Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial
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| Názov: | Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial |
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| Autori: | Bakris, George L, Agarwal, Rajiv, Chan, Juliana C., Cooper, Mark E., Gansevoort, Ron T., Haller, Hermann, Remuzzi, Giuseppe, Rossing, Peter, Schmieder, Roland E., Nowack, Christina, Kolkhof, Peter, Joseph, Amer, Pieper, Alexander, Kimmeskamp Kirschbaum, Nina, Ruilope, Luis M., DEL PRATO, STEFANO |
| Zdroj: | JAMA. 314:884 |
| Informácie o vydavateľovi: | American Medical Association (AMA), 2015. |
| Rok vydania: | 2015 |
| Predmety: | Mineralocorticoid receptor antagonists - therapeutic use, Male, 0301 basic medicine, Dose-response relationship, Administration, Oral, Angiotensin-Converting Enzyme Inhibitors, Blood Pressure, oral, Diabetes mellitus, 0302 clinical medicine, Diabetic Nephropathies, Analysis of variance, Middle aged, Diabetic nephropathies - physiopathology, Mineralocorticoid Receptor Antagonists, 2. Zero hunger, Diabetic nephropathies - ethnology, Incidence, Potassium - blood, drug, Middle Aged, 16. Peace & justice, 3. Good health, Angiotensin-converting enzyme inhibitors - therapeutic use, type 2 - complications, Creatinine, Administration, Female, Least-squares analysis, Drug, Type 2, Glomerular Filtration Rate, Oral, Double-blind method, Diabetic nephropathies - urine, Glomerular filtration rate - drug effects, Hyperkalemia - epidemiology, Drug Administration Schedule, Dose-Response Relationship, Angiotensin Receptor Antagonists, 03 medical and health sciences, Double-Blind Method, Diabetic nephropathies - drug therapy, Diabetes Mellitus, Albuminuria, Humans, Naphthyridines, Least-Squares Analysis, Aged, Creatinine - urine, Analysis of Variance, Dose-Response Relationship, Drug, Angiotensin receptor antagonists - therapeutic use, Blood pressure - drug effects, Drug administration schedule, Naphthyridines - administration & dosage, ta3121, type 2 - ethnology, Naphthyridines - adverse effects, Diabetes Mellitus, Type 2, Hyperkalemia, Potassium, Medicine (all), Hyperkalemia - chemically induced, Albuminuria - drug therapy, type 2 - urine |
| Popis: | Steroidal mineralocorticoid receptor antagonists, when added to a renin-angiotensin system blocker, further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events.To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone, given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.Randomized, double-blind, placebo-controlled, parallel-group study conducted at 148 sites in 23 countries. Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014. Of 1501 screened patients, 823 were randomized and 821 received study drug.Participants were randomly assigned to receive oral, once-daily finerenone (1.25 mg/d, n = 96; 2.5 mg/d, n = 92; 5 mg/d, n = 100; 7.5 mg/d, n = 97; 10 mg/d, n = 98; 15 mg/d, n = 125; and 25 mg/d, n = 119) or matching placebo (n = 94) for 90 days.The primary outcome was the ratio of the urinary albumin-creatinine ratio (UACR) at day 90 vs at baseline. Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate.The mean age of the participants was 64.2 years; 78% were male. At baseline, 36.7% of patients treated had very high albuminuria (UACR ≥300 mg/g) and 40.0% had an estimated glomerular filtration rate of 60 mL/min/1.73 m2 or lower. Finerenone demonstrated a dose-dependent reduction in UACR. The primary outcome, the placebo-corrected mean ratio of the UACR at day 90 relative to baseline, was reduced in the finerenone 7.5-, 10-, 15-, and 20-mg/d groups (for 7.5 mg/d, 0.79 [90% CI, 0.68-0.91; P = .004]; for 10 mg/d, 0.76 [90% CI, 0.65-0.88; P = .001]; for 15 mg/d, 0.67 [90% CI, 0.58-0.77; P |
| Druh dokumentu: | Article |
| Popis súboru: | application/pdf |
| Jazyk: | English |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2015.10081 |
| Prístupová URL adresa: | https://jamanetwork.com/journals/jama/articlepdf/2432163/joi150099.pdf https://pubmed.ncbi.nlm.nih.gov/26325557 http://hdl.handle.net/11588/659964 https://research.monash.edu/en/publications/effect-of-finerenone-on-albuminuria-in-patients-with-diabetic-nep https://research.rug.nl/en/publications/effect-of-finerenone-on-albuminuria-in-patients-with-diabetic-nep https://air.unimi.it/handle/2434/335378 https://www.ncbi.nlm.nih.gov/pubmed/26325557 https://jamanetwork.com/journals/jama/articlepdf/2432163/joi150099.pdf https://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2015.10081 https://hdl.handle.net/11568/837948 https://doi.org/10.1001/jama.2015.10081 http://jama.jamanetwork.com/data/Journals/JAMA/934374/joi150099.pdf https://hdl.handle.net/11588/659964 |
| Rights: | taverne |
| Prístupové číslo: | edsair.doi.dedup.....ce81b997614268bcc9ef9a35f3eb243c |
| Databáza: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstrakt: | Steroidal mineralocorticoid receptor antagonists, when added to a renin-angiotensin system blocker, further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events.To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone, given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.Randomized, double-blind, placebo-controlled, parallel-group study conducted at 148 sites in 23 countries. Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014. Of 1501 screened patients, 823 were randomized and 821 received study drug.Participants were randomly assigned to receive oral, once-daily finerenone (1.25 mg/d, n = 96; 2.5 mg/d, n = 92; 5 mg/d, n = 100; 7.5 mg/d, n = 97; 10 mg/d, n = 98; 15 mg/d, n = 125; and 25 mg/d, n = 119) or matching placebo (n = 94) for 90 days.The primary outcome was the ratio of the urinary albumin-creatinine ratio (UACR) at day 90 vs at baseline. Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate.The mean age of the participants was 64.2 years; 78% were male. At baseline, 36.7% of patients treated had very high albuminuria (UACR ≥300 mg/g) and 40.0% had an estimated glomerular filtration rate of 60 mL/min/1.73 m2 or lower. Finerenone demonstrated a dose-dependent reduction in UACR. The primary outcome, the placebo-corrected mean ratio of the UACR at day 90 relative to baseline, was reduced in the finerenone 7.5-, 10-, 15-, and 20-mg/d groups (for 7.5 mg/d, 0.79 [90% CI, 0.68-0.91; P = .004]; for 10 mg/d, 0.76 [90% CI, 0.65-0.88; P = .001]; for 15 mg/d, 0.67 [90% CI, 0.58-0.77; P |
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| ISSN: | 00987484 |
| DOI: | 10.1001/jama.2015.10081 |