Post-marketing Special Survey of the Efficacy and Safety of Gliclazide (Glmicron) on Type 2 Diabetes Patients with Mild Disease Severity or Being Treated Only with an Alpha Glucosidase Inhibitor without Sufficient Efficacy
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Accession number;03A0794396
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| Title;Post-marketing Special Survey of the Efficacy and Safety of Gliclazide (Glmicron) on Type 2 Diabetes Patients with Mild Disease Severity or Being Treated Only with an Alpha Glucosidase Inhibitor without Sufficient Efficacy |
| Author;
KAWAMORI RYUZO
(Juntendo Univ., School of Medicine, JPN)
TAKAHASHI KIYOHITO
(Naikatakahashikiyohitokurinikku)
FUNAYAMA HIDEAKI
(Funayamanaika)
DOI KUNIHIRO
(Doinaika)
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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.19;NO.10;PAGE.1157-1174(2003)
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| Figure&Table&Reference;FIG.6, TBL.17, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A post-marketing survey was conducted to collect information on the efficacy and safety of gliclazide administered to Type 2 diabetes patients whose disease severity was mild or who were treated only with an alpha-glucosidase inhibitor. The purpose of this survey was to evaluate an appropriate use of gliclazide for Type 2 diabetes patients. 1) The surveyed patients were classified into Group A, gliclazide monotherapy, including 155 patients; and Group B, add-on therapy of gliclazide to alpha-glucosidase inhibitor, including 61 patients. The efficacy of gliclazide on 149 patients in Group A and 58 patients in Group B was evaluated (18 patients in all were excluded from the efficacy evaluation). 2) No statistical bias affecting the correct evaluation of the study results was found in demographic data of the surveyed patients. 3) HbA1c, glucoalbumin and blood glucose (fasting and postprandial state) after treatment with gliclazide was significantly decreased in both of Group A and Group B, consequently it was suggested that the blood glucose of the patients in both groups was controlled well. 4) The mean doses of gliclazide in the surveyed patients slightly increased to 35.5 .+-. 24.8mg/day in Group A and 34.1 .+-. 30.0mg/day in Group B, from 29.8 .+-. 16.9mg/day in Group A and 29.0 .+-. 26.3mg/day in Group B before treatment with gliclazide. 5) The incidence of adverse reactions was 5.16% (8/155) and 8.20% (5/61) in Group A and Group B, respectively. The incidence of adverse reactions in Group B was a little higher than that in Group A with no statistically significant difference, suggesting no safety problems for gliclazide. 6) The efficacy of gliclazide was evaluated as "improved" or "markedly improved" in 89.1% of cases in Group A and 94.5% of cases in Group B.... (author abst.) |
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