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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 in fasting blood glucose levels (arithmetic mean ± SD) from baseline to each observation timepoint during the 18-month treatment period in the safety population. *p < 0.05 (Dunnett’s multiple comparison).
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Fig3: Changes in fasting blood glucose levels (arithmetic mean ± SD) from baseline to each observation timepoint during the 18-month treatment period in the safety population. *p < 0.05 (Dunnett’s multiple comparison).

Mentions: This survey was for use of carvedilol in daily clinical practice and did not always require laboratory tests. However, because many β-blockers are likely to adversely affect glucose metabolism, a change from baseline to the last observation time (or dropout/discontinuation of treatment) was examined for fasting blood glucose, an indicator of glucose metabolism alterations. Figure 2 illustrates the change in fasting blood glucose levels in patients with both baseline and last observation values among the 363 patients in the safety population. Mean fasting blood glucose was 118.1 ± 46.5 mg/dL at baseline and 114.6 ± 43.3 mg/dL at the last observation, giving a change in value of -3.5 mg/dL (p = 0.310; not significant). Figure 3 shows changes in fasting blood glucose levels from baseline at each observation timepoint (months 6, 12, and 18). Mean fasting blood glucose was 117.7 ± 44.8 mg/dL at baseline, 117.1 ± 37.9 mg/dL at month 6, 112.4 ± 34.6 mg/dL at month 12 (p < 0.05 vs baseline), and 111.8 ± 39.0 mg/dL at month 18. Thus, no increase in fasting blood glucose was seen throughout the 18-month observation period.


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 in fasting blood glucose levels (arithmetic mean ± SD) from baseline to each observation timepoint during the 18-month treatment period in the safety population. *p < 0.05 (Dunnett’s multiple comparison).
© Copyright Policy
Related In: Results  -  Collection

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

Fig3: Changes in fasting blood glucose levels (arithmetic mean ± SD) from baseline to each observation timepoint during the 18-month treatment period in the safety population. *p < 0.05 (Dunnett’s multiple comparison).
Mentions: This survey was for use of carvedilol in daily clinical practice and did not always require laboratory tests. However, because many β-blockers are likely to adversely affect glucose metabolism, a change from baseline to the last observation time (or dropout/discontinuation of treatment) was examined for fasting blood glucose, an indicator of glucose metabolism alterations. Figure 2 illustrates the change in fasting blood glucose levels in patients with both baseline and last observation values among the 363 patients in the safety population. Mean fasting blood glucose was 118.1 ± 46.5 mg/dL at baseline and 114.6 ± 43.3 mg/dL at the last observation, giving a change in value of -3.5 mg/dL (p = 0.310; not significant). Figure 3 shows changes in fasting blood glucose levels from baseline at each observation timepoint (months 6, 12, and 18). Mean fasting blood glucose was 117.7 ± 44.8 mg/dL at baseline, 117.1 ± 37.9 mg/dL at month 6, 112.4 ± 34.6 mg/dL at month 12 (p < 0.05 vs baseline), and 111.8 ± 39.0 mg/dL at month 18. Thus, no increase in fasting blood glucose was seen throughout the 18-month observation period.

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