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1.
Glob Heart ; 19(1): 65, 2024.
Article in English | MEDLINE | ID: mdl-39157208

ABSTRACT

Background: There is limited real-world data of lipid control and healthcare costs among patients with and without Atherosclerotic Cardiovascular Disease (ASCVD) in Latin America. Methods: A retrospective cohort study including patients with LDL-cholesterol (LDL-C) assessment from 2015 to 2017 was performed in a health insurance database. Patient characteristics, comorbidities and laboratory data were collected, and International Classification of Diseases (ICD) codes were used to identify a subcohort of patients with ASCVD (secondary prevention) and assess the proportion of these patients with LDL-C controlled. Lipid control among patients without ASCVD (primary prevention) and healthcare costs in one year in the overall population were also assessed. Results: From the 17,434 patients selected, 5,208 (29.8%) had ASCVD. The mean age of these patients in secondary prevention was 68.9 (±12.3) years and 47.8% were male patients. LDL-C < 70 mg/dL was identified in 19.1% of the ASCVD population and only 4.1% had an LDL-C < 50 mg/dL. LDL control was worse in women compared to men (13.1% vs. 25.7%; P < 0.01). The average cost in one year was 3,591 American dollars (USD) per patient in primary prevention compared to 8,210 dollars per year for patients in secondary prevention (P < 0.01). While outpatient costs accounted for 59.8% of the total cost in the primary prevention group, the main cost of the secondary prevention population was related to hospital costs (54.1%). Conclusion: Despite the favorable evidence for intensive cholesterol reduction, the evaluation of large real-world database with more than 17,000 individuals showed that the targets of guideline recommendations have not yet been adequately incorporated into clinical practice. Average annual cost per patient in secondary prevention is more than twice compared to primary prevention. Hospital expenses account for most of the cost in the secondary prevention group, while outpatient costs predominate in primary prevention.


Subject(s)
Atherosclerosis , Health Care Costs , Humans , Male , Female , Retrospective Studies , Aged , Atherosclerosis/economics , Atherosclerosis/epidemiology , Atherosclerosis/prevention & control , Health Care Costs/statistics & numerical data , Brazil/epidemiology , Middle Aged , Cholesterol, LDL/blood , Follow-Up Studies , Secondary Prevention/economics
2.
JACC Heart Fail ; 12(8): 1473-1486, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39111953

ABSTRACT

Chronic Chagas cardiomyopathy (CCC) has unique pathogenic and clinical features with worse prognosis than other causes of heart failure (HF), despite the fact that patients with CCC are often younger and have fewer comorbidities. Patients with CCC were not adequately represented in any of the landmark HF studies that support current treatment guidelines. PARACHUTE-HF (Prevention And Reduction of Adverse outcomes in Chagasic Heart failUre Trial Evaluation) is an active-controlled, randomized, phase IV trial designed to evaluate the effect of sacubitril/valsartan 200 mg twice daily vs enalapril 10 mg twice daily added to standard of care treatment for HF. The study aims to enroll approximately 900 patients with CCC and reduced ejection fraction at around 100 sites in Latin America. The primary outcome is a hierarchical composite of time from randomization to cardiovascular death, first HF hospitalization, or relative change from baseline to week 12 in NT-proBNP levels. PARACHUTE-HF will provide new data on the treatment of this high-risk population. (Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC [PARACHUTE-HF]; NCT04023227).


Subject(s)
Aminobutyrates , Angiotensin Receptor Antagonists , Biphenyl Compounds , Chagas Cardiomyopathy , Drug Combinations , Enalapril , Heart Failure , Tetrazoles , Valsartan , Humans , Biphenyl Compounds/therapeutic use , Aminobutyrates/therapeutic use , Enalapril/therapeutic use , Angiotensin Receptor Antagonists/therapeutic use , Chagas Cardiomyopathy/drug therapy , Heart Failure/drug therapy , Tetrazoles/therapeutic use , Stroke Volume/physiology , Peptide Fragments/blood , Chronic Disease , Natriuretic Peptide, Brain/blood , Male , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Female , Treatment Outcome
3.
JAMA ; 2024 Aug 14.
Article in English | MEDLINE | ID: mdl-39141382

