Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-11-06DOI: 10.1007/s40119-024-00390-5
Uday M Jadhav, Saumitra Ray, T Govindan Unni, J P S Sawhney, Ashwani Mehta, Shantanu Guha, Rajiv D Karnik, Bhupen N Desai, Aziz Khan, Keyur Patel, Jayesh S Prajapati, Hitesh J Shah, Rama Krishna Reddy, Sanjeev Kumar, Soumya Kanti Dutta, Saujatya Chakraborty, Ashfaque Ahmed, Ravi Vishnu Prasad, Gaurav Chaudhary, Amit Kumar, M Manjappa, Sujal Shetty, Praveen Raja, Vimalraj Bogana Shanmugam
{"title":"Expert Opinion on the Role of Sacubitril/Valsartan in the Management of Hypertension in India.","authors":"Uday M Jadhav, Saumitra Ray, T Govindan Unni, J P S Sawhney, Ashwani Mehta, Shantanu Guha, Rajiv D Karnik, Bhupen N Desai, Aziz Khan, Keyur Patel, Jayesh S Prajapati, Hitesh J Shah, Rama Krishna Reddy, Sanjeev Kumar, Soumya Kanti Dutta, Saujatya Chakraborty, Ashfaque Ahmed, Ravi Vishnu Prasad, Gaurav Chaudhary, Amit Kumar, M Manjappa, Sujal Shetty, Praveen Raja, Vimalraj Bogana Shanmugam","doi":"10.1007/s40119-024-00390-5","DOIUrl":"10.1007/s40119-024-00390-5","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"663-677"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-25DOI: 10.1007/s40119-024-00384-3
Hung-Fat Tse, Hung-Yu Chang, David Colquhoun, Jung-Sun Kim, Kian Keong Poh, Karam Kostner, Pisit Hutayanon, Meejin Cho, Jeff Lange, Kamlanathan Kodiappan, Saikiran Leekha
{"title":"Asia-Pacific Real-World Evolocumab Use, LDL-C Reduction, Physician Goals, and Patient Perceptions: HALES Observational Study.","authors":"Hung-Fat Tse, Hung-Yu Chang, David Colquhoun, Jung-Sun Kim, Kian Keong Poh, Karam Kostner, Pisit Hutayanon, Meejin Cho, Jeff Lange, Kamlanathan Kodiappan, Saikiran Leekha","doi":"10.1007/s40119-024-00384-3","DOIUrl":"10.1007/s40119-024-00384-3","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.·.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"737-760"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-23DOI: 10.1007/s40119-024-00382-5
Arnt V Kristen, Carsten Tschöpe, Stephanie Schwarting, Fabian Aus dem Siepen
{"title":"Letter to the Editor Regarding 'Tafamidis 61 mg Patient Characteristics and Persistency? A Retrospective Analysis of German Statutory Health Insurance Data (IQVIA™ LRx)'.","authors":"Arnt V Kristen, Carsten Tschöpe, Stephanie Schwarting, Fabian Aus dem Siepen","doi":"10.1007/s40119-024-00382-5","DOIUrl":"10.1007/s40119-024-00382-5","url":null,"abstract":"","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"811-814"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-25DOI: 10.1007/s40119-024-00381-6
Mohamed Sobhy, Adel Eletriby, Hany Ragy, Hossam Kandil, Mohamed Ayman Saleh, Nabil Farag, Ramez Guindy, Ahmed Bendary, Ahmed Mohamed Elmahmoudy Nayel, Ahmed Shawky, Ayman Khairy, Ayman Mortada, Bassem Zarif, Haitham Badran, Hazem Khorshid, Kareem Mahmoud, Karim Said, Khaled Leon, Mahmoud Abdelsabour, Mazen Tawfik, Mohamed Aboel-Kassem F Abdelmegid, Mohamed Koriem, Mohamed Loutfi, Moheb Wadie, Mohamed Elnoamany, Mohamed Sadaka, Mohamed Seleem, Mohamed Zahran, Osama A Amin, Sameh Elkaffas, Sherif Ayad, Wael El Kilany, Walid Ammar, Waleed Elawady, Walid Elhammady, Yasser Abdelhady
{"title":"ACE Inhibitors and Angiotensin Receptor Blockers for the Primary and Secondary Prevention of Cardiovascular Outcomes: Recommendations from the 2024 Egyptian Cardiology Expert Consensus in Collaboration with the CVREP Foundation.","authors":"Mohamed Sobhy, Adel Eletriby, Hany Ragy, Hossam Kandil, Mohamed Ayman Saleh, Nabil Farag, Ramez Guindy, Ahmed Bendary, Ahmed Mohamed Elmahmoudy Nayel, Ahmed Shawky, Ayman Khairy, Ayman Mortada, Bassem Zarif, Haitham Badran, Hazem Khorshid, Kareem Mahmoud, Karim Said, Khaled Leon, Mahmoud Abdelsabour, Mazen Tawfik, Mohamed Aboel-Kassem F Abdelmegid, Mohamed Koriem, Mohamed Loutfi, Moheb Wadie, Mohamed Elnoamany, Mohamed Sadaka, Mohamed Seleem, Mohamed Zahran, Osama A Amin, Sameh Elkaffas, Sherif Ayad, Wael El Kilany, Walid Ammar, Waleed Elawady, Walid Elhammady, Yasser