Use-result surveillance of Azelnidipine (Calblock Tab)
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Accession number;05A0483226
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| Title;Use-result surveillance of Azelnidipine (Calblock Tab) |
| Author;
KITAI TOSHIO
(Sankyo Co., Ltd., JPN)
MURATA ETSURO
(Sankyo Co., Ltd., JPN)
UEHARA YASUJIRO
(Sankyo Co., Ltd., JPN)
IWASHITA MIKIO
(Sankyo Co., Ltd., JPN)
ISHIHARA YOKO
(Sankyo Co., Ltd., JPN)
YAGINUMA MAI
(Sankyo Co., Ltd., JPN)
ISHIKAWA YOSUKE
(Sankyo Co., Ltd., JPN)
KODAMA HIROKO
(Sankyo Co., Ltd., JPN)
KURAMOTO KIZUKU
(Tokyo Metropolitan Geriatric Medical Center, JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.21;NO.5;PAGE.511-527(2005)
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| Figure&Table&Reference;FIG.1, TBL.8, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;[Objectives] The results of clinical experience of azelnidipine (Calblock tablets) were investigated to detect problems in safety and efficacy of the drug used under routine medical care at an early stage, and to obtain other information on the proper use of the drug. [Study design] Use-result surveillance (case series study) [Methods] The survey was performed by centralized registration method with the registration period of one year from the initial marketing of azelnidipine (May 2003). Registered patients were treated with azelnidipine for 12 week. Patient baseline characteristics as well as the use status of the drug during treatment, concomitant drugs, blood pressure, laboratory data, and occurrences of adverse events were collected. [Results] The CRFs were collected from 5,292 of 5,303 patients registered in the survey. The percentage of patients developing adverse reactions was 3.5% among 5,146 safety-evaluable patients in this survey. Major adverse reactions included headache, dizziness, abnormal hepatic function, rash, increased .GAMMA.-GTP, increased blood urea nitrogen, and increased alanine aminotransferase. Major adverse reactions that had not been observed before the approval of the drug were increased .GAMMA.-GTP in 17 patients (0.3%), abnormal hepatic function in 12 patients (0.2%), abnormal feeling in 6 patients (0.1%), nausea in 5 patients (0.1%), stomach discomfort in 5 patients (0.1%), increased blood creatinine in 5 patients (0.1%), and increased blood triglycerides in 5 patients (0.1%). Significant associations between baseline characteristic and incidence of adverse reaction were observed in following factors: presence of hepatic disease, predisposition to hypersensitivity (to drugs) and concomitant drugs including antihypertensive drugs (all types), .BETA.-blockers, calcium antagonist (diltiazem) and cyclosporine.... (author abst.) |
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