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ObjectiveSystemic arterial hypertension (HT) is a major modifiable risk factor for cardiovascular disease (CVDs), associated with all-cause death (ACD). Understanding its progression from the early state to late complications should lead to more timely intensification of treatment. This study aimed to construct a real-world cohort profile of HT and to estimate transition probabilities from the uncomplicated state to any of these long-term complications; chronic kidney disease (CKD), coronary artery disease (CAD), stroke, and ACD.MethodsThis real-world cohort study used routine clinical practice data for all adult patients diagnosed with HT in the Ramathibodi Hospital, Thailand from 2010 to 2022. A multi-state model was developed based on the following: state 1-uncomplicated HT, 2-CKD, 3-CAD, 4-stroke, and 5-ACD. Transition probabilities were estimated using Kaplan-Meier method.ResultsA total of 144,149 patients were initially classified as having uncomplicated HT. The transition probabilities (95% CI) from the initial state to CKD, CAD, stroke, and ACD at 10-years were 19.6% (19.3%, 20.0%), 18.2% (17.9%, 18.6%), 7.4% (7.1%, 7.6%), and 1.7% (1.5%, 1.8%), respectively. Once in the intermediate-states of CKD, CAD, and stroke, 10-year transition probabilities to death were 7.5% (6.8%, 8.4%), 9.0% (8.2%, 9.9%), and 10.8% (9.3%, 12.5%).ConclusionsIn this 13-year cohort, CKD was observed as the most common complication, followed by CAD and stroke. Among these, stroke carried the highest risk of ACD, followed by CAD and CKD. These findings provide improved understanding of disease progression to guide appropriate prevention measures. Further investigations of prognostic factors and treatment effectiveness are warranted.
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AimTo evaluate the real-life effectiveness and safety of hydrogen inhalation (HI) therapy as an additional treatment in Chinese adults with hypertension.MethodsThis observational, retrospective clinical study included hypertensive patients receiving routine antihypertensives with or without HI initiation from 2018 to 2023. Participants were assigned to the HI group or non-HI group (control group) after propensity score matching. The changes in mean systolic blood pressure (SBP) level during the 24-week follow-up period in different groups were examined primarily. The secondary outcome was the changes in diastolic blood pressure (DBP) and blood pressure (BP) control rate during the study. Several subgroup and sensitivity analyses were performed to confirm the robustness of our main findings. Adverse event (AE) was also assessed in patients of both groups.ResultsIn total, we selected 2,364 patients into the analysis. Both mean SBP and DBP levels significantly decreased in the HI group compared to control group at each follow-up visit with the between group difference of −4.63 mm Hg (95% CI, −6.51 to −2.74) at week 8, −6.69 mm Hg (95% CI, −8.54 to −4.85) at week 16, −7.81 mm Hg (95% CI, −9.57 to −6.04) at week 24 for SBP, and −1.83 mm Hg (95% CI, −3.21 to −0.45) at week 8, −2.57 mm Hg (95% CI, −3.97 to −1.17) at week 16, −2.89 mm Hg (95% CI, −4.24 to −1.54) at week 24 for DBP. Patients in the HI group were more likely to attain controlled BP at the follow-up period with odds ratio of 1.44 (95% CI, 1.21–1.72) at week 8, 1.90 (95% CI, 1.59–2.27) at week 16, and 2.24 (95% CI, 1.87–2.68) at the end. The trends of subgroup and sensitivity analyses were mostly consistent with the main analysis. The incidences of AEs were similar between the HI group and control group with all p-value >0.05.ConclusionThe HI therapy is related to significant amelioration in BP levels with acceptable safety profile in Chinese hypertensive adults after 24 weeks of treatment, building a clinical ground for further research to evaluate the antihypertensive effect of HI therapy.
