Clinical safety profile of sotalol in patients with arrhythmias

作者: Lester F. Soyka , Carol Wirtz , Robert B. Spangenberg

DOI: 10.1016/0002-9149(90)90207-H

关键词:

摘要: Key safety parameters of sotalol were examined in 1,288 patients entered into recent controlled trials ventricular (85% patients) or supraventricular arrhythmias (15%). Most middle-aged male Caucasians with significant heart disease. The most serious adverse event was proarrhythmia, occurring 56 (4.3%). Of these, 27 had hemodynamic compromise due to malignant arrhythmias. a history sustained tachycardia, myocardial infarction, congestive failure (CHF) cardiomyopathy, combination these. other 29 nonsevere events; 38% continued taking sotalol. Proarrhythmia manifested by torsades de pointes 24 the patients. No universal causal relation found commonly associated factors such as bradycardia, hypokalemia and long QT interval. mean QTc at baseline within 1 week severe proarrhythmic greater than those not having proarrhythmia. Nineteen (1%) discontinued therapy because drug-related CHF. Predisposing conditions included low initial ejection fraction, CHF, cardiomyopathy cardiomegaly, both, gender age 65 years. Heart usually occurred 7 30 days initiating therapy. common reason for premature discontinuation drug treated tachycardia ineffectiveness (39%), whereas effects reasons among complex ectopy (21%). Dyspnea bradycardia cardiovascular effects, fatigue, dizziness asthenia noncardiac, effects. Although frequently reported, these resulted only 4% risk.(ABSTRACT TRUNCATED AT 250 WORDS)

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