FELIX GALLEGOS, CAMILO EDGAR VINICIO

Preferred name

Main Affiliation

Facultad de Ciencias de la Salud Eugenio Espejo

CENIEC - Grupo de Investigación de Enfermedades Crónicas

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ORCID

0000-0003-0224-2321

Scopus Author ID

57210396829

Now showing 1 - 10 of 21

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The Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges
(Elsevier BV, 2022-06)
John Eikelboom
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Sumathy Rangarajan
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Sanjit S. Jolly
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Emilie P. Belley-Cote
;
Richard Whitlock
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Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
(Massachusetts Medical Society, 2017-10-05)
John W. Eikelboom
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Stuart J. Connolly
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Jackie Bosch
;
Gilles R. Dagenais
;
Robert G. Hart
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Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial
(Elsevier BV, 2021-08)
David Collister
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Lawrence Mbuagbaw
;
Gordon Guyatt
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P.J. Devereaux
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Karthik K. Tennankore
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Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial
(Elsevier BV, 2022-12)
John W Eikelboom
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Sanjit S Jolly
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Emilie P Belley-Cote
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Richard P Whitlock
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Sumathy Rangarajan
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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
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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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Prevalence of metabolic syndrome and diabetes mellitus type-2 and their association with intake of dairy and legume in Andean communities of Ecuador
(Public Library of Science (PLoS), 2021-07-23)
Manuel E. Baldeón
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FELIX GALLEGOS, CAMILO EDGAR VINICIO
;
Marco Fornasini
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Federico Zertuche
;
Carolina Largo
<jats:p>Metabolic syndrome (MetS) and type 2 diabetes (T2D) are metabolic alterations associated with high morbidity and mortality, particularly in low and middle-income countries. Diet has a significant impact on the risk to develop MetS and T2D; in this regard, consumption of fruits, vegetables, and protein rich foods (from plant and animals) are important to prevent and manage these pathologies. There are limited studies regarding the potential association between Andean foods rich in proteins and the presence of cardio-metabolic conditions in Ecuador. It is necessary to develop new low-cost, local-culturally acceptable strategies to reduce the burden of cardio-metabolic diseases. We describe the prevalence (baseline data) of MetS and T2D in the Ecuadorian cohort of the Prospective Urban and Rural Epidemiology (PURE) study and their potential association with the consumption of protein rich foods, including beef, white meat, dairy and legumes. In this cross-sectional study, we assessed 1,997 individuals aged 35–70 years (mean age 51 years, 72% women), included in the Ecuadorian cohort of the PURE study, from February to December 2018. The prevalence of MetS was 42% for male and 44% for female participants; the prevalence of T2D was 9% for male and 10% for female. Metabolic syndrome and T2D were more common in women older than 50 years of age with primary education or less, low economic income, and with obesity; MetS was more frequent in the rural area while T2D was more frequent in the urban area. Using logistic regression analysis, we observed a significant protective effect of higher consumption of dairy and legumes in the prevalence of MetS and T2D compared with low consumption. It will be important to develop policies for ample production and consumption of protein rich foods such as legumes and dairy, part of traditional diets, to reduce the burden of cardio-metabolic diseases.</jats:p>
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The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol
(SAGE Publications, 2025-06)
Michael Walsh
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David Collister
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Martin Gallagher
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Patrick B. Mark
;
Janak R. de Zoysa
