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Artist® tablets (carvedilol) for hypertensive patients in Japan: results of a long-term special survey.

Iizuka T, Nishikawa Y, Mori Y, Zenimura N, Matsumoto T, Hiramatsu K, Komiya M - Drugs R D (2011)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Post Marketing Study Management Department, Daiichi Sankyo Co., Ltd., Tokyo, 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 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 β-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20 mg (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 ± 46.5 mg/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.

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Related in: MedlinePlus

Patient disposition.
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Related In: Results  -  Collection


getmorefigures.php?uid=PMC3585767&req=5

Fig1: Patient disposition.

Mentions: The disposition of patients in the survey is shown in figure 1. A total of 401 patients were registered. Case report forms were collected from 380 patients at 61 medical institutions. Among the 380 patients, ten received carvedilol during periods other than the survey period, two started the drug before a contract was completed, one provided two case report forms, and four failed to revisit the medical institution after the initial visit and were not evaluated for the presence/absence of ADRs; these 17 patients were excluded from the safety analyses and the remaining 363 patients were included in the safety population. In the safety population, one patient had unknown target disease and 21 were not evaluated for efficacy (BP control); these 22 patients were excluded from the efficacy analyses, and the remaining 341 patients were included in the efficacy population.


Artist® tablets (carvedilol) for hypertensive patients in Japan: results of a long-term special survey.

Iizuka T, Nishikawa Y, Mori Y, Zenimura N, Matsumoto T, Hiramatsu K, Komiya M - Drugs R D (2011)

Patient disposition.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585767&req=5

Fig1: Patient disposition.
Mentions: The disposition of patients in the survey is shown in figure 1. A total of 401 patients were registered. Case report forms were collected from 380 patients at 61 medical institutions. Among the 380 patients, ten received carvedilol during periods other than the survey period, two started the drug before a contract was completed, one provided two case report forms, and four failed to revisit the medical institution after the initial visit and were not evaluated for the presence/absence of ADRs; these 17 patients were excluded from the safety analyses and the remaining 363 patients were included in the safety population. In the safety population, one patient had unknown target disease and 21 were not evaluated for efficacy (BP control); these 22 patients were excluded from the efficacy analyses, and the remaining 341 patients were included in the efficacy population.

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Post Marketing Study Management Department, Daiichi Sankyo Co., Ltd., Tokyo, 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 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 β-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20 mg (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 ± 46.5 mg/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.

Show MeSH
Related in: MedlinePlus