High-intensity Statin Use Research Articles

Associations of statin use with 30-day adverse outcomes among 4 801 406 US Veterans with and without SARS-CoV-2: an observational cohort study

ObjectiveTo estimate associations of statin use with hospitalisation, intensive care unit (ICU) admission and mortality at 30 days among individuals with and without a positive test for SARS-CoV-2.DesignRetrospective cohort study.SettingUS...

Impact of Statin Treatment Intensity after Endovascular Revascularization on Lower Extremity Peripheral Artery Disease.

PurposeOnly a few Asian studies have discussed the impact of statin intensity on clinical outcomes in patients with peripheral artery disease (PAD). We aimed to investigate the clinical impact of statin intensity in patients with PAD after endovascular revascularization.Materials and MethodsFrom April 2009 to June 2019, 376 patients with lower extremity PAD treated with endovascular revascularization were enrolled. They were classified into three groups according to statin intensity: no-statin, low-to-moderate intensity (LMI), and high-intensity (HI). The primary outcomes were major adverse cardiovascular events (MACE) and major adverse limb events (MALE).ResultsDuring the 40-month follow-up, MACE occurred less frequently in the HI and LMI groups than the no-statin group (11.4% vs. 16.0% vs. 39%, p<0.001). In adjusted Cox models, the HI group had the fewest MACE [hazard ratio (HR): 0.447; 95% confidence interval (CI): 0.244–0.834; p=0.018] and MALE (HR: 0.360; 95% CI: 0.129–1.006; p=0.051) events, while the LMI group had fewer MACE (HR: 0.571; 95% CI: 0.326–1.0; p=0.050) events than the no-statin group. HI statin therapy was associated with better outcomes in terms of MALE (HR: 0.432; 95% CI: 0.223–0.837; p=0.003) than LMI statin therapy after inverse probability treatment weighting analysis.ConclusionHI and LMI statin use is associated with a significant reduction in MACE events than no-statin use. HI statin use was associated with better MALE outcomes than no-statin or LMI statin use.

Abstract 10361: Cardiovascular Risk Factor Control and Treatment Across the Spectrum of Patients with Atherosclerotic Cardiovascular Disease: The Precision Medicine Initiative - All of Us Study

Objective: The 2018 Multisociety Cholesterol Guideline categorized patients with atherosclerotic cardiovascular disease (ASCVD) according to very high risk status, but there are few reports of recent medication use and risk factor control by risk group. We examined in a current cohort of US adults the extent of ASCVD risk factor control and treatment by these ASCVD groups. Methods: The NIH Precision Medicine Initiative (All of Us Study) is an ongoing program aiming to enroll &gt; 1 million adults across the US. Since May 2018, &gt;315,000 participants have been recruited from &gt;340 sites nationwide, oversampling underrepresented groups. We studied adults age &gt; 18 years with prior ASCVD, classified based on the 2018 guideline as 1) very high risk with &gt; 2 major ASCVD events, 2) very high risk with 1 major event and &gt; 2 major ASCVD conditions, or 3) ASCVD not at very high risk. We examined proportions at recommended therapies (high intensity statin, blood pressure [BP] and diabetes [DM] medication, and aspirin) and desired levels of risk factors (LDL-C, BP, HbA1c, and non-smoking status) across ASCVD risk categories. Results: Our 34,195 participants with ASCVD included 49% female, 20.5% non-Hispanic Black and 12.9% Hispanic or Latino adults, with an overall age of 66.0 + 12.4 years. 44.6% were classified as very high risk, of which 10.8% had &gt; 2 prior ASCVD evets. The table shows the proportion of each risk group on recommended therapies and risk factor targets. Across ASCVD risk groups use of high intensity statins (10-14%) and attainment of acceptable LDL-C levels (17-27%) and BP levels (42-47%) are markedly suboptimal. Across risk groups only 3-8% were on all 4 recommended therapies and &lt;5% were at all desired levels of all 4 risk factors. Conclusions: Improved efforts are needed to communicate the importance of multiple risk factor control and recommended therapies across the spectrum of ASCVD patients, and especially those at very high risk.

