The American journal of cardiology
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Randomized Controlled Trial
Efficacy of fenofibric acid plus statins on multiple lipid parameters and its safety in women with mixed dyslipidemia.
The combination of fibrate and statin therapies may be a treatment option for women with multiple lipid abnormalities. We, therefore, initiated the present safety and efficacy analysis to address the paucity of such data in women with mixed dyslipidemia. A total of 1,393 women with mixed dyslipidemia (low-density lipoprotein [LDL] cholesterol ≥ 130 mg/dl, triglycerides [TG] ≥ 150 mg/dl, high-density lipoprotein [HDL] cholesterol <50 mg/dl), who had enrolled in any 1 of 3 randomized clinical trials, were evaluated. ⋯ High-dose statins decreased the baseline LDL cholesterol 47%; however, the increase in HDL cholesterol (9%) and decrease in TG (25%) were similar to the changes observed with lower doses of statins. The safety profiles of the combinations were comparable to those of the component therapies. In conclusion, these data suggest that a combination of fenofibric acid and a statin could be considered safe and efficacious for treating women with mixed dyslipidemia.
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Randomized Controlled Trial
A simple strategy improves prehospital electrocardiogram utilization and hospital treatment for patients with acute coronary syndrome (from the ST SMART Study).
Although the American Heart Association recommends a prehospital electrocardiogram (ECG) be recorded for all patients who access the emergency medical system with symptoms of acute coronary syndrome (ACS), widespread use of prehospital ECG has not been achieved in the United States. A 5-year prospective randomized clinical trial was conducted in a predominately rural county in northern California to test a simple strategy for acquiring and transmitting prehospital ECGs that involved minimal paramedic training and decision making. A 12-lead ECG was synthesized from 5 electrodes and continuous ST-segment monitoring was performed with ST-event ECGs automatically transmitted to the destination hospital emergency department. ⋯ Mean paramedic scene time in patients with a prehospital ECG was just 2 minutes longer than in those without a prehospital ECG (95% confidence interval 1.2 to 3.6, p <0.001). Patients with non-ST-elevation myocardial infarction or unstable angina pectoris had a faster time to first intravenous drug and there was a suggested trend for a faster door-to-balloon time and lower risk of mortality in patients with ST-elevation myocardial infarction. In conclusion, increased paramedic use of prehospital ECGs and decreased hospital treatment times for ACS are feasible with a simple approach tailored to characteristics of a local geographic region.
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Randomized Controlled Trial Multicenter Study Comparative Study
Predictors of reperfusion delay in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention from the HORIZONS-AMI trial.
Primary percutaneous coronary intervention (PCI) is the optimal method of reperfusion when performed expeditiously. Factors contributing to delays in PCI for ST-segment elevation myocardial infarction (STEMI) have not been thoroughly characterized or quantified. We sought to identify the factors associated with the delays to reperfusion in patients with STEMI undergoing primary PCI. ⋯ Other independent predictors of prolonged door-to-balloon times included presentation with respiratory failure (42-minute incremental delay, p = 0.003), presentation during off-work hours (11-minute incremental delay, p < 0.001), and co-morbid conditions such as diabetes and heart failure. In conclusion, among patients undergoing primary PCI, presentation to a non-PCI hospital was the variable associated with the greatest delay to reperfusion. Systems of care that encourage ambulance diagnosis and direct delivery of patients with STEMI to a PCI hospital might shorten the overall door-to-balloon times and improve the clinical outcomes.
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Randomized Controlled Trial Multicenter Study Comparative Study
Pharmacoepidemiology safety study of fibrate and statin concomitant therapy.
Combinations of statins and fibrates may be increasingly prescribed to achieve lipid goals in high-risk patients and those with other cardiovascular risk factors, such as mixed dyslipidemia. The purpose of this retrospective cohort study was to compare rates of hospitalization for specific diagnoses in a cohort of new users of statins or fibrates, using claims data from a large United States health insurer. New users of statin, fibrate, or statin-fibrate therapy from 2004 to 2007 were identified; followed for hospitalization with rhabdomyolysis, renal impairment, hepatic injury, or pancreatitis; and confirmed by medical record review. ⋯ The IR of hepatic injury with statins was 8.57 per 100,000 patient-years, with no risk difference between exposure groups. In conclusion, the risk for rhabdomyolysis was low, although higher in patients newly treated with statin-fibrate concurrent therapy than those treated with either as monotherapy. The risk for pancreatitis was higher in patients treated with fenofibrate, whether in combination with statins or alone.
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Randomized Controlled Trial Multicenter Study
Usefulness of vernakalant hydrochloride injection for rapid conversion of atrial fibrillation.
The objective of the present study was to assess the safety and effectiveness of vernakalant hydrochloride injection (RSD1235), a novel antiarrhythmic drug, for the conversion of atrial fibrillation (AF) or atrial flutter to sinus rhythm (SR). Patients with either AF or atrial flutter were randomized in a 1:1 ratio to receive vernakalant (n = 138) or placebo (n = 138) and were stratified by an arrhythmia duration of >3 hours to ≤7 days (short duration) and 8 to ≤45 days (long duration). The first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if the arrhythmia had not terminated. ⋯ Transient dysgeusia and sneezing were the most common adverse events in the vernakalant patients. One vernakalant patient who had severe aortic stenosis experienced hypotension and ventricular fibrillation and died. In conclusion, vernakalant demonstrated a rapid and high rate of conversion for short-duration AF and was well tolerated.