) was predicted among ASCVD patients receiving stabilized LLT. For patients with LDL-C ≥ 70 mg/dl, the absolute LDL-C reduction required to achieve an LDL-C of < 70 or < 55 mg/dl (LDL-C of 69 or 54 mg/dl, respectively) was calculated. Relative and absolute risk reductions (RRRs and ARRs) were simulated., Results: Of the 2039 patients, 61% did not achieve LDL-C < 70 mg/dl. For patients with LDL-C ≥ 70 mg/dl, median (interquartile range) baseline LDL-C and 10-year CVR were 93 (81-115) mg/dl and 32% (25-43%), respectively. Median LDL-C reductions of 24 (12-46) and 39 (27-91) mg/dl were needed to achieve an LDL-C of 69 and 54 mg/dl, respectively. Attaining ACC/AHA or ESC/EAS goals resulted in simulated RRRs of 14% (7-25%) and 22% (15-32%), respectively, and ARRs of 4% (2-7%) and 6% (4-9%), respectively., Conclusion: In ASCVD patients, achieving ESC/EAS LDL-C goals could result in a 2% additional ARR over 10 years versus the ACC/AHA approach., (© 2022. The Author(s).)

Introduction: Cardiovascular disease (CVD) is the leading cause of death in the United States, and high cholesterol is a leading risk factor for CVD. While statins are effective at reducing cholesterol, they are frequently underused in patients at highest risk of CVD. The objective of this study was to identify interventions which may improve adherence to statins and to assess their cost effectiveness within the US Medicare population. Methods: A literature review was undertaken to identify interventions to improve adherence in patients with CVD at highest risk of a recurrent event and to quantify non-adherence and the consequences of non-adherence to statins in this population. A Markov cost-utility model was developed to assess the cost effectiveness of these interventions. Results: Ten adherence interventions were identified in the literature, with 6 demonstrating statistically significant improvement in adherence. The six interventions were disease management, interactive voice response, nurse counselling, discharge letter, nurse/dietician counselling and electronic pill bottle with feedback. The model found the cost effectiveness of an intervention was highly dependent on its effectiveness and costs. Incremental cost effectiveness ratios ranged from $27,545/QALY for discharge letter with large adherence gain to $130,399/QALY for disease management program with small adherence gain. Conclusion: Some interventions to improve adherence have been shown to be effective, but little attention has been paid to the costs. Further studies on adherence interventions should include economic evaluations. [ABSTRACT FROM AUTHOR]

Background: Role of statins in prevention of contrast-induced acute kidney injury (CI-AKI) in patients undergoing coronary angiography remains controversial. We studied the use of statins in decreasing CI-AKI following coronary angiography.Methods: We reviewed all patients who underwent coronary angiography with or without PCI and had a follow-up creatinine from January 2012 to December 2016 at a single tertiary care center in the United States. CI-AKI was defined as 0.3 mg/dL absolute rise in creatinine. Patients who were on moderate to high-intensity statins or received moderate to high-intensity statins prior to coronary angiography were included in the statin group. Crude and adjusted odds ratios (AOR) were calculated using univariate multiple logistic regression analysis.Results: Out of 2055 patients (females = 30.7%, mean age 58.0 ± 12.5 years, statin group = 886, non-statin group = 1169), 293 (14.3%) developed CI-AKI. Mean estimated glomerular filtration rate (eGFR) was not significantly different between the statin and the non-statin group (86.5 mL/min/1.73 m2 vs 87.1 mL/min/1.73 m2, p = 0.65). There was no significant difference in the incidence of CI-AKI between statin and non-statin group (14.4% vs 14.1%, p = 0.83). When adjusted for other risk factors, statin use was not significantly associated with decreased risk of CI-AKI (AOR) = 0.8, [95% confidence interval (CI) = 0.6-1.1, p = 0.19]. Results remained statistically non-significant on subgroup analysis of patients with acute coronary syndrome (ACS) (OR = 0.8, 95% CI = 0.6-1.2, p = 0.27), patients who had percutaneous coronary intervention (PCI) (OR = 1.1, 95% CI = 0.6-1.7, p = 0.81) and patients with eGFR < 60 mL/min/1.73 m2 (OR = 0.9, 95% CI = 0.6-1.5, p = 0.9).Conclusion: Statin use prior to coronary angiography is not associated with decreased incidence of CI-AKI. [ABSTRACT FROM AUTHOR]

Background: Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates. However, PCSK9i prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option. We tested the hypothesis that acute coronary syndromes, coronary interventions, stroke, and cardiac arrest are more prevalent in patients with rejected or abandoned PCSK9i prescriptions than for those with paid PCSK9i prescriptions.Methods and Results: We identified 139 036 individuals aged ≥18 years who met the following 3 criteria: prescribed PCSK9i between August 2015 and December 2017, had claims history, and had an established date of exposure for paid, rejected, or abandoned status. To compare the effects of rejected versus paid and abandoned versus paid status, propensity score matching was performed to minimize confounding because of baseline differences in patient groups. Cox regression analyses and incidence density rates for cardiovascular events were estimated on the propensity score-matched cohorts. Patients who received 168 or more days of paid PCSK9i medication within a 12-month period were defined as paid. The hazard ratios for composite cardiovascular events outcome in propensity score-matched analyses were 1.10 (95% CI, 1.01-1.19; P=0.02) for rejected versus paid and 1.12 (95% CI, 1.01-1.24; P=0.03) for abandoned versus paid. In a stricter analysis where paid patients were defined by receiving 338 or more days of therapy within 12-months, hazard ratio was 1.16 (95% CI, 1.02-1.30; P=0.04) for rejected versus paid and 1.21 (95% CI, 1.04-1.38; P=0.03) for the abandoned versus paid status. Higher PCSK9i rejection rates were observed with women, racial minorities, and lower-income groups.Conclusions: Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates. [ABSTRACT FROM AUTHOR]

Background Statin medications have immunomodulatory effects. Several recent studies suggest that statins may reduce influenza vaccine response and reduce influenza vaccine effectiveness (VE). Methods We compared influenza VE in statin users and nonusers aged ≥45 years enrolled in the US Vaccine Effectiveness Network study over 6 influenza seasons (2011–2012 through 2016–2017). All enrollees presented to outpatients clinics with acute respiratory illness and were tested for influenza. Information on vaccination status, medical history, and statin use at the time of vaccination were collected by medical and pharmacy records. Using a test-negative design, we estimated VE as (1 – OR) × 100, in which OR is the odds ratio for testing positive for influenza virus among vaccinated vs unvaccinated participants. Results Among 11692 eligible participants, 3359 (30%) were statin users and 2806 (24%) tested positive for influenza virus infection; 78% of statin users and 60% of nonusers had received influenza vaccine. After adjusting for potential confounders, influenza VE was 36% (95% confidence interval [CI], 22%–47%) among statin users and 39% (95% CI, 32%–45%) among nonusers. We observed no significant modification of VE by statin use. VE against influenza A(H1N1)pdm09, A(H3N2), and B viruses were similar among statin users and nonusers. Conclusions In this large observational study, influenza VE against laboratory-confirmed influenza illness was not affected by current statin use among persons aged ≥45 years. Statin use did not modify the effect of vaccination on influenza when analyzed by type and subtype. [ABSTRACT FROM AUTHOR]