Statin and Icosapent Ethyl Use and Lipid Control in US Adults with Diabetes According to DM Risk Groups, Sex and Ethnicity in the NIH Precision Medicine Initiative All of Us Study

ObjectiveData on statin therapy intensity and icosapent ethyl use among adults with diabetes mellitus (DM) are limited. We studied statin intensity and icosapent ethyl use with lipid levels among US adults with DM across risk groups, sex and ethnicity. MethodsAmong adults ≥18 years of age with DM from the NIH Precision Medicine Initiative All of Us Study, we categorized risk groups as 1) low risk with ≤1 DM risk factor, 2) high risk with ≥2 DM risk factors, and 3) DM with known ASCVD. Risk factors included age >60 years, hypertension, LDL-C ≥160 mg/dL, cigarette smoking, and HDL-C <40 mg/dL (males) and <50 mg/dL (females). We examined the % of people on low, moderate, and high-intensity statin therapy and at LDL-C levels <70 mg/dL, 70-99 mg/dL, and ≥100 mg/dL. We also studied the % of people on icosapent ethyl and examined triglyceride (TG) levels <100 mg/dL, 100-149 mg/dL, and ≥150 mg/dL. ResultsOur 42,064 participants with DM included 27.1% non-Hispanic black and 21.7% Hispanic. Inadequate statin use and improperly controlled LDL-C remain common, with 33.8% of people on high-intensity statins having LDL-C levels ≥100 mg/dL. Additionally, 1.7% of those with TG levels ≥150 mg/dL were on icosapent ethyl. ConclusionsGuideline-recommended use of high intensity statins among our higher risk DM patients is lacking, with many having inadequately controlled LDL-C levels. Moreover, icosapent ethyl use remains low, even among those with high TG levels. Further provider and patient education need to be prioritized— especially among those at highest risk.

High-Intensity Statin vs. Low-Density Lipoprotein Cholesterol Target for Patients Undergoing Percutaneous Coronary Intervention: Insights From a Territory-Wide Cohort Study in Hong Kong.

Background: Different guidelines recommend different approaches to lipid management in patients with atherosclerotic cardiovascular disease. We aim to determine the best strategy for lipid management in Asian patients undergoing percutaneous coronary intervention (PCI).Method: This was a retrospective cohort study conducted in patients who underwent first-ever PCI from 14 hospitals in Hong Kong. All participants either achieved low-density lipoprotein cholesterol (LDL-C) target of <55 mg/dl with ≥50% reduction from baseline (group 1), or received high-intensity statin (group 2), or both (group 3) within 1 yr after PCI. The primary endpoint was a composite outcome of all-cause mortality, myocardial infarction, stroke, and any unplanned coronary revascularization between 1 and 5 yr after PCI.Results: A total of 8,650 patients were analyzed with a median follow-up period of 4.2 yr. After the adjustment of baseline characteristics, complexity of PCI and medications prescribed and the risks of the primary outcome were significantly lower in group 2 (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.74–0.93, P = 0.003) and group 3 (HR, 0.75; 95% CI, 0.62–0.90; P = 0.002). The primary outcome occurred at similar rates between group 2 and group 3.Conclusions: Use of high intensity statin, with or without the attainment of guidelines recommended LDL-C target, was associated with a lower adjusted risk of MACE at 5 yr, compared with patients who attained LDL-C target without high intensity statin.

Cardiovascular risk profile in Portugal: evidence from a large population-based cohort

Abstract Background The rising prevalence of CVD in Portugal translates into more than 35 thousand annual deaths (1,2), with stroke and ischemic heart disease as the leading causes of death (3). Reducing the incidence of ASCVD is a public health priority, for which LDL-C lowering is paramount to halt atherosclerotic plaque progression (4,5). Real-world data is lacking regarding patient characterization, lipid-lowering therapy, and LDL-C levels by CV risk profile. Purpose To assess the proportion of patients with low, intermediate, high, and very high CV risk in a population with a complete spectrum of care, and describe their clinical characteristics, cardiovascular medications, and degree of LDL-C control. Methods This non-interventional, cross-sectional study included adult patients between 40 and 80 years old followed for primary or secondary CV risk prevention at a major healthcare institution that provides both primary and hospital care. Patient data spanned the period from 1/1/2008 to 31/12/2019. The index date for patient identification and characterization was 31/12/2019. CVD risk assessment was computed according to the 2019 ESC/EAS Guidelines for the management of dyslipidemias (6). Every criterion for risk assessment (excluding imaging and family history) was reconstructed using the most granular available records of clinical observations, measurements, episodes, lab orders, diagnosis and medications recorded at all primary and secondary care sites of the institution. We described patient demographic and clinical characteristics for each CV risk level, lipid-lowering treatment (LLT), and LDL-C levels. Results We identified 111.394 patients eligible for analysis. Sufficient records for CV risk assessment were available for 82.271 patients. According to 2019 ESC/EAS Guidelines CV risk categories, 25.7%, 21.4%, 12.2% and 40.7% of patients had low, intermediate, high and very high CV risk. High/very high CV risk patients had a mean (SD) age of 65.6 (10.1) years. Type 2 diabetes was present in 13.1% of high CV risk and 40% of very high CV risk groups. Although approximately 70% of patients with high/very high CV risk were treated with a LLT, only 5.1% of high CV risk and 3.6% of very high CV risk had LDL-C levels within the recommended targets. There was a very low use of high intensity statins or combination therapies in high/very high CV risk categories (table 1). Patients with atherosclerotic CV disease accounted for 34.6% of those at very high CV risk and only 4.8% attained desired goals (table 2). Conclusions There is a pressing need for better control of LDL-C levels at every stage of CV risk, with a particular focus on high and very high CV risk patients. Effective strategies for LCL-C control are thus needed. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This study was funded by Novartis Farma, Produtos Farmacêuticos S.A.

