Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED)
Autor: | Aneliya Parvanova, Matias Trillini, Manuel A Podestà, Ilian Petrov Iliev, Barbara Ruggiero, Manuela Abbate, Annalisa Perna, Francesco Peraro, Olimpia Diadei, Nadia Rubis, Flavio Gaspari, Fabiola Carrara, Nadia Stucchi, Antonio Belviso, Antonio C Bossi, Roberto Trevisan, Giuseppe Remuzzi, Martin de Borst, Piero Ruggenenti, Norberto Perico, Stefano Rota, Maria Carolina Aparicio, Silvia Prandini, Daniela Cugini, Giulia Gherardi, Anna Corsi, Antonio C. Bossi, S Yakymchuk, Veruscka Lecchi, Ruggero Mangili, Wally Calini, Bogdan Ene-Iordache, Sergio Carminati, Davide Martinetti, Giovanni Antonio Giuliano, Angela Russo, Silvia Ferrari, Antonio Nicola Cannata, Paola Boccardo, Sara Peracchi, Martin De Borst, Serena Bettoni, Irene Cattaneo, Davide Franchina, Haian Ha Phan, Grace Igiraneza, Tamas Kaucsár, Sergio Luis Lima, Meg Lunney, Huong Tran |
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Přispěvatelé: | Groningen Kidney Center (GKC), Lifestyle Medicine (LM), Groningen Institute for Organ Transplantation (GIOT), Parvanova, A, Trillini, M, Podesta, M, Iliev, I, Ruggiero, B, Abbate, M, Perna, A, Peraro, F, Diadei, O, Rubis, N, Gaspari, F, Carrara, F, Stucchi, N, Belviso, A, Bossi, A, Trevisan, R, Remuzzi, G, de Borst, M, Ruggenenti, P, Perico, N, Rota, S, Aparicio, M, Prandini, S, Cugini, D, Gherardi, G, Corsi, A, Yakymchuk, S, Lecchi, V, Mangili, R, Calini, W, Ene-Iordache, B, Carminati, S, Martinetti, D, Giuliano, G, Russo, A, Ferrari, S, Cannata, A, Boccardo, P, Peracchi, S, Bettoni, S, Cattaneo, I, Franchina, D, Ha Phan, H, Igiraneza, G, Kaucsar, T, Lima, S, Lunney, M, Tran, H |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Male
Paricalcitol Endocrinology Diabetes and Metabolism Drug Resistance 030232 urology & nephrology PROGRESSION Type 2 diabetes 030204 cardiovascular system & hematology THERAPY 0302 clinical medicine Endocrinology Outpatient clinic VITAMIN-D ACE-INHIBITION education.field_of_study Cross-Over Studies Cross-Over Studie Middle Aged Diet Sodium-Restricted Treatment Outcome Losartan Italy D-RECEPTOR ACTIVATION Ergocalciferols Female medicine.symptom Human medicine.drug medicine.medical_specialty NEPHROPATHY Population Urology DIETARY-SODIUM RESTRICTION Placebo Ergocalciferol 03 medical and health sciences Double-Blind Method Internal medicine Internal Medicine medicine Humans Albuminuria MED/13 - ENDOCRINOLOGIA education Aged business.industry KIDNEY-DISEASE medicine.disease Crossover study MED/14 - NEFROLOGIA Diabetes Mellitus Type 2 RESIDUAL PROTEINURIA CHRONIC RENAL-DISEASE business |
Zdroj: | Lancet Diabetes & Endocrinology, 6(1), 27-40. ELSEVIER SCIENCE INC |
ISSN: | 2213-8595 2213-8587 |
DOI: | 10.1016/S2213-8587(17)30359-5 |
Popis: | Background Macroalbuminuria predicts renal and cardiovascular events in patients with type 2 diabetes. We aimed to assess the albuminuria-lowering effects of salt restriction, paricalcitol therapy, or both, in this population.Methods In this randomised, double-blind, placebo-controlled, crossover trial, we recruited adult patients with type 2 diabetes from six diabetology outpatient clinics in northern Italy, with 24 h albuminuria of more than 300 mg despite 100 mg per day losartan therapy, blood pressure of less than 140/90 mm Hg, serum creatinine concentration of less than 2 mg/dL, stable renal function on stable renin-angiotensin system inhibitor therapy with a fixed dose of losartan, parathyroid hormone concentration of 20 pg/mL to 200 mEq [4.8 g] per day) or low-sodium (Findings Between Dec 13, 2011, and Feb 17, 2015, we randomly allocated 57 (50%) patients to a low-sodium diet (28 [49%] to paricalcitol then placebo and 29 [51%] to placebo then paricalcitol) and 58 (50%) to a high-sodium diet (29 [50%] to paricalcitol then placebo and 29 [50%] to placebo then paricalcitol). In the low-sodium group (30 mEq of daily sodium intake reduction, equivalent to approximately 1.7-1.8 g per day), 24 h albuminuria was reduced by 36.6% (95% CI 28.5-44.9) from 724 mg (441-1233) at baseline to 481 mg (289-837) at month 3 (pInterpretation In patients with macroalbuminuria and type 2 diabetes, moderate salt restriction enhances the antialbuminuric effect of losartan, an effect that could be nephroprotective and cardioprotective in the long term. The finding that paricalcitol prevents a sodium-induced increase in albuminuria provides support for trials to test the longterm risk-benefit profile of paricalcitol add-on therapy in patients with type 2 diabetes and macroalbuminuria refractory to dietary salt restriction, including patients refractory to even moderate salt restriction. |
Databáze: | OpenAIRE |
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