The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial

Satoru Muto, Haruna Kawano, Eiji Higashihara, Ichiei Narita, Yoshifumi Ubara, Takayuki Matsuzaki, John Ouyang, Vicente Torres, Shigeo Horie

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background: Japan is the first country in the world to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD), which was based on the results of Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial. To evaluate the safety and efficacy of tolvaptan, we performed a subgroup analysis in the participating Japanese ADPKD patient population. Methods: The primary outcome was the annual rate of percentage change in the total kidney volume (TKV). The secondary endpoint was the rate of kidney function change. Results: The tolvaptan and placebo groups included 118 and 59 patients, respectively. The annual rate of percentage changes in TKV were 1.3 % [95 % confidence interval (CI) 0.4–2.1] in the tolvaptan group, and 5.0 % (95 % CI 3.9–6.2) in the placebo group (P 2 in the tolvaptan group and −5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m2 (95 % CI 0.41–2.02: P = 0.003). Hepatic function abnormal as a serious adverse event was observed in 3 patients (2.5 %) in the tolvaptan group. Conclusions: Administration of tolvaptan in the Japanese sub-population reduced the annual rate of TKV growth and slowed the rate of kidney function decline over 36 months compared to patients on placebo, thus providing a novel and effective therapy for the treatment of ADPKD. (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948).

Original languageEnglish (US)
Pages (from-to)867-877
Number of pages11
JournalClinical and Experimental Nephrology
Volume19
Issue number5
DOIs
StatePublished - Oct 1 2015

Fingerprint

Autosomal Dominant Polycystic Kidney
Kidney
Placebos
Confidence Intervals
Safety Management
tolvaptan
TEMPO
Therapeutics
Population
Japan
Safety
Liver

Keywords

  • Autosomal dominant polycystic kidney disease
  • Japanese population
  • Kidney function decline
  • TEMPO 3:4 trial
  • Tolvaptan
  • Total kidney volume

ASJC Scopus subject areas

  • Nephrology
  • Physiology
  • Physiology (medical)

Cite this

The effect of tolvaptan on autosomal dominant polycystic kidney disease patients : a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. / Muto, Satoru; Kawano, Haruna; Higashihara, Eiji; Narita, Ichiei; Ubara, Yoshifumi; Matsuzaki, Takayuki; Ouyang, John; Torres, Vicente; Horie, Shigeo.

In: Clinical and Experimental Nephrology, Vol. 19, No. 5, 01.10.2015, p. 867-877.

Research output: Contribution to journalArticle

Muto, Satoru ; Kawano, Haruna ; Higashihara, Eiji ; Narita, Ichiei ; Ubara, Yoshifumi ; Matsuzaki, Takayuki ; Ouyang, John ; Torres, Vicente ; Horie, Shigeo. / The effect of tolvaptan on autosomal dominant polycystic kidney disease patients : a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. In: Clinical and Experimental Nephrology. 2015 ; Vol. 19, No. 5. pp. 867-877.
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abstract = "Background: Japan is the first country in the world to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD), which was based on the results of Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial. To evaluate the safety and efficacy of tolvaptan, we performed a subgroup analysis in the participating Japanese ADPKD patient population. Methods: The primary outcome was the annual rate of percentage change in the total kidney volume (TKV). The secondary endpoint was the rate of kidney function change. Results: The tolvaptan and placebo groups included 118 and 59 patients, respectively. The annual rate of percentage changes in TKV were 1.3 {\%} [95 {\%} confidence interval (CI) 0.4–2.1] in the tolvaptan group, and 5.0 {\%} (95 {\%} CI 3.9–6.2) in the placebo group (P 2 in the tolvaptan group and −5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m2 (95 {\%} CI 0.41–2.02: P = 0.003). Hepatic function abnormal as a serious adverse event was observed in 3 patients (2.5 {\%}) in the tolvaptan group. Conclusions: Administration of tolvaptan in the Japanese sub-population reduced the annual rate of TKV growth and slowed the rate of kidney function decline over 36 months compared to patients on placebo, thus providing a novel and effective therapy for the treatment of ADPKD. (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948).",
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T1 - The effect of tolvaptan on autosomal dominant polycystic kidney disease patients

T2 - a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial

AU - Muto, Satoru

AU - Kawano, Haruna

AU - Higashihara, Eiji

AU - Narita, Ichiei

AU - Ubara, Yoshifumi

AU - Matsuzaki, Takayuki

AU - Ouyang, John

AU - Torres, Vicente

AU - Horie, Shigeo

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Background: Japan is the first country in the world to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD), which was based on the results of Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial. To evaluate the safety and efficacy of tolvaptan, we performed a subgroup analysis in the participating Japanese ADPKD patient population. Methods: The primary outcome was the annual rate of percentage change in the total kidney volume (TKV). The secondary endpoint was the rate of kidney function change. Results: The tolvaptan and placebo groups included 118 and 59 patients, respectively. The annual rate of percentage changes in TKV were 1.3 % [95 % confidence interval (CI) 0.4–2.1] in the tolvaptan group, and 5.0 % (95 % CI 3.9–6.2) in the placebo group (P 2 in the tolvaptan group and −5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m2 (95 % CI 0.41–2.02: P = 0.003). Hepatic function abnormal as a serious adverse event was observed in 3 patients (2.5 %) in the tolvaptan group. Conclusions: Administration of tolvaptan in the Japanese sub-population reduced the annual rate of TKV growth and slowed the rate of kidney function decline over 36 months compared to patients on placebo, thus providing a novel and effective therapy for the treatment of ADPKD. (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948).

AB - Background: Japan is the first country in the world to approve tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD), which was based on the results of Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 3:4 trial. To evaluate the safety and efficacy of tolvaptan, we performed a subgroup analysis in the participating Japanese ADPKD patient population. Methods: The primary outcome was the annual rate of percentage change in the total kidney volume (TKV). The secondary endpoint was the rate of kidney function change. Results: The tolvaptan and placebo groups included 118 and 59 patients, respectively. The annual rate of percentage changes in TKV were 1.3 % [95 % confidence interval (CI) 0.4–2.1] in the tolvaptan group, and 5.0 % (95 % CI 3.9–6.2) in the placebo group (P 2 in the tolvaptan group and −5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m2 (95 % CI 0.41–2.02: P = 0.003). Hepatic function abnormal as a serious adverse event was observed in 3 patients (2.5 %) in the tolvaptan group. Conclusions: Administration of tolvaptan in the Japanese sub-population reduced the annual rate of TKV growth and slowed the rate of kidney function decline over 36 months compared to patients on placebo, thus providing a novel and effective therapy for the treatment of ADPKD. (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948).

KW - Autosomal dominant polycystic kidney disease

KW - Japanese population

KW - Kidney function decline

KW - TEMPO 3:4 trial

KW - Tolvaptan

KW - Total kidney volume

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