Introduction: The benefits of statin medications in patients receiving maintenance dialysis remains controversial and clinical trials overall have shown no benefit. Potential side effects of statin medications include myalgias, myopathy, and memory loss and risk of side effects associated with statin medications increase with higher statin doses. We examined statin use and statin dose among Veterans with dialysis dependent CKD. Such information may help clinicians modulate medication use and reduce pill burden in appropriate patients. Methods: This cross‐sectional analysis ascertained medication utilization by linking records from the U.S. Department of Veteran's Affairs (VA) Managerial Cost Accounting Pharmacy National Data Extracts and Medicare Part D during calendar year 2013 for Veterans with dialysis‐dependent CKD enrolled in and/or using VA healthcare. The venue of dialysis and patient characteristics were ascertained by linking VA Medical SAS datasets, VA Fee Basis datasets (for non‐VA care paid for by VA), Medicare claims and the United States Renal Data Systems patient core files. Findings: We identified 18,494 Veterans with dialysis‐dependent CKD who were enrolled in and/or used VA healthcare, had no history of kidney transplantation, and were alive on January 1, 2014. More than half (58.1%) of Veterans with dialysis‐dependent CKD used statins and 35.7% of statin utilization was high dose. Statins were the third most commonly prescribed medication after beta blockers (64.8%) and phosphate binders (64.5%). Discussion: Statins are a commonly prescribed medication among Veterans receiving maintenance dialysis and approximately one‐third of statin utilization is high dose in this population. Future studies should examine patient preferences, comorbidities, and dialysis characteristics that impact the risks and benefits of statin use in order to identify those patients who will or will not benefit from continued statin use. [ABSTRACT FROM AUTHOR]

Background Statin therapy remains the primary treatment for mixed dyslipidemia, even with moderate triglyceride (TG) elevations. Objective We examined the prevalence of elevated TG levels in adults with and without statin use and the associated 10-year predicted atherosclerotic cardiovascular disease (ASCVD) risk. Methods We studied 9593 US adults aged ≥20 years (219.9 million projected) in the US National Health and Nutrition Examination Surveys, 2007 to 2014. We determined the proportions of TG categories (<150, 150–199, 200–499, and ≥500 mg/dL) according to statin use, as well as the 10-year estimated ASCVD risk and number of events. Results Among those not taking statin therapy, the prevalence of TG < 150, 150 to 199, and ≥200 mg/dL was 75.3%, 12.8%, and 11.9%; among statin users, these proportions were 68.4%, 16.2%, and 15.4%, respectively. Among persons with low-density lipoprotein cholesterol <100 mg/dL (or <70 mg/dL in those with ASCVD), despite statin use, 27.7% had TG ≥ 150 mg/dL. The odds of TG ≥ 150 mg/dL in statin users was associated with greater age, higher body mass index, lower high-density lipoprotein cholesterol, higher low-density lipoprotein cholesterol, and diabetes. Estimated mean 10-year ASCVD risk from TG < 150 to ≥500 mg/dL, ranged from 11.3% to 19.1% in statin users and 6.0% to 15.6% in nonusers, with an overall 3.4 million ASCVD events expected in the next 10 years. Conclusions One-fourth of US adults overall, including nearly one-third of those on statin therapy, have suboptimal TG levels. More than 3 million ASCVD events are expected to occur over the next decade in those with TG ≥ 150 mg/dL, with approximately 1 million events expected in statin users. Highlights • We examined the prevalence of hypertriglyceridemia in US adults by statin use. • We also examined the 10-year estimated ASCVD risk and number of events. • In non-statin users 24.7% had TG ≥150 mg/dL versus 31.6% in statin users. • Mean 10-year ASCVD risk ranged from 7.1% to 16.1% with TG<150–≥500 mg/dL. • We estimate >3 million ASCVD events in 10 years in those with TG ≥ 150 mg/dL. [ABSTRACT FROM AUTHOR]

Keywords: dyslipidemias; ezetimibe; guideline; statins EN dyslipidemias ezetimibe guideline statins 1121 1123 3 04/20/20 20200407 NES 200407 The 2018 American Heart Association (AHA)/American College of Cardiology (ACC) Multisociety Guideline on the Management of Blood Cholesterol[1] divides patients with clinical atherosclerotic cardiovascular disease (ASCVD) into high-risk and very high-risk categories. Very high-risk patients are those with ASCVD plus other high-risk conditions; these patients are potential candidates for maximal statin therapy plus 2 nonstatins (ezetimibe and/or proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitors). This may expand the number of patients who are candidates for nonstatin add-on therapy, especially patients without ASCVD who are classified as very high risk in the ESC/EAS guidelines. [Extracted from the article]

Background: Polycythemia vera (PV) and essential thrombocythemia (ET) are linked to increased risk of cardiovascular morbidity and mortality. In addition to the reduction in of arterial thrombotic events, statins may prevent venous thrombosis including among patients with cancer. As previous registry- and claims-based studies revealed that the use of statins may improve the survival of patients with various malignancies we evaluated their impact on outcomes of older adults with PV and ET., Methods: We identified 4010 older adults (aged 66-99 years at diagnosis) with PV (n = 1809) and ET (n = 2201) in a population-based cohort study using the Surveillance, Epidemiology, and End Results-Medicare database with median follow-up of 3.92 (interquartile range: 2.58-5.75) years. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) approaches were utilized to assess potential association between statins and overall survival. Multivariable competing risk models with death as a competing risk were used to evaluate possible relationship between statins and the incidence of thrombosis., Results: 55.8% of the patients used statins within the first year after PV/ET diagnosis, and statin use was associated with a 22% reduction in all-cause mortality (PSM: hazard ratio [HR] = 0.78, 95% confidence interval [CI]: 0.63-0.98, p = 0.03; IPTW: HR = 0.79, 95% CI: 0.64-0.97, p = 0.03). Statins also reduced the risk of thrombosis in this patient population (PSM: HR = 0.63, 95% CI: 0.51-0.78, p < 0.01; IPTW: HR = 0.57, 95% CI: 0.49-0.66, p < 0.01) as well as in PV and ET subgroups., Conclusions: These findings suggest that it may be important to incorporate statins into the therapeutic strategy for older adults with PV and ET., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Purpose: Statins are among the most prevalent medications prescribed and associated with adverse events that may prompt additional treatment (i.e., a prescribing cascade). No comprehensive assessment of statin-related prescribing cascades has been performed to our knowledge., Methods: We utilized sequence symmetry analysis to iteratively screen prescribing sequences of all therapeutic classes ("marker" classes) based on Level 4 Anatomical Therapeutic Chemical codes among adult statin initiators, using IBM Marketscan commercial and Medicare supplemental claims databases (2005-2019). Order of initiation and secular trend-adjusted sequence ratios were calculated for each statin-marker class dyad, among marker class initiators ±90 days of statin initiation. Among signals classified as prescribing cascades, we calculated naturalistic number needed to harm (NNTH) within 1 year as the inverse of the excess risk among exposed., Results: We identified 2 265 519 statin initiators (mean ± SD age, 56.4 ± 12.0 years; 48.7% women; 7.5% with cardiovascular disease). Simvastatin (34.4% of statin initiators) and atorvastatin (33.9%) were the most commonly initiated statins. We identified 160 significant statin-marker class dyad signals, of which 35.6% (n = 57) were classified as potential prescribing cascades. Of the top 25 strongest signals (lowest NNTH), 12 were classified as potential prescribing cascades, including osmotically acting laxatives (NNTH, 44, 95% CI 43-46), opioids + non-opioid combination analgesics (81, 95% CI 74-91), and first-generation cephalosporins (204, 95% CI 175-246)., Conclusions: Using high-throughput sequence symmetry analysis screening, we identified previously known prescribing cascades as well as potentially new prescribing cascades based on known and unknown statin-related adverse events., (© 2023 John Wiley & Sons Ltd.)

