Comparative bioequivalence and efficacy of two sustained-release procainamide formulations in patients with cardiac arrhythmias

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Abstract

This investigation evaluated the bioequivalence and efficacy of two sustained-release procainamide products. Ten patients with cardiac arrhythmias were randomized to product A (Procan-SR) or product B (Pronestyl-SR). After nine doses of study medication, plasma procainamide and N-acetylprocainamide concentrations were obtained to determine the area under the concentration versus time curve at steady state (AUC(ss)), mean plasma concentration (C(ss)(av)), the observed peak plasma concentration (C(ss)(max)), the observed trough plasma concentration (C(ss)(min)), and the apparent time to achieve C(ss)(max)(t(max)). The products were compared on a milligram-equivalent (adjusted) basis. Following completion of blood sampling, patients were crossed-over to the alternate product. There was no washout between treatments. After nine doses of the alternate test medications, blood sampling was repeated. Differences in AUC(ss), C(ss)(av), C(ss)(max), t(max), and intradose peak/trough ratios were not statistically significant. Within-group variability in AUC(ss), C(ss)(av) C(ss)(max), and t(max) was greater with product B, but this trend did not reach statistical significance. Antiarrhythmic efficacy was not significantly different between the two treatments. Although the greater bioequivalence, lesser variability, and the greater number of tablet dosage sizes would favor product A, patients stabilized on a particular brand of sustained-release procainamide should not be switched to another product without careful monitoring. One patient in this study developed nonsustained ventricular tachycardia with low procainamide plasma concentrations after being switched from product A to product B.

Original languageEnglish
Pages (from-to)554-558
Number of pages5
JournalDrug Intelligence and Clinical Pharmacy
Volume22
Issue number7-8
StatePublished - 1988

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Procainamide
Therapeutic Equivalency
Area Under Curve
Cardiac Arrhythmias
Acecainide
Hematologic Tests
Ventricular Tachycardia
Tablets

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

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title = "Comparative bioequivalence and efficacy of two sustained-release procainamide formulations in patients with cardiac arrhythmias",
abstract = "This investigation evaluated the bioequivalence and efficacy of two sustained-release procainamide products. Ten patients with cardiac arrhythmias were randomized to product A (Procan-SR) or product B (Pronestyl-SR). After nine doses of study medication, plasma procainamide and N-acetylprocainamide concentrations were obtained to determine the area under the concentration versus time curve at steady state (AUC(ss)), mean plasma concentration (C(ss)(av)), the observed peak plasma concentration (C(ss)(max)), the observed trough plasma concentration (C(ss)(min)), and the apparent time to achieve C(ss)(max)(t(max)). The products were compared on a milligram-equivalent (adjusted) basis. Following completion of blood sampling, patients were crossed-over to the alternate product. There was no washout between treatments. After nine doses of the alternate test medications, blood sampling was repeated. Differences in AUC(ss), C(ss)(av), C(ss)(max), t(max), and intradose peak/trough ratios were not statistically significant. Within-group variability in AUC(ss), C(ss)(av) C(ss)(max), and t(max) was greater with product B, but this trend did not reach statistical significance. Antiarrhythmic efficacy was not significantly different between the two treatments. Although the greater bioequivalence, lesser variability, and the greater number of tablet dosage sizes would favor product A, patients stabilized on a particular brand of sustained-release procainamide should not be switched to another product without careful monitoring. One patient in this study developed nonsustained ventricular tachycardia with low procainamide plasma concentrations after being switched from product A to product B.",
author = "Hilleman, {Daniel E.} and Patterson, {A. J.} and Mohiuddin, {Syed M.} and Ortmeier, {B. G.} and Destache, {Christopher J.}",
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T1 - Comparative bioequivalence and efficacy of two sustained-release procainamide formulations in patients with cardiac arrhythmias

AU - Hilleman, Daniel E.

AU - Patterson, A. J.

AU - Mohiuddin, Syed M.

AU - Ortmeier, B. G.

AU - Destache, Christopher J.

PY - 1988

Y1 - 1988

N2 - This investigation evaluated the bioequivalence and efficacy of two sustained-release procainamide products. Ten patients with cardiac arrhythmias were randomized to product A (Procan-SR) or product B (Pronestyl-SR). After nine doses of study medication, plasma procainamide and N-acetylprocainamide concentrations were obtained to determine the area under the concentration versus time curve at steady state (AUC(ss)), mean plasma concentration (C(ss)(av)), the observed peak plasma concentration (C(ss)(max)), the observed trough plasma concentration (C(ss)(min)), and the apparent time to achieve C(ss)(max)(t(max)). The products were compared on a milligram-equivalent (adjusted) basis. Following completion of blood sampling, patients were crossed-over to the alternate product. There was no washout between treatments. After nine doses of the alternate test medications, blood sampling was repeated. Differences in AUC(ss), C(ss)(av), C(ss)(max), t(max), and intradose peak/trough ratios were not statistically significant. Within-group variability in AUC(ss), C(ss)(av) C(ss)(max), and t(max) was greater with product B, but this trend did not reach statistical significance. Antiarrhythmic efficacy was not significantly different between the two treatments. Although the greater bioequivalence, lesser variability, and the greater number of tablet dosage sizes would favor product A, patients stabilized on a particular brand of sustained-release procainamide should not be switched to another product without careful monitoring. One patient in this study developed nonsustained ventricular tachycardia with low procainamide plasma concentrations after being switched from product A to product B.

AB - This investigation evaluated the bioequivalence and efficacy of two sustained-release procainamide products. Ten patients with cardiac arrhythmias were randomized to product A (Procan-SR) or product B (Pronestyl-SR). After nine doses of study medication, plasma procainamide and N-acetylprocainamide concentrations were obtained to determine the area under the concentration versus time curve at steady state (AUC(ss)), mean plasma concentration (C(ss)(av)), the observed peak plasma concentration (C(ss)(max)), the observed trough plasma concentration (C(ss)(min)), and the apparent time to achieve C(ss)(max)(t(max)). The products were compared on a milligram-equivalent (adjusted) basis. Following completion of blood sampling, patients were crossed-over to the alternate product. There was no washout between treatments. After nine doses of the alternate test medications, blood sampling was repeated. Differences in AUC(ss), C(ss)(av), C(ss)(max), t(max), and intradose peak/trough ratios were not statistically significant. Within-group variability in AUC(ss), C(ss)(av) C(ss)(max), and t(max) was greater with product B, but this trend did not reach statistical significance. Antiarrhythmic efficacy was not significantly different between the two treatments. Although the greater bioequivalence, lesser variability, and the greater number of tablet dosage sizes would favor product A, patients stabilized on a particular brand of sustained-release procainamide should not be switched to another product without careful monitoring. One patient in this study developed nonsustained ventricular tachycardia with low procainamide plasma concentrations after being switched from product A to product B.

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