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BackgroundWhether specific antihypertensive treatments increase cancer risk in patients with hypertension is still controversial. We aimed to estimate the associations of different antihypertensive treatments with cancer risk in real-world settings.MethodsA longitudinal cohort study was designed in a population of 1.2 million individuals from the CHinese Electronic health Records Research in Yinzhou (CHERRY). Propensity score matching (PSM) and the Cox regression model were used to estimate the associations. Several sensitivity analyses were then performed to reduce potential residual confounding.ResultsFrom 2009 to 2019, a total of 270,320 patients with newly diagnosed hypertension were included in this study. With a median follow-up time of 7.7 years, 14,264 cases of cancer occurred. There were no significant associations of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), β-blockers, or thiazide diuretics (TDs) with cancer risk (p > 0.05). Compared with other antihypertensive treatments, the use of calcium channel blockers (CCBs) was significantly associated with a marginally mild increase in the risk of all cancers (hazard ratio, HR = 1.05; 95% CI: 1.01, 1.09; p = 0.017). However, this association was no longer observed in sensitivity analyses excluding patients with less than 1, 2, or 3 years of follow-up. Nevertheless, the association between CCBs and the risk of endocrine cancer, especially thyroid cancer, still exists.ConclusionDespite previous controversy, in this study, we found no clinically meaningful cancer risk associated with antihypertensive medications. However, the association of CCBs with specific cancer still requires further research. These findings should be interpreted with caution due to the potential residual confounding.
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Background: There is little experience in the economic evaluation of pharmacy/primary care collaborative health interventions using interprofessional technology-driven communication under real-world conditions. This study aimed to conduct cost-effectiveness and cost-utility analyses of a collaborative care intervention in hypertension and hyperlipidemia management between pharmacies and primary care versus usual (fragmented) care alongside a trial.Methods: An economic evaluation was conducted alongside a 6-month pragmatic quasi-experimental controlled trial. Data sources included primary care clinical software; pharmacy dispensing software; patient telephone surveys; and published literature. The target population was adult patients on hypertension and/or lipid-lowering medication. The perspective was societal. We collected patient-level data on resource use to estimate trial costs. Effect outcomes included blood pressure (BP) and quality-adjusted life years (QALYs). Bootstrapping was used to estimate uncertainty around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness planes and acceptability curves were estimated.Results: The intervention was not shown to have reasonable levels of cost-effectiveness or cost-utility when compared to usual care as denoted by the levels of uncertainty expressed in wide confidence intervals. The probability of the intervention being cost-effective is 28% at the threshold of €20,000 per QALY gained and 57% at the threshold of €500 per mmHg systolic BP decrease.Conclusion: Considering the limitations of the trial which affected effectiveness and economic outcomes, our results are not generalizable for community pharmacy and primary care in Portugal. This research offers, however, valuable lessons on methods and strategies that can be used in future economic evaluations of collaborative public health interventions with the potential for reimbursement.Clinical trial registration:https://www.isrctn.com/ISRCTN13410498, identifier ISRCTN13410498
As per the latest research conducted in 2025, the global renal denervation market size has reached USD 540 million in 2024, driven by a surge in hypertension cases and the growing preference for minimally invasive surgical procedures. The market is set to expand at a robust CAGR of 35.8% during the forecast period, with the overall market expected to reach USD 6.22 billion by 2033. This remarkable growth is underpinned by increasing clinical evidence supporting the efficacy of renal denervation technologies, favorable reimbursement scenarios, and the rising burden of cardiovascular diseases globally.
One of the primary growth drivers for the renal denervation market is the escalating prevalence of hypertension, which remains a significant risk factor for cardiovascular morbidity and mortality worldwide. The World Health Organization estimates that over 1.28 billion adults aged 30–79 years globally suffer from hypertension, with only a fraction having their condition under control. Traditional pharmacological therapies, while effective for many, are often insufficient for a substantial subset of patients, leading to a persistent unmet need. Renal denervation offers an innovative, device-based therapy that targets the renal nerves to reduce blood pressure, providing hope for patients with resistant hypertension or those intolerant to medications. As awareness of this technology grows among clinicians and patients, adoption rates are expected to rise, further fueling market expansion.
