title: 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).
  
  
  METHODS
  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.affiliation: Post Marketing Study Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Iizuka
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Nishikawa
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Mori
authors.forename: Natsuko
authors.initials: N
authors.lastname: Zenimura
authors.forename: Takuyuki
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Hiramatsu
authors.forename: Masahiro
authors.initials: M
authors.lastname: Komiya
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D002986:Clinical Trials as Topic; D000081005:Cyclohexane Monoterpenes; D048909:Diabetes Complications / Q000503:physiopathology; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000453:epidemiology; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006331:Heart Diseases / Q000150:complications / Q000453:epidemiology; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D015994:Incidence; D007564:Japan; D007674:Kidney Diseases / Q000150:complications / Q000453:epidemiology; D008107:Liver Diseases / Q000150:complications / Q000453:epidemiology; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D039821:Monoterpenes / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D010352:Patient Dropouts / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013607:Tablets; D016896:Treatment Outcome; D028761:Withholding Treatment / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D000081005:Cyclohexane Monoterpenes; D007004:Hypoglycemic Agents; D039821:Monoterpenes; D013607:Tablets; C075856:carveol