Background Statins are used to reduce cardiovascular disease risk. Recent studies suggest that statin use may be associated with an increased influenza risk among influenza vaccinees. We used Medicare data to evaluate associations between statins and risks of influenza-related encounters among vaccinees. Methods In this retrospective cohort study, we identified Medicare beneficiaries aged > 65 years who received high-dose (HD) or standard-dose (SD) influenza vaccines at pharmacies from 2010–2011 through 2014–2015. Statin users were matched to nonusers by vaccine type, demographics, prior medical encounters, and comorbidities. We used multivariable Poisson models to estimate associations between statin use around the time of vaccination and risk of influenza-related encounters. Study outcomes included influenza-related office visits with a rapid test followed by dispensing of oseltamivir and influenza-related hospitalizations (including emergency room visits) during high influenza circulation periods. Results The study included 1403651 statin users matched to nonusers. Cohorts were well balanced, with standardized mean differences ≤0.03 for all measured covariates. For statin users compared to nonusers, the adjusted relative risk was 1.086 (95% confidence interval [CI], 1.025–1.150) for influenza-related visits and 1.096 (95% CI, 1.013–1.185) for influenza-related hospitalizations. The risk difference ranged from ‒0.02 to 0.23 for influenza-related visits and from ‒0.04 to 0.13 for hospitalizations, depending on season severity. Results were similar for HD and SD vaccinees and for nonsynthetic and synthetic statin users. Conclusions Among 2.8 million Medicare beneficiaries, these results suggest that statin use around the time of vaccination does not substantially affect the risk of influenza-related medical encounters among older adults. [ABSTRACT FROM AUTHOR]

Background: Obesity is known to be a major risk factor for diabetes, but the magnitude of risk and variation between blacks and whites are less well documented in populations heavily affected by obesity. Herein we assess rates and risks of incident diabetes in a diverse southern population where obesity is common. Methods: A total of 24,000 black and 14,064 white adults aged 40–79 in the Southern Community Cohort Study with no self-reported diabetes at study enrollment during 2002–2009 was followed for up to 10 (median 4.5) years. Incidence rates, odds ratios (OR) and accompanying 95% confidence intervals (CI) for medication-treated incident diabetes were determined according to body mass index (BMI) and other characteristics, including tobacco and alcohol consumption, healthy eating and physical activity indices, and socioeconomic status (SES). Results: Risk of incident diabetes rose monotonically with increasing BMI, but the trends differed between blacks and whites (pinteraction < .0001). Adjusted ORs (CIs) for diabetes among those with BMI≥40 vs 20–25 kg/m2 were 11.9 (8.4–16.8) for whites and 4.0 (3.3–4.8) for blacks. Diabetes incidence was more than twice as high among blacks than whites of normal BMI, but the racial difference became attenuated as BMI rose, with estimated 5-year probabilities of developing diabetes approaching 20% for both blacks and whites with BMI≥40 kg/m2. Diabetes risk was also associated with low SES, significantly (pinteraction≤.02) more so for whites, current cigarette smoking, and lower healthy eating and physical activity indices, although high BMI remained the predominant risk factor among both blacks and whites. From baseline prevalence and 20-year projections of the incidence trends, we estimate that the large majority of surviving cohort participants with BMI≥40 kg/m2 will be diagnosed with diabetes. Conclusions: Even using conservative criteria to ascertain diabetes incidence (i.e., requiring diabetes medication use and ignoring undiagnosed cases), rates of obesity-associated diabetes were exceptionally high in this low-income adult population. The findings indicate that effective strategies to halt the rising prevalence of obesity are needed to avoid substantial increases in diabetes in coming years. [ABSTRACT FROM AUTHOR]

Background/Objectives We sought to determine whether statin use for primary prevention is associated with a lower risk of cardiovascular events or mortality in older men. Design Prospective cohort study. Setting Physicians' Health Study participants. Participants 7,213 male physicians ≥70 years without a history of cardiovascular disease ( CVD). Measurements Multivariable propensity score for statin use with greedy matching (1:1) to minimize confounding by indication. Results Median baseline age was 77 (70-102), median follow-up was 7 years. Non-users were matched to 1,130 statin users. Statin use was associated with an 18% lower risk of all-cause mortality, HR 0.82 (95% CI 0.69-0.98) and non-significant lower risk of CVD events, HR 0.86 (95% CI 0.70-1.06) and stroke, HR 0.70 (95% CI 0.45-1.09). In subgroup analyses, results did not change according to age group at baseline (70-76 or >76 years) or functional status. There was a suggestion that those >76 at baseline did not benefit from statins for mortality, HR 1.14 (95% CI 0.89-1.47), compared to those 70-76 at baseline, HR 0.83 (95% CI 0.61-1.11); however the CIs overlap between the two groups, suggesting no difference. Statin users with elevated total cholesterol had fewer major CVD events than non-users, HR 0.68 (95% CI 0.50-0.94) and HR 1.43 (95% CI 0.99-2.07)), respectively. Conclusions Statin use was associated with a significant lower risk of mortality in older male physicians ≥70 and a nonsignificant lower risk of CVD events. Results did not change in those who were >76 years at baseline or according to functional status. There was a suggestion that those with elevated total cholesterol may benefit. Further work is needed to determine which older individuals will benefit from statins as primary prevention. [ABSTRACT FROM AUTHOR]

Background/Objectives Secondary prevention medications are recommended for older adults after acute myocardial infarction ( AMI), but little is known about whether nursing home ( NH) residents receive these medications. The objective was to evaluate new use of secondary prevention medications after AMI in NH residents who were previously nonusers and to evaluate what factors were associated with use. Design Retrospective cohort using linked national Minimum Data Set assessments; Online Survey, Certification and Reporting records; and Medicare claims. Setting U.S. NHs. Participants National cohort of 11,192 NH residents aged 65 and older who were hospitalized for an AMI between May 2007 and March 2010, had no beta-blocker or statin use for 4 months or longer before the hospitalization, and survived 14 days or more after NH readmission. Measurements The outcome was the number of secondary prevention medications initiated within 30 days of NH readmission. Results Thirty-seven percent of residents had no secondary prevention medications initiated after AMI, 41% had 1 initiated, and 22% had 2 initiated. After covariate adjustment, fewer secondary prevention medications were used in older residents (proportional odds ratio ( POR) = 0.48, 95% confidence interval ( CI) = 0.40-0.57 for ≥95 vs 65-74); women ( POR = 0.88, 95% CI = 0.80-0.96);and those with a do-not-resuscitate ( DNR) order ( POR = 0.90, 95% CI = 0.83-0.98), functional impairment (dependent or totally dependent vs independent to limited assistance, POR = 0.77, 95% CI = 0.69-0.86), and cognitive impairment (moderate to severe vs no impairment, POR = 0.79, 95% CI = 0.70-0.89). Conclusion More than one-third of older NH residents in the United States do not have any secondary prevention medications initiated after AMI, with fewer medications initiated in older residents; women; and those with, DNR orders, poor physical function, and cognitive impairment. A lack of evidence about the safety and effectiveness of secondary preventions medications in the NH population and unmeasured person-centered goals of care are plausible explanations for these findings. [ABSTRACT FROM AUTHOR]

