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 language | English |
|---|---|
| Pages (from-to) | 554-558 |
| Number of pages | 5 |
| Journal | Drug Intelligence and Clinical Pharmacy |
| Volume | 22 |
| Issue number | 7-8 |
| State | Published - 1988 |
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All Science Journal Classification (ASJC) codes
- Pharmacology (medical)
- Pharmacology, Toxicology and Pharmaceutics(all)
Cite this
Comparative bioequivalence and efficacy of two sustained-release procainamide formulations in patients with cardiac arrhythmias. / Hilleman, Daniel E.; Patterson, A. J.; Mohiuddin, Syed M.; Ortmeier, B. G.; Destache, Christopher J.
In: Drug Intelligence and Clinical Pharmacy, Vol. 22, No. 7-8, 1988, p. 554-558.Research output: Contribution to journal › Article
}
TY - JOUR
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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UR - http://www.scopus.com/inward/citedby.url?scp=0023710292&partnerID=8YFLogxK
M3 - Article
C2 - 2458219
AN - SCOPUS:0023710292
VL - 22
SP - 554
EP - 558
JO - Annals of Pharmacotherapy
JF - Annals of Pharmacotherapy
SN - 1060-0280
IS - 7-8
ER -