Protocol design and preliminary evaluation of the REAL-Health Triple Aim, an open-cohort CVD-care optimisation initiative

IntroductionEffective treatment of cardiovascular disease (CVD) in primary care could be improved. We aim to assess the efficacy of a scalable treatment optimisation programme in unselected community populations in South East England, with the triple aim of improved blood pressure control in people with hypertension, increased high-intensity statin use in people with CVD and reduced gastrointestinal bleeding in patients on antithrombotic medication.MethodThis observational study comprises an open cohort of approximately 200,000 adults at high cardiovascular risk registered with general practitioners in five South East England Clinical Commissioning Groups (CCGs). An intervention programme is planned in four of these CCGs with a further non-intervention CCG acting as a control group. The intervention will consist of: clinical guidelines and educational outreach; virtual patient-reviews software; peer-performance “dashboards” and, where available, financial incentives.The study will examine 3 primary outcomes: 1. Diagnosed hypertension with a blood pressure <140/90mmHg; 2. Diagnosed CVD on a high-intensity statin; 3. A cardiovascular indication for antithrombotic therapy with one or more factors for increased risk of gastrointestinal bleeding (e.g. age ≥65) on gastroprotection. A further 17 secondary outcomes related to these three aims will be assessed.AnalysisWe will use an interrupted time series analysis over 18 months, representing the pre-implementation, implementation and the post-implementation phases with comparison to the control CCG and applicable national Quality and Outcomes Framework and national prescribing statistics (e.g. OpenPrescribing). Secondary outcomes include an equity impact analysis with results stratified by age, gender, ethnic group and index of deprivation.Preliminary dataWe present preliminary data on Key Performance Indicators (KPIs) collected from 191 GP practices including [percentage achievement on 01/09/2019, on 01/09/2020]: 1. Patients with hypertension and most recent blood pressure ≤140/90mmHg [68.7%, 60.6%]. 2. Patients eligible for treatment with a high-intensity statin on such treatment [53.8%, 55.8%]. 3. Patients on antithrombotics with ≥1 risk factors for gastrointestinal bleeding on gastroprotection [59.0%, 60.1%]. We also present our virtual patient-review software tool and outcome visualisation dashboard.ConclusionThe REAL-Health Triple Aim initiative is a large-scale primary care cardiovascular risk reduction initiative which was launched almost contemporaneously with the United Kingdom's first SARS-CoV-2 related lockdown. Preliminary data justify the need for the Triple Aim initiative and give us an insight on the impact of the pandemic on its implementation.FUNDunding AcknowledgementType of funding sources: Other. Main funding source(s): Barts CharityBritish Heart Foundation

Effects of Statin Intensity on Long-term Outcomes After Coronary Artery Bypass Grafting

