Abstract | BACKGROUND: 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 < 0.001). The annual estimated glomerular filtration rate change was -3.83 mL/min/1.73 m(2) in the tolvaptan group and -5.05 mL in the placebo group for a treatment effect of +1.22 mL/min/1.73 m(2) (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).
|
Authors | Satoru Muto, Haruna Kawano, Eiji Higashihara, Ichiei Narita, Yoshifumi Ubara, Takayuki Matsuzaki, John Ouyang, Vicente E Torres, Shigeo Horie |
Journal | Clinical and experimental nephrology
(Clin Exp Nephrol)
Vol. 19
Issue 5
Pg. 867-77
(Oct 2015)
ISSN: 1437-7799 [Electronic] Japan |
PMID | 25663351
(Publication Type: Clinical Trial, Journal Article)
|
Chemical References |
- Antidiuretic Hormone Receptor Antagonists
- Benzazepines
- Tolvaptan
|
Topics |
- Adolescent
- Adult
- Antidiuretic Hormone Receptor Antagonists
(adverse effects, therapeutic use)
- Asian People
- Benzazepines
(adverse effects, therapeutic use)
- Disease Progression
- Endpoint Determination
- Female
- Follow-Up Studies
- Glomerular Filtration Rate
- Humans
- Japan
- Kidney
(pathology)
- Liver Function Tests
- Male
- Middle Aged
- Polycystic Kidney, Autosomal Dominant
(drug therapy, pathology)
- Tolvaptan
- Young Adult
|