Technological advancements in renal denervation devices are also propelling market growth. Early-generation radiofrequency systems have evolved into more sophisticated platforms, incorporating multi-electrode catheters, ultrasound ablation, and micro-infusion technologies. These innovations have significantly improved procedural safety, efficacy, and patient outcomes. Furthermore, ongoing clinical trials and real-world studies continue to demonstrate the long-term benefits of renal denervation, not only in lowering blood pressure but also in reducing the overall risk of cardiovascular events. Regulatory agencies in key markets such as the United States, Europe, and Asia Pacific have begun granting approvals for new-generation devices, which is expected to accelerate commercialization and broaden the application of renal denervation.
Another critical factor contributing to market growth is the increasing support from healthcare systems and payers. As the economic burden of uncontrolled hypertension mounts, payers are recognizing the value proposition of renal denervation in reducing downstream healthcare costs associated with stroke, heart failure, and chronic kidney disease. Several countries have introduced reimbursement codes for renal denervation procedures, improving patient access and incentivizing hospitals to adopt the technology. Additionally, collaborations between device manufacturers, research institutions, and healthcare providers are fostering innovation and facilitating large-scale clinical adoption.
Regionally, North America and Europe dominate the renal denervation market, accounting for over 65% of global revenue in 2024, owing to advanced healthcare infrastructure, high awareness levels, and favorable reimbursement policies. However, the Asia Pacific region is emerging as the fastest-growing market, supported by a large hypertensive population, rapid urbanization, and increasing healthcare investments. Leading players are expanding their presence in emerging economies through strategic partnerships and local manufacturing initiatives, which is expected to further boost market penetration in these regions.
The renal denervation market is segmented by technology into radiofrequency, ultrasound, micro-infusion, and others, each presenting unique advantages and challenges. Radiofrequency-based renal denervation has historically dominated the market, owing to its established clinical track record and
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Machine learning methodologies are increasingly popular in health care research. This shift to integrated data science approaches necessitates professional development of the existing health care data analyst workforce. To enhance a smooth transition, educational resources need to be developed. Barriers to accessing real healthcare datasets, vital for health care data analyses methodologies training purposes, include financial, ethical and patient confidentiality concerns. Synthetic datasets mimicking real-world complexities offer a simpler solution.
We present a synthetic dataset which mirrors routinely collected primary care data on heart attack and stroke among the adult population. The data incorporates much of the practical challenges encountered in routinely collected primary care systems such as missing data, informative censoring, interactions, variable irrelevance, and noise and can be used for training in methods which handle these difficulties. The intent is for the user to build models of heart/stroke risk using survival-based methodologies.
By sharing this synthetic dataset openly, our goal is to contribute a transformative asset for professional training in health and social care data analysis. The dataset covers demographics, lifestyle variables, comorbidities, systolic blood pressure, hypertension treatment, family history of cardiovascular diseases, respiratory functioning, and experience of heart-attack and/or stroke. This initiative aims to bridge the gap in sophisticated healthcare datasets for training, fostering professional development of the health and social care research workforce.
This study is funded by the National Institute for Health and Care Research ARC Wessex and the National Centre for Research Methods. The views expressed in this summary are those of the author(s) and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care.
According to our latest research, the global renal denervation devices market size reached USD 1.12 billion in 2024, with a robust compound annual growth rate (CAGR) of 36.2% expected from 2025 to 2033. This exceptional growth is projected to drive the market to USD 13.21 billion by 2033. The primary growth factor underpinning this surge is the rising global prevalence of hypertension and treatment-resistant hypertension, which has intensified the demand for innovative interventional therapies such as renal denervation. As per our latest research, the market’s expansion is further fueled by increasing adoption rates, technological advancements, and a favorable regulatory landscape that supports the introduction of next-generation devices.