BackgroundThe current study sought to investigate the association between statin intensity and long-term clinical outcomes according to initial clinical presentation after coronary artery bypass grafting (CABG). MethodsThe 6531 patients who underwent CABG included in this study were classified into 4 groups according to statin intensity: 731 in the no or low statin group (atorvastatin <10 mg), 2310 in the lower-moderate group (atorvastatin 10-mg equivalent), 2404 in the higher-moderate group (atorvastatin 20-mg equivalent), and 1086 in the high-intensity group (atorvastatin ≥ 40-mg equivalent). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 5 years. Multivariate Cox and inverse probability weighting methods were performed to adjust for baseline differences. ResultsAt least moderate-intensity statin use was associated with significantly lower risk of 5-year MACCE compared with no or low-intensity statin use (hazard ratio [HR], 0.694; 95% confidence interval [CI], 0.493-0.977; P = .036). Among patients who were taking at least a moderate-intensity statin, both higher-moderate intensity (HR, 0.622; 95% CI, 0.479-0.807; P < .001) and high-intensity statin (HR, 0.613; 95% CI, 0.421-0.894; P = .011) groups showed significantly lower risks of MACCE than the lower-moderate intensity statin group at 5 years after CABG. There was no significant difference in the risk of MACCE between higher-moderate intensity and high-intensity statin groups (HR, 0.987; 95% CI, 0.661-1.475; P = .950). Multivariable Cox and inverse probability weighting methods yielded similar results. In a subgroup analysis compared with the use of a lower-moderate intensity statin, the use of a higher-moderate or high-intensity statin (equivalent dose with atorvastatin ≥20 mg) was associated with a significantly lower risk of MACCE among CABG patients who presented with acute coronary syndrome but not in those who presented with stable ischemic heart disease (interaction P = .001). ConclusionsThe use of a lower-moderate intensity statin (atorvastatin 10-mg equivalent) was associated with relatively poorer long-term clinical outcomes than the use of higher-moderate or high-intensity statin, especially in acute coronary syndrome patients after CABG.

Impact of statin intensity on adverse cardiac and cerebrovascular events in older adult patients with myocardial infarction.

BACKGROUNDThere is insufficient evidence regarding the effect of high-intensity statin therapy in older adults. This study aimed to investigate the effects of high-intensity statin treatment on the clinical outcomes in older adults with myocardial infarction (MI).METHODSConsecutive patients with MI aged at least 75 years were analyzed retrospectively. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of all-cause death, MI, rehospitalization due to unstable angina, repeat revascularization, and ischemic stroke. The high-intensity group was compared to the low-to-moderate intensity group in the propensity score-matched cohort.RESULTSAverage age of total 546 patients was 81 years. Among them, 84% of patients underwent percutaneous coronary intervention. The unadjusted seven-year MACCE rate differed by statin intensity (high-intensity statin group: 38%, moderate-intensity statin group: 42%, low-intensity statin group: 56%, and no-statin group: 61%, P = 0.004). However, among these groups, many baseline characteristics were significantly different. Among the 74 propensity score-matched pairs, which lacked any significant differences in all baseline characteristics, the high-intensity group had a significantly lower rate of MACCE than the low-to-moderate intensity group (37% vs. 53%, P = 0.047). Follow-up low-density lipoprotein cholesterol levels were significantly lower in the high-intensity group than that in the low-to-moderate intensity group (69.4 ± 16.0 mg/dL vs. 77.9 ± 25.9 mg/dL, P = 0.026). CONCLUSIONSIn older adult patients with MI, the use of high-intensity statin caused significantly less occurrence of MACCE in comparison to that in low-to-moderate intensity for up to seven years of follow-up.

Management of Dyslipidemia in Women and Men with Coronary Heart Disease: Results from POLASPIRE Study

Cardiovascular diseases (CVDs) are the leading cause of death in Poland. Starting from 1992, a gradual decrease in mortality due to CVDs has been observed, which is less noticeable in women. Following this notion, we assessed sex differences in the implementation of ESC recommendations regarding lipid control and the use of statins as part of secondary CVDs prevention in 1236 patients with acute coronary syndrome or elective coronary revascularization within the last 6–24 months. During hospitalization women had more frequently abnormal TC levels than men (p = 0.035), with overall higher TC levels (p = 0.009) and lower HDL-C levels (p = 0.035). In the oldest group, they also had more frequently elevated LDL-C levels (p = 0.033). Similar relationships were found during the follow-up visit. In addition, women less often achieved the secondary lipid therapeutic goal for non-HDL-C (p = 0.009). At discharge from hospital women were less frequently prescribed statins (p = 0.001), which included high-intensity statins (p = 0.002). At the follow-up visit the use of high-intensity statins was still less frequent in women (p = 0.02). We conclude that women generally have less optimal lipid profiles than men and are less likely to receive high-intensity statins. There is a need for more organized care focused on the management of risk factors.

