TEMPO 3:4 — PubMed · REPRISE — PubMed · FDA JYNARQUE label, 2026 · KDIGO 2025 ADPKD, corrected April 2026
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TEMPO 3:4 enrolled 1,445 selected adults and followed them for three years: kidney-volume growth was 2.8%/year with tolvaptan versus 5.5%/year with placebo. REPRISE randomized 1,370 adults with later-stage disease after a tolerability run-in: one-year eGFR change was −2.34 versus −3.61 mL/min/1.73 m², a difference of 1.27 (95% CI 0.86–1.68). These endpoints show slower progression, not proof that dialysis is prevented or a guaranteed number of dialysis-free years.
Balance benefit against thirst, polyuria/nocturia, dehydration and possible serious liver injury. The U.S. label requires REMS participation and liver tests before treatment, at 2 and 4 weeks, monthly for 18 months, then every 3 months. Discuss ability to maintain hydration, monitoring, costs and patient preferences. Evaluate early, while guideline-supported initiation remains an option.
Andrew Bland, MD, FACP, FAAP