ABSTRACT

Importance: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)-based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI). Objective: To replicate the finding of TACT in individuals with diabetes and previous MI. Design, Setting, and Participants: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons. Interventions: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study. Main Outcomes and Measures: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion. Results: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P = .53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 µg/L at baseline to 3.46 µg/L at infusion 40 (P < .001). Corresponding levels in the placebo group were 9.3 µg/L and 8.7 µg/L, respectively. Conclusions and Relevance: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI. Trial Registration: ClinicalTrials.gov Identifier: NCT02733185.

4.
Heart Rhythm ; 2024 Aug 16.
Article in English | MEDLINE | ID: mdl-39154873

ABSTRACT

BACKGROUND: Despite many atrial fibrillation (AF) patients being at risk of bleeding, very limited data are available on bleeding rates of different direct oral anticoagulants (DOACs) based on the spectrum of bleeding risk. OBJECTIVE: To compare the risk of major bleeding and thromboembolic events with apixaban versus rivaroxaban among AF patients, stratified by bleeding risk. METHODS: We conducted a population-based, retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada, who were treated with apixaban or rivaroxaban between April 1, 2011 and March 31, 2020. Bleeding risk was estimated using the HAS-BLED score with high bleeding risk defined as a score of 3 or greater. The primary safety outcome was major bleeding and the primary efficacy outcome was thromboembolic events. Comparisons were adjusted for baseline comorbidities using inverse probability of treatment weighting (IPTW). RESULTS: This study included 18,156 AF patients with high bleeding risk and 55,186 AF patients with low bleeding risk. Apixaban use was more common in high bleeding risk patients; 63% of high risk patients used apixaban compared to 56% of low risk patients. Apixaban users had lower rates of major bleeding in high risk patients (2.9% vs 4.2% per year; HR 0.69 [95%CI, 0.58-0.81]) and in low risk patients (1.8% vs 2.9% per year; HR 0.63 [95%CI, 0.56-0.70]), compared with rivaroxaban. There were no differences in rates of thromboembolic events 3.1% vs 3.0% per year (HR 1.02 [95%CI, 0.86-1.22]) in high risk patients and 1.9% vs 1.9% per year (HR 1.00 [95%CI, 0.89-1.14]) in low risk patients. CONCLUSIONS: Among older AF patients with high or low bleeding risk, treatment with apixaban was associated with lower rates of major bleeding with no difference in risk for thromboembolic events compared with rivaroxaban.

5.
Eur Heart J Suppl ; 26(Suppl 4): iv4-iv11, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39099575

ABSTRACT

Subclinical, device-detected atrial fibrillation (AF) is frequently recorded by pacemakers and other implanted cardiac rhythm devices. Patients with device-detected AF have an elevated risk of stroke, but a lower risk of stroke than similar patients with clinical AF captured with surface electrocardiogram. Two randomized clinical trials (NOAH-AFNET 6 and ARTESiA) have tested a direct oral anticoagulant (DOAC) against aspirin or placebo. A study-level meta-analysis of the two trials found that treatment with a DOAC resulted in a 32% reduction in ischaemic stroke and a 62% increase in major bleeding; the results of the two trials were consistent. The annualized rate of stroke in the control arms was ∼1%. Several factors point towards overall net benefit from DOAC treatment for patients with device-detected AF. Strokes in ARTESiA were frequently fatal or disabling and bleeds were rarely lethal. The higher absolute rates of major bleeding compared with ischaemic stroke while on treatment with a DOAC in the two trials are consistent with the ratio of bleeds to strokes seen in the pivotal DOAC vs. warfarin trials in patients with clinical AF. Prior research has concluded that patients place a higher emphasis on stroke prevention than on bleeding. Further research is needed to identify the characteristics that will help identify patients with device-detected AF who will receive the greatest benefit from DOAC treatment.

