Statin Prescription Research Articles

Abstract 4119868: Statin and PCSK9 Inhibitor Utilization and Spending in Medicaid between 2018 to 2022: A National Analysis

Introduction: Low-income working-aged adults in the Medicaid program have a high burden of cardiovascular risk factors and disease, but often face barriers accessing necessary therapies. Little is known about contemporary patterns of utilization and spending on lipid-lowering therapies in Medicaid programs. Goal: To evaluate national trends in utilization and spending on statins and proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in Medicaid. Methods: We performed a serial cross-sectional study using the Medicaid Spending by Drug Database, which contains national-level Medicaid spending data for medications partially or fully reimbursed by Medicaid for the approximately 84 million beneficiaries. We evaluated annual trends in utilization (prescription fills) and total spending for statins and PCSK9i from 2018 to 2022, both overall and by individual drug formulation. Spending was adjusted for inflation and reported in 2022 US dollars. Results: Medicaid beneficiaries filled 20.4 million statin prescriptions in 2018 compared to 20.3 million in 2022, representing a 0.4% decrease. However, Medicaid spending on statins decreased by 7.1%, from $246.2 million to $226.8 million over the same period. Prescription fills for generic Rosuvastatin increased the most (0.79 million to 2.6 million, +224.2%), while fills for brand-name Crestor decreased the most (0.065 million to 0.003 million, -95.2%). Medicaid beneficiaries filled 121,737 prescriptions for PCSK9 inhibitors in 2022 compared to 7,617 in 2018 (+1498%), coinciding with a 640% increase in total spending ($8.9 million to $65.7 million). Repatha Sureclick was the most filled PCSK9i in Medicaid with 80,503 fills in 2022, representing $43.9 million in total Medicaid spending. Conclusions: Despite almost no change in statin utilization between 2018 and 2022, Medicaid spending on statins fell by approximately $20 million, driven by a shift from brand-name to generic formulations. In contrast, spending on PCSK9 inhibitors increased by $57 million as these medications became more widely used. Understanding these trends is critical as Medicaid programs work to ensure access to effective cardiovascular therapies while also identifying opportunities for cost efficiencies nationwide.

Abstract 4124606: Disparities in statin use following identification of Coronary Artery Calcium

Introduction: Coronary artery calcium (CAC) scoring is a useful tool for risk stratification in asymptomatic individuals, and guidelines recommend statin use in individuals with CAC. A growing body of research has aimed to identify and mitigate health disparities and their relation to CVD risk. Likewise, studies have highlighted social determinants of health (SDOH) that contribute to health disparities in CVD. We sought to extend this work by evaluating whether disparities exist with regards to statin use after identification of CAC within the Multi-Ethnic Study of Atherosclerosis (MESA). Methods: The sample consisted of all MESA participants with baseline CAC >0, not already on statin therapy, and without prior CVD events (n=2665). The association between race/ethnicity, age, sex, primary language, and an aggregate SDOH score with statin prescription at short (exam 2, median 1.6 year) and long (exam 5, median 9.4 year) term follow-up was evaluated in logistic regression models with adjustment for traditional CVD risk factors. The SDOH score was created from 14 components which covered the 5 general domains described in the Healthy People 2030 initiative (Figure 1). Results: Rates of statin prescription after CAC identification by race/ethnicity, language, and SDOH score tertile are shown in Figure 2. At short-term follow up, those with a higher SDOH score (worse burden) (OR 0.39, 95% CI 0.16-0.91), Hispanic / Latino participants (OR 0.59, 95% CI 0.40-0.85) and Spanish speaking participants (OR 0.51, 95% CI 0.30-0.83) were less likely to report statin use following CAC identification. At long-term follow up, Black participants (OR 0.71, 95% CI 0.52-0.96), Chinese participants (OR 0.58, 95% CI 0.39-0.86) and Chinese speaking participants (OR 0.50, 95% CI 0.33-0.76) were also less likely to report statin use following CAC identification, and a trend was noted for SDOH score (OR 0.53, 95% CI 0.26-1.09). Conclusion: This study identifies disparities in statin use after identification of CAC by race/ethnicity, language and social determinants of health. Future studies should investigate underlying reasons for these disparities and potential interventions to reduce disparities in cardiovascular care.

Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial

IntroductionGenetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as statins, outside...

The association of statin use with in-hospital mortality in patients with acute kidney injury during hospitalization: A retrospective analysis.

