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Spironolactone versus placebo in patients undergoing maintenance dialysis - ACHIEVE: an international, parallel-group, randomised controlled trial
(Elsevier BV, 2025-08)
Michael Walsh
;
David Collister
;
Martin Gallagher
;
Patrick B Mark
;
Janak R de Zoysa
Background: Patients undergoing maintenance dialysis for kidney failure are at substantial risk of cardiovascular morbidity and mortality. We aimed to establish if spironolactone reduces heart failure and cardiovascular deaths in these patients. Methods: ACHIEVE was an international, parallel-group, randomised controlled trial done in 143 dialysis programmes in 12 countries. Patients were aged 45 years or older, or aged 18 years or older with a history of diabetes, and were receiving maintenance dialysis for kidney failure for at least 3 months at the time of recruitment. Patients who were able to tolerate and adhere to spironolactone 25 mg daily orally during an open-label run-in were randomly assigned (1:1) to continue spironolactone or matching placebo, using a central computerised block randomisation system (block sizes of 4) stratified by centre. Participants, health-care providers, and those assessing outcomes were masked to group assignment. The primary outcome was a composite of cardiovascular mortality or hospitalisation for heart failure analysed as time-to-event in all randomly assigned participants. The trial was registered at ClinicalTrials.gov, NCT03020303. Findings: After a planned interim analysis of 75% of the expected primary outcome events, the external safety and efficacy monitoring committee recommended the trial be stopped early for futility. From Sept 19, 2017, to Oct 31, 2024, 3689 patients were screened for inclusion, 3565 of whom were enrolled in the open-label run-in phase, and 2538 were randomly assigned to spironolactone (n=1260) or placebo (n=1278). 931 (36·7%) participants were female and 1607 (63·3%) were male. Median follow-up was 1·8 years (IQR 0·85–3·35). The composite primary outcome occurred in 258 participants (10·46 events per 100 patient-years) in the spironolactone group and in 276 participants (11·33 per 100 patient-years) in the placebo group (hazard ratio [HR] 0·92 [95% CI 0·78–1·09]; p=0·35). Death from any cause was similar between groups (HR 0·95 [0·83–1·09]) as was hospitalisation for any cause (HR 0·96 [0·87–1·06]). Interpretation: Among patients receiving maintenance dialysis, spironolactone 25 mg daily orally did not reduce the composite outcome of cardiovascular mortality and hospitalisation due to heart failure compared with placebo. This trial did not identify a benefit of initiating spironolactone in patients receiving maintenance dialysis. Future research should consider alternatives to steroidal mineralocorticoid receptor antagonism to reduce cardiovascular morbidity and mortality in patients receiving maintenance haemodialysis. Funding: The Canadian Institutes of Health Research, The Medical Research Future Fund, The Health Research Council, The British Heart Foundation, Population Health Research Institute/Hamilton Health Sciences Research Institute, St Joseph's Healthcare Hamilton Division of Nephrology, Accelerating Clinical Trials Consortium, Can-SOLVE CKD Network, and the Dalhousie Department of Medicine.
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Timing matters: lipid intake and its influence on menopausal-related symptoms
(Springer Science and Business Media LLC, 2025-08-18)
Ludovica Verde
;
Luigi Barrea
;
Evelyn Frias-Toral
;
Raynier Zambrano-Villacres
;
SIMANCAS RACINES, DANIEL ALEJANDRO
Background Menopause contributes to central obesity and increases cardiovascular risk in women. Diet influences both menopausal symptoms and cardiovascular health, but the impact of chrononutrition, namely food timing, is not well understood. This cross-sectional study investigated whether the timing of food intake affected menopausal symptoms in 100 postmenopausal women with overweight or obesity. Methods Anthropometric and clinical parameters, and lifestyle habits were assessed. Menopausal symptoms were evaluated using the Menopause Rating Scale (MRS). Nutritional assessment utilized 7-day food records. Food intake was divided into morning intake (meals from breakfast to lunch) and evening intake (meals from afternoon snacks to dinner). Results The mean MRS score was 22.7 ± 7.8, showing a high prevalence of symptoms in the study population. Postmenopausal women under the median of morning energy intake showed a significantly a higher score for heart discomfort (p = 0.045), while those under the median of morning intake of lipids showed significantly higher scores for heart discomfort and lower scores for bladder problems (p = 0.013 and p = 0.040, respectively). Postmenopausal women above the median evening intake of lipids showed a significantly higher score for heart discomfort (p = 0.007). The heart discomfort score correlated negatively and positively with the morning (r = -0.210, p = 0.034) and evening (r = 0.210, p = 0.034) intakes of lipids, respectively, even after correction for confounding factors (r = -0.219 and r = 0.219, p = 0.028 for both). Conclusion Consuming most of the energy and lipids later in the day was linked to higher prevalence of menopausal symptoms in postmenopausal women with overweight or obesity. This eating pattern may potentially have adverse effects on the cardiovascular health of these women. Therefore, adopting chrononutrition behaviors, particularly favoring an earlier intake of energy and lipids, could prove beneficial as an additional measure in the nutritional therapy for postmenopausal women dealing with overweight or obesity.