Impact of the 2016 Canadian Lipid Guidelines on Daily Practice at a Community Hospital

ObjectivesThe aim of this study was to determine the impact of the 2016 Canadian cardiovascular society guidelines for the management of dyslipidemia. More specifically, we assessed the use of 1) alternate lipid targets when triglyceride (TG) levels are high; and 2) nonfasting lipid testing. MethodsLipid profiles and pharmacy data were obtained from patients with a history of myocardial infarction and from patients ≥40 years of age with a diagnosis of diabetes. ResultsAs TG increased to >1.5 mmol/L, percent within target for non–high-density lipoprotein cholesterol and apolipoprotein B 18 months after guideline release remained low in both patients with atherosclerotic cardiovascular disease (40%) and patients with diabetes in primary prevention (30%). Approximately 50% of patients were fasting when presenting for lipid testing. Use of high-intensity statin was suboptimal in both groups. ConclusionsThe concept of alternate lipid targets may not be well understood by many physicians, leading to undertreatment of patients. Progress was made in the promotion of routine nonfasting lipid testing.

Tailored clinical management after blinded statin challenge improved long-term lipid control in coronary patients with self-perceived muscle side-effects

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Helse Sør-Øst, Vestre Viken Trust Background Statin discontinuation due to self-perceived muscle side-effects is a major challenge in clinical practice. Strategies are needed to improve lipid control in these patients. Purpose We studied if information about the results of a blinded statin challenge experiment, followed by tailored lipid lowering treatment, had long-term effects on lipid control in coronary patients with self-perceived muscle side-effects. Methods A post-trial intervention study of patients classified with statin dependent (N = 20) and independent (N = 50) muscle complaints in the MUscle Side-Effects of atorvastatin (MUSE), a randomized, double-blinded, crossover trial. All participants were informed of the MUSE trial results in an individual consultation and provided tailored lipid-lowering treatment according to protocol with 1-2 follow-up calls. Lipids were controlled at the end of follow-up. Results Mean age was 64 (SD 9.5) years and 33% (N = 23) were females. During an average follow-up of 13 months (SD 3.3), mean LDL-cholesterol was reduced by 0.3 (SD 0.6) mmol/L (p = 0.005) in patients with statins and by 1.7 (SD 1.0) mmol/L (p = 0.005) in patients without statins at inclusion in the MUSE trial (Table). We found no changes in the overall use of high-intensity statins, but ezetimibe was used by 11 additional patients and 4 patients were prescribed a PCSK9-inhibitor. Participants in the subgroup without statins at inclusion used; atorvastatin (N = 2), rosuvastatin (N = 3) or a PCSK9-inhibitor (N = 2) at follow-up. 90% found their own trial results useful in making decisions about future statin use. Conclusions Information about the results of a statin challenge experiment combined with tailored and systematical prescription of lipid-lowering agents had favourable long-term effects on lipid control in coronary patients with self-perceived muscle side-effects. Characteristics of the study population Using statins at inclusion (n = 62) Not using statins at inclusion (n = 8) Classified with statin-dependent side-effects, n (%) 15 (24) 5 (63) LDL-cholesterol at inclusion, mean (SD) 2.2 (0.8) 4.2 (1.1) LDL-cholesterol at follow-up, mean (SD) 1.9 (0.7) 2.5 (0.8) High intensity statin (ie. ≥40 mg atorvastatin or ≥20 mg rosuvastatin) at inclusion, n (%) 40 (55.6) 0 (0) High intensity statin at follow-up, n (%) 38 (61) 2 (25) Ezetimibe at inclusion, n (%) 13 (21) 3 (38) Ezetimibe at follow-up, n (%) 26 (42) 1 (13) PCSK-9 inhibitor at follow-up, n (%) 2 (3) 2 (25) Usefulness of own trial result in making decisions about future statin use on a 0 to 10 Likert scale, mean (SD) 8.1 (2.0) 9.6 (0.6)

National Trends in Statin Use among the United States Nursing Home Population (2011-2016).