Acute kidney injury (AKI) is a severe condition in hospitalized patients and carries high mortality. The influence of statin use on the outcomes of AKI patients remains inconsistent. We aimed to discover the association between statin use and in-hospital mortality. This retrospective study screened all adult admissions in Peking University First Hospital between 1 January 2018 and 31 December 2020, and patients with AKI during hospitalization were included. Exposure was defined as any statin prescription prior to AKI onset. Patients were followed up until death or discharge. The primary outcome was in-hospital all-cause mortality; secondary outcomes included cardiovascular- and sepsis-related mortality, elevated transaminases, rhabdomyolysis and kidney nonrecovery at discharge. A total of 2034 AKI patients were included. 551 (27%) patients were statin users. During a median of 10 days of follow-up, we documented 283 (14%) in-hospital deaths. Compared with statin nonusers, statin users experienced a significantly lower risk in in-hospital all-cause mortality (adjust hazard ratio [aHR], 0.54; 95% CI, 0.35-0.84) and cardiovascular-related mortality (aHR, 0.48; 95% CI, 0.24-0.97) after covariate adjustment. The survival benefit of statin use was consistent across subgroups, that is, age, sex, initial AKI stage and major surgery (all P for heterogeneity >.05). For sepsis-related mortality, elevated transaminases, rhabdomyolysis and kidney nonrecovery, the association was no longer significant in the fully adjusted model. For any type of statins, a statistically significant association was only observed in atorvastatin (aHR, 0.49; 95% CI, 0.30-0.81). Statin use may improve survival, and atorvastatin may be preferred in patients with AKI.

Statin prescription disparities in patients with breast cancer and diabetes for primary cardiovascular disease prevention

BackgroundThis brief report examines statin prescription trends for primary cardiovascular disease (CVD) prevention in breast cancer (BC) survivors with diabetes, a large population at particularly high CVD risk.MethodsA population-based, retrospective cohort study was conducted using Surveillance, Epidemiology, and End Results (SEER) cancer registry data linked to Medicare claims. We identified women with preexisting diabetes who were diagnosed with stage 0–III primary BC between 2008 and 2017 without preexisting CVD. We assessed statin prescription rates over time and also examined differences in statin prescription rates according to patient sociodemographic characteristics. Using a multivariate logistic regression adjusted for sociodemographic and clinical variables, independent predictors of statin prescription were identified.ResultsOf 8,423 BC patients with diabetes without preexisting CVD, 5,698 (68%) had a statin prescription. Statin prescriptions increased over time (BC diagnosis year 2008–2009: 65%, 2010–2011: 67%, 2012–2013: 66%, 2014–2015: 69%, 2016–2017: 70%; p = 0.01) and differed by age (66–69: 66%, 70–74: 70%, 75–79: 69%, ≥80: 65%; p < 0.01) and race (White: 68%, Black: 62%, Latina: 66%, Other: 72%; p < 0.01). In a multivariate analysis, race (Black vs. White: OR 0.80, 95% CI: 0.68–0.95) remained a predictor of statin prescription.ConclusionIn older early-stage BC survivors, statin prescriptions increased over time and varied by age, race, and BC stage. These findings can potentially inform strategies to improve guideline-concordant statin prescriptions in a group at high risk for CVD and reduce disparities.

Real-world evaluation of a lipid transformation project in primary care settings

Abstract Background The National Health Service England Long-Term Plan (2019) highlights the need to optimise lipid management to reduce cardiovascular disease (CVD) risk. A collaborative project was funded between a local health service and an industry partner to review current practice and improve outcomes in a UK region through introduction of lipid management pathways, primary care education and patient-focused reviews to optimise lipid-lowering therapies among high-risk patient groups. Purpose The project aimed to increase prescribing of CVD risk reduction therapies such as high-intensity statins (HIST), escalation of therapy to achieve lipid-lowering treatment targets, to improve clinician knowledge and confidence in lipid management and provide benefits for local populations in reducing CVD risk. Methods Systematic patient searches across six Primary Care Networks (PCNs) prioritised high-risk patients for review. Community of Practice sessions were held to facilitate shared learning and problem-solving. A pragmatic, real-world evaluation was conducted to explore the impact of the new pathways and tools on prescribing outcomes and optimisation of lipid-lowering therapies. To examine the changes in HIST prescriptions, a statistical analysis of open-source prescribing data was undertaken between baseline (December 2021) and follow-up (December 2022) on over 39,000 eligible patient records. Qualitative interviews with clinicians from all participating PCNs and a thematic analysis of emerging themes was conducted in 2023. Results A paired sample t-test demonstrated a significant increase in the percentage of HIST prescribed, of the total number of statins prescribed, across the six PCNs between baseline and follow-up t(5) = -3.38, p = 0.01. Table 1 illustrates the changes at individual PCN level. Four of the six PCNs reached the National Institute for Health and Care Excellence minimum threshold of 65% target for HIST prescribing in statin prescriptions and three of these PCNs exceeded the optimal target of 75% HIST. An additional 600 patients were prescribed Ezetimibe (as therapy escalation or for statin intolerance). Through qualitative data, clinicians reported development of new skills and knowledge, leading to increased confidence in optimising lipid management with medication and lifestyle interventions. Conclusion The lipid transformation project demonstrated significant improvements in prescribing of lipid-lowering therapies and improved clinician competence in lipid management pathways and guidance. This has enabled sustainable improvements in lipid management and cardiovascular disease reduction in local populations.

