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  • Montalcini, T., et al. (författare)
  • Carotid intima-media thickness: A target or a marker?
  • 2014
  • Ingår i: American Journal of Therapeutics. - 1075-2765. ; 21:6, s. 535-539
  • Tidskriftsartikel (refereegranskat)abstract
    • Evidence-based medicine requires us to use pharmacological agents that have been tested and that have been showed to reduce the disease in that particular group of affected patients. The choice of the efficacy endpoint is one of the most controversial issues in designing the trials. To reduce the high economic costs resulting by the large-scale trials design and implementation, the substitution of the primary endpoints with a surrogate one, is an optimal opportunity. Carotid intima-media thickness is considered an excellent predictor of cardiovascular events, and it is also seen as a perfect model of surrogate endpoint for pharmacological studies. However, the results from studies using it as a surrogate endpoints could lead to erroneous conclusions and could lead marketing of products with limited or doubt effectiveness on cardiovascular prevention. Studies showed that many interventions targeting the Carotid intima-media thickness not impact the final clinical endpoints of interest, whereas low-density lipoprotein cholesterol level is an excellent biomarker because it can predict the cardiovascular outcomes and interventions therapy can efficaciously reduce it.
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  • Wang, N. C., et al. (författare)
  • Implantable cardioverter-defibrillators in patients hospitalized for heart failure with chronically reduced left ventricular ejection fraction
  • 2010
  • Ingår i: American Journal of Therapeutics. - 1075-2765. ; 17:4
  • Tidskriftsartikel (refereegranskat)abstract
    • The aim of this study was to investigate the association between implantable cardioverter-defibrillator (ICD) status at the time of hospitalization for worsening heart failure (HF) with postdischarge events in patients with reduced left ventricular ejection fraction. We conducted an analysis of 4133 patients hospitalized for HF with left ventricular ejection fraction 40% or less in EVEREST. The final analysis included patients without an electrophysiological device (n = 3102) and those with an ICD (n = 600) at the time of enrollment. During a median follow-up of 300 days, all-cause mortality was 22.9% in the no device group and 35.2% in the ICD group (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.39-1.89). Rehospitalization for HF was 27.0% in the no device group and 46.8% in the ICD group (HR, 2.20; 95% CI, 1.92-2.52). After adjustment for multiple variables, the rates for all-cause mortality were similar (HR, 1.01; 95% CI, 0.83-1.22), but the ICD group had elevated rates of HF hospitalizations compared with the no device group (HR, 1.35; 95% CI, 1.14-1.60). In patients with reduced left ventricular ejection fraction, an ICD at presentation for hospitalization for worsening HF was associated with similar rates of death but higher rates of rehospitalization for HF. Given our findings, further studies should investigate optimization of care in patients already implanted with an ICD as well as the role of ICD implantation during or soon after hospitalization for HF in patients not yet implanted.
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