The renal denervation devices market is experiencing significant momentum due to the escalating burden of hypertension worldwide. With over one billion people affected by hypertension globally, and a substantial proportion of these patients demonstrating resistance to conventional pharmacological therapies, there is a clear need for alternative solutions. Renal denervation, which targets the sympathetic nerves in the renal arteries to reduce blood pressure, has emerged as a promising intervention. Clinical trials demonstrating the efficacy and safety of these devices have further bolstered physician and patient confidence, leading to increased adoption in both developed and emerging markets. Additionally, the aging global population, which is more susceptible to hypertension and its complications, continues to drive demand for these minimally invasive devices.
Technological innovation remains a cornerstone of growth for the renal denervation devices market. Leading manufacturers are investing heavily in research and development to enhance the safety, efficacy, and ease of use of these devices. Recent advancements include the introduction of next-generation radiofrequency and ultrasound-based systems that offer improved precision and shorter procedure times. The development of micro-infusion technologies and pharmacologic denervation approaches is also expanding the therapeutic landscape, making renal denervation accessible to a broader patient population. These innovations are not only improving patient outcomes but are also attracting the attention of healthcare providers seeking to deliver cutting-edge care in a competitive market.
Another critical growth factor is the evolving regulatory environment, particularly in regions such as North America and Europe, where agencies have established clear pathways for device approval. Regulatory support has encouraged market entry for new players and facilitated the rapid commercialization of advanced renal denervation technologies. Moreover, increasing collaborations between device manufacturers, healthcare providers, and academic institutions are accelerating clinical research and real-world evidence generation, which is essential for broader market acceptance. Favorable reimbursement policies in key markets are also reducing the financial barriers associated with renal denervation procedures, further supporting market growth.
From a regional perspective, North America and Europe currently dominate the renal denervation devices market, accounting for a combined market share of over 65% in 2024. These regions benefit from high healthcare expenditure, well-established healthcare infrastructures, and proactive regulatory frameworks. However, the Asia Pacific region is expected to witness the fastest growth over the forecast period, driven by increasing awareness, expanding healthcare access, and a rapidly growing hypertensive population. Latin America and the Middle East & Africa are also emerging as important markets, albeit at a slower pace, as local healthcare systems gradually integrate advanced interventional therapies. This dynamic regional landscape underscores the global relevance and growth potential of renal denervation devices.
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Letairis (ambrisentan), an endothelin receptor antagonist (ERA), is a critical medication for pulmonary arterial hypertension (PAH). Despite its efficacy, its safety profile is under scrutiny, warranting a detailed analysis. This study leveraged the FDA Adverse Event Reporting System (FAERS) from Q1 2007 to Q4 2023, focusing on Letairis as the primary suspect in adverse events. Employing advanced data mining techniques, such as Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), the study aimed to uncover safety signals. A total of 43,774 cases were identified, with Letairis implicated in 16,038,963 adverse event reports. There was a notable predominance of female patients (75.30%), with a median age around 64 years. Severe outcomes, including hospitalization (51.63%) and fatalities (20.44%), were prevalent. Signal strength analysis highlighted concerns in infections and infestations, as well as cardiac disorders. The analysis underscores the need for vigilant pharmacovigilance and highlights Letairis’s potential to induce serious AEs, particularly in female and elderly populations. These findings are instrumental in guiding clinical practice and future drug safety assessments.
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Context
Cardiovascular disease (CVD) is a major cause of mortality in adults with type 1 diabetes.
Objective
We prospectively evaluated CVD risk factors in a large, contemporary cohort of adults with type 1 diabetes living in the United States.
Design
Observational study of CVD and CVD risk factors over a median of 5.3 years.
Setting
The T1D Exchange clinic network.
Patients
Adults (age ≥18 years) with type 1 diabetes and without known CVD diagnosed before or at enrollment.
Main Outcome Measure
Associations between CVD risk factors and incident CVD were assessed by multivariable logistic regression.
