Cardiology and Therapy最新文献

Introduction: Tafamidis is approved in many countries for the treatment of patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Approval is largely based on findings from an international phase 3 trial. This post-approval commitment study aimed to evaluate the safety and efficacy of tafamidis in patients with ATTR-CM in China.

Methods: A multicenter, single-arm study in Chinese patients with symptomatic ATTR-CM in China. All patients received once-daily, open-label tafamidis free acid 61 mg for 12 months. Safety reporting was ongoing with efficacy assessments at months 6 and 12, including 6-min walk test distance, New York Heart Association (NYHA) functional classification, National Amyloidosis Centre staging, N-terminal pro-B-type natriuretic peptide and troponin I concentrations, Kansas City Cardiomyopathy Questionnaire Overall Summary score, 5-level EQ-5D index score, EQ visual analog scale, and 12-item Short Form Survey.

Results: Patients (n = 53) were aged 60 (standard deviation [SD]: 12) years, 89% were male, and 94% had variant ATTR-CM (21% had A97S [p.A117S]). At baseline, most (81%) patients had NYHA class II symptoms (6% class I; 13% class III) and National Amyloidosis Centre stage I disease (74%; 21% stage II; 6% stage III). Median treatment exposure was 345 (range, 24‒418) days. Overall, 85% of patients reported treatment-emergent adverse events (TEAEs). The nature and incidence of TEAEs were consistent with the known safety profile of tafamidis. There were no serious or severe treatment-related TEAEs. At 6 and 12 months, there were minimal changes from baseline in all efficacy outcomes with tafamidis, and a high proportion of patients (≥ 44%) showed clinically relevant stability or improvement in each measure.

Conclusions: The safety of tafamidis in Chinese patients with ATTR-CM was consistent with that previously determined. Tafamidis treatment was associated with a stable disease profile over 12 months in a population of patients where most had variant ATTR-CM and mild heart failure symptoms.

Trial registration: NCT04814186.

Cardiogenic shock is the most common cause of mortality in patients with acute myocardial infarction (AMI). Historically, AMI complicated by cardiogenic shock was associated with in-hospital survival of only ~50%. Recent advances in mechanical circulatory support have allowed for improved survival rates compared with only conventional medical treatment. However, the management strategy for AMI-related cardiogenic shock remains largely empirical due to limited high-quality evidence-based studies. In this review, we provide an overview of the four types of left ventricular mechanical circulatory support currently available, review new guideline updates from the American College of Cardiology Foundation/American Heart Association and European Society of Cardiology, and discuss recent and ongoing studies and registries in cardiogenic shock following AMI.

Introduction: Cardiovascular diseases are a leading cause of global mortality, with hypertension as a major risk factor. Low control rates are often attributed to monotherapy, while evidence and clinical guidelines support the effectiveness of combination therapies. This study aimed to evaluate blood pressure changes and the achievement of target levels in patients treated with losartan/chlorthalidone (L/C) compared to losartan/hydrochlorothiazide (L/H).

Methods: A randomized, double-blind, prospective, multicenter clinical trial was conducted. Patients were assigned to one of two treatment groups, starting with a lower dose (50/12.5 mg of losartan/chlorthalidone or losartan/hydrochlorothiazide). Blood pressure was evaluated at 30 days, and patients not meeting therapeutic goals were escalated to a higher dose (100/50 mg of losartan/chlorthalidone or losartan/hydrochlorothiazide) and followed until the study end (60 days).

Results: The study recruited 163 patients (83 for losartan/chlorthalidone [L/C] group and 80 for the losartan/hydrochlorothiazide [L/H] group), with a mean age of 53.1 years. Both treatment groups demonstrated significant reductions in systolic and diastolic blood pressure, with L/C achieving an average reduction in systolic blood pressure (SBP) of - 24.6 mmHg and - 13.3 mmHg for diastolic blood pressure (DBP), while L/H had reductions of - 25.3-mmHg and - 11.5 mmHg, respectively. The L/C group exhibited a higher likelihood of achieving blood pressure goals compared to the L/H. Adverse events were comparable between groups and were mostly mild.

Conclusions: The study showed that both combinations are effective for hypertension, with losartan/chlorthalidone demonstrating greater efficacy in reducing diastolic blood pressure and achieving target levels. Both treatments exhibited similar and favorable safety profiles.

Clinical trials registration: NCT04927299. Registered August 6, 2021- https://clinicaltrials.gov/study/NCT04927299.

Introduction: The V-GOOD study evaluated the effectiveness of trimetazidine modified-release (MR) 80 mg once daily (OD) in patients with chronic coronary syndrome (CCS) who remained symptomatic despite antianginal therapies in routine clinical practice.