Background: Impact of cardiorespiratory fitness on statin-related incidence of type 2 diabetes has not been assessed. We assessed the cardiorespiratory fitness and diabetes incidence association in dyslipidemic patients on statins.Methods: We identified dyslipidemic patients with a normal exercise test performed during 1986 and 2014 at the Veterans Affairs Medical Centers in Washington, DC or Palo Alto, Calif. The statin-treated patients (n = 4092; age = 58.8 ± 10.9 years) consisted of 2701 Blacks and 1391 Whites. None had evidence of type 2 diabetes prior to statin therapy. We formed 4 fitness categories based on age and peak metabolic equivalents achieved: Least-fit (n = 954), Low-fit (n = 1201), Moderate-fit (n = 1242), and High-fit (n = 695). The non-statin-treated cohort (n = 3001; age = 57.2 ± 11.2 years) with no evidence of type 2 diabetes prior to the exercise test served as controls.Results: Diabetes incidence was 24% higher in statin-treated compared with non-statin-treated patients (P <.001). In the statin-treated cohort, 1075 (26.3%) developed diabetes (average annual incidence rate of 30.6 events/1000 person-years). Compared with the Least-fit, adjusted risk decreased progressively with increasing fitness and was 34% lower for High-fit patients (hazard ratio [HR] 0.66; 95% confidence interval [CI], 0.53-0.82; P <.001). Compared with the nonstatin cohort, elevated risk was evident only in the Least-fit (HR 1.50; 95% CI, 1.30-1.73; P <.001) and Low-fit patients (HR 1.22; 95% CI, 1.06-1.41; P = .006).Conclusions: Risk of diabetes in statin-treated dyslipidemic patients was inversely and independently associated with cardiorespiratory fitness. The increased risk was evident only in relatively low-fitness patients. Improving fitness may modulate the potential diabetogenic effects of statins. [ABSTRACT FROM AUTHOR]

In 2016, the American College of Cardiology published the first expert consensus decision pathway (ECDP) on the role of non-statin therapies for low-density lipoprotein (LDL)-cholesterol lowering in the management of atherosclerotic cardiovascular disease (ASCVD) risk. Since the publication of that document, additional evidence and perspectives have emerged from randomized clinical trials and other sources, particularly considering the longer-term efficacy and safety of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors in secondary prevention of ASCVD. Most notably, the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial and SPIRE-1 and -2 (Studies of PCSK9 Inhibition and the Reduction of Vascular Events), assessing evolocumab and bococizumab, respectively, have published final results of cardiovascular outcomes trials in patients with clinical ASCVD and in a smaller number of high-risk primary prevention patients. In addition, further evidence on the types of patients most likely to benefit from the use of ezetimibe in addition to statin therapy after acute coronary syndrome has been published. Based on results from these important analyses, the ECDP writing committee judged that it would be desirable to provide a focused update to help guide clinicians more clearly on decision making regarding the use of ezetimibe and PCSK9 inhibitors in patients with clinical ASCVD with or without comorbidities. In the following summary table, changes from the 2016 ECDP to the 2017 ECDP Focused Update are highlighted, and a brief rationale is provided. The content of the full document has been changed accordingly, with more extensive and detailed guidance regarding decision making provided both in the text and in the updated algorithms. Revised recommendations are provided for patients with clinical ASCVD with or without comorbidities on statin therapy for secondary prevention. The ECDP writing committee judged that these new data did not warrant changes to the decision pathways and algorithms regarding the use of ezetimibe or PCSK9 inhibitors in primary prevention patients with LDL-C <190 mg/dL with or without diabetes mellitus or patients without ASCVD and LDL-C ≥190 mg/dL not due to secondary causes. Based on feedback and further deliberation, the ECDP writing committee down-graded recommendations regarding bile acid sequestrant use, recommending bile acid sequestrants only as optional secondary agents for consideration in patients intolerant to ezetimibe. For clarification, the writing committee has also included new information on diagnostic categories of heterozygous and homozygous familial hypercholesterolemia, based on clinical criteria with and without genetic testing. Other changes to the original document were kept to a minimum to provide consistent guidance to clinicians, unless there was a compelling reason or new evidence, in which case justification is provided. [ABSTRACT FROM AUTHOR]

Background Residual atherosclerotic cardiovascular disease (ASCVD) risk in statin-treated US adults without known ASCVD is not well described. Objective To quantitate residual ASCVD risk and its predictors in statin-treated adults. Methods We studied 1014 statin-treated adults (53.3% female, mean 66.0 years) free of clinical ASCVD in the Multi-Ethnic Study of Atherosclerosis. We examined ASCVD event rates by National Lipid Association risk groups over 11-year follow-up and the relation of standard risk factors, biomarkers, and subclinical atherosclerosis measures with residual ASCVD event risk. Results Overall, 5.3% of participants were at low, 12.2% at moderate, 60.3% at high, and 22.2% at very high baseline risk. Despite statin therapy, age- and race-standardized ASCVD rates per 1000 person-years for men and women were both 4.9 for low/moderate risk, 19.1 and 14.2 for high risk, and 35.6 and 26.7 for very high risk, respectively. Specific independent predictors of residual risk included current smoking, family history, diabetes, high-sensitivity C-reactive protein, low-density lipoprotein particle number, carotid intimal medial thickness, and especially coronary artery calcium score. Those on moderate- or high-intensity statins at baseline (compared with low intensity) had 39% lower risks and those who increased statin intensity 62% lower ASCVD event risks ( P < .01). Conclusion Residual risk of ASCVD remains high despite statin treatment and is predicted by specific risk factors and subclinical atherosclerosis. These findings may be helpful for identifying those at highest risk needing more aggressive treatment. [ABSTRACT FROM AUTHOR]

Objectives: To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins.Data Sources: Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008.Study Design: We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost.Principal Findings: We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands.Conclusions: Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health. [ABSTRACT FROM AUTHOR]

Introduction: Statin discontinuation has been investigated in a wide range of diseases and injuries, but there is a paucity of data in the older adult population with traumatic brain injury (TBI). The purpose of this study was to re-examine the extent to which early discontinuation of pre-injury statin (PIS) therapy increases the risk of poor patient outcomes in older adult patients suffering a TBI.Methods: This was a retrospective observational cohort study of adult trauma patients with a blunt TBI across three trauma centres over four years. Patients were excluded because of no PIS use, age <55years, or a hospital length of stay (LOS) less than three days. Patients found to be intentionally discontinued from statin therapy within 48h of hospital admission for injury-related reasons were excluded. The primary and secondary outcomes were in-hospital mortality and a hospital LOS ≥1 week. Outcomes were analysed using logistic regression.Results: There were 266 patients in the continuation group, and 131 in the discontinuation group. The statin discontinuation group had a significantly higher proportion of patients with a moderate or severe head injury, intubation in emergency department (ED), and disposition to the intensive care unit or operating room. Overall, 23 (6%) patients died while in the hospital. After adjusting for ED Glasgow coma scale, the odds of dying in the hospital were not significantly larger for patients having been discontinued from PIS, compared to those who were continued (OR=1.75, 95%CI=0.71-4.31, p=0.22). Among patients who received an in-hospital statin, the median (interquartile range) time between hospital admission and first administration of statin medication did not differ between patients who died and those who survived (22.8h [10.96-28.91] vs. 22.9h [11.67-39.80], p=0.94). There were no significant differences between study groups in the proportion of patients with a hospital length of stay >1 week (continuation=29% vs. discontinuation=36%, p=0.19).Conclusion: We did not observe a significantly increased odds of in-hospital mortality following PIS discontinuation, compared to PIS continuation, in an older adult population with TBI. It remains to be seen whether statin discontinuation is a proxy variable for injury severity, or whether it exerts deleterious effects after injury. [ABSTRACT FROM AUTHOR]

