Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics

Kiyoshi Kubota, Eri Kawabe, Shiro Hinotsu, Chikuma Hamada, Yasuo Ohashi, Kiyoshi Kurokawa

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objective: To examine adverse events reported in a pilot study of the prescription-event monitoring in Japan (J-PEM) scheme, comparing troglitazone with other oral hypoglycemics. Methods: We used a cohort study with a concurrent control in which information was gathered from both doctors and pharmacists. Crude event rates were calculated and compared between troglitazone (T) and alternative oral hypoglycemics (control drugs, C) using the likelihood ratio test. When the difference was statistically significant, possible confounding mechanisms were examined using Poisson regression analysis. Results: Of 3115 patient codes registered, pharmacists were sent 2078 questionnaires and returned 1814 (87%), while doctors were sent 1858 questionnaires and returned 671 (36%). The difference in crude rates was statistically significant in 11 events (seven where T > C and four where C > T) reported by pharmacists and ten events (three where T > C and seven where C > T) reported by doctors. Among those, in two events, "weight increased" (T > C) and "abnormal hepatic function" (T > C), significant differences were observed in data from both doctors and pharmacists. Regression analysis revealed that the difference in crude rates for "nausea" (T > C) was possibly due to an uneven distribution of genders and that for "weight increased" (T > C) was possibly due to an uneven distribution of compliance. Patients with hepatic function abnormalities associated with troglitazone could be divided into two subtypes: one with a slight increase in serum lactate dehydrogenase concentration only and the other with elevated serum alanine aminotransferase. Conclusions: Comparison of the event rates between troglitazone and control drugs, followed by regression analysis, revealed several features of adverse events associated with drugs, including possible confounding mechanisms. Troglitazone-induced hepatic function abnormalities may be divided into two subtypes.

Original languageEnglish
Pages (from-to)831-838
Number of pages8
JournalEuropean Journal of Clinical Pharmacology
Volume56
Issue number11
DOIs
Publication statusPublished - 2001
Externally publishedYes

Fingerprint

troglitazone
Hypoglycemic Agents
Prescriptions
Japan
Pharmacists
Regression Analysis
Liver
Weights and Measures
Drug and Narcotic Control
Serum
Alanine Transaminase
L-Lactate Dehydrogenase
Nausea
Compliance
Cohort Studies

Keywords

  • Cohort study
  • Prescription-event monitoring
  • Troglitazone

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics. / Kubota, Kiyoshi; Kawabe, Eri; Hinotsu, Shiro; Hamada, Chikuma; Ohashi, Yasuo; Kurokawa, Kiyoshi.

In: European Journal of Clinical Pharmacology, Vol. 56, No. 11, 2001, p. 831-838.

Research output: Contribution to journalArticle

Kubota, Kiyoshi ; Kawabe, Eri ; Hinotsu, Shiro ; Hamada, Chikuma ; Ohashi, Yasuo ; Kurokawa, Kiyoshi. / Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics. In: European Journal of Clinical Pharmacology. 2001 ; Vol. 56, No. 11. pp. 831-838.
@article{fa1969ceb84a4ee59f1385cfa3040a05,
title = "Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics",
abstract = "Objective: To examine adverse events reported in a pilot study of the prescription-event monitoring in Japan (J-PEM) scheme, comparing troglitazone with other oral hypoglycemics. Methods: We used a cohort study with a concurrent control in which information was gathered from both doctors and pharmacists. Crude event rates were calculated and compared between troglitazone (T) and alternative oral hypoglycemics (control drugs, C) using the likelihood ratio test. When the difference was statistically significant, possible confounding mechanisms were examined using Poisson regression analysis. Results: Of 3115 patient codes registered, pharmacists were sent 2078 questionnaires and returned 1814 (87{\%}), while doctors were sent 1858 questionnaires and returned 671 (36{\%}). The difference in crude rates was statistically significant in 11 events (seven where T > C and four where C > T) reported by pharmacists and ten events (three where T > C and seven where C > T) reported by doctors. Among those, in two events, {"}weight increased{"} (T > C) and {"}abnormal hepatic function{"} (T > C), significant differences were observed in data from both doctors and pharmacists. Regression analysis revealed that the difference in crude rates for {"}nausea{"} (T > C) was possibly due to an uneven distribution of genders and that for {"}weight increased{"} (T > C) was possibly due to an uneven distribution of compliance. Patients with hepatic function abnormalities associated with troglitazone could be divided into two subtypes: one with a slight increase in serum lactate dehydrogenase concentration only and the other with elevated serum alanine aminotransferase. Conclusions: Comparison of the event rates between troglitazone and control drugs, followed by regression analysis, revealed several features of adverse events associated with drugs, including possible confounding mechanisms. Troglitazone-induced hepatic function abnormalities may be divided into two subtypes.",
keywords = "Cohort study, Prescription-event monitoring, Troglitazone",
author = "Kiyoshi Kubota and Eri Kawabe and Shiro Hinotsu and Chikuma Hamada and Yasuo Ohashi and Kiyoshi Kurokawa",
year = "2001",
doi = "10.1007/s002280000232",
language = "English",
volume = "56",
pages = "831--838",
journal = "European Journal of Clinical Pharmacology",
issn = "0031-6970",
publisher = "Springer Verlag",
number = "11",