6.
Arq Bras Cardiol ; 121(7): e202400415, 2024 Jul 26.
Article in Portuguese, English | MEDLINE | ID: mdl-39082572
7.
Article in English | MEDLINE | ID: mdl-39078536

ABSTRACT

When selecting an anticoagulant, clinicians consider individual patient characteristic, the treatment indication, drug pharmacology, and safety and efficacy as demonstrated in randomized trials. An ideal anticoagulant prevents thrombosis with little or no increase in bleeding. Direct oral anticoagulants represent a major advance over traditional anticoagulants (e.g., unfractionated heparin, warfarin) but still cause bleeding, particularly from the gastrointestinal tract which can limit their use. Epidemiological studies indicate that patients with congenital factor XI (FXI) deficiency have a lower risk of venous thromboembolism (VTE) and ischemic stroke (IS) than non-deficient individuals, and do not have an increased risk of spontaneous bleeding, even with severe deficiency. These observations provide the rationale for targeting FXI as a new class of anticoagulant. Multiple FXI inhibitors have been introduced and several are being evaluated in Phase III trials. In this review, we explain why drugs that target FXI may be associated with a lower risk of bleeding than currently available anticoagulants and summarize the completed and ongoing trials.

9.
Circulation ; 150(4): 317-335, 2024 Jul 23.
Article in English | MEDLINE | ID: mdl-39038086

ABSTRACT

For almost two decades, 12-month dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) has been the only class I recommendation on DAPT in American and European guidelines, which has resulted in 12-month durations of DAPT therapy being the most frequently implemented in ACS patients undergoing percutaneous coronary intervention (PCI) across the globe. Twelve-month DAPT was initially grounded in the results of the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trial, which, by design, studied DAPT versus no DAPT rather than the optimal DAPT duration. The average DAPT duration in this study was 9 months, not 12 months. Subsequent ACS studies, which were not designed to assess DAPT duration, rather its composition (aspirin with prasugrel or ticagrelor compared with clopidogrel) were further interpreted as supportive evidence for 12-month DAPT duration. In these studies, the median DAPT duration was 9 or 15 months for ticagrelor and prasugrel, respectively. Several subsequent studies questioned the 12-month regimen and suggested that DAPT duration should either be fewer than 12 months in patients at high bleeding risk or more than 12 months in patients at high ischemic risk who can safely tolerate the treatment. Bleeding, rather than ischemic risk assessment, has emerged as a treatment modifier for maximizing the net clinical benefit of DAPT, due to excessive bleeding and no clear benefit of prolonged treatment regimens in high bleeding risk patients. Multiple DAPT de-escalation treatment strategies, including switching from prasugrel or ticagrelor to clopidogrel, reducing the dose of prasugrel or ticagrelor, and shortening DAPT duration while maintaining monotherapy with ticagrelor, have been consistently shown to reduce bleeding without increasing fatal or nonfatal cardiovascular or cerebral ischemic risks compared with 12-month DAPT. However, 12-month DAPT remains the only class-I DAPT recommendation for patients with ACS despite the lack of prospectively established evidence, leading to unnecessary and potentially harmful overtreatment in many patients. It is time for clinical practice and guideline recommendations to be updated to reflect the totality of the evidence regarding the optimal DAPT duration in ACS.


Subject(s)
Acute Coronary Syndrome , Dual Anti-Platelet Therapy , Platelet Aggregation Inhibitors , Humans , Acute Coronary Syndrome/drug therapy , Acute Coronary Syndrome/therapy , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Hemorrhage/chemically induced , Percutaneous Coronary Intervention , Time Factors , Treatment Outcome , Prasugrel Hydrochloride/therapeutic use , Prasugrel Hydrochloride/administration & dosage , Prasugrel Hydrochloride/adverse effects , Drug Administration Schedule
10.
J Am Coll Cardiol ; 84(4): 354-364, 2024 Jul 23.
Article in English | MEDLINE | ID: mdl-39019530

ABSTRACT

BACKGROUND: ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation. OBJECTIVES: To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHA2DS2-VASc score. METHODS: We performed a subgroup analysis according to baseline CHA2DS2-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding. RESULTS: Baseline CHA2DS2-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHA2DS2-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHA2DS2-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHA2DS2-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds. CONCLUSIONS: One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHA2DS2-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHA2DS2-VASc score <4. A substantial intermediate group (CHA2DS2-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248).


