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
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