Dynamic recommendation for anticoagulant treatment in patients with atrial fibrillation using deep reinforcement learning method

Abstract Background Recent evidence suggests that the guideline-directed anticoagulant therapy for atrial fibrillation (AF) remains controversial. Widely-used CHA2DS2-VASc score is solely based on limited traditional cardiovascular risk factors, omitting AF characteristics and other markers of thromboembolic risk. A more efficient, safer and more personalized anticoagulant approach is warranted. Purpose To develop a data-driven deep reinforcement learning (DRL) model for guiding dynamic anticoagulant treatment in AF patients to improve cardiovascular outcomes. Methods Participants of this study were enrolled from the multicentred China Atrial Fibrillation (China-AF) Registry between August 2011 and December 2022, who were with regular follow-up every 6 months. We excluded patients on warfarin at baseline due to its declining usage trend in non-valvular AF patients in China. The DRL model was trained in 70% randomly selected patients for optimal dynamic decision-making, and then subsequently tested in the remaining 30%. Data of sociodemographic characteristics, AF characteristics, medical history, lifestyle factors, laboratory examination, and medications were input for model training. Concordance rate between DRL model’s recommendations and physicians’ actual decisions of non-vitamin-K-antagonist oral anticoagulant (NOAC) prescription among all visits before censoring was calculated for each patient. Primary outcome was the composite of cardiovascular death, ischemic stroke, transient ischemic attack or systemic embolism (SSE), and major bleeding. Shapley additive explanation analysis ranked the most important factors affecting decision-making of the DRL model. Results A total of 20068 patients (mean age: 63.0±12.0 years; 36.2% female) were randomly divided into a training cohort of 14050 patients and a testing cohort of 6018 patients. The model’s NOAC recommendations were mostly affected by age, prior NOAC prescription, body mass index, hypertension history and prior statin prescription (Figure 1). Patients with concordance rates of 50.1%-75% and 75.1%-100% had significant risk reductions for the primary outcome (adjusted HR =0.63; 95% CI, 0.46-0.85; P = 0.003 and adjusted HR =0.59; 95% CI, 0.46-0.75; P <0.001, respectively), compared to those with a concordance rate of 0-25%. Similar results were observed for all-cause death, cardiovascular death and SSE outcomes, that patients with the highest concordance rate had a significant lower risk, compared to those with the lowest concordance rate. There was a nonsignificant but similar trend with regard to major bleeding events (Figure 2). Conclusions This modelling study suggests that a data-driven DRL model might provide more efficient, safer and more personalized anticoagulant suggestions, potentially assisting physicians in clinical practice.

Temporal trends in lipid management among Korean patients following acute myocardial infarction from 2011 to 2020

Abstract Background/Purpose Real-world data trends on dyslipidaemia prevalence and lipid management for patients following acute myocardial infarction (AMI) are lacking in South Korea, one of the Asia-Pacific nations. Our study aimed to evaluate the 10-year temporal trends of dyslipidaemia prevalence and lipid management in this patient population. Methods The study utilized datasets from two Korean AMI observational cohort (2011–2020) including a total of 26,751 participants (Figure 1A). The primary endpoints were as follows: (1) absolute low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL; (2) relative LDL-C target of >50% LDL-C reduction from the baseline; (3) absolute or relative LDL-C target (American target); and (4) both absolute and relative LDL-C targets (European target). Results The prevalence of dyslipidaemia increased from 11.1% to 17.1% (Table 1, Figure 1B), while the statin prescription rates increased from 92.9% to 97.0% from 2011 to 2020. High-intensity statin use increased from 12.80% in 2012 to 69.30% in 2020 (Table 1) Interestingly, the yearlong substantial increases in the prescription rates of high-intensity statins were prominent between 2013 (21.9%) and 2014 (37.7%) and between 2018 (52.4%) and 2019 (66.1%), which may have been influenced by major revisions to the international lipid management guidelines and their adoption (Figure 1C). Ezetimibe use increased from 4.50% in 2016 to 22.50% in 2020. The achievement rate of the absolute and relative LDL-C targets increased from 41.4% and 20.8% in 2012 to 62.5% and 39.5% in 2019, respectively (Table 1). The achievement rates of the American (45.7% in 2012 to 68.6% in 2019) and European (16.5% in 2012 to 33.8% in 2019) targets showed similar increasing trends (Table 1, Figure 1D). Conclusions Despite the adoption of lipid management guidelines in clinical practice has improved, some patients some patients are unable to reduce their LDL-C concentrations to their target levels. Our real-world analyses emphasise the need for multidirectional and continued efforts to optimise lipid management and improve the clinical outcomes in these patients.Figure 1

Temporal trend in quality indicators of diabetes care performance among persons with type 2 diabetes in primary care practice: a serial cross-sectional analytical study, 2013/14 to 2021/22.