Background: Numerous studies demonstrate that, even with use of statins, many patients are unable to meet their LDL-C goals. This study examined modifications to statin and/or ezetimibe therapy among patients with hyperlipidemia and prior history of cardiovascular (CV) events in a US commercially insured population.Methods: Adults (age ≥18 years) initiating statins and/or ezetimibe between 1 January 2007 and 31 December 2008 were identified from HealthCore Integrated Research Database. The index date was the initiation date of statins and/or ezetimibe. All patients had ≥1 medical claims related to myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, coronary artery bypass graft, or percutaneous coronary intervention within 12 months prior to the index date. Treatment modifications to statins and/or ezetimibe initiated on the index date (index therapy) included permanent discontinuation of any lipid lowering therapy (LLT), rechallenge, switching, subtraction, augmentation, and dose changes.Results: Among 17,902 patients, around 90% initiated with statin monotherapy, followed by statin and ezetimibe combination (3.0%: 18-64 years; 3.8%: ≥65 years). Ten percent or less initiated on high intensity statins. Most common treatment modifications were rechallenging index therapy (25.2%: 18-64 years, 27.0%: ≥65 years), switching (27.5%: 18-64 years, 24.6%: ≥65 years), and permanent discontinuation of any LLT (18.6%: 18-64 years, 21.0%: ≥65 years). Only 10% of patients in both groups underwent dose escalation.Conclusions: Real-world evidence indicates that few high-risk patients initiate therapy with high-intensity statins. More than 50% of patients underwent a rechallenge or switching. Despite high CVD risk profile, approximately 20% of patients permanently discontinued any LLT. Key limitations: Pharmacy claims do not provide information on whether patients who had a pharmacy fill actually took the medication as prescribed. It is unknown whether rechallenge was a simple delay in filling a prescription or an actual rechallenge of their index therapy. Reasons for treatment discontinuations or modifications were unavailable in claims data. [ABSTRACT FROM AUTHOR]

Statins are lipid-lowering medications used for primary and secondary prevention of atherosclerotic disease and represent a substantial portion of drug costs in the United States. A better understanding of prescribing patterns and drug costs should lead to more rational utilization and help constrain health care expenditures in the United States. The 2013 Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File for the State of Hawai'i was analyzed. The number of prescriptions for statins, total annual cost, and daily cost were calculated by prescriber specialty and drug. Potential savings from substituting the highest-cost statin with lower-cost statins were calculated. Over 421,000 prescriptions for statins were provided to Medicare Part D beneficiaries in Hawai'i in 2013, which cost $17.6M. The three most commonly prescribed statins were simvastatin (33.4%), atorvastatin (33.4%), and lovastatin (13.9%). Although rosuvastatin comprised 5.4% of the total statin prescriptions, it represented 30.1% of the total cost of statins due to a higher daily cost ($5.53/day) compared to simvastatin ($0.25/day) and atorvastatin ($1.10/day). Cardiologists and general practitioners prescribed the highest percentage of rosuvastatin (8% each). Hypothetical substitution of rosuvastatin would have resulted in substantial annual cost savings (Simvastatin would have saved $1.3M for 25% substitution and $5.1M for 100% substitution, while atorvastatin would have saved $1.1M for 25% substitution and $4.3M for 100% substitution). Among Medicare Part D beneficiaries in Hawai'i, prescribing variation for statins between specialties were observed. Substitution of higher-cost with lower-cost statins may lead to substantial cost savings. [ABSTRACT FROM AUTHOR]

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.Methods: We studied 105,329 Medicare beneficiaries who began a moderate- or high-intensity statin dosage after hospitalization for MI between 2007 and 2013. Statin intolerance was defined as down-titrating statins and initiating ezetimibe therapy, switching from statins to ezetimibe monotherapy, having International Classification of Diseases, 9th revision, diagnostic codes for rhabdomyolysis or an antihyperlipidemic adverse event, followed by statin down-titration or discontinuation, or switching between ≥3 types of statins within 1 year after initiation. High statin adherence over the year following hospital discharge was defined as proportion of days covered ≥80%. Recurrent MI, CHD events (recurrent MI or a coronary revascularization procedure), and mortality were identified from 1 year after hospital discharge through December 2014.Results: Overall, 1,741 patients (1.65%) had statin intolerance, and 55,567 patients (52.8%) had high statin adherence. Over a median of 1.9 to 2.3 years of follow-up, there were 4,450 recurrent MIs, 6,250 CHD events, and 14,311 deaths. Compared to beneficiaries with high statin adherence, statin intolerance was associated with a 36% higher rate of recurrent MI (41.1 vs. 30.1 per 1,000 person-years, respectively), a 43% higher rate of CHD events (62.5 vs. 43.8 per 1,000 person-years, respectively), and a 15% lower rate of all-cause mortality (79.9 vs. 94.2 per 1,000 person-years, respectively). The multivariate-adjusted hazard ratios (HR) comparing beneficiaries with statin intolerance versus those with high statin adherence were 1.50 (95% confidence interval [CI]: 1.30 to 1.73) for recurrent MI, 1.51 (95% CI: 1.34 to 1.70) for CHD events, and 0.96 (95% CI: 0.87 to 1.06) for all-cause mortality.Conclusions: Statin intolerance was associated with an increased risk for recurrent MI and CHD events but not all-cause mortality. [ABSTRACT FROM AUTHOR]

Background: In contrast to guidelines related to lipid therapy in other areas, 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend conducting a lipid profile upon diagnosis of chronic kidney disease (CKD) and treating all patients older than 50 years without defining a target for lipid levels. We evaluated multinational practice patterns for lipid management in patients with advanced CKD under nephrology care., Methods: We analyzed lipid-lowering therapy (LLT), LDL- cholesterol (LDL-C) levels, and nephrologist-specified LDL-C goal upper limits in adult patients with eGFR < 60 ml/min from nephrology clinics in Brazil, France, Germany, and the United States (2014-2019). Models were adjusted for CKD stage, country, cardiovascular risk indicators, sex, and age., Results: LLT treatment differed significantly by country, from 51% in Germany to 61% in the US and France (p = 0.002) for statin monotherapy. For ezetimibe with or without statins, the prevalence was 0.3% in Brazil to 9% in France (< 0.001). Compared with patients not taking lipid-lowering therapy, LDL-C was lower among treated patients (p < 0.0001) and differed significantly by country (p < 0.0001). At the patient level, the LDL-C levels and statin prescription did not vary significantly by CKD stage (p = 0.09 LDL-C and p = 0.24 statin use). Between 7-23% of untreated patients in each country had LDL-C ≥ 160 mg/dL. Only 7-17% of nephrologists believed that LDL-C should be < 70 mg/dL., Conclusion: There is substantial variation in practice patterns regarding LLT across countries but not across CKD stages. Treated patients appear to benefit from LDL-C lowering, yet a significant proportion of hyperlipidemia patients under nephrologist care are not receiving treatment., (© 2023. The Author(s).)

