This meta-analysis of prospective observational studies shows that the chance of being asymptomatic linearly progressively decreased over time after the first syncope. Short-term (10-30 days) mortality after syncope was <2% and that the overall 10-day rate of the composite endpoint of death and major events was ∼9%. The knowledge of syncope prognosis could help clinicians to understand syncope patients' prognosis and researchers to design future studies.
The aim of the present study was to compare the characteristics of patients referred to our heart failure outpatient clinic with those of patients enrolled in clinical trials on heart failure pharmacological treatment. Thus, we estimated the proportion of patients admitted to our heart failure outpatient clinic who would have been included in randomized controlled trials evaluating the effects of medical treatments on heart failure mortality, published over a 10 years period (1993-2003). Sixteen studies (n = 45276) and 299 consecutive outpatients, were included. On average, only 34% of the outpatients would have been included in at least one of the 16 trials (8-71%). The main reasons for exclusion were: NYHA class (70% were in NYHA class II), ejection fraction (29% had EF > 35%), co-morbidity (51% had co-morbidity, mainly renal failure, COPD, and disthyroidism), age (22% were older than 80 years), and occurrence of a recent acute event (50% experienced an ischemic coronary syndrome, revascularization, pulmonary edema, or stroke in the prior 6 months). These results underline the crucial role of patient selection in clinical trials, raising uncertainties about the complete applicability of trial results to clinical practice.
Sepsis is a common and high-burden healthcare problem with a mortality exceeding 20 % in severe sepsis and nearly 50 % when septic shock is present. Early goal-directed therapy (EGDT) is recommended by sepsis guidelines as the standard of care following a landmark study by Rivers et al. alongside other observational studies. Three recent randomized controlled trials have questioned the Rivers' results. The objective of our systematic review was to assess the effectiveness of EGDT in reducing the mortality of severe sepsis or septic shock. Relevant primary studies were identified by searching the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Clinical Trials to identify randomized controlled trials assessing the effectiveness of EGDT for sepsis. Data from all trials were combined and analyzed using a random effects model. Five studies, enrolling a total of 4033 patients, were included in the meta-analysis. In-hospital mortality did not differ between the two treatment groups (RR 0.93, 95 % CI 0.77-1.11, P = 0.42), although moderate heterogeneity between studies was noted (I (2) = 48 %). A non-significant trend toward reduction in 60-day mortality in the EGDT group was noted (RR 0.93, 95 % CI 0.82-1.05, P = 0.22, I (2) = 24 %). Heterogeneity between trials precludes a definitive conclusion on the utility of EGDT in severe sepsis. Until further evidence is available, it is reasonable to consider EGDT in the care of patients with severe sepsis and septic shock.
BackgroundLow Molecular Weight Heparins (LMWH) are at least as effective antithrombotic drugs as Unfractionated Heparin (UFH). However, it is still unclear whether the safety profiles of LMWH and UFH differ. We performed a systematic review to compare the bleeding risk of fixed dose subcutaneous LMWH and adjusted dose UFH for treatment of venous thromboembolism (VTE) or acute coronary syndromes (ACS). Major bleeding was the primary end point.MethodsElectronic databases (MEDLINE, EMBASE, and the Cochrane Library) were searched up to May 2010 with no language restrictions. Randomized controlled trials in which subcutaneous LMWH were compared to intravenous UFH for the treatment of acute thrombotic events were selected. Two reviewers independently screened studies and extracted data on study design, study quality, incidence of major bleeding, patients’ characteristics, type, dose and number of daily administrations of LMWH, co-treatments, study end points and efficacy outcome. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated using the random effects model.ResultsTwenty-seven studies were included. A total of 14,002 patients received UFH and 14,635 patients LMWH. Overall, no difference in major bleeding was observed between LMWH patients and UFH (OR = 0.79, 95% CI 0.60–1.04). In patients with VTE LMWH appeared safer than UFH, (OR = 0.68, 95% CI 0.47–1.00).ConclusionThe results of our systematic review suggest that the use of LMWH in the treatment of VTE might be associated with a reduction in major bleeding compared with UFH. The choice of which heparin to use to minimize bleeding risk must be based on the single patient, taking into account the bleeding profile of different heparins in different settings.
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