Results
The study included 8,727 participants (53% female, 88% non-Hispanic white, median age 33 years [IQR=21, 48], type 1 diabetes duration 16 years [IQR=9, 26]). At enrollment, median HbA1c was 7.6% (66 mmol/mol) [IQR=6.9 (52), 8.6 (70)], 33% used a statin, and 37% used blood pressure medication. Over a mean follow-up of 4.6 years, 325 (3.7%) participants developed incident CVD. Ischemic heart disease was the most common CVD event. Increasing age, BMI, HbA1c, presence of hypertension and dyslipidemia, increasing duration of diabetes, and diabetic nephropathy were associated with increased risk for CVD. There were no significant gender differences in CVD risk.
Conclusion
HbA1c, hypertension, dyslipidemia and diabetic nephropathy are important risk factors for CVD in adults with type 1 diabetes. A longer follow-up is likely required to assess the impact of other traditional CVD risk factors on incident CVD in the current era.
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Additional file 1. List of ICD codes. ICD codes of comorbidities most common to hypertension and identified in this data set.
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Background/aim: Hypertensive nephropathy (HN) is a common complication of hypertension. Traditional Chinese medicine has long been used in the clinical treatment of Hypertensive nephropathy. However, botanical drug prescriptions have not been summarized. The purpose of this study is to develop a prescription for improving hypertensive nephropathy, explore the evidence related to clinical application of the prescription, and verify its molecular mechanism of action.Methods: In this study, based on the electronic medical record data on Hypertensive nephropathy, the core botanical drugs and patients’ symptoms were mined using the hierarchical network extraction and fast unfolding algorithm, and the protein interaction network between botanical drugs and Hypertensive nephropathy was established. The K-nearest neighbors (KNN) model was used to analyze the clinical and biological characteristics of botanical drug compounds to determine the effective compounds. Hierarchical clustering was used to screen for effective botanical drugs. The clinical efficacy of botanical drugs was verified by a retrospective cohort. Animal experiments were performed at the target and pathway levels to analyze the mechanism.Results: A total of 14 botanical drugs and five symptom communities were obtained from real-world clinical data. In total, 76 effective compounds were obtained using the K-nearest neighbors model, and seven botanical drugs were identified as Gao Shen Formula by hierarchical clustering. Compared with the classical model, the Area under the curve (AUC) value of the K-nearest neighbors model was the best; retrospective cohort verification showed that Gao Shen Formula reduced serum creatinine levels and Chronic kidney disease (CKD) stage [OR = 2.561, 95% CI (1.025–6.406), p < 0.05]. With respect to target and pathway enrichment, Gao Shen Formula acts on inflammatory factors such as TNF-α, IL-1β, and IL-6 and regulates the NF-κB signaling pathway and downstream glucose and lipid metabolic pathways.Conclusion: In the retrospective cohort, we observed that the clinical application of Gao Shen Formula alleviates the decrease in renal function in patients with hypertensive nephropathy. It is speculated that Gao Shen Formula acts by reducing inflammatory reactions, inhibiting renal damage caused by excessive activation of the renin-angiotensin-aldosterone system, and regulating energy metabolism.
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Additional file 2. List of drugs. Antihypertensives, beta blockers, calcium-channel blockers and diuretics identified in this data set.
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Introduction. The effect of clothing on the recording of blood pressure in a normotensive and hypertensive population remains essential remains to diagnosing and managing. Methods. This is a cross-sectional study to measure blood pressure using a validated oscillometric sphygmomanometer in two populations. The records were made over the thicker sleeve arm and non-sleeved arm (either on bare arm or indicating the removal of the outermost garment). Clothing was categorized according to how patients attended the outpatient clinic based on the real world. Results. A total of 75 patients were included with a diagnosis of hypertension whose mean age was 67.1 years (SD ± 16.3). The group of normotension included 63 patients whose mean age was 21.1 years (DS ± 2.2). There was not variability related to technique or inherent to the condition of the subject on the first and second measurements of blood pressure. In the comparative analysis, the group with normotension did not report a significant difference in systolic or diastolic blood pressure due to the effect of clothing during the first or second measurement (p> 0.05). In the group with hypertension, a significant difference was observed in the first measurement, between the group over the sleeve and non-sleeved arm (systolic blood pressure, p: 0.021, and diastolic, p: 0.001). However, when the variable order of measurement was analyzed by randomizing the initial registry with or without clothing was not found a statistical difference. Conclusion. Clothing does not a significant difference in the measure of blood pressure in a normotensive or hypertensive population.