Objective: To quantify the effect of the unemployment created by COVID-19 on access to (sales of) statin drugs in the United States population., Methods: Approximately half a billion transactions for statin drugs in the United States between January 2018 and September 2020 are analyzed. We studied the potential causal relation between abnormal levels of unemployment during the first wave of COVID-19 in the U.S. and abnormal levels of sales of statin products (both variables defined at the state/week level). Variables are analyzed using the Two-Stage Least Squares (2SLS) method, which exploits comparisons of statin sales between states where, given the occupational distribution of their workforce, unemployment was more structurally vulnerable to mobility restrictions derived from COVID-19 against states where it was less structurally vulnerable., Results: While we do not find unemployment effects on statin sales on most of the population, our estimates link COVID-fueled unemployment with a sharp sales reduction among Medicaid-insured populations, particularly those in working age. For the period between March and August of 2020, these estimates imply a 31% drop of statin sales among this population., Discussion: COVID-fueled unemployment may have had a negative and significant effect on access to statin populations among Medicaid-insured populations., Competing Interests: CA is past Chair and a current member of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Advisory Committee; is a consultant and holds equity in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and is a member of OptumRx's National P&T Committee. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Hermosilla, Alexander and Polsky.)

Background Understanding current trends in cholesterol screening, lipid levels, and lipid management therapies may inform health policy and practice. Methods and Results In 50 928 US adult National Health and Nutrition Examination Survey (NHANES) participants, trends were assessed in cholesterol screening, mean levels of total cholesterol, triglycerides, low-density-lipoprotein cholesterol, and lipid-lowering medication use from 1999 through 2018. Point estimates were also calculated using the 2017 to March 2020 prepandemic data set. The age- and sex-adjusted proportion of having cholesterol screened within 5 years increased from 63.2% (95% CI, 60.0-66.3) in 1999 to 2000 to 72.5% (95% CI, 69.5-75.3) in 2017 to 2018 ( P <0.001 for linear trend). Mean total cholesterol decreased from 203.3 mg/dL (95% CI, 201.0-205.7) in 1999 to 2000 to 188.4 mg/dL in 2017 to 2018 (95% CI, 185.4-191.5) ( P <0.001 for nonlinear trend). The mean triglyceride level decreased from 121.3 mg/dL (95% CI, 116.4-126.4) in 1999 to 2000 to 91.4 mg/dL (95% CI, 88.4-94.6) in 2017 to 2018 ( P <0.001 for nonlinear trend). Low-density lipoprotein cholesterol decreased from 127.9 mg/dL (95% CI, 125.3-130.5) in 1999 to 2000 to 111.7 mg/dL (95% CI, 109.0-114.4) in 2017 to 2018 ( P <0.001 for nonlinear trend). Among statin-eligible US adults, the proportion of statin use increased from 14.9% (95% CI, 12.2-17.9) in 1999 to 2000 to 27.8% (95% CI, 23.0-33.2) in 2017 to 2018 ( P <0.001 for nonlinear trend). Statin use increased in adults with diabetes aged 40 to 75 years from 21.4% in 1999 to 2000 to 51.9% in 2017 to 2018 ( P <0.001 for overall linear trend). Statin use plateaued in all other groups. The proportions of using ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors were 3.7% (95% CI, 1.3-9.8) and 0.03% (95% CI, 0.01-0.15) in 2017 to March 2020, respectively. Conclusions From 1999 through 2018, cholesterol screening increased while mean total cholesterol, triglycerides, and low-density lipoprotein cholesterol levels decreased, with a modest increase in statin use and low uptake of nonstatin therapy in the US population.

Background The 2013 American College of Cardiology/American Heart Association Cholesterol Management Guideline identifies 4 statin-eligible groups: (1) known atherosclerotic cardiovascular disease (ASCVD) aged ≥21 years, (2) low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL (4.9 mmol/L) aged ≥21 years, (3) diabetes mellitus aged 40 to 75 years with LDL-C 70 to 189 mg/dL (1.8–4.9 mmol/L), or (4) ≥7.5% 10-year ASCVD risk aged 40 to 75 years with LDL-C 70 to 189 mg/dL (1.8–4.9 mmol/L). Objectives We examined the number of statin-eligible US adults, statin use, LDL-C goal attainment, and adherence to lifestyle management. Methods We identified subjects from the US National Health and Nutrition Examination Survey 2011–2012 in the 4 statin-eligible groups, proportion on statin, proportion at recommended LDL-C levels using National Lipid Association goals (<70 mg/dL [1.8 mmol/L] for very high risk and <100 mg/dL [2.6 mmol/L] for others), and adherence to lifestyle measures. Results Of 5206 adults (representing 219 million), 1677 adults representing 62.6 million adults fit into 1 of the 4 statin-eligible groups. Statin use was 63.7% for the ASCVD, 61.4% for the LDL-C ≥ 190 mg/dL (4.9 mmol/L), 43.2% for the diabetes mellitus, and 27.2% for the 10-year risk ≥7.5% groups. Of those on statins with LDL-C measured, 79.7%, 98.0%, 42.3%, and 46.8% were not at LDL-C goal. Adherence to recommended <6% calories from saturated fat ranged from 3.3% to 6.4% and ≥40 minutes of physical activity ≥3 times a week from 54.7% to 65.1% across statin-eligible groups. Conclusion Many US adults eligible to receive statins based on American College of Cardiology/American Heart Association guidelines are not taking statins, and LDL-C levels still remain suboptimal. [ABSTRACT FROM AUTHOR]

The roundtable discussion in this issue will focus on the problems faced by young women with lipid disorders. This is often the source of confusion for the patient and physician because the myth continues that young women do not have complications of atherosclerosis as a result of elevated blood cholesterol. The essential role of women in bearing children during the early years of adulthood also produces difficult decisions because the mother and fetus are usually experiencing similar exposure to therapeutic regimens. We are joined in this discussion by Drs. Pamela Morris of the Medical University of South Carolina and Robert Wild of the University of Oklahoma Health Sciences Center. Dr Morris is an Internist, and Dr Wild is an Obstetrician and Gynecologist. Both are board certified in clinical lipidology and are actively publishing in this field. We have recorded this roundtable discussion during the National Lipid Association Scientific Sessions held in New Orleans during May 2016. [ABSTRACT FROM AUTHOR]

Background: Recently released American College of Cardiology/American Heart Association (ACC/AHA) guideline recommends the Pooled Cohort equations for evaluating atherosclerotic cardiovascular risk of individuals. The impact of the clinical input variable uncertainties on the estimates of ten-year cardiovascular risk based on ACC/AHA guidelines is not known.Methods: Using a publicly available the National Health and Nutrition Examination Survey dataset (2005-2010), we computed maximum and minimum ten-year cardiovascular risks by assuming clinically relevant variations/uncertainties in input of age (0-1 year) and ±10 % variation in total-cholesterol, high density lipoprotein- cholesterol, and systolic blood pressure and by assuming uniform distribution of the variance of each variable. We analyzed the changes in risk category compared to the actual inputs at 5 % and 7.5 % risk limits as these limits define the thresholds for consideration of drug therapy in the new guidelines. The new-pooled cohort equations for risk estimation were implemented in a custom software package.Results: Based on our input variances, changes in risk category were possible in up to 24 % of the population cohort at both 5 % and 7.5 % risk boundary limits. This trend was consistently noted across all subgroups except in African American males where most of the cohort had ≥7.5 % baseline risk regardless of the variation in the variables.Conclusions: The uncertainties in the input variables can alter the risk categorization. The impact of these variances on the ten-year risk needs to be incorporated into the patient/clinician discussion and clinical decision making. Incorporating good clinical practices for the measurement of critical clinical variables and robust standardization of laboratory parameters to more stringent reference standards is extremely important for successful implementation of the new guidelines. Furthermore, ability to customize the risk calculator inputs to better represent unique clinical circumstances specific to individual needs would be highly desirable in the future versions of the risk calculator. [ABSTRACT FROM AUTHOR]