Methods: This prospective, observational study involved 1026 adult outpatients with symptomatic CCS from 70 sites in Brazil who were prescribed trimetazidine MR 80 mg OD plus background antianginal treatment. Data on number of angina attacks, short-acting nitrate consumption, prevalence of angina-free patients, severity of angina, patient-reported daily physical activity impairment, treatment adherence, tolerability, and cardiologist and patient satisfaction were collected at baseline (V1), then at 1 month (V2) and 3 months (V3).

Results: Following the addition of trimetazidine MR 80 mg OD, the mean ± standard deviation number of angina attacks per week decreased from 3.1 ± 2.8 at V1 to 1.0 ± 2.1 at V2, and 0.7 ± 1.7 at V3, with concurrent reductions in short-acting nitrate consumption, patient-reported daily physical activity impairment and the proportion of patients with limiting angina (Canadian Cardiovascular Society class III or IV), and increases in the proportion of angina-free patients (all p < 0.001 vs. V1). Most cardiologists rated trimetazidine MR 80 mg OD as satisfactory/very satisfactory (90.7% for effectiveness and 94.8% for tolerability); most patients rated the treatment schedule as convenient/very convenient (97.2%) and satisfactory/very satisfactory (97.1%). Treatment was well tolerated.

Conclusions: These data support the symptomatic benefits and good tolerability associated with adding trimetazidine MR 80 mg OD to other antianginal therapies in patients with persistent symptoms. Graphical abstract available for this article.

Trial registration number: NCT06464276.

Introduction: Real-world data on atrial fibrillation (AF) in the Middle East and North Africa (MENA) region, including Egypt, are sparse. The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of newly diagnosed non-valvular atrial fibrillation (NVAF) patients within the MENA region, including Egypt.

Methods: This multicenter, prospective, observational registry enrolled newly diagnosed patients with NVAF from January 2020 to December 2022 at eight private-sector healthcare centers in Egypt. Data were collected at enrollment (baseline), and then at 6-month and 12-month follow-up. Baseline data included demographics, AF characteristics, medical history, and antithrombotic treatment patterns. Follow-up data included clinical events, healthcare resource utilization, and related costs.

Results: A total of 723 patients were enrolled. Overall, 51.87% were females, and the mean age was 61.9 years. All patients attended the private health sector. The mean (standard deviation) CHA₂DS₂-VASc and HAS-BLED risk scores were 2.37 (1.55) and 1.46 (1.18), respectively. Non-vitamin K antagonist oral anticoagulants (62.52%), vitamin K antagonists (22.28%), and antiplatelet therapy (9.85%) were among the prescribed treatments. Rates of transient ischemic attack and all-cause mortality were 2.64% and 0.83%, respectively; all other outcomes (stroke, bleeding, myocardial infarction, systemic embolism) occurred at a rate of ≤ 0.41%. Antithrombotic medications were the major contributors to per-patient total yearly cost (USD 381.2).

Conclusions: The FLOW-AF study showed that patients with NVAF in Egypt are younger and exhibit lower mean baseline CHA₂DS₂-VASc and HAS-BLED scores compared to Western and other Eastern regions. Additional research, including a broader study population with a longer follow-up, is essential to comprehensively assess the characteristics and outcomes of the NVAF population in Egypt.

Introduction: In dyslipidemia associated with type 2 diabetes (T2DM), elevated triglycerides (TG), increased low-density lipoprotein cholesterol (LDL-C), and decreased high-density lipoprotein cholesterol (HDL-C) levels are commonly found, resulting in a high prevalence of mixed dyslipidemia among patients with T2DM. Therefore, the combination therapy of atorvastatin/fenofibrate may be useful for simplifying pharmacological regimens, enhancing adherence, and requiring fewer doses of each drug to achieve the target, which decreases the number of adverse events.

Methods: We conducted a randomized multicenter, double-blind clinical trial of patients with T2DM and mixed dyslipidemia to evaluate the magnitude of change in lipid profile with a fixed-dose combination (FDC) therapy group of atorvastatin 20 mg/fenofibrate 160 mg (G_FDC) versus atorvastatin 20 mg monotherapy group (G_M), both oral route, one tablet every 24 h. The magnitude of change in the lipid profile at 2 and 4 months was compared within each group and between groups using the analysis of variance (ANOVA) test. A p value ≤ 0.05 was considered statistically significant.

