Fp055exploring the Impact of Tolvaptan on the Long Term Rate of Renal Function Decline Using the Adpkd Outcomes Model

O'Reilly, K.; McEwan, Phil; Wilton, Hayley Bennett; Robinson, Paul

doi:10.1093/ndt/gfv167.11

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“…The same model indicated that treatment with tolvaptan may substantially delay the onset of ESRD, leading to increased life expectancy, improved quality of life and reduced burden on renal replacement therapy services (available as an abstract plus poster) [41]. Application of the treatment effect of tolvaptan from the TEMPO 3:4 trial was associated with an average 4.9-year delay in time to ESRD across the baseline population without treatment discontinuation [41].…”

Section: Place Of Tolvaptan In the Management Of Adpkdmentioning

confidence: 99%

“…The ADPKD Outcomes Model (developed to predict renal progression to ESRD in ADPKD) estimated the mean age at ESRD to be 52.1 years for the average TEMPO 3:4 placebo patient, with an estimated life expectancy of 65.6 years (available as an abstract plus poster) [40]. The same model indicated that treatment with tolvaptan may substantially delay the onset of ESRD, leading to increased life expectancy, improved quality of life and reduced burden on renal replacement therapy services (available as an abstract plus poster) [41]. Application of the treatment effect of tolvaptan from the TEMPO 3:4 trial was associated with an average 4.9-year delay in time to ESRD across the baseline population without treatment discontinuation [41].…”

Section: Place Of Tolvaptan In the Management Of Adpkdmentioning

confidence: 99%

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Tolvaptan: A Review in Autosomal Dominant Polycystic Kidney Disease

Blair

Keating

2015

Drugs

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Tolvaptan (Jinarc(®)) is a highly selective vasopressin V2 receptor antagonist indicated for use in patients with autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan is the first pharmaceutical agent to be approved in Europe for delaying the progression of ADPKD in adults with stage 1-3 chronic kidney disease at initiation of treatment. In the large phase III TEMPO 3:4 trial in adults with ADPKD, 3 years' treatment with oral tolvaptan significantly reduced growth in total kidney volume and slowed renal function decline relative to placebo. Tolvaptan was also associated with a significantly lower rate of events for the composite secondary endpoint of time to investigator-assessed clinical progression relative to placebo, an effect that was largely attributable to reductions in the risk of worsening renal function and the risk of worsening kidney pain. Many of the most common adverse events in the tolvaptan group were related to its aquaretic mechanism of action (e.g. polyuria, nocturia, polydipsia and thirst). Tolvaptan was also associated with idiosyncratic elevations of liver enzymes which were reversible on discontinuation of the drug. Although the use of tolvaptan requires careful consideration and balancing of benefits and risks, current evidence suggests that tolvaptan is a promising new treatment option for patients with ADPKD.

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Section: Place Of Tolvaptan In the Management Of Adpkdmentioning

confidence: 99%