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A Comprehensive Review of Vision-Based Sensor Systems for Human Gait Analysis
(MDPI AG, 2025-01-16)
Xiaofeng Han
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GUFFANTI MARTINEZ, DIEGO ANDRES
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Alberto Brunete
Analysis of the human gait represents a fundamental area of investigation within the broader domains of biomechanics, clinical research, and numerous other interdisciplinary fields. The progression of visual sensor technology and machine learning algorithms has enabled substantial developments in the creation of human gait analysis systems. This paper presents a comprehensive review of the advancements and recent findings in the field of vision-based human gait analysis systems over the past five years, with a special emphasis on the role of vision sensors, machine learning algorithms, and technological innovations. The relevant papers were subjected to analysis using the PRISMA method, and 72 articles that met the criteria for this research project were identified. A detailing of the most commonly used visual sensor systems, machine learning algorithms, human gait analysis parameters, optimal camera placement, and gait parameter extraction methods is presented in the analysis. The findings of this research indicate that non-invasive depth cameras are gaining increasing popularity within this field. Furthermore, depth learning algorithms, such as convolutional neural networks (CNNs) and long short-term memory (LSTM) networks, are being employed with increasing frequency. This review seeks to establish the foundations for future innovations that will facilitate the development of more effective, versatile, and user-friendly gait analysis tools, with the potential to significantly enhance human mobility, health, and overall quality of life. This work was supported by [GOBIERNO DE ESPANA/PID2023-150967OB-I00].
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Interleukin-receptor antagonist and tumour necrosis factor inhibitors for the primary and secondary prevention of atherosclerotic cardiovascular diseases
(Wiley, 2024-09-19)
MARTI CARVAJAL, ARTURO JOSE
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Mario A Gemmato-Valecillos
;
Diana Monge Martín
;
Mark Dayer
;
Eduardo Alegría-Barrero
Background: Atherosclerotic cardiovascular disease (ACVD) is worsened by chronic inflammatory diseases. Interleukin receptor antagonists (IL-RAs) and tumour necrosis factor-alpha (TNF) inhibitors have been studied to see if they can prevent cardiovascular events. Objectives: The purpose of this study was to assess the clinical benefits and harms of IL-RAs and TNF inhibitors in the primary and secondary prevention of ACVD. Search methods: The Cochrane Heart Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, EBSCO CINAHL plus, and clinical trial registries for ongoing and unpublished studies were searched in February 2024. The reference lists of relevant studies, reviews, meta-analyses and health technology reports were searched to identify additional studies. No limitations on language, date of publication or study type were set. Selection criteria: RCTs that recruited people with and without pre-existing ACVD, comparing IL-RAs or TNF inhibitors versus placebo or usual care, were selected. The primary outcomes considered were all-cause mortality, myocardial infarction, unstable angina, and adverse events. Data collection and analysis: Two or more review authors, working independently at each step, selected studies, extracted data, assessed the risk of bias and used GRADE to judge the certainty of evidence. Main results: We included 58 RCTs (22,053 participants; 21,308 analysed), comparing medication efficacy with placebo or usual care. Thirty-four trials focused on primary prevention and 24 on secondary prevention. The interventions included IL-1 RAs (anakinra, canakinumab), IL-6 RA (tocilizumab), TNF-inhibitors (etanercept, infliximab) compared with placebo or usual care. The certainty of evidence was low to very