Subject(s)
Aspirin , Atrial Fibrillation , Factor Xa Inhibitors , Pyrazoles , Pyridones , Stroke , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Pyridones/adverse effects , Pyridones/administration & dosage , Aspirin/therapeutic use , Male , Female , Aged , Middle Aged , Stroke/prevention & control , Stroke/etiology , Stroke/epidemiology , Factor Xa Inhibitors/therapeutic use , Risk Assessment/methods , Hemorrhage/chemically induced , Hemorrhage/epidemiology
11.
Am J Med ; 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38876331

ABSTRACT

OBJECTIVE: We aimed to evaluate the safety and efficacy of antithrombotic strategies by age in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention in AUGUSTUS. METHODS: Patients were stratified into 3 age groups: <65, 65-74, and ≥75 years. Outcomes of interest were major or clinically relevant non-major bleeding, major bleeding, death or rehospitalization, and ischemic events. Treatment effects of apixaban vs. vitamin K antagonist (VKA) and aspirin vs. placebo were assessed across age groups using Cox models. RESULTS: Of 4614 patients, 1267 (27.5%) were <65, 1802 (39.0%) were 65-74, and 1545 (33.5%) were ≥75 years. Apixaban was associated with lower rates of major or clinically relevant non-major bleeding than VKA (<65: HR 0.69 [0.47-1.00]; 65-74: HR 0.57 [0.43-0.75]; ≥75: HR 0.81 [0.63-1.04]). Death or hospitalization occurred less often with apixaban, regardless of age. No differences were observed in rates of ischemic events between apixaban and VKA according to age. Aspirin was associated with higher rates of bleeding than placebo (<65: HR 1.67 [1.15-2.43]; 65-74: HR 2.32 [1.73-3.10]; ≥75: HR 1.69 [1.31-2.19]). Rates of death or rehospitalization and ischemic events were similar among patients receiving aspirin or placebo across age groups. CONCLUSIONS: Apixaban was associated with greater absolute reduction in bleeding than VKA in older age groups, reflecting their higher hemorrhagic risk. Aspirin increased bleeding in all age groups vs. placebo. Our findings support the use of apixaban plus a purinergic receptor P2Y12(P2Y12) inhibitor without aspirin in patients with atrial fibrillation and recent acute coronary syndrome/percutaneous coronary intervention, regardless of age.

12.
Heart Rhythm ; 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38878942

ABSTRACT

BACKGROUND: There are no clinical trials with a head-to-head comparison between the 2 most commonly used oral anticoagulants (apixaban and rivaroxaban) in patients with atrial fibrillation (AF). The comparative efficacy and safety between these drugs remain unclear, especially in older patients who are at the highest risk for stroke and bleeding. OBJECTIVE: The purpose of this study was to compare the risk of major bleeding and thromboembolic events between apixaban and rivaroxaban in older patients with AF. METHODS: We conducted a population-based retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada, who were treated with apixaban or rivaroxaban between April 1, 2011, and March 31, 2020. The primary safety outcome was major bleeding, and the primary efficacy outcome was thromboembolic events. Secondary outcomes included any bleeding. Rates and hazard ratios (HRs) were adjusted for baseline comorbidities with inverse probability of treatment weighting. RESULTS: This study included 42,617 patients with AF treated with apixaban and 30,725 patients treated with rivaroxaban. After inverse probability of treatment weighting using the propensity score, patients in the apixaban and rivaroxaban groups were well balanced for baseline values of demographic characteristics, comorbidities, and medications; both groups had a similar mean age of 77.4 years, and 49.9% were female. At 1 year, the apixaban group had a lower risk for both major bleeding with an absolute risk reduction at 1 year of 1.1% (2.1% vs 3.2%; HR 0.65; 95% confidence interval [CI] 0.59-0.71]) and any bleeding (8.1% vs 10.9%; HR 0.73; 95% CI 0.69-0.77), with no difference in the risk for thromboembolic events (2.2% vs 2.2%; HR 1.02; 95% CI 0.92-1.13). CONCLUSION: In patients with AF, 66 years or older, treatment with apixaban was associated with lower risk for major bleeding, with no difference in the risk for thromboembolic events compared with rivaroxaban.