Abdelhady","doi":"10.1007/s40119-024-00381-6","DOIUrl":"10.1007/s40119-024-00381-6","url":null,"abstract":"<p><strong>Introduction: </strong>The renin-angiotensin-aldosterone system (RAAS) plays a pivotal role in regulating blood pressure (BP), with dysregulation of RAAS resulting in hypertension and potentially heart failure (HF), myocardial infarction (MI), cardio-renal syndrome, and stroke. RAAS inhibitors, such as angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs), have advantages beyond BP control. However, differences between these two drug classes need to be considered when choosing a therapy for preventing cardiovascular events.</p><p><strong>Methods: </strong>A panel of 36 Egyptian cardiologists developed consensus statements on RAAS inhibitors for primary and secondary prevention of cardiovascular outcomes and stroke, using a modified three-step Delphi process.</p><p><strong>Results: </strong>The consensus statements highlight the importance of effective BP control and the role of RAAS blockade for prevention and management of various cardiovascular diseases. ACEis and ARBs differ in their mode of action and, thus, clinical effects. On the basis of available evidence, the consensus group recommended the following: ACEis should be considered as first choice (in preference to ARBs) to reduce the risk of MI, for primary prevention of HF, and for secondary prevention of stroke. ACEis and ARBs show equivalent efficacy for the primary prevention of stroke. Evidence also favors the preferential use of ACEis in patients with type 2 diabetes, for BP control, for the primary prevention of diabetic kidney disease, and to reduce the risk of major cardiovascular and renal outcomes. Treatment with an ACEi should be started within 24 h of ST segment elevation MI (and continued long term) in patients with HF, left ventricular systolic dysfunction, and/or diabetes. Angiotensin receptor/neprilysin inhibitors (ARNIs) are the first choice for patients with HF and reduced ejection fraction, with ACEis being the second choice in this group. ARBs are indicated as alternatives in patients who cannot tolerate ACEis. ACEis may be associated with cough development, but the incidence tends to be overestimated, and the risk can be reduced by use of a lipophilic ACEi or combining the ACEi with a calcium channel blocker.</p><p><strong>Conclusion: </strong>RAAS blockade is an essential component of hypertension therapy; however, the protective effects provided by ACEis are superior to those of ARBs. Therefore, an ACEi is indicated in almost all cases, unless not tolerated.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"707-736"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-11-01DOI: 10.1007/s40119-024-00388-z
Rhys Williams, William Ford, Alexander James, Kerys Thomas, Aaron Wong
{"title":"Sodium Zirconium Cyclosilicate for Renin-Angiotensin-Aldosterone System Inhibitor Optimization in Patients with Heart Failure with Reduced Ejection Fraction: A Retrospective Analysis.","authors":"Rhys Williams, William Ford, Alexander James, Kerys Thomas, Aaron Wong","doi":"10.1007/s40119-024-00388-z","DOIUrl":"10.1007/s40119-024-00388-z","url":null,"abstract":"<p><strong>Introduction: </strong>In this retrospective analysis, we evaluate the effectiveness of the potassium (K<sup>+</sup>) binder sodium zirconium cyclosilicate (SZC) in maintaining normokalemia and facilitating the initiation, optimization, and maintenance of renin-angiotensin-aldosterone system inhibitors (RAASi) in patients with heart failure (HF) with reduced ejection fraction (HFrEF).</p><p><strong>Methods: </strong>A total of 44 patients with HFrEF and a history of hyperkalemia who were receiving SZC to enable the prescription of RAASi were identified from two district general hospital sites. Retrospective analysis was performed to determine biochemical response, alterations in pharmacotherapy, and subsequent HF outcomes following initiation of SZC.