low due to biases and imprecision; all trials had a high risk of bias. Primary prevention: IL-1 RAs  The evidence is very uncertain about the effects of the intervention on all-cause mortality(RR 0.33, 95% CI 0.01 to 7.58, 1 trial), myocardial infarction (RR 0.71, 95% CI 0.04 to 12.48, I² = 39%, 2 trials), unstable angina (RR 0.24, 95% CI 0.03 to 2.11, I² = 0%, 2 trials), stroke (RR 2.42, 95% CI 0.12 to 50.15; 1 trial), adverse events (RR 0.85, 95% CI 0.59 to 1.22, I² = 54%, 3 trials), or infection (rate ratio 0.84, 95% 0.55 to 1.29, I² = 0%, 4 trials). Evidence is very uncertain about whether anakinra and cankinumab may reduce heart failure (RR 0.21, 95% CI 0.05 to 0.94, I² = 0%, 3 trials). Peripheral vascular disease (PVD) was not reported as an outcome. IL-6 RAs The evidence is very uncertain about the effects of the intervention on all-cause mortality (RR 0.68, 95% CI 0.12 to 3.74, I² = 30%, 3 trials), myocardial infarction (RR 0.27, 95% CI 0.04 to1.68, I² = 0%, 3 trials), heart failure (RR 1.02, 95% CI 0.11 to 9.63, I² = 0%, 2 trials), PVD (RR 2.94, 95% CI 0.12 to 71.47, 1 trial), stroke (RR 0.34, 95% CI 0.01 to 8.14, 1 trial), or any infection (rate ratio 1.10, 95% CI: 0.88 to 1.37, I2 = 18%, 5 trials). Adverse events may increase (RR 1.13, 95% CI 1.04 to 1.23, I² = 33%, 5 trials). No trial assessed unstable angina. TNF inhibitors The evidence is very uncertain about the effects of the intervention on all-cause mortality (RR 1.78, 95% CI 0.63 to 4.99, I² = 10%, 3 trials), myocardial infarction (RR 2.61, 95% CI 0.11 to 62.26, 1 trial), stroke (RR 0.46, 95% CI 0.08 to 2.80, I² = 0%; 3 trials), heart failure (RR 0.85, 95% CI 0.06 to 12.76, 1 trial). Adverse events may increase (RR 1.13, 95% CI 1.01 to 1.25, I² = 51%, 13 trials). No trial assessed unstable angina or PVD. Secondary prevention: IL-1 RAs The evidence is very uncertain about the effects of the intervention on all-cause mortality (RR 0.94, 95% CI 0.84 to 1.06, I² = 0%, 8 trials), unstable angina (RR 0.88, 95% CI 0.65 to 1.19, I² = 0%, 3 trials), PVD (RR 0.85, 95% CI 0.19 to 3.73, I² = 38%, 3 trials), stroke (RR 0.94, 95% CI 0.74 to 1.2, I² = 0%; 7 trials), heart failure (RR 0.91, 95% 0.5 to 1.65, I² = 0%; 7 trials), or adverse events (RR 0.92, 95% CI 0.78 to 1.09, I² = 3%, 4 trials). There may be little to no difference between the groups in myocardial infarction (RR 0.88, 95% CI 0.0.75 to 1.04, I² = 0%, 6 trials). IL6-RAs The evidence is very uncertain about the effects of the intervention on all-cause mortality (RR 1.09, 95% CI 0.61 to 1.96, I² = 0%, 2 trials), myocardial infarction (RR 0.46, 95% CI 0.07 to 3.04, I² = 45%, 3 trials), unstable angina (RR 0.33, 95% CI 0.01 to 8.02, 1 trial), stroke (RR 1.03, 95% CI 0.07 to 16.25, 1 trial), adverse events (RR 0.89, 95% CI 0.76 to 1.05, I² = 0%, 2 trials), or any infection (rate ratio 0.66, 95% CI 0.32 to 1.36, I² = 0%, 4 trials). No trial assessed PVD or heart failure. TNF inhibitors The evidence is very uncertain about the effect of the intervention on all-cause mortality (RR 1.16, 95% CI 0.69 to 1.95, I² = 47%, 5 trials), heart failure (RR 0.92, 95% 0.75 to 1.14, I² = 0%, 4 trials), or adverse events (RR 1.15, 95% CI 0.84 to 1.56, I² = 32%, 2 trials). No trial assessed myocardial infarction, unstable angina, PVD or stroke. Adverse events may be underestimated and benefits inflated due to inadequate reporting. Authors' conclusions: This Cochrane review assessed the benefits and harms of using interleukin-receptor antagonists and tumour necrosis factor inhibitors for primary and secondary prevention of atherosclerotic diseases compared with placebo or usual care. However, the evidence for the predetermined outcomes was deemed low or very low certainty, so there is still a need to determine whether these interventions provide clinical benefits or cause harm from this perspective. In summary, the different biases and imprecision in the included studies limit their external validity and represent a limitation to determining the effectiveness of the intervention for both primary and secondary prevention of ACVD.
