Cardiology and Therapy最新文献

Introduction: This prospective, single-arm pharmacodynamic study assessed the effect of colchicine (COLC) [Strides Pharma UK Ltd, Watford, Hertfordshire, England] 0.5 mg administered orally once daily for 14 days on platelet reactivity with respect to aspirin reaction units (ARUs) and P2Y₁₂ reaction units (PRUs).

Methods: Twenty-two patients with stable coronary artery disease (CAD) on dual antiplatelet therapy (DAPT) with daily maintenance aspirin and clopidogrel were recruited. Baseline platelet function was evaluated with the VerifyNow™ ARU and PRU assays (Werfen, Bedford, MA, USA) and assessed post-completion of COLC 0.5 mg once daily for 14 days.

Results: In this study, the median ARU baseline score was 463, and post-COLC it was 436, which was not statistically significant (p = 0.485). The mean difference in scores was -18.31 (95% confidence interval [CI] -74.34 to 37.71, p = 0.504). At baseline, 27.3% of the patients had "aspirin resistance" or were non-responders, compared to 13.6% post-COLC (p = 0.423). The median baseline PRU score was 210, and post-COLC it was 199, which was also not statistically significant (p = 0.581). The mean difference in scores was -7.31 (95% CI -31.1 to 16.5, p = 0.530). At baseline, 50% of the patients had "clopidogrel resistance" or were non-responders, compared to 45.5% post-COLC (p = 0.999). Two patients experienced mild gastrointestinal upset during the trial without interruption of COLC, and there were no serious adverse events or treatment-emergent adverse events.

Conclusions: There were no significant differences in ARUs and PRUs post-COLC trial in patients with stable CAD. This pilot pharmacodynamic study could be clinically informative in patients on DAPT. Further studies are required to confirm these exploratory findings.

Trial registration: ClinicalTrials.gov identifier, NCT06567678, prospectively registered 20/8/2024.

Introduction: Data on the prevalence of hypertrophic cardiomyopathy (HCM), characteristics of patients with HCM, and treatment patterns in Japan are limited. This study aimed to estimate the prevalence of HCM and describe the patient characteristics, treatment patterns, and utilization of medical expense subsidies in Japan, using payer claims data from insurers.

Methods: This retrospective study of patients with HCM in Japan utilized payer claims data from insurers (Advanced Elderly Medical Service System [AEMSS], Kokuho, and Kempo) from January 1, 2017, to December 31, 2021. The prevalence of HCM was calculated annually; while medication use, comorbidities, and usage of medical expense subsidies were described for 2021 as representative data.

Results: The estimated prevalence of HCM increased from 9.3/10,000 people in 2017 to 11.1/10,000 people in 2021. In 2021, the highest prevalence was observed in patients aged 85-89 years (39.0/10,000 people). For patients with HCM, mean (standard deviation) age was 82.5 (5.5) years (AEMSS), 66.7 (9.2) years (Kokuho), and 53.4 (14.0) years (Kempo). Hypertension was the most common comorbidity (AEMSS, 90.7%; Kokuho, 85.7%; Kempo, 71.4%), followed by heart failure (AEMSS, 77.3%; Kokuho, 64.4%; Kempo, 56.9%). Mental health disorders were reported in 22.4% (AEMSS), 16.3% (Kokuho), and 11.3% (Kempo) of patients with HCM. Beta-blockers were the most frequently prescribed medications (AEMSS, 65.1%; Kokuho, 63.2%; Kempo, 56.6%). A small proportion of patients whose HCM was diagnosed in 2021 received medical expense subsidies (AEMSS, 2.6%; Kokuho, 4.6%).

Conclusions: This study is the first to evaluate the prevalence of HCM in Japan using data from the general population as the denominator. It indicated that patients with HCM are typically > 50 years old, have a high prevalence of comorbidities, are commonly treated with beta-blockers, and rarely receive medical expense subsidies for designated intractable diseases. About one-fifth of the patients had mental health disorders.

Introduction: Oral anticoagulants (OAC) reduce the risk of stroke among patients with atrial fibrillation (AF). However, adherence remains suboptimal. We focused on primary nonadherence to OAC and its associations with patient characteristics-specifically social determinants of health collected in electronic health records (EHR).

Methods: This retrospective cohort study used EHR data linked to prescription fill data from a large, integrated Midwestern community healthcare system. Adult patients with an incident AF diagnosis from 2020 to 2021 and a first OAC prescription (index visit) were included. Primary nonadherence was defined as failure to fill an initial OAC prescription within 30 days. Outcomes included 1-year all-cause mortality, first stroke, and first bleed after first OAC prescription. Multivariable logistic regression models evaluated the likelihood of primary nonadherence, and multivariable Cox proportional hazard models evaluated the association between primary nonadherence with outcomes.