14.
Med Sci Educ ; 34(3): 551-560, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38887406

ABSTRACT

Background: Problem-based learning (PBL) constructs a curriculum that merges theory and practice by employing clinical scenarios or real-world problems. Originally designed for the pre-clinical phase of undergraduate medicine, PBL has since been integrated into diverse aspects of medical education. Therefore, this study aims to map the global scientific landscape related to PBL in medical education in the last ten years. Methods: We combined bibliometrics and network analysis to analyze the metadata of related research articles published between 2013 and 2022 and indexed in the Web of Science Core Collection. Results: Our results show an annual publication rate of 9.42%. The two main journals disseminating research on this subject are BMC Medical Education and Medical Teacher. Education & Educational Research and Health Care Sciences & Services are the two most frequent research areas, and also the two most central nodes of the related network. The USA and China are the most publishing countries, while the Netherlands and Canada are the most collaborative. The Maastricht University holds the position of most publishing and collaborative research organization. The University of California ranks second in publications, while the University of Toronto is the second most central research organization. Conclusions: Our study provides an overview of the last ten years of publications related to PBL and medical education, and we hope it can be of interest to educators, researchers, and students involved with this subject. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-024-02003-1.

15.
Circulation ; 150(3): 180-189, 2024 Jul 16.
Article in English | MEDLINE | ID: mdl-38934111

ABSTRACT

BACKGROUND: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. METHODS: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. RESULTS: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). CONCLUSIONS: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660.


Subject(s)
Diabetes Mellitus, Type 2 , Humans , Female , Male , Diabetes Mellitus, Type 2/ethnology , Diabetes Mellitus, Type 2/therapy , Aged , Middle Aged , Cardiovascular Diseases/ethnology , Sex Factors , Ethnicity , Evidence-Based Medicine , Treatment Outcome , United States/epidemiology , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
16.
Pharmaceuticals (Basel) ; 17(6)2024 May 27.
Article in English | MEDLINE | ID: mdl-38931353

ABSTRACT

Autism Spectrum Disorder (ASD) encompasses a wide range of neurodevelopmental conditions characterized by deficits in social interaction, communication and behavior. Current pharmacological options are limited and feature significant side effects. In this study, we conducted a retrospective, observational, and cross-sectional cohort study to evaluate the effects of Cannabidiol (CBD)-dominant, full-spectrum cannabis extract, containing Tetrahydrocannabinol (THC) in a ratio of 33:1 (CBD:THC), on non-syndromic children and adolescents (5-18 years old) with moderate to severe ASD. Thirty volunteers were recruited, underwent neuropsychological evaluations and were treated with individualized doses of CBD-dominant extract. Clinical assessments were conducted by the designated clinician. Additionally, parents or caregivers were independently interviewed to assess perceived treatment effects. We found significant improvements in various symptomatic and non-symptomatic aspects of ASD, with minimal untoward effects, as reported by both clinical assessments and parental perceptions. The observed improvements included increased communicative skills, attention, learning, eye contact, diminished aggression and irritability, and an overall increase in both the patient's and family's quality of life. Despite its limitations, our findings suggest that treatment with full-spectrum CBD-dominant extract may be a safe and effective option for core and comorbid symptoms of ASD, and it may also increase overall quality of life for individuals with ASD and their families.

