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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 (arithmetic mean ± SD) in (a) blood pressure (BP) and (b) pulse rate from baseline at each observation timepoint during the 18-month treatment period in patients with diabetes mellitus complications in the efficacy population. DBP = diastolic BP; SBP = systolic BP; * p < 0.05, *** p < 0.001 (Dunnett’s multiple comparison).
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Fig5: Changes (arithmetic mean ± SD) in (a) blood pressure (BP) and (b) pulse rate from baseline at each observation timepoint during the 18-month treatment period in patients with diabetes mellitus complications in the efficacy population. DBP = diastolic BP; SBP = systolic BP; * p < 0.05, *** p < 0.001 (Dunnett’s multiple comparison).

Mentions: Figure 5 shows changes in BP and pulse rate from baseline at each observation time point in patients with diabetes complications. There was also a stable reduction in BP throughout the 18-month treatment period in this subgroup of patients, as demonstrated by the changes in SBP and DBP from 163.5 ± 17.0 mmHg and 90.4 ± 11.5 mmHg at baseline to 142.2 ± 19.5 mmHg and 80.5 ± 11.1 mmHg in month 6, 138.8 ± 18.8 mmHg and 79.6 ± 13.2 mmHg in month 12, and 137.4 ± 12.4 mmHg and 76.1 ± 8.8 mmHg in month 18 (p < 0.001 for all timepoints), respectively. Mean pulse rate was 74.6 ± 9.0 beats/min at baseline, 68.4 ± 7.7 beats/min in month 6, 70.3 ± 11.4 beats/min in month 12, and 69.3 ± 8.1 beats/min in month 18. Overall, pulse rate was also significantly reduced from baseline in this subgroup (p < 0.001 for month 6; p < 0.05 for month 18), although it was transiently increased at month 12. In terms of the change in values for BP and pulse rate between baseline and the last observation, as well as changes in BP and pulse rate during the 18-month treatment period, the 58 patients with diabetes mellitus complications had similar results to those seen in the 341 patients 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)

Changes (arithmetic mean ± SD) in (a) blood pressure (BP) and (b) pulse rate from baseline at each observation timepoint during the 18-month treatment period in patients with diabetes mellitus complications in the efficacy population. DBP = diastolic BP; SBP = systolic BP; * p < 0.05, *** p < 0.001 (Dunnett’s multiple comparison).
© Copyright Policy
Related In: Results  -  Collection

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

Fig5: Changes (arithmetic mean ± SD) in (a) blood pressure (BP) and (b) pulse rate from baseline at each observation timepoint during the 18-month treatment period in patients with diabetes mellitus complications in the efficacy population. DBP = diastolic BP; SBP = systolic BP; * p < 0.05, *** p < 0.001 (Dunnett’s multiple comparison).
Mentions: Figure 5 shows changes in BP and pulse rate from baseline at each observation time point in patients with diabetes complications. There was also a stable reduction in BP throughout the 18-month treatment period in this subgroup of patients, as demonstrated by the changes in SBP and DBP from 163.5 ± 17.0 mmHg and 90.4 ± 11.5 mmHg at baseline to 142.2 ± 19.5 mmHg and 80.5 ± 11.1 mmHg in month 6, 138.8 ± 18.8 mmHg and 79.6 ± 13.2 mmHg in month 12, and 137.4 ± 12.4 mmHg and 76.1 ± 8.8 mmHg in month 18 (p < 0.001 for all timepoints), respectively. Mean pulse rate was 74.6 ± 9.0 beats/min at baseline, 68.4 ± 7.7 beats/min in month 6, 70.3 ± 11.4 beats/min in month 12, and 69.3 ± 8.1 beats/min in month 18. Overall, pulse rate was also significantly reduced from baseline in this subgroup (p < 0.001 for month 6; p < 0.05 for month 18), although it was transiently increased at month 12. In terms of the change in values for BP and pulse rate between baseline and the last observation, as well as changes in BP and pulse rate during the 18-month treatment period, the 58 patients with diabetes mellitus complications had similar results to those seen in the 341 patients 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