Although the national-based policy implemented an initiative program to offer diabetes care management in Thailand, there are limited time trends of evidence to gauge whether the quality of diabetes care in primary care practice is improving. As such, we aimed to identify temporal trends in the quality of diabetes care performance among type 2 diabetes mellitus (T2DM) patients in primary care practice. Using assembled patient-level data from a suburban community in northern Thailand, this serial retrospective cross-sectional analytical study obtained adult T2DM patients from nine consecutive fiscal years 2013/14 (n = 976) to 2021/22 (n = 1,242). Based on international and national guidelines recommended, nine quality indicators were examined, namely, smoking cessation, hemoglobin A1c monitoring, foot and eye examinations, albuminuria testing, statin prescription, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) prescription for chronic kidney disease (CKD)/albuminuria, and blood pressure and glycemic control. Rates and time trends achieved in each quality indicator performance were estimated. Differences in the rates of patients who met each quality indicator across reimbursement schemes were explored. From 2013/14 to 2021/22, all quality indicators have increased over time (p for trend <0.05) except for smoking cessation, which remained steady. In 2021/22, only three out of nine quality indicators (i.e., smoking cessation, annual HbA1c monitoring, and annual foot examination) were successfully met at 70% or greater. Differences in quality indicators of diabetes performance were observed, particularly those under the Civil Servant Medical Benefit Scheme compared with other health insurance counterparts. For overall time trends analysis (compared with 2013/14), significant relative changes in the fiscal year 2021/22 were found in the annual foot examination (adjusted 12.1% increase; p = 0.048), annual albuminuria testing (adjusted 12.1% increase; p = 0.048), and ACEI/ARB prescription for persons with CKD or albuminuria (adjusted 22.2% increase; p = 0.025). Among adult T2DM patients from 2013/14 to 2021/22, overall quality indicators for diabetes performance have substantially improved over time. However, health inequity regarding diabetes care performance was found across different reimbursement schemes. Sustainable policy implementation and innovative strategies to narrow health inequity are warranted to optimize diabetes care in primary care practice.

Lipoprotein (a) testing patterns among subjects with a measured lipid panel: The Mayo Clinic experience

ObjectiveLipoprotein(a) [Lp(a)] has been associated with Atherosclerotic Cardiovascular Disease (ASCVD). Approximately 20 % of the population has elevated Lp(a). Despite its well-recognized role in ASCVD, universal screening remains controversial. The aim of our study is to investigate laboratory testing patterns for Lp(a) in subjects screened with a standard lipid panel at a large tertiary referring US institution. MethodsData were retrospectively collected at Mayo Clinic from the Mayo Data Explorer (MDE). Subjects were included if they had a lipid panel measured between May 1, 2022, and April 30, 2023. Demographic data, Lp(a) measurements, statins and aspirin prescription and ASCVD events which occurred at any time in the life of a subject were recorded along with respective dates. The cumulative number of Lp(a) laboratory test orders were also tallied from 1994 to 2023 independently of the lipid panel requests. ResultsBetween May 1, 2022, and April 30, 2023, 257,225 subjects had a lipid panel ordered. Of these, only 386 (0.15 %) had Lp(a) tested within 1 year of the lipid panel, while 2406 (0.94 %) had Lp(a) tested at any time. Lp(a) was tested more frequently in males (67 %) and in subjects who developed Myocardial Infarction (MI) at any time (12 %). Following Lp(a) results, there was no significant change in statin or aspirin prescription associated with Lp(a) levels. Secondary prevention was the main setting for ordering Lp(a) testing, and there was no change in this trend throughout the years. ConclusionsTesting rates for Lp(a) in the general population are low and the main setting remains secondary prevention. Women are less tested than men. When Lp(a) is found to be elevated, often times there is no change in patient management to mitigate the ASCVD risk.

Optimal risk thresholds for prescribing statins as primary prevention of cardiovascular disease in Iranian general population: a benefit-harm modelling study

PurposeThe use of statins for the primary prevention of cardiovascular diseases (CVD) is associated with various beneficial outcomes, alongside certain undesirable effects. This study aims to determine optimal risk thresholds above which statin therapy yields a net benefit, considering both the positive effects and potential adverse effects, as well as their probabilities and patient preferences.MethodsQuantitative benefit-harm balance modeling was applied to the Iranian general population aged 40 to 75 years with no history of CVD. The analysis utilized data from prior studies, including statin effect estimates for different outcomes from a meta-analysis, patient preferences obtained from an Iranian survey, and baseline incidence rates of adverse outcomes sourced from the Global Burden of Disease study for Iran. Outcomes were defined as angina, myocardial infarction, fatal coronary heart disease, fatal or non-fatal stroke, and heart failure. Benefit-harm balance indices were calculated for various combinations of age, sex, and 10-year CVD risk.ResultsStatin therapy was found to be advantageous at a lower 10-year CVD risk threshold in men (18–23%) compared to women (24–28%). Furthermore, individuals aged 40–45 years exhibited a lower risk threshold (18% in men, 24% in women) than those aged 70–75 years (23% in men, 28% in women).ConclusionThe desirable 10-year risk thresholds for statin prescription in the primary prevention of CVD vary by age and gender, ranging from 18 to 28%, encompassing a spectrum of outcomes from angina to CVD mortality. These results suggest hard-CVD risk thresholds of 7.5% to 10% for both sexes.

