Efficacy, plasma concentrations and adverse effects of a new sustained release procainamide preparation

E. G V Giardina, Paul E Fenster, J. T. Bigger, Michael Mayersohn, D. Perrier, F. I. Marcus

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Abstract

To assess the efficacy, plasma drug concentrations and adverse effects of a new sustained release preparation of procainamide, 33 patients with heart disease were studied in an acute dose-ranging protocol and a chronic treatment protocol. Patients initially received a daily dose of 3 g of sustained release procainamide; this dose was increased by 1.5 g daily until ventricular premature depolarizations were suppressed by 75 percent or more, adverse drug effects occurred or a total daily dose of 7.5 g of sustained-release procainamide was reached. Twenty-five patients (76 percent) had at least a 75 percent reduction (range 75 to 100 percent [mean ± standard deviation 91 ± 8.2]) in ventricular premature depolarization frequency at a dosage of 4.8 ± 1.46 g/day (range 3.0 to 7.5). Despite the 8 hour dosing interval, the variation between maximal and minimal plasma procainamide and N-acetylprocainamide concentrations under steady state conditions was very small. Mean maximal procainamide and N-acetylprocainamide plasma concentrations were 10.4 ± 6.02 and 12.0 ± 7.40 μg/ml, respectively. The respective mean minimal concentrations were 6.8 ± 4.50 and 8.7 ± 5.99 μg/ml. In nine patients (27 percent) treatment with sustained release procainamide resulted in conversion of the antinuclear antibody test from negative to positive. Adverse drug effects occurred in 17 (52 percent) of the subjects. In general, adverse effects were minor and abated within 24 hours after administration of the drug was stopped. One patient had the procainamide-induced systemic lupus erythematosus-like syndrome.

Original languageEnglish (US)
Pages (from-to)855-862
Number of pages8
JournalThe American journal of cardiology
Volume46
Issue number5
DOIs
StatePublished - 1980

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Delayed-Action Preparations
Procainamide
Acecainide
Pharmaceutical Preparations
Antinuclear Antibodies
Clinical Protocols
Systemic Lupus Erythematosus
Heart Diseases

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Efficacy, plasma concentrations and adverse effects of a new sustained release procainamide preparation. / Giardina, E. G V; Fenster, Paul E; Bigger, J. T.; Mayersohn, Michael; Perrier, D.; Marcus, F. I.

In: The American journal of cardiology, Vol. 46, No. 5, 1980, p. 855-862.

Research output: Contribution to journalArticle

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