Little is known about trends in statin use in United States (US) nursing homes. The aim of this study was to describe national trends in statin use in nursing homes and evaluate the impact of the introduction of generic statins, safety warnings, and guideline recommendations on statin use. This study employed a repeated cross-sectional prevalence design to evaluate monthly statin use in long-stay US nursing home residents enrolled in Medicare fee-for-service using the Minimum Data Set 3.0 and Medicare Part D claims between April 2011 and December 2016. Stratified by age (65-75years, ≥76years), analyses estimated trends and level changes with 95% confidence intervals (CI) following statin-related events (the availability of generic statins, American Heart Association/American College of Cardiology guideline updates, and US FDA safety warnings) through segmented regression models corrected for autocorrelation. Statin use increased from April 2011 to December 2016 (65-75 years: 38.6-43.3%; ≥76 years: 26.5% to 30.0%), as did high-intensity statin use (65-75 years: 4.8-9.5%; ≥76 years: 2.3-4.5%). The introduction of generic statins yielded little impact on the prevalence of statins in nursing home residents. Positive trend changes in high-intensity statin use occurred following national guideline updates in December 2011 (65-75years: β=0.16, 95% CI 0.09-0.22; ≥76 years: β=0.09, 95% CI 0.06-0.12) and November 2013 (65-75 years: β=0.11, 95% CI 0.09-0.13; ≥76 years: β=0.04, 95% CI 0.03-0.05). There were negative trend changes for any statin use concurrent with FDA statin safety warnings in March 2012 among both age groups (65-75 years: β trend change=-0.06, 95% CI -0.10 to -0.02; ≥76 years: β trend change = -0.05, 95% CI -0.08 to -0.01). The publication of the results of a statin deprescribing trial yielded a decrease in any statin use among the ≥76 years age group (β level change=-0.25, 95% CI -0.48 to -0.09; β trend change=-0.03, 95% CI -0.04 to -0.01), with both age groups observing a positive trend change with high-intensity statins (65-75 years: β=0.11, 95% CI 0.02-0.21; ≥76 years: β=0.05, 95% CI 0.01-0.09). Overall, statin use in US nursing homes increased from 2011 to 2016. Guidelines and statin-related events appeared to impact use in the nursing home setting. As such, statin guidelines and messaging should provide special consideration for nursing home populations, who may have more risk than benefit from statin pharmacotherapy.

Geographic Variation of Statin Use Among US Nursing Home Residents With Life-limiting Illness.

Medically compromised nursing home residents continue to be prescribed statins, despite questionable benefits. To describe regional variation in statin use among residents with life-limiting illness. Cross-sectional study using 2016 Minimum Data Set 3.0 assessments linked to Medicare administrative data and health service utilization area resource files. Nursing homes (n=14,147) within hospital referral regions (n=306) across the United States. Long-stay residents (aged 65 y and older) with life-limiting illness (eg, serious illness, palliative care, or prognosis <6 mo to live) (n=361,170). Prevalent statin use was determined by Medicare Part D claims. Stratified by age (65-75, 76 y or older), multilevel logistic models provided odds ratios with 95% confidence intervals. Statin use was prevalent (age 65-75 y: 46.0%, 76 y or more: 31.6%). For both age groups, nearly all resident-level variables evaluated were associated with any and high-intensity statin use and 3 facility-level variables (ie, higher proportions of Black residents, skilled nursing care provided, and average number of medications per resident) were associated with increased odds of statin use. Although in residents aged 65-75 years, no associations were observed, residents aged 76 years or older located in hospital referral regions (HRRs) with the highest health care utilization had higher odds of statin use than those in nursing homes in HRRs with the lowest health care utilization. Our findings suggest extensive geographic variation in US statin prescribing across HRRs, especially for those aged 76 years or older. This variation may reflect clinical uncertainty given the largely absent guidelines for statin use in nursing home residents.

Apabetalone and hospitalization for heart failure in patients following an acute coronary syndrome: a prespecified analysis of the BETonMACE study

BackgroundPatients with diabetes and acute coronary syndrome (ACS) are at high risk for subsequent heart failure. Apabetalone is a selective inhibitor of bromodomain and extra-terminal (BET) proteins, epigenetic regulators of gene expression. Preclinical data suggest that apabetalone exerts favorable effects on pathways related to myocardial structure and function and therefore could impact subsequent heart failure events. The effect of apabetalone on heart failure events after an ACS is not currently known.MethodsThe phase 3 BETonMACE trial was a double-blind, randomized comparison of apabetalone versus placebo on the incidence of major adverse cardiovascular events (MACE) in 2425 patients with a recent ACS and diabetes. This prespecified secondary analysis investigated the impact of apabetalone on hospitalization for congestive heart failure, not previously studied.ResultsPatients (age 62 years, 74.4% males, 90% high-intensity statin use, LDL-C 70.3 mg/dL, HDL-C 33.3 mg/dL and HbA1c 7.3%) were followed for an average 26 months. Apabetalone treated patients experienced the nominal finding of a lower rate of first hospitalization for heart failure (2.4% vs. 4.0%, HR 0.59 [95%CI 0.38–0.94], P = 0.03), total number of hospitalizations for heart failure (35 vs. 70, HR 0.47 [95%CI 0.27–0.83], P = 0.01) and the combination of cardiovascular death or hospitalization for heart failure (5.7% vs. 7.8%, HR 0.72 [95%CI 0.53–0.98], P = 0.04).ConclusionApabetalone treatment was associated with fewer hospitalizations for heart failure in patients with type 2 diabetes and recent ACS. Future studies are warranted to define the potential for BET inhibition with apabetalone to prevent heart failure in patients with diabetes and ACS.