Results: Among 8679 patients, 46% were female, 82% were non-Hispanic white, and the mean age was 71.3 ± 12.1 years. Twenty-one percent were primary nonadherent. The odds of primary nonadherence were greater among patients who were non-Hispanic Black, older (≥ 75 years), male, lacking commercial insurance, not employed/retired, and referred to social work; similar results were observed for secondary nonadherence. Primary nonadherence was associated with an increased risk of all-cause mortality (hazard ratio, 1.69; 95% confidence interval, 1.42-2.01).

Conclusion: These results reveal disparities in primary nonadherence among patients with a new AF diagnosis. There is a need to develop and test interventions for primary nonadherence that are implemented in disadvantaged patients, among whom nonadherence is highest.

In addition to traditional risk factors, patients with breast cancer are at an increased risk of atrial fibrillation due to cancer itself and certain cancer therapies. Atrial fibrillation in these patients adds to their morbidity and mortality. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood. The main goal of atrial fibrillation management in this population is to facilitate uninterrupted cancer treatment while addressing the arrhythmia and other cardiovascular sequelae of cancer treatment. Rhythm control is often challenging to implement in patients with breast cancer during active antineoplastic therapy because of the need for uninterrupted anticoagulation, potential drug-drug interactions between cancer treatments and antiarrhythmic medications, and the increased likelihood of atrial fibrillation recurrence. Prevention of thromboembolism and anticoagulation can also be challenging in patients with breast cancer as a result of the increased risk of cancer-related procoagulant state and coagulopathies. The integration of a cardio-oncology team and a multidisciplinary approach are crucial for better outcomes. The therapeutic interventions should be tailored toward individual patients' profiles through a shared decision-making approach. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood, highlighting the gaps in our knowledge. More research is required to reduce these gaps, refine risk stratification, and optimize treatment strategies in these patients.

Introduction: Very elderly patients with nonvalvular atrial fibrillation (NVAF) are at high risk for both ischemic and hemorrhagic events. This study aimed to understand the characteristics and real-world treatment of very elderly patients with NVAF in Japan.

Methods: We conducted a retrospective analysis of electronic health records and claims data from acute care hospitals for very elderly patients with NVAF with medical records available on or after their 80th birthday. The outcomes of interest were (1) characteristics of very elderly patients and (2) patterns of anticoagulation and impact of clinical condition on anticoagulation.

Results: Of 1,278,404 patients with newly diagnosed atrial fibrillation (AF), 443,820 were eligible for the analysis. Mean ± standard deviation age was 84.5 ± 5.5 years, CHADS₂ score was 2.4 ± 1.0, and CHA₂DS₂-VASc score was 4.3 ± 1.3. Among patients diagnosed with NVAF before age 80 years, 39.1% were not receiving anticoagulation therapy, while among those diagnosed with NVAF at age ≥ 90 years, 46.1% were not prescribed any anticoagulant. Patients diagnosed with NVAF before 80 years of age tended to stop anticoagulation therapy, especially those receiving warfarin, upon reaching 80 years of age. Among those who were newly diagnosed with NVAF after 80 years, most received reduced doses of direct oral anticoagulants (DOACs).

Conclusions: A significant proportion of very elderly patients with NVAF in Japan were diagnosed with NVAF after the age of 80 years and were not receiving anticoagulation therapy, particularly with increasing age. Furthermore, warfarin use declined with age, and patients on DOACs frequently received reduced doses.

Introduction: Since its invention in 1897, aspirin (ASA) has been the most widely used and cost-effective antiplatelet agent to prevent and treat atherosclerotic cardiovascular disease (ASCVD). We aimed to study the trends and expenditures associated with ASA use in the USA.

Methods: We conducted a serial cross-sectional analysis using the Medical Expenditure Panel Survey data from January 2000 to December 2021, focusing on adults aged ≥ 40 years. Total and out-of-pocket expenditures associated with ASA were estimated to 2021 US dollars (USD). Trends, demographics, and predictors of ASA use among patients with and without ASCVD were also evaluated.