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Single-pill combination therapy is the standard of care for hypertension, but it is time for the next step: Implementation
(Elsevier BV, 2024-12)
Jose P. Lopez-Lopez
;
LOPEZ JARAMILLO, JOSÉ PATRICIO
The GMRx2 trial1 in adults with high blood pressure (BP) demonstrated that after 12 weeks, a low-dose single-pill combination of telmisartan, amlodipine, and indapamide significantly reduced BP levels compared to several dual combinations (telmisartan with amlodipine, telmisartan with indapamide, or amlodipine with indapamide). Adverse events did not differ between the groups. This novel therapeutic option could improve high BP control
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Efficacy and Complication Profiles of Left Ventricular Assist Devices in Adult Heart Failure Management: A Systematic Review and Meta-Analysis
(Elsevier BV, 2024-01)
Jordan Llerena-Velastegui
;
Gerson Santafe-Abril
;
Cecibel Villacis-Lopez
;
Claudia Hurtado-Alzate
;
Marcela Placencia-Silva
Left ventricular assist devices (LVADs) have marked a milestone in the evolution of treatment for patients with end-stage heart failure. Their popularity and use are steadily rising. This systematic review and meta-analysis aimed to evaluate the effectiveness of LVADs in improving the survival rate of patients with end-stage heart failure and to identify the complications or adverse events associated with LVAD use. Articles for this systematic review and meta-analysis were sourced from PubMed, Google Scholar, and the Cochrane Library databases. Only studies that met the predefined PICOS eligibility criteria were analyzed. LVADs significantly improved the 6, 12, 18, and 24-month survival rates in patients with end-stage heart failure compared to no LVAD or other therapies: OR 1.87 (95%CI [1.27-2.76]), OR 2.29 (95%CI [1.61-3.26]), OR 2.07 (95%CI [0.61-6.61]), and OR 1.73 (95%CI [0.88-3.41]) for 6, 12, 18, and 24 months, respectively. The incidence of adverse events was significantly higher in the LVAD group than in the non-LVAD treatments: bleeding OR 12.53 (95%CI [2.60-60.41]), infections OR 4.15 (95%CI [1.19-14.45]), stroke OR 2.58 (95%CI [1.38-4.82]), and arrhythmia OR 2.81 (95%CI [1.64-4.80]). Overall, complications were higher in the LVAD group compared to those without LVAD treatment. Hospital readmissions due to adverse events were significantly more frequent in the LVAD group, OR 2.98 (95%CI [1.38-6.43]). Despite the elevated risk of adverse events associated with LVADs, these devices have demonstrated a notable enhancement in the survival outcomes for patients with end-stage heart failure.
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Increasing transmission of dengue virus across ecologically diverse regions of Ecuador and associated risk factors
(Public Library of Science (PLoS), 2024-01-31)
Leah C. Katzelnick
;
QUENTIN, EMMANUELLE
;
Savannah Colston
;
Thien-An Ha
;
Paulina Andrade
The distribution and intensity of viral diseases transmitted by <jats:italic>Aedes aegypti mosquitoes, including dengue, have rapidly increased over the last century. Here, we study dengue virus (DENV) transmission across the ecologically and demographically distinct regions or Ecuador. We analyzed province-level age-stratified dengue incidence data from 2000–2019 using catalytic models to estimate the force of infection of DENV over eight decades. We found that provinces established endemic DENV transmission at different time periods. Coastal provinces with the largest and most connected cities had the earliest and highest increase in DENV transmission, starting around 1980 and continuing to the present. In contrast, remote and rural areas with reduced access, like the northern coast and the Amazon regions, experienced a rise in DENV transmission and endemicity only in the last 10 to 20 years. The newly introduced chikungunya and Zika viruses have age-specific distributions of hospital-seeking cases consistent with recent emergence across all provinces. To evaluate factors associated with geographic differences in DENV transmission potential, we modeled DENV vector risk using 11,693 Aedes aegypti presence points to the resolution of 1 hectare. In total, 56% of the population of Ecuador, including in provinces identified as having increasing DENV transmission in our models, live in areas with high risk of Aedes aegypti, with population size, trash collection, elevation, and access to water as important determinants. Our investigation serves as a case study of the changes driving the expansion of DENV and other arboviruses globally and suggest that control efforts should be expanded to semi-urban and rural areas and to historically isolated regions to counteract increasing dengue outbreaks.