Sex, ethnicity and language differences in statin prescribing in community health center patients

BackgroundStatins have been shown to reduce atherosclerotic cardiovascular disease (ASCVD). In the United States, statins are underutilized, and the literature suggests women and Latine individuals received even fewer prescriptions than men even when eligible. No study has shown how statins are prescribed when looking at language, ethnicity, and considering sex. MethodsData were analyzed from a multistate EHR network across the US from 2014 to 2020. We included patients aged 40+ that were non-Hispanic White, English speaking Latine, and Spanish speaking Latine and further disaggregated by sex with the aim to examine statin prescription prevalence and rates between groups. GEE logistic and negative binomial regression models were used determine the outcomes adjusted by appropriate covariates. ResultsWe found compared to non-Hispanic White men, only Spanish speaking Latinos had higher odds of receiving a statin prescription, but once one statin was prescribed, non-Hispanic White women were the only group with higher rates. We found a higher percent of Spanish speaking Latine patients regardless of sex had a statin prescription. Prevalence of having a statin prescription was 59.3 % and 59.7 % for Spanish speaking Latinos and Latinas respectively compared to 55.5 % 57.0 % for non-Hispanic White men and women respectively. ConclusionsOverall, we found ethnicity, language, and sex differences. Clinicians in CHCs play an important role in the process to eliminate the sex gap in preventive health. The attention to statin prescribing in Spanish speaking Latine patients indicates more conscious care is being implemented in these vulnerable populations.

8707 Are We Adequately Prescribing Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) Or Glucagon-Like Peptide 1 Receptor Agonist (GLP-1 RA) In Patients With Type 2 Diabetes Mellitus (T2DM) And Established Atherosclerotic Cardiovascular Disease (ASCVD) Or Chronic Kidney Disease (CKD) In An Outpatient Setting: A Community Center Experience

Abstract Disclosure: R.K. Maan: None. A. Sawhney: None. A. Hayat: None. S. Kc: None. A. Madan: None. S. K c: None. L. Williams: None. A. Zweben: None. A. Rana: None. Introduction: The American Diabetes Association (ADA) recommends prescribing Sodium-Glucose Cotransporter 2 inhibitors (SGLT2i) or Glucagon-Like Peptide 1 Receptor Agonist (GLP-1 RA) in patients with Type 2 Diabetes Mellitus (T2DM) and established Atherosclerotic Cardiovascular Disease (ASCVD) or Chronic Kidney Disease (CKD) for its cardiovascular benefits. Methods: Our retrospective study analyzed data from 511 T2DM patients who visited the outpatient clinic between 7/1/22 to 6/30/23. Using Microsoft Excel, we assessed adherence to ADA guidelines by collecting data for SGLT2i, GLP-1 RA and statin prescriptions, urine microalbumin creatinine ratio measurements, and appropriate management of albuminuria. The study also investigated patients on dipeptidyl peptidase-4 inhibitors (DPP-4i) who were eligible for SGLT2i or GLP-1 RA. Results: Out of the 511 patients, 478 were eligible for SGLT2i or GLP-1 RA, and only 60% were prescribed these medications. Out of 479 patients eligible for statin prescription, only 85% were on it. Albuminuria was appropriately managed in 76% of eligible patients with Angiotensin-Converting Enzyme Inhibitors (ACEI) or Angiotensin II Receptor Blockers (ARBs). Additionally, 8 out of 11 patients on DPP-4i were eligible for SGLT2i or GLP-1 RA. Conclusion: We concluded that 60% of the patients eligible for SGLT2i or GLP-1 RA were prescribed the medication in our outpatient settings. The barriers identified were issues with insurance prior authorization and knowledge gaps. We aim to improve adherence to guidelines through multifaceted education strategies combined with audits and feedback.

8455 Denosumab Is Associated With Decreased Mortality Compared To Zoledronic Acid In Diabetic Osteoporotic Patients: A Population-Based Cohort Study

Abstract Disclosure: V. Rouach: Consulting Fee; Self; Amgen Inc. H. Gortler: None. Y. Greenman: None. C. Gabriel: None. G. inbalL: None. Background: Anti-resorptive therapies are the mainstay of osteoporosis management, but evidence of their efficacy in the diabetic population is limited and comparison between treatments is lacking. A retrospective analysis, presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, suggests that denosumab leads to greater reduction in fracture risk than zoledronic acid among treatment-naive postmenopausal women with osteoporosis. However, a comparative study recently published suggests higher mortality with denosumab versus oral bisphosphonates. Aim: To assess the association between zoledronic acid or denosumab and the risk of major osteoporotic fracture and mortality in osteoporotic patients with diabetes type 2. Methods: The study population was identified by electronic records of a diabetes registry cross-linked with an osteoporosis registry of a large provider healthcare organization in Israel. Index date was at osteoporosis registry entry. Demographics, Comorbidity Index (CCI), diabetes complications, bone mineral density (BMD) T-scores, hemoglobin A1c levels, eGFR, purchase of statins, and anti-resorptive agents were collected. Propensity score matching was performed. Kaplan-Meier curves were generated to assess the time to outcomes. Multivariable Cox's proportional hazards survival model was performed. Results: A total of 27503 diabetic osteoporotic patients were identified, 13343 (48%) patients initiated treatment; 12214 (91.5%) started an oral bisphosphonate, 627 (4.7%) zoledronic acid and 502 (3.7%) denosumab. The median follow-up was 8.9 years. The denosumab treated patients were older (75.7 vs 71.9, p&amp;lt;0.01), had longer diabetes duration (8.4 vs 7.2, p&amp;lt;0.01), were more frequently treated with insulin (29.7 vs 23.9, p=0.02) and had a lower eGFR (59.4 vs 75.3, p&amp;lt;0.01). Male/Female ratio, BMI, CCI, smoking status, alcohol consumption, Hip BMD, HbA1c levels, microvascular complications, hypoglycemic events and statins prescriptions were similar. After propensity weighting, we observed a significant reduced risk of death among the denosumab treated patients (RR=0.72 [0.58-0.91]) without a significant difference in the risk of fracture (RR=0.9 [0.82-1.12]). Conclusions: In this cohort of diabetic osteoporotic patients, denosumab was associated with a significantly reduced mortality compared to zoledronic acid, without a significant difference in the risk of fractures. The effect of denosumab on mortality is yet to be explored. Presentation: 6/1/2024