17.
Fernandes, Fabio; Simões, Marcus V; Correia, Edileide de Barros; Marcondes-Braga, Fabiana Goulart; Filho, Otavio Rizzi Coelho; Mesquita, Cláudio Tinoco; Mathias Junior, Wilson; Antunes, Murillo de Oliveira; Arteaga-Fernández, Edmundo; Rochitte, Carlos Eduardo; Ramires, Felix José Alvarez; Alves, Silvia Marinho Martins; Montera, Marcelo Westerlund; Lopes, Renato Delascio; Oliveira Junior, Mucio Tavares de; Scolari, Fernando Luis; Avila, Walkiria Samuel; Canesin, Manoel Fernandes; Bocchi, Edimar Alcides; Bacal, Fernando; Moura, Lidia Zytynski; Saad, Eduardo Benchimol; Scanavacca, Mauricio Ibrahim; Valdigem, Bruno Pereira; Cano, Manuel Nicolas; Abizaid, Alexandre Antonio Cunha; Ribeiro, Henrique Barbosa; Lemos Neto, Pedro Alves; Ribeiro, Gustavo Calado de Aguiar; Jatene, Fabio Biscegli; Dias, Ricardo Ribeiro; Beck-da-Silva, Luis; Rohde, Luis Eduardo Paim; Bittencourt, Marcelo Imbroinise; Pereira, Alexandre da Costa; Krieger, José Eduardo; Villacorta Junior, Humberto; Martins, Wolney de Andrade; Figueiredo Neto, José Albuquerque de; Cardoso, Juliano Novaes; Pastore, Carlos Alberto; Jatene, Ieda Biscegli; Tanaka, Ana Cristina Sayuri; Hotta, Viviane Tiemi; Romano, Minna Moreira Dias; Albuquerque, Denilson Campos de; Mourilhe-Rocha, Ricardo; Hajjar, Ludhmila Abrahão; Brito Junior, Fabio Sandoli de; Caramelli, Bruno; Calderaro, Daniela; Farsky, Pedro Silvio; Colafranceschi, Alexandre Siciliano; Pinto, Ibraim Masciarelli Francisco; Vieira, Marcelo Luiz Campos; Danzmann, Luiz Claudio; Barberato, Silvio Henrique; Mady, Charles; Martinelli Filho, Martino; Torbey, Ana Flavia Malheiros; Schwartzmann, Pedro Vellosa; Macedo, Ariane Vieira Scarlatelli; Ferreira, Silvia Moreira Ayub; Schmidt, Andre; Melo, Marcelo Dantas Tavares de; Lima Filho, Moysés Oliveira; Sposito, Andrei C; Brito, Flávio de Souza; Biolo, Andreia; Madrini Junior, Vagner; Rizk, Stephanie Itala; Mesquita, Evandro Tinoco.
Arq. bras. cardiol ; 121(7): e202400415, jun.2024. ilus, tab
Article in Portuguese | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1556404

Subject(s)
Diagnosis
18.
Eur Heart J Digit Health ; 5(3): 389-393, 2024 May.
Article in English | MEDLINE | ID: mdl-38774370

ABSTRACT

Aims: The accuracy of voice-assisted technologies, such as Amazon Alexa, to collect data in patients who are older or have heart failure (HF) is unknown. The aim of this study is to analyse the impact of increasing age and comorbid HF, when compared with younger participants and caregivers, and how these different subgroups classify their experience using a voice-assistant device, for screening purposes. Methods and results: Subgroup analysis (HF vs. caregivers and younger vs. older participants) of the VOICE-COVID-II trial, a randomized controlled study where participants were assigned with subsequent crossover to receive a SARS-CoV2 screening questionnaire by Amazon Alexa or a healthcare personnel. Overall concordance between the two methods was compared using unweighted kappa scores and percentage of agreement. From the 52 participants included, the median age was 51 (34-65) years and 21 (40%) were HF patients. The HF subgroup showed a significantly lower percentage of agreement compared with caregivers (95% vs. 99%, P = 0.03), and both the HF and older subgroups tended to have lower unweighted kappa scores than their counterparts. In a post-screening survey, both the HF and older subgroups were less acquainted and found the voice-assistant device more difficult to use compared with caregivers and younger individuals. Conclusion: This subgroup analysis highlights important differences in the performance of a voice-assistant-based technology in an older and comorbid HF population. Younger individuals and caregivers, serving as facilitators, have the potential to bridge the gap and enhance the integration of these technologies into clinical practice. Study Registration: ClinicalTrials.gov Identifier: NCT04508972.