</p><p><strong>Results: </strong>Mean K<sup>+</sup> was reduced by 0.9 mmol/L within 1 month of initiation of SZC; mean K<sup>+</sup> after 12 months of treatment was 4.8 mmol/L with a median (interquartile range) duration of treatment of 13 (8.4-15.1) months. Following SZC treatment, 100% of patients received an angiotensin receptor-neprilysin inhibitor (18% increase) and 93% received a mineralocorticoid receptor antagonist (41% increase), with 59% and 37% achieving guideline-recommended dosing, respectively. Ninety-one percent of patients were able to receive triple or quadruple therapy with the addition of a beta-blocker and a sodium glucose co-transporter 2 inhibitor. Reduced rates of hospitalization for HF (HHF) were observed with 12 episodes per 100 patient-years recorded (reduced from 21) in addition to improvements in mean left ventricular ejection fraction (29-36%) and median N-terminal pro-B-type natriuretic peptide (3458-2055 ng/L, 45% median reduction). Renal function (creatinine clearance increased from 48.4 to 49.3 ml/min) and systolic blood pressure (decreased from 124 to 122 mmHg) were similar following optimization, and no tolerability issues were identified.</p><p><strong>Conclusions: </strong>Extended real-world treatment with the K<sup>+</sup> binder SZC was effective at maintaining normokalemia, and was associated with a greater uptake of RAASi, a reduced rate of HHF, and improvements in cardiac biomarkers in patients with HFrEF.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"797-809"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607300/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-11-04DOI: 10.1007/s40119-024-00387-0
Danial Amoey, Mohamed Samy, Karim Elbasha, Ahmad Alali, Martin Landt, Arief Kurniadi, Holger Nef, Ralph Tölg, Gert Richardt, Nader Mankerious
{"title":"Predictors and Outcomes of Inappropriate Dosing of Direct Oral Anticoagulants in Patients Receiving Transcatheter Aortic Valve Implantation.","authors":"Danial Amoey, Mohamed Samy, Karim Elbasha, Ahmad Alali, Martin Landt, Arief Kurniadi, Holger Nef, Ralph Tölg, Gert Richardt, Nader Mankerious","doi":"10.1007/s40119-024-00387-0","DOIUrl":"10.1007/s40119-024-00387-0","url":null,"abstract":"<p><strong>Introduction: </strong>Direct oral anticoagulant (DOAC) dose adjustment is based on age, renal function, and body weight. There is a paucity of data describing the factors associated with the prescription of inappropriate dosage and their impact on clinical outcomes among patients receiving transcatheter aortic valve implantation (TAVI).</p><p><strong>Methods: </strong>In a single-center study, 432 patients who were on long-term DOAC therapy and underwent TAVI between 2015 and 2022 were included. We analyzed the predictors and outcomes of inappropriate dosing of DOACs; namely apixaban, dabigatran, edoxaban, and rivaroxaban. A composite endpoint, including all-cause mortality, life-threatening/major bleeding, stroke, peripheral thromboembolic complications, or myocardial infarction, was assessed after 1 year.</p><p><strong>Results: </strong>In this TAVI cohort, inappropriate DOAC dosing was observed in 20.6% of patients. Inappropriate DOAC dosage was related to female gender (adj. odds ratio [OR] 2.72, 95% confidence interval [CI] 1.64-4.51, p < 0.001) as well as lower estimated glomerular filtration rate (eGFR) (adj. OR 0.99, 95% CI 0.98-1.00, p = 0.019), and to the administration of non-rivaroxaban DOACs (adj. OR 0.28, 95% CI 0.16-0.50, p < 0.001). After 1 year, patients on both appropriate and inappropriate DOAC dosage exhibited comparable rates of the composite endpoint (OR 0.88, 95% CI 0.53-1.46, p = 0.622). Old age (adj. OR 1.05, 95% CI 1.01-1.10, p = 0.018) as well as anemia (adj. OR 0.86, 95% CI 0.75-0.99, p = 0.031) emerged as independent predictors of the composite endpoint.</p><p><strong>Conclusions: </strong>In this TAVI cohort, female gender and renal insufficiency were associated with inappropriate DOAC dosage, whereas rivaroxaban was linked to appropriate dosing. Inadequate DOAC dosage did not translate into a worse outcome in our TAVI population.</p><p><strong>Trial registration: </strong>Prospective Segeberg TAVI Registry (ClinicalTrials.gov identifier: NCT03192774).</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"761-773"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-08-17DOI: 10.1007/s40119-024-00379-0
