Evaluation of the Long-Term Durability and Glycemic Control of Fasting Plasma Glucose and Glycosylated Hemoglobin for Pioglitazone in Japanese Patients with Type 2 Diabetes
| العنوان: | Evaluation of the Long-Term Durability and Glycemic Control of Fasting Plasma Glucose and Glycosylated Hemoglobin for Pioglitazone in Japanese Patients with Type 2 Diabetes |
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| المؤلفون: | Emiko Koumura, Meindert Danhof, Joost DeJongh, Frances Stringer, Kazuaki Enya, Kohei Kaku |
| المصدر: | Diabetes Technology & Therapeutics. 17:215-223 |
| بيانات النشر: | Mary Ann Liebert Inc, 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, medicine.medical_specialty, endocrine system diseases, medicine.drug_class, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Gastroenterology, Time, Endocrinology, Asian People, Japan, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Prospective Studies, Thiazolidinedione, Prospective cohort study, Aged, Glycemic, Glycated Hemoglobin, Pioglitazone, business.industry, nutritional and metabolic diseases, Type 2 Diabetes Mellitus, Fasting, Original Articles, Middle Aged, medicine.disease, Medical Laboratory Technology, Treatment Outcome, Diabetes Mellitus, Type 2, Pharmacodynamics, Drug Therapy, Combination, Female, Thiazolidinediones, business, medicine.drug |
| الوصف: | This study applied a pharmacodynamic model-based approach to evaluate the long-term durability and glycemic control of pioglitazone in comparison with other oral glucose-lowering drugs in Japanese type 2 diabetes mellitus (T2DM) patients.Japanese T2DM patients were enrolled in a prospective, randomized, open-label, blinded-end point study and received pioglitazone with or without other oral glucose-lowering drugs (excluding another thiazolidinedione [TZD]) (n=293) or oral glucose-lowering drugs excluding TZD (n=294). Treatment was adjusted to achieve glycosylated hemoglobin (HbA1c)6.9%, and samples for fasting plasma glucose (FPG) and HbA1c were collected over 2.5-4 years. A simultaneous cascading indirect response model structure was applied to describe the time course of FPG and HbA1c. HbA1c levels were described using both an FPG-dependent and an FPG-independent function. To account for titration, drug effects for both treatment groups were implemented using a time-dependent Emax model.Pioglitazone was superior in both time to maximum effect and the magnitude of reduction achieved in FPG and HbA1c. A greater reduction in median FPG (-21 mg/dL vs. -9 mg/dL) was observed with pioglitazone (P0.05). Maximum drug effect for FPG was predicted to occur earlier (11 months) for pioglitazone than for the control group (14 months). The simulated additional reduction in FPG and HbA1c achieved with pioglitazone was predicted to be maintained beyond the currently observed study duration.Pioglitazone was found to result in improved glycemic control and durability compared with control treatment. This model-based approach enabled the quantification of differences in FPG and HbA1c for both treatment groups and simulation to evaluate longer-term durability on FPG and HbA1c. |
| تدمد: | 1557-8593 1520-9156 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b8fc17a81a6a8c9fe49a629bfceefcaf https://doi.org/10.1089/dia.2014.0222 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b8fc17a81a6a8c9fe49a629bfceefcaf |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15578593 15209156 |
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