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
N1 - Funding Information:
Acknowledgements This report is part of a Health Sciences Research Project (`A pilot study of the Japanese version of Prescription-Event Monitoring' 1998.4-2001.3) supported by the Ministry of Health and Welfare. The Japan Pharmaceutical Association (JPA), Japanese Society of Hospital Pharmacies (JSHP), and Japan Medical Association Research Institute (JMARI) are participating in this research.
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
SN - 0031-6970
VL - 56
SP - 831
EP - 838
JO - European Journal of Clinical Pharmacology
JF - European Journal of Clinical Pharmacology
IS - 11
ER -