Background: The mineralocorticoid aldosterone may contribute to the risk of cardiovascular morbidity and mortality in patients receiving maintenance dialysis. Whether spironolactone, a mineralocorticoid receptor antagonist, improves outcomes for patients receiving maintenance dialysis is unclear. Objective: To assess the efficacy and safety of spironolactone in patients receiving maintenance dialysis. Design: Placebo-controlled, randomized controlled trial. Setting: Dialysis units Patients: Patients receiving maintenance dialysis who are adherent to and able to tolerate spironolactone 25 mg daily during an open-label run-in period of at least 49 days were randomized to spironolactone 25 mg daily or matching placebo. Measurements: Randomized participants were followed for the primary outcome of cardiovascular death or hospitalization due to heart failure. Secondary outcomes include cause specific deaths, hospitalization due to heart failure, all-cause death, all-cause hospitalizations, and severe hyperkalemia. All deaths and possible hospitalizations for heart failure were adjudicated. Methods: Eligible participants received open-label spironolactone 25 mg daily for at least 7 weeks during a run-in period. Participants who tolerated and adhered to treatment were randomly allocated to continue spironolactone 25 mg daily or a matching placebo. We followed participants until trial close. Results: The trial began recruitment in 2018 and concluded recruitment in December 2024. Despite a reduced rate of recruitment during the global COVID-19 pandemic 3565 eligible participants were enrolled of whom 2538 were randomized to spironolactone or placebo from 143 dialysis programs. Limitations: Limited funding and the trial was stopped early due to futility to demonstrate an effect. Conclusions: ACHIEVE was designed as a large, simple trial to determine if spironolactone 25 mg daily prevents cardiovascular mortality and heart failure hospitalizations in patients with kidney failure receiving maintenance dialysis. ACHIEVE demonstrates the possibility of conducting large, international, investigator initiated randomized controlled trials for patients with kidney failure receiving dialysis.
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Variations between women and men in risk factors, treatments, cardiovascular disease incidence, and death in 27 high-income, middle-income, and low-income countries - PURE: a prospective cohort study
(Elsevier BV, 2020-07)
Marjan Walli-Attaei
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Philip Joseph
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Annika Rosengren
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Clara K Chow
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Sumathy Rangarajan
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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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The burden of cardiovascular events according to cardiovascular risk profile in adults from high-income, middle-income, and low-income countries - PURE: a cohort study
(Elsevier BV, 2025-08)
Darryl P Leong
;
Rita Yusuf
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Romaina Iqbal
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Alvaro Avezum
;
Afzalhussein Yusufali
Background: Current strategies to prevent adverse cardiovascular outcomes focus primary prevention in high-risk groups and secondary prevention in people with known cardiovascular disease. We aimed to determine the proportion of events occurring in lower-risk groups globally. Methods: We included people aged 40 years to younger than 75 years who were enrolled in the Prospective Urban Rural Epidemiology (PURE) study, which is an ongoing, international, prospective, population-based cohort study that started recruiting adults from households selected to be broadly representative of the sociodemographic composition of their communities. We prospectively documented fatal or non-fatal myocardial infarction, stroke, heart failure, or any other fatal cardiovascular event stratified by history of cardiovascular disease and by the 10-year predicted disease risk scores based on WHO 2019 laboratory risk tables (<10% [low], 10% to <20% [intermediate], and ≥20% [high]) in people without previous cardiovascular disease from 26 high-income, middle-income, and low-income countries. Outcome event rates were standardised for the cohort's age and sex distribution. Findings: Between July 11, 2000, and May 6, 2019, 128 973 participants were included from 26 countries (mean age 53·6 years [SD 8·2]; 75 858 [58·8%] were female and 53 115 [41·2%] were male). We observed 11 483 outcome events affecting 8·9% of the cohort during a median follow-up of 12·3 years (IQR 9·8–14·6). Among participants, 89 508 (69·4%) had a low cardiovascular disease risk, 22 363 (17·3%) had an intermediate cardiovascular disease risk, and 5529 (4·3%) had a high cardiovascular disease risk, while 11 573 (9·0%) had known cardiovascular disease. The age-standardised and sex-standardised cardiovascular disease incidence rates per 1000 person-years was 4·1 (95% CI 4·0–4·2) in the low-risk group, 17·7 (15·2–20·2) in the intermediate-risk group, and 40·8 (25·1–56·4) in the high-risk group. Overall, 41% of outcome events occurred in cardiovascular disease-naive participants at low risk. The proportion of adverse cardiovascular outcomes occurring in this low-risk group was inversely related to country income level (32% in high-income, 38% in middle-income, and 54% in low-income countries) and was higher in women (51%) than in men (32%). Interpretation: To achieve a substantial population-level reduction in cardiovascular disease, a fundamental change is needed, so that preventive strategies for cardiovascular disease extend beyond those at high or even intermediate predicted risk to include those at considered to be at low risk. Funding: The funding bodies are listed in the appendix (p 29).

FELIX GALLEGOS, CAMILO EDGAR VINICIO

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