Shyon Parsa, Sneha S Jain, Olu Akinrimisi, Carolyn S P Lam, Kenneth W Mahaffey
{"title":"Milvexian: An Oral, Bioavailable Factor XIa Inhibitor.","authors":"Shyon Parsa, Sneha S Jain, Olu Akinrimisi, Carolyn S P Lam, Kenneth W Mahaffey","doi":"10.1007/s40119-024-00379-0","DOIUrl":"10.1007/s40119-024-00379-0","url":null,"abstract":"<p><p>Direct oral anticoagulants have a dose-dependent increased bleeding risk which limits use in certain populations. Studies in both animals and humans with inherited variations in factor XI levels provide a theoretical basis for a drug target capable of addressing current unmet needs. Milvexian is an oral factor XIa inhibitor that has the potential to provide robust anticoagulant effect without increased bleeding compared with current standard of care. Several key studies in the preclinical, phase I, and phase II stages have reported promising safety data in venous thromboembolism and stroke prevention without compromising hemostasis. The planned phase III trials will examine the efficacy of milvexian for prevention of thrombotic events in patients with acute stroke, acute coronary syndrome, and atrial fibrillation.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"645-661"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-23DOI: 10.1007/s40119-024-00383-4
Sepideh Attal
{"title":"A Response to: Letter to the Editor Regarding \"Tafamidis 61 mg Patient Characteristics and Persistency? A Retrospective Analysis of German Statutory Health Insurance Data (IQVIA™ LRx)\".","authors":"Sepideh Attal","doi":"10.1007/s40119-024-00383-4","DOIUrl":"10.1007/s40119-024-00383-4","url":null,"abstract":"","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"815-817"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-12-01Epub Date: 2024-11-25DOI: 10.1007/s40119-024-00386-1
Kelly M Chin, Richard Channick, Nick H Kim, Rose Ong, Stefano Turricchia, Nicolas Martin, Lada Mitchell, Vallerie V McLaughlin
{"title":"Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies.","authors":"Kelly M Chin, Richard Channick, Nick H Kim, Rose Ong, Stefano Turricchia, Nicolas Martin, Lada Mitchell, Vallerie V McLaughlin","doi":"10.1007/s40119-024-00386-1","DOIUrl":"10.1007/s40119-024-00386-1","url":null,"abstract":"<p><strong>Introduction: </strong>Data on real-world clinical practice and outcomes of patients with pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD) are scarce. The OPUS/OrPHeUS studies enrolled patients with PAH newly initiating macitentan, including those with PAH associated with CHD (CHD-PAH).</p><p><strong>Methods: </strong>OPUS was a prospective, United States, multicenter, long-term, observational drug registry (April 2014-June 2020). OrPHeUS was a retrospective, United States, multicenter medical chart review (October 2013-March 2017). The characteristics, treatment patterns, safety, and outcomes during macitentan treatment of patients with CHD-PAH and the subgroups Eisenmenger syndrome, left-to-right shunts and small/coincidental CHD were descriptively compared.</p><p><strong>Results: </strong>The combined OPUS/OrPHeUS population included 272 (6.1%) patients with CHD-PAH (80 patients with Eisenmenger syndrome; 82 patients with left-to-right shunts and 92 patients with small/coincidental defects). Most patients across the CHD-PAH subgroups were in World Health Organization Functional Class II/III (82.9-94.6%). Macitentan was initiated as combination therapy in 65.0% of patients with CHD-PAH. During follow-up, 81.4% of patients experienced ≥ 1 adverse event (AE), the most common being dyspnea (23.5%), nausea (13.7%), dizziness (12.7%), headache (12.7%) and edema (10.8%). The 1- and 2-year Kaplan-Meier (95% confidence limits) estimates of patients with CHD-PAH being free from hospitalization were 64.5% (57.9, 70.4) and 49.3% (41.9, 56.3); for survival, the 1- and 2-year Kaplan-Meier estimates were 93.5% (89.3, 96.1) and 90.2% (84.9, 93.7).