19.
Curr Cardiol Rep ; 26(6): 505-520, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38743352

ABSTRACT

PURPOSE OF REVIEW: Polyvascular disease has a significant global burden and is associated with increased risk of major adverse cardiac events with each additional vascular territory involved. The purpose of this review is to highlight the risk factors, associated outcomes, emerging genetic markers, and evidence for screening and treatment of polyvascular disease. RECENT FINDINGS: Polyvascular disease is the presence of atherosclerosis in two or more vascular beds. It has a significant global burden, with a prevalence of 30-70% in patients with known atherosclerosis. Patients with polyvascular disease experience elevated rates of cardiovascular death, myocardial infarction and stroke, especially among high-risk subgroups like those with type 2 diabetes mellitus and there is a step-wise increased risk of adverse outcomes with each additional vascular territory involved. Genetic analyses demonstrate that some individuals may carry a genetic predisposition, while others exhibit higher levels of atherogenic lipoproteins and inflammatory markers. Routine screening for asymptomatic disease is not currently recommended by major cardiovascular societies unless patients are high-risk. While there are no established protocols for escalating treatment, existing guidelines advocate for lipid-lowering therapy. Additionally, recent studies have demonstrated benefit from antithrombotic agents, such as P2Y12 inhibitors and low-dose anticoagulation, but the optimal timing and dosage of these agents has not been established, and the ischemic benefit must be balanced against the increased risk of bleeding in the polyvascular population. Due to the high prevalence and risks associated with polyvascular disease, early identification and treatment intensification are crucial to reduce disease progression. Future research is needed to develop screening protocols and determine the optimal timing and dosing of therapy to prevent ischemic events.


Subject(s)
Diabetes Mellitus, Type 2 , Humans , Risk Factors , Diabetes Mellitus, Type 2/complications , Atherosclerosis , Cardiovascular Diseases/etiology , Genetic Predisposition to Disease , Prevalence
20.
Adv Ther ; 41(7): 2868-2889, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38802637

ABSTRACT

INTRODUCTION: Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA. METHODS: This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates. The data collection occurred at enrollment (baseline) and after 6- and 12-months (follow-up). Baseline data included demographics, AF characteristics, medical history, and anti-thrombotic treatment patterns. Clinical events, healthcare resource utilization, and direct costs were collected at follow-up. RESULTS: The study enrolled a total of 1418 patients (52.7% males and 47.3% females). The mean age of the patients was 64.5 years and 90.6% were white. The mean (standard deviation) CHA2DS2-VASc and HAS-BLED risk scores were 2.7 (1.6) and 1.6 (1.2), respectively. Non-vitamin K antagonist oral anticoagulants, antiplatelet therapy, and vitamin K antagonists were prescribed to 65.8%, 16.4%, and 12.9% patients, respectively. During follow-up, the following rates of clinical outcomes were observed: bleeding events (1.7%), transient ischemic attack (1.7%), all-cause mortality (1.7%), stroke (0.6%), myocardial infarction (0.2%), and systemic embolism (0.08%). CONCLUSIONS: This MENA patient population was younger and had lower mean baseline CHA2DS2-VASc and HAS-BLED scores. The rates of clinical outcomes over 1-year in this study were low. Longer follow-up is required to comprehensively assess clinical outcomes in this patient population.


Subject(s)
Anticoagulants , Atrial Fibrillation , Registries , Humans , Atrial Fibrillation/epidemiology , Atrial Fibrillation/drug therapy , Male , Female , Middle Aged , Middle East/epidemiology , Africa, Northern/epidemiology , Aged , Prospective Studies , Anticoagulants/therapeutic use , Treatment Outcome , Stroke/epidemiology
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