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Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey
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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585767/ https://www.ncbi.nlm.nih.gov/pubmed/21679008 http://dx.doi.org/10.2165/11592460-000000000-00000 |
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author | Iizuka, Tomoko Nishikawa, Yasuhiro Mori, Yoshihiro Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro |
author_facet | Iizuka, Tomoko Nishikawa, Yasuhiro Mori, Yoshihiro Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro |
author_sort | Iizuka, Tomoko |
collection | PubMed |
description | 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 long-term special survey that we conducted as a post-marketing survey. Objective: The results of a prospective post-marketing survey that was conducted to assess the safety and efficacy of the b-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20mg (carvedilol) in patients with hypertension in Japan, were investigated in order to examine the safety and efficacy of the drug during long-term treatment (18 months). Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: We performed this survey as a prospective cohort study (special survey) utilizing a centralized registration method over 3 years (starting from April 1994), for an observation period of 18 months of carvedilol treatment. Results: Sixty-one medical institutions across Japan collected 380 case report forms of patients who received long-term administration of carvedilol, with 363 and 341 cases evaluated for safety and efficacy, respectively. The discontinuation rate was 7.2% and the incidence of adverse drug reactions was 5.23% (19 of 363) in the safety population. There was no significant change in fasting plasma glucose levels from baseline (118.1 ± 46.5mg/dL) to after carvedilol treatment (114.6 ± 43.3 mg/dL) [n = 141; p = 0.310]. In 341 evaluable patients in the efficacy population, decreases in both blood pressure and pulse rate were statistically significant at all assessment points in comparison with baseline data (p < 0.001). Similarly, in hypertensive patients with diabetes mellitus, decreases in blood pressure were statistically significant at all assessment points in comparison with baseline data (p < 0.001). Conclusions: The results of this study show that carvedilol exerted stable antihypertensive effects leading to favorable blood pressure control throughout long-term treatment, without showing any safety concerns. It was concluded that there were no clinically significant issues in terms of safety or efficacy with the long-term treatment of carvedilol in patients with hypertension. |
format | Online Article Text |
id | pubmed-3585767 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-35857672013-03-07 Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey Iizuka, Tomoko Nishikawa, Yasuhiro Mori, Yoshihiro Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro Drugs R D Original Research Article 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 long-term special survey that we conducted as a post-marketing survey. Objective: The results of a prospective post-marketing survey that was conducted to assess the safety and efficacy of the b-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20mg (carvedilol) in patients with hypertension in Japan, were investigated in order to examine the safety and efficacy of the drug during long-term treatment (18 months). Patients: Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension. Methods: We performed this survey as a prospective cohort study (special survey) utilizing a centralized registration method over 3 years (starting from April 1994), for an observation period of 18 months of carvedilol treatment. Results: Sixty-one medical institutions across Japan collected 380 case report forms of patients who received long-term administration of carvedilol, with 363 and 341 cases evaluated for safety and efficacy, respectively. The discontinuation rate was 7.2% and the incidence of adverse drug reactions was 5.23% (19 of 363) in the safety population. There was no significant change in fasting plasma glucose levels from baseline (118.1 ± 46.5mg/dL) to after carvedilol treatment (114.6 ± 43.3 mg/dL) [n = 141; p = 0.310]. In 341 evaluable patients in the efficacy population, decreases in both blood pressure and pulse rate were statistically significant at all assessment points in comparison with baseline data (p < 0.001). Similarly, in hypertensive patients with diabetes mellitus, decreases in blood pressure were statistically significant at all assessment points in comparison with baseline data (p < 0.001). Conclusions: The results of this study show that carvedilol exerted stable antihypertensive effects leading to favorable blood pressure control throughout long-term treatment, without showing any safety concerns. It was concluded that there were no clinically significant issues in terms of safety or efficacy with the long-term treatment of carvedilol in patients with hypertension. Springer International Publishing 2012-11-27 2011-06 /pmc/articles/PMC3585767/ /pubmed/21679008 http://dx.doi.org/10.2165/11592460-000000000-00000 Text en © Iizuka et al., publisher and licensee Adis Data Information BV 2011 |
spellingShingle | Original Research Article Iizuka, Tomoko Nishikawa, Yasuhiro Mori, Yoshihiro Zenimura, Natsuko Matsumoto, Takuyuki Hiramatsu, Katsutoshi Komiya, Masahiro Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title | Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title_full | Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title_fullStr | Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title_full_unstemmed | Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title_short | Artist® Tablets (Carvedilol) for Hypertensive Patients in Japan: Results of a Long-Term Special Survey |
title_sort | artist® tablets (carvedilol) for hypertensive patients in japan: results of a long-term special survey |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585767/ https://www.ncbi.nlm.nih.gov/pubmed/21679008 http://dx.doi.org/10.2165/11592460-000000000-00000 |
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