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Activity limitations, use of assistive devices, and mortality and clinical events in 25 high-income, middle-income, and low-income countries: an analysis of the PURE study
(Elsevier BV, 2024-08)
Raed A Joundi
;
Bo Hu
;
Sumathy Rangarajan
;
Darryl P Leong
;
Shofiqul Islam
Background: The focus of most epidemiological studies has been mortality or clinical events, with less information on activity limitations related to basic daily functions and their consequences. Standardised data from multiple countries at different economic levels in different regions of the world on activity limitations and their associations with clinical outcomes are sparse. We aimed to quantify the prevalence of activity limitations and use of assistive devices and the association of limitations with adverse outcomes in 25 countries grouped by different economic levels. Methods: In this analysis, we obtained data from individuals in 25 high-income, middle-income, and low-income countries from the Prospective Urban Rural Epidemiological (PURE) study (175 660 participants). In the PURE study, individuals aged 35–70 years who intended to continue living in their current home for a further 4 years were invited to complete a questionnaire on activity limitations. Participant follow-up was planned once every 3 years either by telephone or in person. The activity limitation screen consisted of questions on self-reported difficulty with walking, grasping, bending, seeing close, seeing far, speaking, hearing, and use of assistive devices (gait, vision, and hearing aids). We estimated crude prevalence of self-reported activity limitations and use of assistive devices, and prevalence standardised by age and sex. We used logistic regression to additionally adjust prevalence for education and socioeconomic factors and to estimate the probability of activity limitations and assistive devices by age, sex, and country income. We used Cox frailty models to evaluate the association between each activity limitation with mortality and clinical events (cardiovascular disease, heart failure, pneumonia, falls, and cancer). The PURE study is registered with ClinicalTrials.gov, NCT03225586. Findings: Between Jan 12, 2001, and May 6, 2019, 175 584 individuals completed at least one question on the activity limitation questionnaire (mean age 50·6 years [SD 9·8]; 103 625 [59%] women). Of the individuals who completed all questions, mean follow-up was 10·7 years (SD 4·4). The most common self-reported activity limitations were difficulty with bending (23 921 [13·6%] of 175 515 participants), seeing close (22 532 [13·4%] of 167 801 participants), and walking (22 805 [13·0%] of 175 554 participants); prevalence of limitations was higher with older age and among women. The prevalence of all limitations standardised by age and sex, with the exception of hearing, was highest in low-income countries and middle-income countries, and this remained consistent after adjustment for socioeconomic factors. The use of gait, visual, and hearing aids was lowest in low-income countries and middle-income countries, particularly among women. The prevalence of seeing close limitation was four times higher (6257 [16·5%] of 37 926 participants vs 717 [4·0%] of 18 039 participants) and the prevalence of seeing far limitation was five times higher (4003 [10·6%] of 37 923 participants vs 391 [2·2%] of 18 038 participants) in low-income countries than in high-income countries, but the prevalence of glasses use in low-income countries was half that in high-income countries. Walking limitation was most strongly associated with mortality (adjusted hazard ratio 1·32 [95% CI 1·25–1·39]) and most consistently associated with other clinical events, with other notable associations observed between seeing far limitation and mortality, grasping limitation and cardiovascular disease, bending limitation and falls, and between speaking limitation and stroke. Interpretation: The global prevalence of activity limitations is substantially higher in women than men and in low-income countries and middle-income countries compared with high-income countries, coupled with a much lower use of gait, visual, and hearing aids. Strategies are needed to prevent and mitigate activity limitations globally, with particular emphasis on low-income countries and women. Funding: Funding sources are listed at the end of the Article.

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