Results: A total of 76 patients were included (38 per group), with an age of 56.7 ± 10.2 years, and 56.6% were women. The values at 4 months for G_FDC vs. G_M were as follow: TG mg/dL (-144.3 vs. -64.0, p = 0.004), TG percentage change (%C) (-47.9 vs. -33.1, p = 0.007); LDL-C mg/dL (-50.5 vs. -51.7, p = 0.784), LDL-C %C (-42.5 vs. -45.6, p = 0.899). The percentage of patients who achieved the targets for triglycerides (TG) was 56.7% compared to 43.8% (p = 0.309), while for LDL-C, it was 73.3% compared to 78.1% (p = 0.660). Finally, the predictive cardiovascular risk indices (∆ of change) showed a TG/HDL index of -3.9 ± 4.6 vs. -1.5 ± 2.9 (p = 0.015) and a Tg/glucose index of -0.7 ± 0.5 vs. -0.3 ± 0.4 (p = 0.003).

Conclusion: The FDC therapy of atorvastatin 20 mg/fenofibrate 160 mg achieved a greater percentage reduction in lipid profile than atorvastatin alone. No differences in adverse events were observed between the groups.

Clinical trials registration: ClinicalTrials.gov No. NCT04882293, registration date: February 28, 2022.

Introduction: Mavacamten, a cardiac myosin inhibitor, has demonstrated positive outcomes in left ventricular outflow tract (LVOT) gradient reduction and improvements of symptoms and function in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in EXPLORER-CN. This exploratory analysis aimed to evaluate the effect of mavacamten on echocardiographic measures of cardiac structure and function and its relationship with other clinical biomarkers.

Methods: Key echocardiographic parameters acquired over 30 weeks from 81 patients (n = 54 on mavacamten and n = 27 on placebo) were assessed in a central laboratory.

Results: At 30 weeks, greater improvements in measures of diastolic function were observed with mavacamten versus placebo, including lateral E/e' (least-squares mean [LSM] change from baseline [CFB] - 5.1 vs. 0.6; between-group LSM difference - 5.7; 95% confidence interval [CI] - 7.6 to - 3.7), septal E/e' (LSM CFB - 6.0 vs. - 0.3; between-group LSM difference - 5.7; 95% CI - 7.8 to - 3.7), and left atrial volume index (LAVI) (LSM CFB - 11.7 vs. - 3.5 ml/m²; between-group LSM difference - 8.2; 95% CI - 12.0 to - 4.4) (nominal p < 0.001 for all). Twelve patients (23.1%) treated with mavacamten had complete resolution of mitral valve systolic anterior motion (SAM) versus two patients (7.4%) receiving placebo. Among mavacamten-treated patients, reductions in resting and Valsalva LVOT gradients, left ventricular (LV) mass index, LAVI, and lateral and septal E/e' were associated with reduced N-terminal pro-B-type natriuretic peptide levels (nominal p < 0.0001 for all). In the mavacamten group, reductions in LVOT gradients and LV end-diastolic interventricular septal thickness were associated with improved patient-reported Kansas City Cardiomyopathy Questionnaire Overall Summary Score (nominal p < 0.05 for all).

Conclusions: Clinically meaningful improvements were evident in Chinese patients treated with mavacamten compared with placebo in several hallmarks of obstructive HCM, including measures of LV diastolic function, SAM, and LVOT gradient. These results add further evidence to support the positive effects of mavacamten in cardiac remodeling.

Registration: ClinicalTrials.gov identifier: NCT05174416.

Introduction: The challenge in heart failure medical practice is to address the clinical and laboratory method integrations for the shared decision-making process in caring for patients and families. Furthermore, stressful life events may worsen outcomes in patients with heart failure. This study aimed to explore patient perceptions regarding cardiac care analyzing the individual needs and features of adverse life event experiences.

Methods: A mixed-methods design was used in this study. This quantitative research focuses on clinical (medical and psychological) data. Giorgi's phenomenological method was applied to the interview analysis.

Results: Qualitative analyses highlighted the role of patient-engagement strategies powered by cardiologists in a personalized approach that favors adherence to complex medical therapies. Active patient involvement and associated engagement based on cardiologists' confidence are focal points for facilitating management-therapy strategies to improve outcomes and reduce the perception of the frailty burden. The quality of therapeutic relationships with cardiologists is a key protective factor for accurate risk stratification and therapeutic decision-making in patients, addressing the potential benefits of therapeutic interventions.

Conclusions: In conclusion, the engaged patient contributes to more efficient cardiological care and the personalized patient-centered approach leads to the more efficient 'cure and care' clinical model. In adverse life events, acute psychological and physiological stress responses intensify detrimental outcomes for patients with cardiovascular disorders. Integrative management of physical risks and mental resilience factors in the development of cardiac disease appears to be strategic for patients with a positive quality of life (QoL) and clinical management of heart failure (HF).