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BackgroundThe profiles of cardiovascular toxicity associated with angiogenesis inhibitors, including intravenous monoclonal antibodies (mAbs) and oral tyrosine kinase inhibitors (TKIs), targeting vascular endothelial growth factor (VEGF) remain poorly elucidated in real-world settings. This pharmacovigilance analysis aimed to comprehensively investigate the frequency, spectrum, timing, and outcomes of cardiovascular toxicities associated with angiogenesis inhibitors and to explore the differences in such patterns between mAbs and TKIs.MethodsDisproportionality analysis was performed by leveraging reports from the FDA Adverse Event Reporting System (FAERS) database from 2014 to 2021. Cardiovascular adverse events (AEs) were grouped into nine narrow categories using the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs). Reporting odds ratio (ROR) and information components (ICs) were calculated with statistical shrinkage transformation formulas and a lower limit of 95% confidence interval (CI) for ROR (ROR025) > 1 or IC (IC025) > 0, with at least three reports being considered statistically significant.ResultsA total of 757,577 reports of angiogenesis inhibitors and 70,668 (9.3%) reports of cardiovascular AEs were extracted. Significant disproportionality was detected in angiogenesis inhibitors for cardiovascular AEs (IC025/ROR025 = 0.35/1.27). Bevacizumab (31.8%), a mAb, presented the largest number of reports, followed by sunitinib (12.4%), a TKI. Hypertension (SMQ) was detected with the strongest signal value (IC025/ROR025 = 1.73/3.33), followed by embolic and thrombotic events (SMQ) (IC025/ROR025 = 0.32/1.26). Hypertension showed the shortest time to onset with a median (interquartile range) value of 23 (8, 69) days, while embolic and thrombotic events had the longest value of 51 (16, 153) days. Notably, hypertension presented the lowest proportions of death and life-threatening events (10.9%), whereas embolic and thrombotic events posed the highest (29.3%). Furthermore, both mAbs (IC025/ROR025 = 0.47/1.39) and TKIs (IC025/ROR025 = 0.30/1.23) showed increased cardiovascular AEs. Hypertension was detected in both agents (IC025/ROR025 = 1.53/2.90 for mAbs and IC025/ROR025 = 1.83/3.56 for TKIs) with a shorter time to onset of 17 (6, 48) days for TKIs than mAbs of 42 (14, 131) days. By contrast, embolic and thrombotic events were detected for mAbs (IC025/ROR025 = 0.90/1.87) without TKI (IC025/ROR025 = −0.08/0.95).ConclusionAngiogenesis inhibitors were associated with increased cardiovascular toxicity with a discrepancy between intravenous mAbs and oral TKIs, deserving distinct monitoring and appropriate management.