6550 National Statin Prescription Trends in Patients With Breast Cancer and Diabetes for Primary Cardiovascular Disease Prevention

Abstract Disclosure: A.B. Yang: None. G. Mhango: None. C. Kong: None. J.J. Lin: None. J.P. Wisnivesky: Consulting Fee; Self; Sanofi, Banook, PPD. Grant Recipient; Self; Sanofi, Regeneron Pharmaceuticals, Axella, Arnold Consultants. A. Leiter: None. Background: Cardiovascular disease (CVD) is the leading cause of death in older early-stage breast cancer (BC) survivors. Due to cardiotoxic BC treatments such as chemotherapy and radiation, patients with BC and diabetes (DM) are at increased risk of CVD. In patients with BC and DM, statins decrease CVD mortality. Since 2013, many clinical guidelines broadened statin indications for primary CVD prevention in patients with DM, making &amp;gt;85% of patients eligible. Little is known about statin prescription (Rx) patterns in older BC survivors with DM, a group at high risk of CVD. Hypothesis: We hypothesized that statin Rxs increased over time, but were less likely in BC survivors with more advanced locoregional BC and lower comorbidity burden. Methods: A population-based, retrospective cohort study was conducted using Surveillance, Epidemiology and End Results (SEER) cancer registry data linked to Medicare claims. We identified women with preexisting DM who were diagnosed with stage 0-III primary BC between 2008-17. We excluded patients with prior CVD who died &amp;lt;1 year after BC diagnosis. Statin Rx (atorvastatin, pravastatin, rosuvastatin, simvastatin, fluvastatin, lovastatin) was defined as ≥1 statin pharmacy claim &amp;lt;1 year after BC diagnosis. Comorbidity burden was assessed with a modified Charlson Comorbidity Index (CCI). We compared patient demographic and clinical characteristics by statin Rx status using the chi-square test. Using a multivariate logistic regression adjusting for age, race, CCI, BC stage, and diagnosis year, independent predictors of statin Rx were identified. Results: Of 8,423 BC patients with pre-existing DM, 5,698 (68%) had a statin Rx. Statin Rx increased over time (BC diagnosis year 2008-10: 66%, 2011-13: 66%, 2014-15: 69%, 2016-17: 70%; p=0.01) and differed by age (66-69: 66%, 70-74: 70%, 75-79: 69%, ≥80: 65%; p&amp;lt;0.01) and race (White: 68%, Black: 62%, Latinx: 66%, Other: 72%; p&amp;lt;0.01). Statin Rx did not differ by comorbidity burden (CCI 0: 68%, 1-2: 67%, ≥3: 67%; p=0.87) and declined with higher BC stage (0: 73%, I: 70%, II: 65%, III: 63%; p&amp;lt;0.01). In adjusted analyses, more recent BC diagnosis (2016-17 vs. 2008-10: odds ratio [OR]: 1.19, 95% confidence interval [CI]: 1.04-1.38), age group (70-74 vs. 66-69: OR: 1.24, 95% CI: 1.09-1.41), race (Black vs. White: OR 0.77, 95% CI: 0.66-0.89) and higher BC stages (II vs. 0: OR: 0.76, 95% CI: 0.58-1.00; III vs. 0: OR: 0.72, 95% CI: 0.54-0.97) remained predictors of statin Rx. Conclusions: In a nationally representative cohort analysis of older early-stage BC patients, statin Rx increased between 2008-17 and varied by age, race, and BC stage. Elucidating gaps in statin Rx can potentially improve guideline-concordant Rx in a group at high risk for CVD and reduce disparities. Presentation: 6/2/2024

9236 Denosumab Is Associated With Decreased Mortality Compared To Zoledronic Acid In Diabetic Osteoporotic Patients: A Population-Based Cohort Study

