Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan

Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Mori, Yoshihiro [verfasserIn] Nishikawa, Yasuhiro [verfasserIn] Iizuka, Tomoko [verfasserIn] Zenimura, Natsuko [verfasserIn] Matsumoto, Takuyuki [verfasserIn] Hiramatsu, Katsutoshi [verfasserIn] Komiya, Masahiro [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2011

Schlagwörter:	Antihypertensive Drug Carvedilol Antihypertensive Medication Antihypertensive Effect Achievement Rate

Übergeordnetes Werk:	Enthalten in: Drugs in R & D - [S.l.] : Springer International, 1999, 11(2011), 2 vom: Juni, Seite 171-190
Übergeordnetes Werk:	volume:11 ; year:2011 ; number:2 ; month:06 ; pages:171-190

Links:	Volltext

DOI / URN:	10.2165/11592450-000000000-00000

Katalog-ID:	SPR033293473

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520			\|a Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.
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700	1		\|a Matsumoto, Takuyuki \|e verfasserin \|4 aut
700	1		\|a Hiramatsu, Katsutoshi \|e verfasserin \|4 aut
700	1		\|a Komiya, Masahiro \|e verfasserin \|4 aut
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allfields	10.2165/11592450-000000000-00000 doi (DE-627)SPR033293473 (SPR)11592450-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Mori, Yoshihiro verfasserin aut Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213 Nishikawa, Yasuhiro verfasserin aut Iizuka, Tomoko verfasserin aut Zenimura, Natsuko verfasserin aut Matsumoto, Takuyuki verfasserin aut Hiramatsu, Katsutoshi verfasserin aut Komiya, Masahiro verfasserin aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 11(2011), 2 vom: Juni, Seite 171-190 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:11 year:2011 number:2 month:06 pages:171-190 https://dx.doi.org/10.2165/11592450-000000000-00000 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.40 ASE AR 11 2011 2 06 171-190
spelling	10.2165/11592450-000000000-00000 doi (DE-627)SPR033293473 (SPR)11592450-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Mori, Yoshihiro verfasserin aut Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213 Nishikawa, Yasuhiro verfasserin aut Iizuka, Tomoko verfasserin aut Zenimura, Natsuko verfasserin aut Matsumoto, Takuyuki verfasserin aut Hiramatsu, Katsutoshi verfasserin aut Komiya, Masahiro verfasserin aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 11(2011), 2 vom: Juni, Seite 171-190 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:11 year:2011 number:2 month:06 pages:171-190 https://dx.doi.org/10.2165/11592450-000000000-00000 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.40 ASE AR 11 2011 2 06 171-190
allfields_unstemmed	10.2165/11592450-000000000-00000 doi (DE-627)SPR033293473 (SPR)11592450-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Mori, Yoshihiro verfasserin aut Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213 Nishikawa, Yasuhiro verfasserin aut Iizuka, Tomoko verfasserin aut Zenimura, Natsuko verfasserin aut Matsumoto, Takuyuki verfasserin aut Hiramatsu, Katsutoshi verfasserin aut Komiya, Masahiro verfasserin aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 11(2011), 2 vom: Juni, Seite 171-190 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:11 year:2011 number:2 month:06 pages:171-190 https://dx.doi.org/10.2165/11592450-000000000-00000 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.40 ASE AR 11 2011 2 06 171-190
allfieldsGer	10.2165/11592450-000000000-00000 doi (DE-627)SPR033293473 (SPR)11592450-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Mori, Yoshihiro verfasserin aut Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213 Nishikawa, Yasuhiro verfasserin aut Iizuka, Tomoko verfasserin aut Zenimura, Natsuko verfasserin aut Matsumoto, Takuyuki verfasserin aut Hiramatsu, Katsutoshi verfasserin aut Komiya, Masahiro verfasserin aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 11(2011), 2 vom: Juni, Seite 171-190 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:11 year:2011 number:2 month:06 pages:171-190 https://dx.doi.org/10.2165/11592450-000000000-00000 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.40 ASE AR 11 2011 2 06 171-190
allfieldsSound	10.2165/11592450-000000000-00000 doi (DE-627)SPR033293473 (SPR)11592450-000000000-00000-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Mori, Yoshihiro verfasserin aut Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension. Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213 Nishikawa, Yasuhiro verfasserin aut Iizuka, Tomoko verfasserin aut Zenimura, Natsuko verfasserin aut Matsumoto, Takuyuki verfasserin aut Hiramatsu, Katsutoshi verfasserin aut Komiya, Masahiro verfasserin aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 11(2011), 2 vom: Juni, Seite 171-190 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:11 year:2011 number:2 month:06 pages:171-190 https://dx.doi.org/10.2165/11592450-000000000-00000 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.40 ASE AR 11 2011 2 06 171-190
language	English
source	Enthalten in Drugs in R & D 11(2011), 2 vom: Juni, Seite 171-190 volume:11 year:2011 number:2 month:06 pages:171-190
sourceStr	Enthalten in Drugs in R & D 11(2011), 2 vom: Juni, Seite 171-190 volume:11 year:2011 number:2 month:06 pages:171-190
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Antihypertensive Drug Carvedilol Antihypertensive Medication Antihypertensive Effect Achievement Rate
dewey-raw	610
isfreeaccess_bool	true
container_title	Drugs in R & D
authorswithroles_txt_mv	Mori, Yoshihiro @@aut@@ Nishikawa, Yasuhiro @@aut@@ Iizuka, Tomoko @@aut@@ Zenimura, Natsuko @@aut@@ Matsumoto, Takuyuki @@aut@@ Hiramatsu, Katsutoshi @@aut@@ Komiya, Masahiro @@aut@@
