β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring

Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Boriani, Giuseppe [verfasserIn] Capucci, Alessandro [verfasserIn] Strocchi, Enrico [verfasserIn] Marchesini, Bruno [verfasserIn] Santarelli, Andrea [verfasserIn] Biffi, Mauro [verfasserIn] Magnani, Bruno [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	1993

Schlagwörter:	Drug Invest Propafenone Extensive Metabolisers Holter Monitoring Holter Recording

Übergeordnetes Werk:	Enthalten in: Clinical drug investigation - Berlin [u.a.] : Springer, 1989, 6(1993), 1 vom: Juli, Seite 25-32
Übergeordnetes Werk:	volume:6 ; year:1993 ; number:1 ; month:07 ; pages:25-32

Links:	Volltext

DOI / URN:	10.1007/BF03259424

Katalog-ID:	SPR032998791

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520			\|a Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone.
650		4	\|a Drug Invest \|7 (dpeaa)DE-He213
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700	1		\|a Capucci, Alessandro \|e verfasserin \|4 aut
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700	1		\|a Santarelli, Andrea \|e verfasserin \|4 aut
700	1		\|a Biffi, Mauro \|e verfasserin \|4 aut
700	1		\|a Magnani, Bruno \|e verfasserin \|4 aut
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allfields	10.1007/BF03259424 doi (DE-627)SPR032998791 (SPR)BF03259424-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Boriani, Giuseppe verfasserin aut β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring 1993 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213 Capucci, Alessandro verfasserin aut Strocchi, Enrico verfasserin aut Marchesini, Bruno verfasserin aut Santarelli, Andrea verfasserin aut Biffi, Mauro verfasserin aut Magnani, Bruno verfasserin aut Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 6(1993), 1 vom: Juli, Seite 25-32 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:6 year:1993 number:1 month:07 pages:25-32 https://dx.doi.org/10.1007/BF03259424 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 6 1993 1 07 25-32
spelling	10.1007/BF03259424 doi (DE-627)SPR032998791 (SPR)BF03259424-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Boriani, Giuseppe verfasserin aut β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring 1993 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213 Capucci, Alessandro verfasserin aut Strocchi, Enrico verfasserin aut Marchesini, Bruno verfasserin aut Santarelli, Andrea verfasserin aut Biffi, Mauro verfasserin aut Magnani, Bruno verfasserin aut Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 6(1993), 1 vom: Juli, Seite 25-32 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:6 year:1993 number:1 month:07 pages:25-32 https://dx.doi.org/10.1007/BF03259424 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 6 1993 1 07 25-32
allfields_unstemmed	10.1007/BF03259424 doi (DE-627)SPR032998791 (SPR)BF03259424-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Boriani, Giuseppe verfasserin aut β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring 1993 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213 Capucci, Alessandro verfasserin aut Strocchi, Enrico verfasserin aut Marchesini, Bruno verfasserin aut Santarelli, Andrea verfasserin aut Biffi, Mauro verfasserin aut Magnani, Bruno verfasserin aut Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 6(1993), 1 vom: Juli, Seite 25-32 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:6 year:1993 number:1 month:07 pages:25-32 https://dx.doi.org/10.1007/BF03259424 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 6 1993 1 07 25-32
allfieldsGer	10.1007/BF03259424 doi (DE-627)SPR032998791 (SPR)BF03259424-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Boriani, Giuseppe verfasserin aut β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring 1993 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213 Capucci, Alessandro verfasserin aut Strocchi, Enrico verfasserin aut Marchesini, Bruno verfasserin aut Santarelli, Andrea verfasserin aut Biffi, Mauro verfasserin aut Magnani, Bruno verfasserin aut Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 6(1993), 1 vom: Juli, Seite 25-32 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:6 year:1993 number:1 month:07 pages:25-32 https://dx.doi.org/10.1007/BF03259424 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 6 1993 1 07 25-32
allfieldsSound	10.1007/BF03259424 doi (DE-627)SPR032998791 (SPR)BF03259424-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Boriani, Giuseppe verfasserin aut β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring 1993 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone. Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213 Capucci, Alessandro verfasserin aut Strocchi, Enrico verfasserin aut Marchesini, Bruno verfasserin aut Santarelli, Andrea verfasserin aut Biffi, Mauro verfasserin aut Magnani, Bruno verfasserin aut Enthalten in Clinical drug investigation Berlin [u.a.] : Springer, 1989 6(1993), 1 vom: Juli, Seite 25-32 (DE-627)327645083 (DE-600)2043793-6 1179-1918 nnns volume:6 year:1993 number:1 month:07 pages:25-32 https://dx.doi.org/10.1007/BF03259424 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_702 GBV_ILN_2190 44.40 ASE AR 6 1993 1 07 25-32
language	English
source	Enthalten in Clinical drug investigation 6(1993), 1 vom: Juli, Seite 25-32 volume:6 year:1993 number:1 month:07 pages:25-32
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topic_facet	Drug Invest Propafenone Extensive Metabolisers Holter Monitoring Holter Recording
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container_title	Clinical drug investigation
authorswithroles_txt_mv	Boriani, Giuseppe @@aut@@ Capucci, Alessandro @@aut@@ Strocchi, Enrico @@aut@@ Marchesini, Bruno @@aut@@ Santarelli, Andrea @@aut@@ Biffi, Mauro @@aut@@ Magnani, Bruno @@aut@@
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author	Boriani, Giuseppe
spellingShingle	Boriani, Giuseppe ddc 610 bkl 44.40 misc Drug Invest misc Propafenone misc Extensive Metabolisers misc Holter Monitoring misc Holter Recording β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring
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topic_title	610 ASE 44.40 bkl β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring Drug Invest (dpeaa)DE-He213 Propafenone (dpeaa)DE-He213 Extensive Metabolisers (dpeaa)DE-He213 Holter Monitoring (dpeaa)DE-He213 Holter Recording (dpeaa)DE-He213
topic	ddc 610 bkl 44.40 misc Drug Invest misc Propafenone misc Extensive Metabolisers misc Holter Monitoring misc Holter Recording
topic_unstemmed	ddc 610 bkl 44.40 misc Drug Invest misc Propafenone misc Extensive Metabolisers misc Holter Monitoring misc Holter Recording
topic_browse	ddc 610 bkl 44.40 misc Drug Invest misc Propafenone misc Extensive Metabolisers misc Holter Monitoring misc Holter Recording
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title	β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring
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title_full	β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring
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author_browse	Boriani, Giuseppe Capucci, Alessandro Strocchi, Enrico Marchesini, Bruno Santarelli, Andrea Biffi, Mauro Magnani, Bruno
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title_sort	β-blocking properties of propafenone in extensive oxidisers: a study on heart rate behaviour during holter monitoring
title_auth	β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring
abstract	Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone.
abstractGer	Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone.
abstract_unstemmed	Summary The aims of this study were to evaluate whether the β-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (> 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (> 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [−7.1%] or mean heart rate (HR mean) [−4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p < 0.02 for HR max; r = 0.715, p < 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p < 0.005 for HR max; r = 0.752, p < 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (−8.1%, p < 0.005), suggesting a β-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p < 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p < 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p < 0.001). In conclusion, a β-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical β-blocking effect of propafenone.
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title_short	β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring
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author2	Capucci, Alessandro Strocchi, Enrico Marchesini, Bruno Santarelli, Andrea Biffi, Mauro Magnani, Bruno
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