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10.1093/ndt/gfx043

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suck abstract from ncbi


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pmid28379536
      Nephrol+Dial+Transplant 2018 ; 33 (3 ): 477-489
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  • Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial #MMPMID28379536
  • Torres VE ; Chapman AB ; Devuyst O ; Gansevoort RT ; Perrone RD ; Dandurand A ; Ouyang J ; Czerwiec FS ; Blais JD
  • Nephrol Dial Transplant 2018[Mar]; 33 (3 ): 477-489 PMID28379536 show ga
  • BACKGROUND: In TEMPO 3:4, the vasopressin V2 receptor antagonist tolvaptan slowed total kidney volume (TKV) growth and estimated glomerular filtration rate (eGFR) decline relative to placebo. METHODS: TEMPO 4:4 was designed to provide an additional 2 years of data on the long-term safety and efficacy of tolvaptan in subjects completing TEMPO 3:4. The objective was to assess the disease-modifying effects of tolvaptan on TKV and eGFR end-points including change from baseline over the combined duration of TEMPO 3:4 and TEMPO 4:4, and non-inferiority of slopes during TEMPO 4:4. RESULTS: Of the 1445 subjects randomized to TEMPO 3:4, 871 (60.3%) enrolled in TEMPO 4:4. Percent changes in TKV from TEMPO 3:4 baseline to TEMPO 4:4 Month 24 were 29.9% and 31.6% (prior tolvaptan versus prior placebo, P?=?0.38). Adjusting for baseline covariates improved the TKV treatment difference at Month 24 in TEMPO 4:4 from -1.70% to?-?4.15% between the groups (P?=?0.04). Slopes of TKV growth during TEMPO 4:4 were higher in early- versus delayed-treatment groups (6.16% versus 4.96% per year, P?=?0.05). Analysis of secondary eGFR endpoints demonstrated a persistent effect on eGFR (3.15?mL/min/1.73 m2, P?
  • |*Time-to-Treatment [MESH]
  • |Adult [MESH]
  • |Antidiuretic Hormone Receptor Antagonists/*therapeutic use [MESH]
  • |Benzazepines/therapeutic use [MESH]
  • |Female [MESH]
  • |Glomerular Filtration Rate [MESH]
  • |Humans [MESH]
  • |Male [MESH]
  • |Polycystic Kidney, Autosomal Dominant/*drug therapy [MESH]
  • |Prognosis [MESH]


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