Prevalence of the Use of Aspirin and Statins for Preventing Cardiovascular Events in the Colombian Population with Type 2 Diabetes Mellitus: Comparison of 2008 and 2018.

BackgroundType 2 diabetes mellitus (T2DM) greatly increases cardiovascular risk. Primary and secondary cardiovascular prevention lead to lower cardiovascular events, improved quality of life and lower costs related to complications.ObjectiveTo estimate the proportion of patients with T2DM undergoing drug therapy for cardiovascular prevention (aspirin and statins) in Colombia and to describe the change in patterns of use between 2008 and 2018.MethodsThis was a cross-sectional study comparing prescriptions for aspirin and statins in 2008 and in 2018 in outpatients diagnosed with T2DM. Records were obtained from a national drug claim database. The proportion of use of cardiovascular prevention drugs and antidiabetic drugs, medications for comorbidities and sociodemographic variables were analyzed for both periods.ResultsIn total, 26 742 patients in 2008 and 188 321 in 2018 with a diagnosis of T2DM treated with antidiabetic drugs were identified, among whom 57.5% and 44.2% received aspirin and 44.9% and 60.2% received statins, respectively. The use of high-intensity statins increased from 1.1% in 2008 to 95.2% in 2018. The probabilities of receiving drugs in 2008 and in 2018 were higher for men (OR: 1.12, 95% CI: 1.06-1.17 and OR: 1.26, 95% CI: 1.23-1.28, respectively), for those persons over 75 years of age (OR: 6.5, 95% CI: 5.3-7.9 and OR: 5.8, 95% CI: 5.4-6.2) and for those who also received clopidogrel (OR: 5.8, 95% CI: 4.4-7.6 and OR: 2.2, 95% CI: 2.1-2.4).ConclusionsThe use of high-intensity statins in patients with T2DM has increased significantly in the last decade, which should reduce cardiovascular events, morbidity and mortality.

Role of Lipoprotein Apheresis in the Management of Familial Hypercholesterolemia

Familial Hypercholesterolemia (FH) is an autosomal dominant disorder due to a congenital absence of low-density lipoprotein receptor (LDL-R) that transports cholesterol-carrying lipoprotein particles into cells. Absence of these receptors results in increased levels Non-HDL lipoproteins (like LDL, VLDL, Triglycerides, Lipoprotein a) which predisposes to premature atherosclerosis and cardiac complications. Treatment modalities for this condition include use of high intensity statins and diet control. However some of these patients with familial hypercholesterolemia do not respond to diet and drug therapy. Here Lipoprotein apheresis is believed to be a feasible and effective option. Lipoprotein apheresis is a relatively new technique in India used to treat familial hypercholesterolemia. Lipoprotein apheresis using cascade filter is effective in reducing non-HDL lipoprotein levels by 60-75% in a single procedure. However, the disadvantage of the procedure it is expensive and needs to be repeated every 2 weeks for lifetime. This case is being reported for rarity of this condition (1 case per million) and more so the rarity of the use of Lipoprotein apheresis procedure in our country.

Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real-life setting: the PROSISA Study.

AimStatin‐associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients.MethodsDemographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors.ResultsAnalyses were carried out on 16 717 statin‐treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10–1.37] and OR 1.35 [1.14–1.60], respectively), whist age ≥ 65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid‐lowering drugs (OR 0.87 [0.76–0.99]), use of high‐intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort).ConclusionsThe reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re‐evaluation.

Assessment of Trends in Statin Therapy for Secondary Prevention of Atherosclerotic Cardiovascular Disease in US Adults From 2007 to 2016

