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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 (safety population) and reasons for dropping out or discontinuing carvedilol treatment
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Tab1: Patient disposition (safety population) and reasons for dropping out or discontinuing carvedilol treatment

Mentions: Of 363 patients in the safety population, 224 (61.7%) continued carvedilol treatment for 18 months or longer, while 139 (38.3%) dropped out or discontinued treatment during the course of the survey. Table I shows patient disposition and the reasons why patients dropped out or discontinued carvedilol treatment. A total of 26 patients (7.2%) discontinued carvedilol treatment for the following reasons: occurrence of ADRs (n = 7); inefficacy (n = 12); and an excessive decrease in BP (n = 7). Among the patients who dropped out from the survey, 86 did not revisit the medical institution for reasons such as 27 had changed hospitals, 14 were too busy, 12 had improvement of subjective symptoms, and eight had moved to a new place. The remaining 27 patients dropped out or discontinued treatment due to other reasons such as the patient’s own judgment/will (n = 6), onset of a new concomitant disease (n = 5), priority in treatment of other complications (n = 4), or introduction of the patient to a new physician (n = 3).


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 (safety population) and reasons for dropping out or discontinuing carvedilol treatment
© Copyright Policy
Related In: Results  -  Collection

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

Tab1: Patient disposition (safety population) and reasons for dropping out or discontinuing carvedilol treatment
Mentions: Of 363 patients in the safety population, 224 (61.7%) continued carvedilol treatment for 18 months or longer, while 139 (38.3%) dropped out or discontinued treatment during the course of the survey. Table I shows patient disposition and the reasons why patients dropped out or discontinued carvedilol treatment. A total of 26 patients (7.2%) discontinued carvedilol treatment for the following reasons: occurrence of ADRs (n = 7); inefficacy (n = 12); and an excessive decrease in BP (n = 7). Among the patients who dropped out from the survey, 86 did not revisit the medical institution for reasons such as 27 had changed hospitals, 14 were too busy, 12 had improvement of subjective symptoms, and eight had moved to a new place. The remaining 27 patients dropped out or discontinued treatment due to other reasons such as the patient’s own judgment/will (n = 6), onset of a new concomitant disease (n = 5), priority in treatment of other complications (n = 4), or introduction of the patient to a new physician (n = 3).

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