Background: Statins are a class of medication indicated for atherosclerotic diseases and dyslipidemia. Since their appearance, many adverse events have been associated with their use. Ocular disorders are rare but serious adverse events of statins.Objective: To report the association between statins and ocular adverse events (blurred vision, visual impairment, visual field defect, reduced visual acuity, myopia, hypermetropia, presbyopia, and astigmatism) which might be associated with muscle or liver problems by examining the frequency of ocular adverse events among the reported adverse drug reactions from the Food and Drug Administration (FDA) and Adverse Drug Reactions Advisory Committee (ADRAC) data. Setting The FDA USA and ADRAC Australia databases.Methods: We conducted a retrospective study of statin-associated ocular adverse events reported to FDA between 1988 and 2013 and ADRAC between 1988 and 2011. The recoded data included: patient's age, gender, suspected drug and dosage, concomitant drug, adverse events, duration of therapy, dechallenge and rechallenge therapy. The differences in the adverse events profiles between each of the statins and atorvastatin were performed using Chi square and multivariate (logistic regression) statistical tests.Main Outcome Measure: Percentages of subjects correlated with each Ocular adverse events.Results: Among 131,755 cases of patients taking statins in the FDA, there were 2325 cases reported ocular adverse events after using statins (1.8%). The Chi square statistic showed that the proportions of ocular adverse events varied significantly (p < 0.0001) across the different statin drugs. The most highly reported ocular adverse events associated with statins were blurred vision (48.4%) and visual impairment (25.7%). Results from logistic regression indicated that the ocular problems formed a greater proportion of the adverse events for subjects taking atorvastatin (2.1%). Of the 1.8%, ocular adverse events mostly occurred alone (60.9%), followed by 30.3% where muscle adverse events also were involved. The ADRAC data held 136 cases of statins associated ocular adverse events (47 patients reported blurred vision and 64 reported vision impairment).Conclusion: All statins were associated with ocular side effects, with atorvastatin showed a higher incidence of ocular side effects in conjunction with muscle and liver problems. [ABSTRACT FROM AUTHOR]

Background Despite being on treatment, many persons with dyslipidemia still have suboptimal lipid levels and still experience cardiovascular disease (CVD) events. Objective We examined the extent of residual dyslipidemia in terms of low-density lipoprotein cholesterol (LDL-C), non–high-density lipoprotein cholesterol (non–HDL-C), and apolipoprotein B (apoB), in the US population, despite treatment with statin therapy. Methods We evaluated the attainment of LDL-C, non–HDL-C, and apoB targets in statin-treated subjects in the National Health and Nutrition Examination Survey 2009–2010. We report on percentage of individuals who attained goal and the mean distance from goal. LDL-C goals were set at <70 mg/dL for those with coronary heart disease, <100 mg/dL for those with other CVDs, diabetes, chronic kidney disease or >20% 10-year CVD risk, <130 mg/dL for those with 10% to 20% 10-year CVD risk or 2+ risk factors, and <160 mg/dL in those with <10% 10-year CVD risk or no more than 1 risk factor. Goals for non–HDL-C were 30 mg/dL higher than corresponding LDL-C goals, and goals of apoB were set to correspond with the same percentile of each LDL-C goal. Results Of the 5995 US adults aged ≥18 years surveyed, 463 (7.7%) were identified as being on a statin-based therapy. Overall, 64% of statin users were at goal for LDL-C, 63% were at goal for non–HDL-C, but only 52% were at goal for apoB. Of those who did not reach goal, 41%, 29%, and 39% were 30% or more from goal for LDL-C, non-HDL-C, and apoB, respectively. Non-Hispanic blacks and those with CVD or diabetes had the highest proportions that were not at goal for LDL-C, non–HDL-C, and apoB. Among those at goal for non-HDL-C, 50% of those with CHD and 33% of other high risk adults were not at ApoB goals. Conclusions Despite statin treatment, many persons continue to have residual dyslipidemia with LDL-C, non–HDL-C, and/or apoB levels not being at recommended levels. [ABSTRACT FROM AUTHOR]

Background Pneumonia is a frequent complication after stroke with strong impact on clinical outcome. Statins have pleiotropic immunmodulatory properties and were recently shown to exert beneficial effects on the development and clinical course of pneumonia. Aims We aimed to investigate whether statin use is associated with a reduced risk of poststroke pneumonia in acute ischemic stroke patients treated with tissue plasminogen activator within 4·5hours. Methods Data was extracted from a local register including all consecutive stroke patients who received thrombolysis at our institution. Prior statin use was identified retrospectively from clinical records and had to be continued after hospital admission. Poststroke pneumonia was diagnosed according to standardized criteria of U S Centers for Disease Control and Prevention. Mortality and functional outcome at three-months were further assessed. Results Overall, 481 ischemic stroke patients were analyzed. Continued statin use was documented in 17% of the patients. Frequency of pneumonia was 11%. Patients with statin use were less likely to develop poststroke pneumonia (5% vs. 13%, P = 0·04). After multivariable adjustment for known risk factors for poststroke pneumonia (age, stroke severity, dysphagia, male sex and diabetes), statin treatment was negatively associated with pneumonia ( OR 0·31; 95% CI 0·10-0·94). Occurrence of pneumonia independently predicted three-month mortality and functional outcome. Conclusions Use of statins in acute ischemic stroke patients who receive thrombolysis might reduce the risk of poststroke pneumonia. Further studies are warranted to validate this finding. [ABSTRACT FROM AUTHOR]

Objectives To describe patterns of, and factors associated with, statin use and discontinuation in nursing home ( NH) residents progressing to advanced dementia and followed for at least 90 days. Design Retrospective inception cohort using a dataset linking 2007 to 2008 Minimum Data Set ( MDS) to Medicare denominator and Part D files. Setting All NHs in five states ( Minnesota, Massachusetts, Pennsylvania, California, Florida). Participants NH residents with dementia. Measurements Residents who developed advanced dementia were observed from baseline (date of progression to very severe cognitive impairment with eating problems) and followed for at least 90 days to statin discontinuation or death. Logistic regression was used to identify baseline factors associated with statin use. Cox proportional hazard regression was used to identify factors associated with time to statin discontinuation. Results Of 10,212 residents, 16.6% (n = 1,699) used statins. Greater odds of statin use were associated with having diabetes mellitus (adjusted odds ratio ( AOR) = 1.24, 95% confidence interval ( CI) = 1.09-1.40), stroke ( AOR = 1.31, 95% CI = 1.16-1.48), and hypertension ( AOR = 1.35, 95% CI = 1.18-1.54); hospice enrollment was associated with lower odds ( AOR = 0.75, 95% CI = 0.64-0.89). In follow-up, 37.2% (n = 632) discontinued statins. Median time to discontinuation was 36 days (interquartile range 12-110 days). Shorter time to discontinuation was associated with hospitalization in past 30 days (adjusted hazard ratio ( AHR) = 1.67, 95% CI = 1.40-1.99) and more daily medications ( AHR = 1.02, 95% CI = 1.01-1.04). When statins were discontinued, 15.0% (n = 95) of residents stopped only statins, and 47.5% (n = 300) stopped at least one other medication. Conclusion Most NH residents who use statins at the time of progression to advanced dementia continue use in follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are medications widely prescribed to reduce cholesterol levels. Observational studies in high-risk populations, mostly in Asia, have suggested that statins are associated with a reduced risk of hepatocellular carcinoma (HCC). The current study sought to evaluate the association of statin use and HCC in a U.S.-based, low-risk, general population. Methods: A nested case-control study was conducted among members of the Health Alliance Plan HMO of the Henry Ford Health System enrolled between 1999 and 2010. Electronic pharmacy records of statin use were compared among tumor registry-confirmed cases of HCC (n = 94) and controls (n = 468) matched on age, sex, diagnosis date, and length of HMO enrolment. Results: In multivariate analyses, ever-use of statins was significantly inversely associated with development of HCC (Odds ratio (OR): 0.32,95%CI: 0.15-0.67). No clear dose-response relationship was evident as statin use for <2 years (OR = 0.32, 95%CI = 0.13-0.83) and >2 years (OR = 0.31, 95CI% = 0.12- 9.81) resulted in very similar ORs. Conclusions: The use of statins among populations in low-risk HCC areas may be associated with decreased risk of HCC. [ABSTRACT FROM AUTHOR]

