The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy, safety, tolerability, and pharmacokinetic profile of evacetrapib administered as monotherapy or in combination with atorvastatin in Japanese patients with dyslipidemia.
The cholesteryl ester transfer protein (CETP) inhibitor evacetrapib has been previously shown to increase high-density lipoprotein cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) levels, as monotherapy or in combination with statins. In this study, 165 Japanese patients with elevated LDL-C or low HDL-C levels were randomly assigned to receive placebo, evacetrapib monotherapy 30 mg, 100 mg, or 500 mg, atorvastatin 10 mg, or evacetrapib 100 mg in combination with atorvastatin 10 mg. After 12 weeks, evacetrapib monotherapy increased HDL-C levels by 74%, 115%, and 136% and decreased LDL-C levels by 15%, 23%, and 22% and CETP activity by 50%, 83%, and 95% (for the 30-mg, 100-mg, and 500-mg dose groups, respectively) versus placebo. ⋯ Evacetrapib monotherapy or in combination with atorvastatin was not likely to be associated with any significant change in blood pressure and did not have any adverse effects on mineralocorticoid or glucocorticoid measures. Notably, plasma evacetrapib concentrations were mostly undetectable, and all pharmacodynamic biomarkers (HDL-C and LDL-C levels and CETP mass and activity) returned to baseline after a 4- to 6-week washout. In conclusion, evacetrapib as monotherapy or in combination with atorvastatin effectively decreased CETP activity and LDL-C levels and increased HDL-C levels after 12 weeks in Japanese patients with dyslipidemia.
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Multicenter Study Comparative Study
Analysis of the invasive strategy decision in patients with acute coronary syndrome without ST-segment elevation in a real-world setting.
Observational studies have reported a marked discrepancy between the risk estimated by scores and the use of an invasive strategy in patients with acute coronary syndromes. The objective is to describe the criteria used to decide an early invasive strategy and to determine the differences between those criteria and the thrombolysis in myocardial infarction risk score (TRS). Patients entered to the Epi-Cardio registry with a diagnosis of non-ST-elevation acute coronary syndrome were analyzed. ⋯ In the validation cohort, ROC areas were 0.58 and 0.70, respectively, p <0.0001. In conclusion, invasive strategy was guided by variables not completely included in risk scores. The clinical, evolutionary, and structural variables included in the model can explain, partially, the discordance existing between risk stratification and medical strategies.
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Multicenter Study
Prognostic significance of hyponatremia among ambulatory patients with heart failure and preserved and reduced ejection fractions.
Hyponatremia in heart failure (HF) is an established predictor of adverse outcomes in hospitalized patients with reduced ejection fraction (EF). However, there is a paucity of data in ambulatory patients with HF with preserved ejection fraction (HFpEF). We examined the prevalence, risk factors, and long-term outcomes of hyponatremia (serum sodium ≤135 mEq/L) in ambulatory HFpEF and HF with reduced EF (HFrEF) in a national cohort of 8,862 veterans treated in Veterans Affairs clinics. ⋯ In conclusion, hyponatremia is prevalent at a similar frequency of over 10% in ambulatory patients with HFpEF and HFrEF. Hyponatremia is an independent prognostic marker of mortality across the spectrum of patients with HFpEF and HFrEF. In contrast, it is an independent predictor for hospitalization in patients with HFrEF but not in patients with HFpEF.
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Multicenter Study Comparative Study Observational Study
Comparison of in-hospital outcomes for beta-blocker use versus non-beta blocker use in patients presenting with cocaine-associated chest pain.
Beta blockers are indicated for management of acute coronary syndromes, but they generally are withheld in patients with cocaine-associated chest pain because of concerns for adverse outcomes related to the unique physiological effects of cocaine. Because few clinical studies have evaluated this interaction, we identified patients with toxicology screen results positive for cocaine treated for chest pain at 2 academic hospitals. Clinical characteristics and in-hospital outcomes were compared between patients with and without β-blocker therapy. ⋯ Despite these higher risk clinical characteristics, patients treated with β blockers experienced similar peak troponin levels, individual adverse events, and rates of the composite primary end point (15.9% vs 12.3%, p = 0.32). The primary end point also was similar after propensity score analysis (odds ratio 1.37, 95% confidence interval 0.64 to 2.93, p = 0.42), including specific comparisons of beta-1 selective (odds ratio 1.83, 95% confidence interval 0.79 to 4.24) and nonselective (odds ratio 0.90, 95% confidence interval 0.33 to 2.42) β blockers, when compared with patients not receiving β blockers. In conclusion, no differences in outcomes were observed between patients treated versus not treated with β-blocker therapy in the setting of cocaine-related chest pain.