The American journal of cardiology
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Randomized Controlled Trial Comparative Study Clinical Trial
Amplified benefit of clopidogrel versus aspirin in patients with diabetes mellitus.
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Randomized Controlled Trial Clinical Trial
Thresholds for the electrocardiographic change range of biochemical markers of acute myocardial infarction (GUSTO-IIa data).
The definition of acute myocardial infarction (AMI) is increasingly dependent on levels of biochemical markers, including troponin. We aimed to determine the levels of biochemical markers associated with definite evolutionary electrocardiographic (ECG) changes in patients with ST-segment elevation myocardial infarction. By examining the database of 855 patients from the troponin substudy of GUSTO-IIa, we selected patients with ST-segment elevation at baseline, evidence of evolution of the QRS, T, and ST-segment waveforms on the predischarge electrocardiogram, and 3 measurements of > or =1 of the following: creatine kinase (CK)-MB, troponin T, or troponin I. ⋯ For patients with troponin T measurements, the fifth percentile as a multiple of the upper limit of normal was 11.0 (upper limit of normal 0.1 ng/ml). For patients with troponin I measurements, the fifth percentile as a multiple of the upper limit of normal was 3.8 (upper limit of normal 1.5 ng/ml). This study revealed that 95% of the patients with definite ECG evidence of AMI had a more than twofold increase in CK-MB and more than a 3- to 11-fold increase in troponin.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of thromboembolic events in patients treated with celecoxib, a cyclooxygenase-2 specific inhibitor, versus ibuprofen or diclofenac.
It has been hypothesized that cyclooxygenase 2 specific inhibitors may increase the risk of cardiovascular (CV) thromboembolic events because of their inhibition of vascular prostacyclin synthesis and lack of an effect on platelet thromboxane A(2) production and aggregation. Thus, we analyzed the data for celecoxib and nonsteroidal anti-inflammatory drugs (NSAIDs) from the Celecoxib Long-term Arthritis Safety Study to determine the incidences of serious CV thromboembolic events. This trial included 3,987 persons randomized to celecoxib 400 mg twice daily (2,320 person-years of exposure) and 3,981 persons randomized to either ibuprofen 800 mg 3 times daily or diclofenac 75 mg twice daily (2,203 person-years). ⋯ The relative risks for celecoxib versus NSAIDs for serious CV thromboembolic events were 1.1 for all patients and 1.1 for the subgroup of patients not taking ASA (95% confidence interval 0.7 to 1.6 and 0.6 to 1.9, respectively). In addition, the incidences of adverse CV events such as hypertension, edema, and congestive heart failure were similar to, or significantly lower than, NSAID comparators regardless of the use of ASA. Thus, these analyses demonstrate no increased risk of serious CV thromboembolic events associated with celecoxib compared with conventional NSAIDs and therefore do not support the hypothesis of a class adverse effect of cyclooxygenase 2 specific inhibitors on the CV system.
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Randomized Controlled Trial Clinical Trial
Impact of troponin T determinations on hospital resource utilization and costs in the evaluation of patients with suspected myocardial ischemia.
The evaluation and triage of patients with suspected myocardial ischemia in the emergency department remains challenging and costly. Previous studies of cardiac troponins have focused predominantly on patients with chest pain and have not randomized patients to different diagnostic strategies. Eight hundred fifty-six patients with suspected myocardial ischemia were prospectively randomized to receive a standard evaluation, including serial electrocardiographic and creatine phosphokinase-MB determinations (controls) or a standard evaluation with the addition of serial troponin T determinations (troponin group). ⋯ Total hospital charges were reduced in a similar fashion in troponin patients with and without acute coronary syndromes ($15,004 vs $19,202; p = 0.01, and $4,487 vs $6,187; p = 0.17, respectively) compared with controls. Troponin patients without acute coronary syndromes had fewer hospital admissions (25% vs 31%; p = 0.04), whereas troponin patients with acute coronary syndromes had shorter telemetry and coronary care unit lengths of stay (3.5 vs 4.5 days; p = 0.03) compared with controls. Thus, utilization of troponin T in a broad spectrum of emergency department patients with suspected myocardial ischemia improves hospital resource utilization and reduces costs.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of omapatrilat on hemodynamics and safety in patients with heart failure.
Omapatrilat, a novel vasopeptidase inhibitor, is a highly potent and selective inhibitor of neutral endopeptidase and angiotensin-converting enzyme; its therapeutic potential is being investigated for treatment of hypertension and heart failure. In the present study, the safety, tolerability, and hemodynamic effects of single oral doses of omapatrilat (1 to 50 mg) are compared with placebo in patients with heart failure. Patients with heart failure (New York Heart Association functional class II to IV) and a resting left ventricular ejection fraction < or = 40% were enrolled in a double-blind, placebo-controlled, sequential-panel study of single doses of omapatrilat of 1, 2.5, 5, 10, 25, or 50 mg, followed by hemodynamic assessment for 24 hours. ⋯ Additionally, by 2 hours after dosing with omapatrilat 25 and 50 mg, a trend in peak increases from baseline in plasma atrial natriuretic peptide (twofold) and cyclic guanosine monophosphate (nearly twofold) was observed. Moreover, omapatrilat was well tolerated. Thus, omapatrilat administered orally to patients with heart failure was safe and well tolerated and resulted in improved hemodynamic performance.