}

TY - JOUR

T1 - Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics

AU - Kubota, Kiyoshi

AU - Kawabe, Eri

AU - Hinotsu, Shiro

AU - Hamada, Chikuma

AU - Ohashi, Yasuo

AU - Kurokawa, Kiyoshi

PY - 2001

Y1 - 2001

N2 - Objective: To examine adverse events reported in a pilot study of the prescription-event monitoring in Japan (J-PEM) scheme, comparing troglitazone with other oral hypoglycemics. Methods: We used a cohort study with a concurrent control in which information was gathered from both doctors and pharmacists. Crude event rates were calculated and compared between troglitazone (T) and alternative oral hypoglycemics (control drugs, C) using the likelihood ratio test. When the difference was statistically significant, possible confounding mechanisms were examined using Poisson regression analysis. Results: Of 3115 patient codes registered, pharmacists were sent 2078 questionnaires and returned 1814 (87%), while doctors were sent 1858 questionnaires and returned 671 (36%). The difference in crude rates was statistically significant in 11 events (seven where T > C and four where C > T) reported by pharmacists and ten events (three where T > C and seven where C > T) reported by doctors. Among those, in two events, "weight increased" (T > C) and "abnormal hepatic function" (T > C), significant differences were observed in data from both doctors and pharmacists. Regression analysis revealed that the difference in crude rates for "nausea" (T > C) was possibly due to an uneven distribution of genders and that for "weight increased" (T > C) was possibly due to an uneven distribution of compliance. Patients with hepatic function abnormalities associated with troglitazone could be divided into two subtypes: one with a slight increase in serum lactate dehydrogenase concentration only and the other with elevated serum alanine aminotransferase. Conclusions: Comparison of the event rates between troglitazone and control drugs, followed by regression analysis, revealed several features of adverse events associated with drugs, including possible confounding mechanisms. Troglitazone-induced hepatic function abnormalities may be divided into two subtypes.

AB - Objective: To examine adverse events reported in a pilot study of the prescription-event monitoring in Japan (J-PEM) scheme, comparing troglitazone with other oral hypoglycemics. Methods: We used a cohort study with a concurrent control in which information was gathered from both doctors and pharmacists. Crude event rates were calculated and compared between troglitazone (T) and alternative oral hypoglycemics (control drugs, C) using the likelihood ratio test. When the difference was statistically significant, possible confounding mechanisms were examined using Poisson regression analysis. Results: Of 3115 patient codes registered, pharmacists were sent 2078 questionnaires and returned 1814 (87%), while doctors were sent 1858 questionnaires and returned 671 (36%). The difference in crude rates was statistically significant in 11 events (seven where T > C and four where C > T) reported by pharmacists and ten events (three where T > C and seven where C > T) reported by doctors. Among those, in two events, "weight increased" (T > C) and "abnormal hepatic function" (T > C), significant differences were observed in data from both doctors and pharmacists. Regression analysis revealed that the difference in crude rates for "nausea" (T > C) was possibly due to an uneven distribution of genders and that for "weight increased" (T > C) was possibly due to an uneven distribution of compliance. Patients with hepatic function abnormalities associated with troglitazone could be divided into two subtypes: one with a slight increase in serum lactate dehydrogenase concentration only and the other with elevated serum alanine aminotransferase. Conclusions: Comparison of the event rates between troglitazone and control drugs, followed by regression analysis, revealed several features of adverse events associated with drugs, including possible confounding mechanisms. Troglitazone-induced hepatic function abnormalities may be divided into two subtypes.

KW - Cohort study

KW - Prescription-event monitoring

KW - Troglitazone

UR - http://www.scopus.com/inward/record.url?scp=0035230314&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035230314&partnerID=8YFLogxK

U2 - 10.1007/s002280000232

DO - 10.1007/s002280000232

M3 - Article

C2 - 11294374

AN - SCOPUS:0035230314

VL - 56

SP - 831

EP - 838

JO - European Journal of Clinical Pharmacology

JF - European Journal of Clinical Pharmacology

SN - 0031-6970

IS - 11

ER -