Artist® tablets (carvedilol) for hypertensive patients in Japan: results of a long-term special survey.

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.

• Authors: Tomoko Iizuka, Yasuhiro Nishikawa, Yoshihiro Mori, Natsuko Zenimura, Takuyuki Matsumoto, Katsutoshi Hiramatsu, Masahiro Komiya
• Journal: Drugs in R&D (Drugs R D) Vol. 11 Issue 2 Pg. 191-205 ( 2011) ISSN: 1179-6901 [Electronic] New Zealand
• PMID: 21679008 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Cyclohexane Monoterpenes
• Hypoglycemic Agents
• Monoterpenes
• Tablets
• carveol

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Blood Glucose (drug effects)
• Blood Pressure (drug effects, physiology)
• Clinical Trials as Topic
• Cyclohexane Monoterpenes
• Diabetes Complications (physiopathology)
• Diabetes Mellitus (drug therapy, epidemiology)
• Drug Therapy, Combination
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Heart Diseases (complications, epidemiology)
• Heart Rate (drug effects, physiology)
• Humans
• Hypertension (complications, diagnosis, drug therapy, epidemiology, physiopathology)
• Hypoglycemic Agents (therapeutic use)
• Incidence
• Japan
• Kidney Diseases (complications, epidemiology)
• Liver Diseases (complications, epidemiology)
• Long-Term Care
• Male
• Middle Aged
• Monoterpenes (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Patient Dropouts (statistics & numerical data)
• Product Surveillance, Postmarketing
• Prospective Studies
• Tablets
• Treatment Outcome
• Withholding Treatment (statistics & numerical data)
• Young Adult