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BackgroundThe profiles of cardiovascular toxicity associated with angiogenesis inhibitors, including intravenous monoclonal antibodies (mAbs) and oral tyrosine kinase inhibitors (TKIs), targeting vascular endothelial growth factor (VEGF) remain poorly elucidated in real-world settings. This pharmacovigilance analysis aimed to comprehensively investigate the frequency, spectrum, timing, and outcomes of cardiovascular toxicities associated with angiogenesis inhibitors and to explore the differences in such patterns between mAbs and TKIs.MethodsDisproportionality analysis was performed by leveraging reports from the FDA Adverse Event Reporting System (FAERS) database from 2014 to 2021. Cardiovascular adverse events (AEs) were grouped into nine narrow categories using the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs). Reporting odds ratio (ROR) and information components (ICs) were calculated with statistical shrinkage transformation formulas and a lower limit of 95% confidence interval (CI) for ROR (ROR025) > 1 or IC (IC025) > 0, with at least three reports being considered statistically significant.ResultsA total of 757,577 reports of angiogenesis inhibitors and 70,668 (9.3%) reports of cardiovascular AEs were extracted. Significant disproportionality was detected in angiogenesis inhibitors for cardiovascular AEs (IC025/ROR025 = 0.35/1.27). Bevacizumab (31.8%), a mAb, presented the largest number of reports, followed by sunitinib (12.4%), a TKI. Hypertension (SMQ) was detected with the strongest signal value (IC025/ROR025 = 1.73/3.33), followed by embolic and thrombotic events (SMQ) (IC025/ROR025 = 0.32/1.26). Hypertension showed the shortest time to onset with a median (interquartile range) value of 23 (8, 69) days, while embolic and thrombotic events had the longest value of 51 (16, 153) days. Notably, hypertension presented the lowest proportions of death and life-threatening events (10.9%), whereas embolic and thrombotic events posed the highest (29.3%). Furthermore, both mAbs (IC025/ROR025 = 0.47/1.39) and TKIs (IC025/ROR025 = 0.30/1.23) showed increased cardiovascular AEs. Hypertension was detected in both agents (IC025/ROR025 = 1.53/2.90 for mAbs and IC025/ROR025 = 1.83/3.56 for TKIs) with a shorter time to onset of 17 (6, 48) days for TKIs than mAbs of 42 (14, 131) days. By contrast, embolic and thrombotic events were detected for mAbs (IC025/ROR025 = 0.90/1.87) without TKI (IC025/ROR025 = −0.08/0.95).ConclusionAngiogenesis inhibitors were associated with increased cardiovascular toxicity with a discrepancy between intravenous mAbs and oral TKIs, deserving distinct monitoring and appropriate management.
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Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world.Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework.Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation.Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.
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Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world.Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework.Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation.Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.
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BackgroundThe majority of people with hypertension require more than one medication to achieve blood pressure control. Many patients are prescribed multipill antihypertensive regimens rather than single-pill fixed-dose combination (FDC) treatment. Although FDC use may improve medication adherence, the impact on patient outcomes is unclear. We compared clinical outcomes and medication adherence with FDC therapy versus multipill combination therapy in a real-world setting using linked clinical and administrative databases.Methods and findingsWe conducted a population-based retrospective cohort study of 13,350 individuals 66 years and older in Ontario, Canada with up to 5 years of follow-up. We included individuals who were newly initiated on one angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II-receptor blocker (ARB) plus one thiazide diuretic. High-dimensional propensity score matching was used to compare individuals receiving FDC versus multipill therapy. The primary outcome was a composite of death or hospitalization for acute myocardial infarction (AMI), heart failure, or stroke. We conducted 2 analyses to examine the association between adherence and patient outcomes. First, we performed an on-treatment analysis to determine whether outcomes differed between groups while patients were on treatment, censoring patients when they first discontinued treatment, defined as not receiving medications within 150% of the previous days’ supply. Second, we conducted an intention-to-treat analysis that followed individuals allowing for breaks in treatment to quantify the difference in drug adherence between groups and assess its impact on clinical outcomes. As expected, there was no significant difference in the primary outcome between groups in the on-treatment analysis (HR 1.06, 95% CI 0.86–1.31, P = 0.60). In the intention-to-treat analysis, the proportion of total follow-up days covered with medications was significantly greater in the FDC group (70%; IQR 19–98) than in the multipill group (42%, IQR 11–91, P < 0.01), and the primary outcome was less frequent in FDC recipients (3.4 versus 3.9 events per 100 person-years; HR 0.89, 95% CI 0.81–0.97, P < 0.01). The main limitations of this study were the lack of data regarding cause of death and blood pressure measurements and the possibility of residual confounding.ConclusionsAmong older adults initiating combination antihypertensive treatment, FDC therapy was associated with a significantly lower risk of composite clinical outcomes, which may be related to better medication adherence.