Abstract Disclosure: V. Rouach: Consulting Fee; Self; Amgen Inc. H. Gortler: None. Y. Greenman: None. C. Gabriel: None. G. inbalL: None. Background: Anti-resorptive therapies are the mainstay of osteoporosis management, but evidence of their efficacy in the diabetic population is limited and comparison between treatments is lacking. A retrospective analysis, presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, suggests that denosumab leads to greater reduction in fracture risk than zoledronic acid among treatment-naive postmenopausal women with osteoporosis. However, a comparative study recently published suggests higher mortality with denosumab versus oral bisphosphonates. Aim: To assess the association between zoledronic acid or denosumab and the risk of major osteoporotic fracture and mortality in osteoporotic patients with diabetes type 2. Methods: The study population was identified by electronic records of a diabetes registry cross-linked with an osteoporosis registry of a large provider healthcare organization in Israel. Index date was at osteoporosis registry entry. Demographics, Comorbidity Index (CCI), diabetes complications, bone mineral density (BMD) T-scores, hemoglobin A1c levels, eGFR, purchase of statins, and anti-resorptive agents were collected. Propensity score matching was performed. Kaplan-Meier curves were generated to assess the time to outcomes. Multivariable Cox's proportional hazards survival model was performed. Results: A total of 27503 diabetic osteoporotic patients were identified, 13343 (48%) patients initiated treatment; 12214 (91.5%) started an oral bisphosphonate, 627 (4.7%) zoledronic acid and 502 (3.7%) denosumab. The median follow-up was 8.9 years. The denosumab treated patients were older (75.7 vs 71.9, p&amp;lt;0.01), had longer diabetes duration (8.4 vs 7.2, p&amp;lt;0.01), were more frequently treated with insulin (29.7 vs 23.9, p=0.02) and had a lower eGFR (59.4 vs 75.3, p&amp;lt;0.01). Male/Female ratio, BMI, CCI, smoking status, alcohol consumption, Hip BMD, HbA1c levels, microvascular complications, hypoglycemic events and statins prescriptions were similar. After propensity weighting, we observed a significant reduced risk of death among the denosumab treated patients (RR=0.72 [0.58-0.91]) without a significant difference in the risk of fracture (RR=0.9 [0.82-1.12]). Conclusions: In this cohort of diabetic osteoporotic patients, denosumab was associated with a significantly reduced mortality compared to zoledronic acid, without a significant difference in the risk of fractures. The effect of denosumab on mortality is yet to be explored. Presentation: 6/1/2024

Opposing impact of hypertension/diabetes following hormone therapy initiation and preexisting statins on castration resistant progression of nonmetastatic prostate cancer: a multicenter study

Hormone therapy, especially androgen deprivation therapy (ADT), is effective against prostate cancer (PC), whereas long-term ADT is a risk for metabolic/cardiovascular disorders including diabetes (DM), hypertension (HT) and dyslipidemia (DL), and might result in progression to castration-resistant prostate cancer (CRPC). We thus conducted a multicenter retrospective cohort study to ask whether CRPC progression would be associated positively with HT, DM or DL and negatively with statins prescribed for treatment of DL. In this study, 1,112 nonmetastatic PC patients undergoing ADT were enrolled. Univariate statistical analyses clearly showed significant association of HT or DM developing after ADT onset, though not preexisting HT or DM, with early CRPC progression. On the other hand, preexisting DL or statin use, but not newly developed DL or started statin prescriptions following ADT, was negatively associated with CRPC progression. Multivariate analysis revealed significant independent association of the newly developed DM or HT, or preexisting statin use with CRPC progression [adjusted hazard ratios (95% confidence intervals): 3.85 (1.65–8.98), p = 0.002; 2.75 (1.36–5.59), p = 0.005; 0.25 (0.09–0.72), p = 0.010, respectively]. Together, ADT-related development of HT or DM and preexisting statin use are considered to have positive and negative impact on CRPC progression, respectively.

Risk of Venous Thromboembolism in Statin Users Compared to Fibrate Users in the United Kingdom Clinical Practice Research Datalink (UK CPRD) GOLD.

A substantial proportion of adults receive statins for treatment of hypercholesterolemia and cardiovascular risk, and statins have been found to improve outcomes in this patient population. However, studies have not consistently demonstrated the potential benefits of statins in preventing venous thromboembolism (VTE). Therefore, we conducted this study to investigate this association. We conducted a cohort analysis in a study sample comprised of 40-79-year-old patients with hyperlipidemia who received at least one fibrate or statin prescription between January 1995 and December 2018 in the United Kingdom Clinical Practice Research Datalink (CPRD) GOLD. We evaluated the association between statin use and incident unprovoked VTE, compared to fibrate use, an active comparator, using Kaplan-Meier (KM) analysis, Poisson regression (with and without propensity score matching), and inverse probability of treatment weights (IPTW) marginal structural models (MSM). In this cohort of 166,292 patients with hyperlipidemia, 0.81% (N=1,353) developed incident unprovoked VTE. In analyses using the KM method, patients who received statins had a slightly lower risk of VTE compared to those who received fibrates (Log rank test: p=0.0524). The adjusted incident rate ratio (95% CI) for VTE, calculated using Poisson regression, controlling for serum cholesterol and other baseline covariates, in patients prescribed statins compared to fibrates was 0.77 (0.45-1.33) in the full cohort, 0.74 (0.38-1.45) in the propensity score matched analysis, and 0.51 (95% conservative CI: 0.34-0.76) in the IPTW MSM analysis. While the magnitude of effect varied across the different analytic methods, there is consistent evidence for a protective effect of statin use on the occurrence of unprovoked VTE.

