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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 (all patients)
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Tab6: Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (all patients)

Mentions: Table VI shows changes in BP and pulse rate from baseline at the last observation time (or at dropout/discontinuation of treatment) for patients among the 341 in the efficacy population who underwent BP or pulse rate measurements. The respective mean values of SBP and DBP were 166.7 ± 17.4 mmHg and 93.6 ± 11.4 mmHg at baseline, and 142.1 ± 17.4 mmHg and 81.5 ± 12.0 mmHg at the last observation; the change in value (the last observation value subtracted by the baseline value) was −24.6 mmHg for SBP and −12.1 mmHg for DBP. Hence, a significant reduction was observed for SBP and DBP (p < 0.001 for both). Mean pulse rate was 74.5 ± 11.0 beats per minute (beats/min) at baseline and 68.7 ± 9.4 beats/min at the last observation, giving a change in value of −5.8 beats/min, indicating a significant decrease in pulse rate (p < 0.001).


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 (all patients)
© Copyright Policy
Related In: Results  -  Collection

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

Tab6: Changes from baseline in blood pressure (BP) and pulse rate in the efficacy population (all patients)
Mentions: Table VI shows changes in BP and pulse rate from baseline at the last observation time (or at dropout/discontinuation of treatment) for patients among the 341 in the efficacy population who underwent BP or pulse rate measurements. The respective mean values of SBP and DBP were 166.7 ± 17.4 mmHg and 93.6 ± 11.4 mmHg at baseline, and 142.1 ± 17.4 mmHg and 81.5 ± 12.0 mmHg at the last observation; the change in value (the last observation value subtracted by the baseline value) was −24.6 mmHg for SBP and −12.1 mmHg for DBP. Hence, a significant reduction was observed for SBP and DBP (p < 0.001 for both). Mean pulse rate was 74.5 ± 11.0 beats per minute (beats/min) at baseline and 68.7 ± 9.4 beats/min at the last observation, giving a change in value of −5.8 beats/min, indicating a significant decrease in pulse rate (p < 0.001).

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