publishDateDaySort_date	2011-06-01T00:00:00Z
hierarchy_top_id	357171527
dewey-sort	3610
id	SPR033293473
language_de	englisch
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We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. 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author	Mori, Yoshihiro
spellingShingle	Mori, Yoshihiro ddc 610 bkl 44.40 misc Antihypertensive Drug misc Carvedilol misc Antihypertensive Medication misc Antihypertensive Effect misc Achievement Rate Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan
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topic_title	610 ASE 44.40 bkl Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan Antihypertensive Drug (dpeaa)DE-He213 Carvedilol (dpeaa)DE-He213 Antihypertensive Medication (dpeaa)DE-He213 Antihypertensive Effect (dpeaa)DE-He213 Achievement Rate (dpeaa)DE-He213
topic	ddc 610 bkl 44.40 misc Antihypertensive Drug misc Carvedilol misc Antihypertensive Medication misc Antihypertensive Effect misc Achievement Rate
topic_unstemmed	ddc 610 bkl 44.40 misc Antihypertensive Drug misc Carvedilol misc Antihypertensive Medication misc Antihypertensive Effect misc Achievement Rate
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title	Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan
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title_full	Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan
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author_browse	Mori, Yoshihiro Nishikawa, Yasuhiro Iizuka, Tomoko Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro
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title_sort	artist® tablets (carvedilol) for hypertensive patients in japan
title_auth	Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan
abstract	Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.
abstractGer	Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.
abstract_unstemmed	Abstract Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.
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title_short	Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan
url	https://dx.doi.org/10.2165/11592450-000000000-00000
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author2	Nishikawa, Yasuhiro Iizuka, Tomoko Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro
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up_date	2024-07-03T17:46:04.056Z
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We report the results of a drug use survey, which we conducted as a post-marketing survey. Objective: This prospective post-marketing drug use survey was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol) in patients with hypertension in Japan. Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: This was a prospective survey conducted over 3 years from October 1993 to September 1996. The standard observation period for the patients was defined as 12 weeks of treatment with carvedilol. Results: We collected data on 4961 patients at 561 medical institutions who had not been previously treated with carvedilol; 4574 patients were included in the safety analysis and 4422 in the efficacy analysis. The incidence of adverse drug reactions (the proportion of patients with adverse drug reactions) was 4.31% (197 of 4574 patients), which is less than that shown in the pre-approval clinical trial of carvedilol (6.85%[68 of 993]). The most common adverse drug reactions were bradycardia, dizziness, hypotension, headache, and feeling light-headed. After 12 weeks’ treatment with carvedilol, systolic/diastolic blood pressure (SBP/DBP) was reduced from 168.2 ± 18.6/95.7 ± 11.3mmHg at baseline to 144.3 ± 17.3/83.4 ± 10.8mmHg. Patients were classified according to which antihypertensive drug they had been using when carvedilol treatment was initiated. Coadministered agents were calcium channel blockers (CCBs), angiotensinconverting enzyme inhibitors (ACEIs), diuretics, and a-adrenergic receptor antagonists (α-blockers). At 12 weeks, the change in SBP/DBP in the monotherapy group was −22.7/−12.2mmHg and that of each combination therapy subgroup, CCB, ACEI, diuretic, and b-blocker, was −26.1/−12.7mmHg, −25.4/−11.9mmHg, −26.3/−13.0mmHg, and −24.4/−11.5mmHg, respectively. The achievement rates for target BP (<140/90mmHg) were 29.5% in the monotherapy group, 34.8% in the CCB group, 31.3% in the ACEI group, 31.8% in the diuretic group, and 32.4% in the β-blocker group. There was no significant difference in the achievement of target BP among the four combination therapy subgroups (p = 0.475). These results indicate that carvedilol exerts reasonable BP reduction regardless of whether it is used as monotherapy or in combination therapy, and that the effect is not influenced by the coadministered drug. Moreover, carvedilol was also effective in reducing BP levels in elderly patients (≥65 years) and in patients with diabetes mellitus or renal diseases. Conclusions: The results of this study reflect the results of clinical trials up to the time of approval and it was confirmed that carvedilol is a highly useful drug in the treatment of hypertension.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Antihypertensive Drug</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Carvedilol</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Antihypertensive Medication</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Antihypertensive Effect</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Achievement Rate</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield 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Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan

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