</p><p><strong>Conclusions: </strong>Macitentan was used in clinical practice in patients with CHD-PAH and its subgroups, including as combination therapy in the majority of patients. Safety in this population was consistent with the known profile of macitentan.</p><p><strong>Trial registration: </strong>OPsumit<sup>®</sup> Users Registry (OPUS): NCT02126943; Opsumit<sup>®</sup> Historical Users cohort (OrPHeUS): NCT03197688; URL www.</p><p><strong>Clinicaltrials: </strong>gov .</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"775-796"},"PeriodicalIF":3.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607228/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142709242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cardiology and TherapyPub Date : 2024-09-01Epub Date: 2024-05-21DOI: 10.1007/s40119-024-00370-9
Anthony Yu, Krista L Birkemeier, J Rebecca Mills, Tiffany Kuo, Nina Tachikawa, Feng Dai, Karishma Thakkar, Christian Cable, Allison Brenner, Paul J Godley
{"title":"Implementing a Quality Intervention to Improve Confidence in Outpatient Venous Thromboembolism Management.","authors":"Anthony Yu, Krista L Birkemeier, J Rebecca Mills, Tiffany Kuo, Nina Tachikawa, Feng Dai, Karishma Thakkar, Christian Cable, Allison Brenner, Paul J Godley","doi":"10.1007/s40119-024-00370-9","DOIUrl":"10.1007/s40119-024-00370-9","url":null,"abstract":"<p><strong>Introduction: </strong>Guidelines recommend that patients with acute venous thromboembolism (VTE) represented by low-risk deep vein thrombosis (DVT) and pulmonary embolism (PE) receive initial treatment at home versus at the hospital, but a large percentage of these patients are not managed at home. This study assessed the effectiveness of a quality intervention on provider knowledge and confidence in evaluating outpatient treatment for patients with VTE in the emergency department (ED).</p><p><strong>Methods: </strong>A pilot program to overcome obstacles to outpatient VTE treatment in appropriate patients was initiated at Baylor Scott & White Health Temple ED. Subsequently, a formalized quality intervention with a targeted educational program was developed and delivered to ED providers. Provider surveys were administered pre- and post-quality intervention in order to assess clinical knowledge, confidence levels, and perceived barriers. Patient discharge information was extracted from electronic health records.</p><p><strong>Results: </strong>Twenty-five ED providers completed the pre- and post-surveys; 690 and 356 patients with VTE were included in the pre- and post-pilot and pre- and post-quality intervention periods, respectively. Many ED providers reported that a major barrier to discharging patients to outpatient care was the lack of available and adequate patient follow-up appointments. Notably, after the quality intervention, an increase in provider clinical knowledge and confidence scores was observed. Discharge rates for patients with VTE increased from 25.6% to 27.5% after the pilot intervention and increased from 28.5% to 29.9% after the quality intervention, but these differences were not statistically significant. Despite instantaneous uptick in discharge rates after the interventions, there was not a long-lasting effect.</p><p><strong>Conclusion: </strong>Although the quality intervention led to improvements in provider clinical knowledge and confidence and identified barriers to discharging patients with VTE, discharge rates remained stable, underscoring the need for additional endeavors.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"541-556"},"PeriodicalIF":3.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}