Sex Differences in Prescription Patterns and Medication Adherence to Guideline-directed Medical Therapy Among Patients with Ischemic Stroke.

Background: Ischemic stroke is a leading cause of death and disability. Society guidelines recommend pharmacotherapies for secondary stroke prevention. However, the role of sex differences in prescription and adherence to guideline-directed medical therapies (GDMT) after ischemic stroke remains understudied. The aim of this study was to examine sex differences in prescription and adherence to GDMT at 1-year after ischemic stroke in a cohort of commercially insured patients. Methods: Using the Truven Health MarketScan database from 2016-2020, we identified patients admitted with ischemic stroke. GDMT was defined as any statin, antihypertensive, and anticoagulant prescription within 30-days after discharge. Medication adherence was estimated using the proportion of days covered (PDC) at 1-year. PDC <0.80 was used to define non-adherence. A multivariable model adjusting for covariates was performed to identify the factors associated with non-adherence at 1-year. This analysis was restricted to new users of GDMT. Results: Among 155220 patients admitted with acute ischemic stroke during the study period, 15,919 met the inclusion criteria. The mean age was 55.7 years, and 7,701 (48.3%) were women. Women were less likely prescribed statins (58.0% vs 71.8%), and antihypertensives (27.7% vs 41.8%). In this subset of patients with atrial flutter/fibrillation, women were also less likely prescribed anticoagulants (41.2% vs 45.0%). Women were more likely to be non-adherent (i.e., PDC <0.80) to statins (47.3% vs 41.6%, P<0.0001), antihypertensives (33.3% vs 32.2%, P=0.005), and the combination of both (49.6% vs 45.0%, P=0.003). On multivariable analysis, women were likely to be non-adherent to GDMT at 1-year (odds ratio 1.23, 95% confidence interval 1.08-1.41). Conclusions: In this real-world analysis of commercially insured patients with ischemic stroke, women were less likely initiated on GDMT within 30 days after discharge. Women were more likely to be non-adherent to statins and antihypertensive agents at 1-year. Future efforts and novel interventions are needed to understand the reasons and minimize these disparities.

Do clinical decision support tools improve quality of care outcomes in the primary prevention of cardiovascular disease: A systematic review and meta-analysis

AimTo assess the effectiveness of Clinical Decision Support Tools (CDSTs) in enhancing the quality of care outcomes in primary cardiovascular disease (CVD) prevention. MethodsA systematic review was undertaken in accordance with PRISMA guidelines, and included searches in Ovid Medline, Ovid Embase, CINAHL, and Scopus. Eligible studies were randomized controlled trials of CDSTs comprising digital notifications in electronic health systems (EHS/EHR) in various primary healthcare settings, published post-2013, in patients with CVD risks and without established CVD. Two reviewers independently assessed risk of bias using the Cochrane RoB-2 tool. Attainment of clinical targets was analysed using a Restricted Maximum Likelihood random effects meta-analysis. Other relevant outcomes were narratively synthesised due to heterogeneity of studies and outcome metrics. ResultsMeta-analysis revealed CDSTs showed improvement in systolic (Mean Standardised Difference (MSD)=0.39, 95 %CI=-0.31, -1.10) and diastolic blood pressure target achievement (MSD=0.34, 95 %CI=-0.24, -0.92), but had no significant impact on lipid (MSD=0.01; 95 %CI=-0.10, 0.11) or glucose target attainment (MSD=-0.19, 95 %CI=-0.66, 0.28). The CDSTs with active prompts increased statin initiation and improved patients’ adherence to clinical appointments but had minimal effect on other medications and on enhancing adherence to medication. ConclusionCDSTs were found to be effective in improving blood pressure clinical target attainments. However, the presence of multi-layered barriers affecting the uptake, longer-term use and active engagement from both clinicians and patients may hinder the full potential for achieving other quality of care outcomes. Lay SummaryThe study aimed to evaluate how Clinical Decision Support Tools (CDSTs) impact the quality of care for primary cardiovascular disease (CVD) management. CDSTs are tools designed to support healthcare professionals in delivering the best possible care to patients by providing timely and relevant information at the point of care (ie. digital notifications in electronic health systems). Although CDST are designed to improve the quality of healthcare outcomes, the current evidence of their effectiveness is inconsistent. Therefore, we conducted a systematic review with meta-analysis, to quantify the effectiveness of CDSTs. The eligibility criteria targeted patients with CVD risk factors, but without diagnosed CVD. The meta-analysis found that CDSTs showed improvement in systolic and diastolic blood pressure target achievement but did not significantly impact lipid or glucose target attainment. Specifically, CDSTs showed effectiveness in increasing statin prescribing but not antihypertensives or antidiabetics prescribing. Interventions with CDSTs aimed at increasing screening programmes were effective for patients with kidney diseases and high-risk patients, but not for patients with diabetes or teenage patients with hypertension. Alerts were effective in improving patients' adherence to clinical appointments but not in medication adherence. This study suggests CDSTs are effective in enhancing a limited number of quality of care outcomes in primary CVD prevention, but there is need for future research to explore the mechanisms and context of multiple barriers that may hinder the full potential for cardiovascular health outcomes to be achieved.