Results: A total of 53 million adults were identified during the study period. The number of ASA users increased from 2.9 million to 6.6 million with increased female (36.7%-49.7%; p trend = 0.02) and African American (13%-18.9%; p trend = 0.03) representation amongst all ASA users during the survey period. The use of low-dose ASA increased, while high-dose ASA declined significantly. Only 50% of all ASA users had known ASCVD. The most prevalent ASA users among patients with ASCVD were those aged ≥ 70 years, while patients without ASCVD, it was the 50-69 age group. The total annual expenditure on ASA averaged approximately 60 million USD, with 27.3 million USD out-of-pocket.

Conclusion: Total and low-dose (81 mg) ASA use has increased, while high-dose (325 mg) ASA has declined. ASA use for primary prevention has risen among adults aged 50-69 years, and patients ≥ 70 years continue to use ASA without known ASCVD. Further studies are needed to understand the implications of increased ASA use, especially among those without ASCVD.

Introduction: Elevated low-density lipoprotein cholesterol (LDL-C) is a major residual risk factor among patients with acute coronary syndrome (ACS). In the absence of sufficient real-world evidence, this observational (noninterventional) study investigated the effectiveness and safety of evolocumab in patients with hyperlipidemia treated with evolocumab for ACS in a real-world clinical setting in Korea.

Methods: Between January 2022 and February 2023, patients from 10 hospitals in Korea who initiated evolocumab within 24 weeks of an ACS event were enrolled. Data collected at visit 1 (evolocumab initiation) included patients' characteristics, comorbidities, and lipid-lowering therapies. LDL-C reduction from visit 1 (week 0) to visit 2 (week 8) was assessed. The primary outcome was the proportion of patients who achieved LDL-C < 1.4 mmol/L (55 mg/dL) at follow-up; the secondary outcome was the proportion who achieved LDL-C < 1.8 mmol/L (70 mg/dL) at follow-up.

Results: In this study, 89 out of 142 enrolled patients were included in the effectiveness analysis. The mean (SD) age of the included patients was 59.3 (12.3) years, with the majority being male (87.6%). Sixty-one patients received statin-ezetimibe combination therapy (68.5%). The median [Q1, Q3] LDL-C level at the start of the study was 2.5 [2.0, 3.0] mmol/L (98 [77, 115] mg/dL), which decreased to 1.3 [0.7, 1.7] mmol/L (49 [29, 67] mg/dL) after 8 weeks of evolocumab treatment, resulting in an mean (SD) 50.9 (28.6) % reduction and 1.4 (1.0) mmol/L (55.1 (37.9) mg/dL) absolute reduction. At follow-up, 55.1% and 78.7% of patients achieved LDL-C goals of < 1.4 mmol/L (55 mg/dL) and < 1.8 mmol/L (70 mg/dL), respectively. No adverse or serious adverse drug reactions were reported.

Conclusion: Evolocumab treatment was associated with significant LDL-C lowering and favorable safety and guideline-recommended LDL-C goal achievement rates among patients with ACS in the real-world clinical practice setting in South Korea.

Hypertension, a key modifiable risk factor for cardiovascular diseases (CVD), significantly contributes to premature death and morbidity worldwide. Despite stabilization in age-adjusted global prevalence, the absolute number of hypertensive individuals doubled from 2000 to 2010, largely due to increases in low- and middle-income countries. In 2021, only 21% of hypertensive individuals globally had effective blood pressure (BP) control. In India, hypertension is the leading risk factor for death and disability, with prevalence rates of 24% in men and 21% in women, as reported by the 2019-2020 National Family Health Survey (NFHS-5). Alarmingly, just 25% of rural and 38% of urban hypertensive Indians are undergoing treatment, with only 10% and 20% achieving BP control, respectively. This highlights the hypertension paradox, where clinical inertia and hesitancy in intensifying BP-lowering therapy persist despite the availability of antihypertensive drugs. This expert opinion paper aims to provide a comprehensive evaluation of sacubitril/valsartan in hypertension management, leveraging insights from its approved use in heart failure and examining its benefits and challenges across diverse hypertensive populations. The formulation of this expert opinion involved employing evidence-based methodologies and utilizing all available data. The document underwent scrutiny by expert cardiologists, whose clinical experiences and examination of the evidence and guidelines informed the formation of the expert opinion. This expert opinion paper provides a thorough and informed evaluation of sacubitril/valsartan, highlighting its potential to address unmet needs in BP control, particularly in challenging cases such as resistant hypertension and chronic kidney disease.

Introduction: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia-Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia-Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.

Methods: The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).

Results: Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of - 60.8% at 1-6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.

Conclusion: Real-world, Asia-Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations. Graphical abstract available for this article.·.