Introduction: The United States Preventive Services Taskforce (USPSTF) recently released recommendations for statin therapy eligibility for the primary prevention of cardiovascular disease (CVD). We report the proportion and the absolute number of US adults who would be eligible for statin therapy under these recommendations and compare them with the previously published 2018 American Heart Association (AHA)/ American College of Cardiology (ACC)/ Multisociety (MS) Cholesterol guidelines., Methods: We used data from the National Health and Nutrition Examination Survey (NHANES) 2017-2020 of adults aged 40-75 years without prevalent self-reported atherosclerotic CVD (ASCVD) and low-density lipoprotein-cholesterol <190 mg/dL. The 2022 USPSTF recommends statin therapy for primary prevention in those with a 10-year ASCVD risk of ≥10% and ≥ 1 CVD risk factor (diabetes mellitus, dyslipidemia, hypertension, or smoking). The 2018 AHA/ ACC/ MS Cholesterol guideline recommends considering statin therapy for primary prevention for those with diabetes mellitus, or 10-year ASCVD risk ≥20% or 10-year ASCVD risk 7.5 to <20% after accounting for risk-enhancers and shared decision making. Survey recommended weights were used to project these proportions to national estimates., Results: Among 1799 participants eligible for this study, the weighted mean age was 56.0 ± 0.5 years, with 53.0% women (95% confidence interval [CI] 49.7, 56.3), and 10.6% self-reported NH Black individuals (95% CI 7.7, 14.3). The weighted mean 10-year ASCVD risk was 9.6 ± 0.3%. The 2022 USPSTF recommendations and the 2018 AHA/ ACC/ MS Cholesterol guidelines indicated eligibility for statin therapy in 31.8% (95% CI 28.6, 35.1) and 46.8% (95% CI 43.0, 50.5) adults, respectively. These represent 33.7 million (95% CI 30.4, 37.2) and 49.7 million (95% CI 45.7, 53.7) adults, respectively. For those with diabetes mellitus, 2022 USPSTF recommended statin therapy in 63.0% (95% CI 52.1, 72.7) adults as compared with all adults with diabetes aged 40-75 years under the 2018 AHA/ ACC/ MS Cholesterol guidelines., Conclusion: In this analysis of the nationally representative US population from 2017 to 2020, approximately 15% (~16.0 million) fewer adults were eligible for statin therapy for primary prevention under the 2022 USPSTF recommendations as compared to the 2018 AHA/ ACC/ MS Cholesterol guideline., Competing Interests: Declaration of Competing Interest VB: Through contracts between UAB and the sponsor, VB was national coordinator for the STRENGTH Trial (Astra Zeneca) and the Dalgene trial (DalCor); is national coordinator for the CLEAR Outcomes trial (Esperion) and Steering Committee member for the ODYSSEY OUTCOMES trial (Sanofi/Regeneron) and serves as site PI for the ORION trial (Novartis). She was a consultant for Pfizer and currently serves on a Data Safety and Monitoring Board for Verve Therapeutics. LS: consulting honoraria from Amgen and Regeneron. NJS: honorarium for an educational presentation from Knowledge to Practice. This company has no ties to industry. CJL: Consultant and Speaker for Amgen and Sanofi on their PCSK9Is and for Novartis on their new injectable and speaker and consultant for DSM and GOED on omega-3, speaker and Consultant for Esperion., (Published by Elsevier Inc.)

Abstract: Background: Stroke is a major cause of morbidity and mortality. We describe trends in the incidence, outcomes, and risk factors for stroke in the US Medicare population from 1988 to 2008. Methods: We analyzed data from a 20% sample of hospitalized Medicare beneficiaries with a principal discharge diagnosis of ischemic (n = 918,124) or hemorrhagic stroke (n = 133,218). Stroke risk factors were determined from the National Health and Nutrition Examination Survey (years 1988-1994, 2001-2008) and medication uptake from the Medicare Current Beneficiary Survey (years 1992-2008). Primary outcomes were stroke incidence and 30-day mortality after stroke hospitalization. Results: Ischemic stroke incidence decreased from 927 per 100,000 in 1988 to 545 per 100,000 in 2008, and hemorrhagic stroke decreased from 112 per 100,000 to 94 per 100,000. Risk-adjusted 30-day mortality decreased from 15.9% in 1988 to 12.7% in 2008 for ischemic stroke and from 44.7% to 39.3% for hemorrhagic stroke. Although observed stroke rates decreased, the Framingham stroke model actually predicted increased stroke risk (mean stroke score 8.3% in 1988-1994, 8.8% in 2005-2008). Statin use in the general population increased (4.0% in 1992, 41.4% in 2008), as did antihypertensive use (53.0% in 1992, 73.5% in 2008). Conclusions: Incident strokes in the Medicare population aged ≥65 years decreased by approximately 40% over the last 2 decades, a decline greater than expected on the basis of the population's stroke risk factors. Case fatality from stroke also declined. Although causality cannot be proven, declining stroke rates paralleled increased use of statins and antihypertensive medications. [Copyright &y& Elsevier]

Aggressively managing low-density lipoprotein cholesterol (LDL-C) after myocardial infarction (MI) is a cornerstone of secondary prevention. The changes in LDL-C after MI and the factors associated with LDL-C levels are unknown. Therefore, we directly measured fasting LDL-C levels in 797 MI patients from 24 US hospitals from 2005 to 2008. Mean LDL-C levels at discharge, 1 month, and 6 months were 95.1, 81.9, and 87.1 mg/dL, respectively. In a hierarchical, multivariable, repeated measures model, older age, male sex, and hypertension were associated with lower LDL-C levels, whereas self-reported avoidance of health care because of cost was associated with higher LDL-C. Both the presence and intensity of statin therapy at discharge were strongly associated with LDL-C levels, with adjusted mean 6-month changes of −3.4 mg/dL (95% confidence interval (CI): −12.1, 5.3) for no statins; 1.7 mg/dL (95% CI: −4.7, 8.1) for low statins; −10.2 mg/dL (95% CI: −14.5, −6.0) for moderate statins; and −13.9 mg/dL (95% CI: −19.7, −8.0) for intensive statins (P < 0.001). In conclusion, we found that greater reductions in LDL-C levels after MI were strongly associated with the presence and intensity of statin therapy, older age, male sex, hypertension, and better socioeconomic status. These findings support the use of intensive statin therapy in post-MI patients and provide estimates of the expected LDL-C changes after MI in a real-world population. [ABSTRACT FROM PUBLISHER]