Atherosclerotic cardiovascular disease (ASCVD) is highly prevalent in the US, with studies indicating substantial rates of nonadherence to and undertreatment with statin therapy. The 2013 American College of Cardiology/American Heart Association guideline recommended high-intensity statins for all patients age 75 years and younger with documented ASCVD in whom such therapy is tolerated, but there is limited evidence documenting population trends of statin use, adherence, and outcomes in the periods before and after the update to the guideline. To assess trends in the use, adherence, cost, and outcomes of statin therapy for secondary prevention in patients with different types of ASCVD between 2007 and 2016. This retrospective cohort study used data from the OptumLab Data Warehouse database containing privately insured and Medicare Advantage enrollees with demographic characteristics similar to the national US population. Participants were adult patients (age ≥21 years) who had their first ASCVD event between January 1, 2007, and December 31, 2016. Data were characterized as belonging to 3 groups: (1) cardiovascular heart disease (CHD); (2) ischemic stroke or transient ischemic attack (TIA); and (3) peripheral artery disease (PAD). Data were analyzed from July 1 to August 1, 2018. Calendar year of the initial ASCVD event. Trends in the statin use (within 30 days of discharge from hospitalization), adherence (proportion of days covered ≥80% within the first year), cost, major adverse cardiac events (1-year cumulative risk), and statin intolerance (within the first year). Of the 284 954 patients with a new ASCVD event, 128 422 (45.1%) were women; the median age was 63 years (interquartile range [IQR], 54-72 years); 207 781 (72.9%) were White. The use of statins increased from 50.3% in 2007 to 59.9% in 2016, the use of high-intensity statins increased from 25.0% to 49.2%, and the adherence increased from 58.7% to 70.5% (P < .001 for all trends). Patients with CHD were more likely to receive statins and high-intensity statins and adhere to medications than patients with ischemic stroke, TIA, or PAD despite similar observed treatment benefit. In 2016, 80.9% of patients with CHD used a statin vs 65.8% of patients with ischemic stroke or TIA and 37.5% of patients with PAD. Out-of-pocket cost per 30-day decreased from a median of $20 (interquartile range, $7.6-$31.9) in 2007 to $2 (interquartile range, $1.6-$10.0) in 2016 (P < .001) with the increasing use of generic statins (42.0% in 2007 vs 94.9% in 2016; P < .001). Major adverse cardiac events decreased from 8.9% in 2007 to 6.5% in 2016 (P < .001) whereas statin intolerance increased from 4.0% to 5.1% (P < .001). There have been modest improvements in the use, adherence, and cardiovascular outcomes over the past decade for statin therapy in patients with ASCVD, but a substantial and persistent treatment gap exists between patients with and without CHD, between men and women.

Abstract 15212: Long-term Outcomes Between Genders Are Similar Despite Gender Disparities in High-intensity Statin Use in a Contemporary Cohort of Patients Diagnosed With Nonobstructive Coronary Artery Disease by Invasive Coronary Angiography

Introduction: In current practice, high intensity statins are prescribed for patients diagnosed with CAD. However, studies have shown that women are commonly undertreated with statins. We compared long-term outcomes and medication usage patterns related to gender in a contemporary cohort of patients who underwent invasive coronary angiography (ICA) for index evaluation of suspected CAD for an abnormal stress test, stable or unstable angina, following an NSTEMI, or as part of their evaluation for heart failure. Methods: A cohort of 850 consecutive patients who underwent ICA for suspected CAD was classified as having normal/near-normal coronary arteries (≤20% stenosis, n=264), nonobstructive CAD (21-49% stenosis, n=114), or obstructive CAD (≥50% stenosis, n=472). We prospectively determined outcomes (cardiac death, nonfatal MI, and late revascularization) via Kaplan-Meier analysis in these 3 groups. We also obtained baseline and follow up data on statin use, and compared usage in the 3 groups related to gender by Chi-square analysis. Results: Baseline mean LDL values were 103 in men and 113 in women (p&lt;0.001). At a median follow up of 6.0 years, there was an increase in statin use (51.5% at baseline vs 85.0% at follow up in obstructive CAD group; 54.0% vs 67.3% for nonobstructive CAD group). There were no differences in aspirin, beta-blocker, or overall statin usage by gender across all groups (p&gt;0.05 for all medications). No difference in high intensity statin use (atorvastatin 40/80 mg or rosuvastatin 20/40 mg) was seen between genders in patients with obstructive CAD (61.4% of men vs 62.9% of women, p=0.78). Interestingly, there was a significant difference in usage of high intensity statins between genders in patients with nonobstructive CAD (63.9% of men vs 26.8% of women, p =0.001). Yet, outcomes were similar between genders across all stenosis groups (p&gt;0.05 for all groups). Conclusions: Our study shows that fewer women with nonobstructive CAD are treated with high intensity statins compared to their male cohorts. Despite this disparity in treatment, outcomes remained similar between genders. This discrepancy warrants the need for further study and could represent an area for optimization of medical therapy in female patients with nonobstructive CAD.