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Background and aimsSalt substitute is considered an effective strategy to reduce sodium and increase potassium intake and thereby lower blood pressure in China, but its benefits and risks are uncertain in real-world data. This study is designed to compare the difference in the 1-year efficacy of salt substitute and salt restriction on urinary electrolytes and blood pressure.Methods and resultsA total of 2,929 and 2,071 participants with the 24-h estimated urinary sodium excretion (eUNaE) above 2.36 g/d using salt substitute (SS) and salt restriction (SR) strategies, respectively, were followed for 1 year. Salt substitute users were further divided by potassium chloride (KCl) content (13% vs 25%) and duration (9–11 vs 12 months). The 24-h eUNaE and estimated urinary potassium excretion (eUKE) levels were calculated using the Kawasaki formula from spot urine sample. The SS group (n = 1,897) had lower eUNaE (3.82 ± 1.03 vs 4.05 ± 1.01 g/day, p
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IntroductionPost-stroke depression (PSD) is a serious mental disorder after ischemic stroke. Early detection is important for clinical practice. This research aims to develop machine learning models to predict new-onset PSD using real-world data.MethodsWe collected data for ischemic stroke patients from multiple medical institutions in Taiwan between 2001 and 2019. We developed models from 61,460 patients and used 15,366 independent patients to test the models’ performance by evaluating their specificities and sensitivities. The predicted targets were whether PSD occurred at 30, 90, 180, and 365 days post-stroke. We ranked the important clinical features in these models.ResultsIn the study’s database sample, 1.3% of patients were diagnosed with PSD. The average specificity and sensitivity of these four models were 0.83–0.91 and 0.30–0.48, respectively. Ten features were listed as important features related to PSD at different time points, namely old age, high height, low weight post-stroke, higher diastolic blood pressure after stroke, no pre-stroke hypertension but post-stroke hypertension (new-onset hypertension), post-stroke sleep-wake disorders, post-stroke anxiety disorders, post-stroke hemiplegia, and lower blood urea nitrogen during stroke.DiscussionMachine learning models can provide as potential predictive tools for PSD and important factors are identified to alert clinicians for early detection of depression in high-risk stroke patients.
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ObjectiveSystemic arterial hypertension (HT) is a major modifiable risk factor for cardiovascular disease (CVDs), associated with all-cause death (ACD). Understanding its progression from the early state to late complications should lead to more timely intensification of treatment. This study aimed to construct a real-world cohort profile of HT and to estimate transition probabilities from the uncomplicated state to any of these long-term complications; chronic kidney disease (CKD), coronary artery disease (CAD), stroke, and ACD.MethodsThis real-world cohort study used routine clinical practice data for all adult patients diagnosed with HT in the Ramathibodi Hospital, Thailand from 2010 to 2022. A multi-state model was developed based on the following: state 1-uncomplicated HT, 2-CKD, 3-CAD, 4-stroke, and 5-ACD. Transition probabilities were estimated using Kaplan-Meier method.ResultsA total of 144,149 patients were initially classified as having uncomplicated HT. The transition probabilities (95% CI) from the initial state to CKD, CAD, stroke, and ACD at 10-years were 19.6% (19.3%, 20.0%), 18.2% (17.9%, 18.6%), 7.4% (7.1%, 7.6%), and 1.7% (1.5%, 1.8%), respectively. Once in the intermediate-states of CKD, CAD, and stroke, 10-year transition probabilities to death were 7.5% (6.8%, 8.4%), 9.0% (8.2%, 9.9%), and 10.8% (9.3%, 12.5%).ConclusionsIn this 13-year cohort, CKD was observed as the most common complication, followed by CAD and stroke. Among these, stroke carried the highest risk of ACD, followed by CAD and CKD. These findings provide improved understanding of disease progression to guide appropriate prevention measures. Further investigations of prognostic factors and treatment effectiveness are warranted.