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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

Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (patients with diabetes mellitus complications)
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Tab7: Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (patients with diabetes mellitus complications)

Mentions: Regarding the 58 patients with diabetes complications among the 341 in the efficacy population for whom measurements were taken, table VII shows changes in BP and pulse rate from baseline to the last observation time (or at dropout/discontinuation of treatment). Mean SBP and DBP were 163.5 ± 17.0 mmHg and 90.4 ± 11.5 mmHg at baseline, and 142.1 ± 20.1 mmHg and 77.7 ± 12.3 mmHg at the last observation; the change in values (the last observation value subtracted by the baseline value) for SBP and DBP were -21.4 mmHg and -12.7 mmHg, respectively. Thus, in this subgroup of patients, there was also a significant decrease in SBP and DBP (p < 0.001 for both). Mean pulse rate was 74.7 ± 9.1 beats/min at baseline and 70.4 ± 10.9 beats/min at the last observation, and the change in value was −4.2 beats/min, indicating a significant decrease in pulse rate (p = 0.031).


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)

Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (patients with diabetes mellitus complications)
© Copyright Policy
Related In: Results  -  Collection

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

Tab7: Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (patients with diabetes mellitus complications)
Mentions: Regarding the 58 patients with diabetes complications among the 341 in the efficacy population for whom measurements were taken, table VII shows changes in BP and pulse rate from baseline to the last observation time (or at dropout/discontinuation of treatment). Mean SBP and DBP were 163.5 ± 17.0 mmHg and 90.4 ± 11.5 mmHg at baseline, and 142.1 ± 20.1 mmHg and 77.7 ± 12.3 mmHg at the last observation; the change in values (the last observation value subtracted by the baseline value) for SBP and DBP were -21.4 mmHg and -12.7 mmHg, respectively. Thus, in this subgroup of patients, there was also a significant decrease in SBP and DBP (p < 0.001 for both). Mean pulse rate was 74.7 ± 9.1 beats/min at baseline and 70.4 ± 10.9 beats/min at the last observation, and the change in value was −4.2 beats/min, indicating a significant decrease in pulse rate (p = 0.031).

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