An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)
| Autor: | Yoshio Yasumura, Toshihisa Anzai, Satoshi Yasuda, Toshimitsu Hamasaki, Kiyoshi Mori, Kazuhiko Hashimura, Shin Ito, Fumiki Yoshihara, Masafumi Kitakaze, Haruko Yamamoto, Miki Imazu, Masanori Asakura, Masataka Watanabe |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Time Factors endocrine system diseases Urinary system 030204 cardiovascular system & hematology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Glucosides Japan Risk Factors Internal medicine medicine Albuminuria Humans Multicenter Studies as Topic Diabetic Nephropathies Pharmacology (medical) 030212 general & internal medicine Benzhydryl Compounds Dapagliflozin Sodium-Glucose Transporter 2 Inhibitors Randomized Controlled Trials as Topic Heart Failure Pharmacology business.industry Incidence (epidemiology) Type 2 Diabetes Mellitus General Medicine medicine.disease Treatment Outcome Diabetes Mellitus Type 2 chemistry Heart failure Biomarker (medicine) medicine.symptom Cardiology and Cardiovascular Medicine business Kidney disease |
| Zdroj: | Cardiovascular Drugs and Therapy. 32:183-190 |
| ISSN: | 1573-7241 0920-3206 |
| DOI: | 10.1007/s10557-018-6782-1 |
| Popis: | Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminuria in patients with type 2 diabetes mellitus (T2D). Since albuminuria is a biomarker of not only chronic kidney disease but also cardiovascular events, we hypothesized that, among T2D patients with CHF, SGLT-2 inhibitors will decrease the extent of albuminuria and also improve CHF concomitantly. DAPPER (UMIN000025102) is a multicenter, randomized, open-labeled, parallel-group, standard treatment-controlled study, which is designed to evaluate whether dapagliflozin, one of the SGLT-2 inhibitors, decreases albuminuria in T2D patients with CHF and exerts cardioprotective effects on the failing heart. The patients are randomized to either of the dapagliflozin (5 or 10 mg, once daily orally) or control group (administration of anti-diabetic drugs administered other than SGLT 2 inhibitors). The estimated number of patients that need to be enrolled is 446 in total (223 in each group). The primary objective is the changes in the urinary albumin-to-creatinine ratio from the baseline after 2-year treatment. The key secondary objectives are (1) the safety of dapagliflozin and (2) the cardiovascular and renal efficacies of dapagliflozin. DAPPER study investigates whether dapagliflozin decreases albuminuria and exerts beneficial effects on the failing heart in T2D patients. (UMIN000025102). |
| Databáze: | OpenAIRE |
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