International journal of cardiology
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Randomized Controlled Trial Clinical Trial
The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias.
Ninety-five patients with suspected acute myocardial infarction were randomly allocated on admission to hospital on a double blind basis to treatment with lorcainide, a Class 1C anti-arrhythmic drug, or matching placebo. Treatment was continued for 6 weeks. Twenty-four-hour ECG tape recordings were made immediately on admission, on the sixth or seventh day after admission, and again just before the end of the treatment period. ⋯ The study was not designed to evaluate the effect of lorcainide on survival, but there were nine deaths among the 49 patients treated with lorcainide compared with only one in the patients given placebo. These findings are consistent with the results of the First and Second Cardiac Arrhythmia Suppression trials (CAST and CAST-II). This study was carried out in 1980 but was not published at the time: it now provides an interesting example of 'publication bias'.
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Randomized Controlled Trial Comparative Study Clinical Trial Controlled Clinical Trial
Comparison of dobutamine and enoximone for low output states following cardiac surgery.
Low output syndrome sometimes complicates early postoperative states following cardiac surgery. A comparative study of haemodynamic responses to enoximone and dobutamine was carried out in two groups of 20 patients each, during a 24-hour postoperative observation period. Parameters in addition to routine measurements were determined using a pulmonary artery catheter. ⋯ After dobutamine, cardiac index rose from 2.33 +/- 0.60 litres/minute/m2 to 2.90 +/- 0.81 (15 minutes), 3.52 +/- 0.74 (120 minutes) and 4.12 +/- 1.07 litres/minute/m2 (24 hours). The pulmonary wedge pressure values decreased in this group, from 15.20 +/- 3.14 mm Hg at the beginning to 13.74 +/- 3.02 (15 minutes), 12.17 +/- 5.25 (120 minutes) and 9.81 +/- 4.23 mm Hg (24 hours). The enoximone group showed a diminution of systolic arterial pressure of 14% in the first 120 minutes, with a return to initial values after 24 hours.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Comparative Study Clinical Trial
Acute pulmonary oedema: preliminary results of a randomized trial of the intravenous phosphodiesterase inhibitor, enoximone, vs conventional therapy.
The purpose of this open study was to compare the effects of enoximone and conventional therapy in 44 patients with acute pulmonary oedema. In this preliminary report, 22 patients were randomly assigned to the enoximone group (1 mg/kg bolus, every 8 hours for 48 hours) and 22 patients to conventional therapy (frusemide, nitrates, dopamine-dobutamine). Patients were assessed clinically at 0, 1, 2, 24 and 48 hours by the change in their Killip-Kimball score, dyspnoea, pulmonary rales, blood pressure, diuresis, requirement for additional therapy and/or death. ⋯ On the other hand, in the conventional therapy group, it was necessary to institute enoximone therapy in 9 cases. With the dosage used, enoximone appeared to be at least as effective as conventional therapy in acute pulmonary oedema. Moreover, no side-effects or tachyphylaxis appeared during the hospital assessment.