Examinando por Autor "Maggioni, Aldo P."

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  • Publicación
    Acceso abierto
    Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)
    (2016-05) Punthakee, Zubin; Gerstein, Hertzel C.; Bosch Pagans, Jordi; Tyrwhitt, Jessica; Jung, Hyejung; Lee, Shun Fu; Lonn, Eva; Marsden, Tamara; McKelvie, Robert; McQueen, Matthew J.; Morillo, Carlos; Yusuf, Shazzid; Dagenais, Gilles; Diaz, Rafael; Maggioni, Aldo P.; Probstfield, Jeffrey; Ramachandran, Ambady; Riddle, Matthew C.; Rydén, Lars; Badings, Erik; Birkeland, Kare; Cardona Munoz, Ernesto G.; Commerford, Patrick; Davies, Melanie; Fodor, George J.; Gomis, Ramon; Hanefeld, Markolf; Hildebrandt, Per; Kacerovsky Bielesz, Gertrud; Keltai, Matyas; Lanas, Fernando; Lewis, Basil S.; Lopez-Jaramillo, Patricio; Marin Neto, Jose Antonio; Marre, Michel; Mendoza, Ivan; Pan, Chun yue; Pirags, Valdis; Rosenstock, Julio; Spinas, Giatgen A.; Sreenan, Seamus; Syvänne, Mikko; Yale, Jean Francois; ORIGIN Trial Investigators
    OBJECTIVE The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high–cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years. RESEARCH DESIGN AND METHODS Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94–1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97–1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88–1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88–1.09]; P = 0.68) or other outcomes. CONCLUSIONS During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.
  • Publicación
    Acceso abierto
    Health-related quality of life and mortality in heart failure. The global congestive heart failure study of 23000 patients from 40 countries
    (American Heart Association, Inc., 2021-04-28) Johansson, Isabelle; Joseph, Philip; Balasubramanian, Kumar; McMurray, John J.V.; Lund, Lars H.; Ezekowitz, Justin A.; Kamath, Deepak; Alhabib, Khalid; Bayes-Genis, Antoni; Budaj, Andrzej; Dans, Antonio; Dzudie, Anastase; Probstfield, Jefferey L.; Fox, Keith A.; Karaye, Kamilu M.; Makubi, Abel; Fukakusa, Bianca; Teo, Koon; Temizhan, Ahmet; Wittlinger, Thomas; Maggioni, Aldo P.; Lanas, Fernando; Lopez-Jaramillo, Patricio; Silva-Cardoso, José; Sliwa, Karen; Dokainish, Hisham; Grinvalds, Alex; McCready, Tara; Yusuf, Salim; G-CHF Investigators; Masira
    Background: Poor health-related quality of life (HRQL) is common in heart failure (HF), but there are few data on HRQL in HF and the association between HRQL and mortality outside Western countries. Methods: We used the Kansas City Cardiomyopathy Questionnaire–12 (KCCQ-12) to record HRQL in 23 291 patients with HF from 40 countries in 8 different world regions in the G-CHF study (Global Congestive Heart Failure). We compared standardized KCCQ-12 summary scores (adjusted for age, sex, and markers of HF severity) among regions (scores range from 0 to 100, with higher score indicating better HRQL). We used multivariable Cox regression with adjustment for 15 variables to assess the association between KCCQ-12 summary scores and the composite of all-cause death, HF hospitalization, and each component over a median follow-up of 1.6 years. Results: The mean age of participants was 65 years; 61% were men; 40% had New York Heart Association class III or IV symptoms; and 46% had left ventricular ejection fraction ≥40%. Average HRQL differed between regions (lowest in Africa [mean± SE, 39.5±0.3], highest in Western Europe [62.5±0.4]). There were 4460 (19%) deaths, 3885 (17%) HF hospitalizations, and 6949 (30%) instances of either event. Lower KCCQ-12 summary score was associated with higher risk of all outcomes; the adjusted hazard ratio (HR) for each 10-unit KCCQ-12 summary score decrement was 1.18 (95% CI, 1.17–1.20) for death. Although this association was observed in all regions, it was less marked in South Asia, South America, and Africa (weakest association in South Asia: HR, 1.08 [95% CI, 1.03–1.14]; strongest association in Eastern Europe: HR, 1.31 [95% CI, 1.21–1.42]; interaction P<0.0001). Lower HRQL predicted death in patients with New York Heart Association class I or II and III or IV symptoms (HR, 1.17 [95% CI, 1.14–1.19] and HR, 1.14 [95% CI, 1.12–1.17]; interaction P=0.13) and was a stronger predictor for the composite outcome in New York Heart Association class I or II versus class III or IV (HR 1.15 [95% CI, 1.13–1.17] versus 1.09 [95% CI, [1.07–1.11]; interaction P<0.0001). HR for death was greater in ejection fraction ≥40 versus <40% (HR, 1.23 [95% CI, 1.20–1.26] and HR, 1.15 [95% CI, 1.13–1.17]; interaction P<0.0001). Conclusion: HRQL is a strong and independent predictor of all-cause death and HF hospitalization across all geographic regions, in mildly and severe symptomatic HF, and among patients with preserved and reduced ejection fraction.