Safety and Tolerability of Tolvaptan in an Autosomal Dominant Polycystic Kidney Disease Spanish Cohort: A Real-World Experience.

INTRODUCTION: Autosomal dominant polycystic kidney disease (ADPKD) is the commonest inherited disorder of the kidneys. A vasopressin V2-receptor antagonist (tolvaptan) was recently approved for the treatment of ADPKD. This study aims to analyze the safety and tolerability of tolvaptan for the management of ADPKD patients in a real-world setting. METHODS: We conducted a descriptive retrospective study in ADPKD patients in an outpatient clinic setting in Spain from 2018 to 2019. Descriptive statistical analysis of demographics and clinical data, at baseline and one year after tolvaptan initiation, was assessed. Data are presented as median and interquartile range, and as frequencies for categorical variables. RESULTS: Ten patients with ADPKD were identified. At baseline median age was 49.5 (38.5-63.5) years and 60% were males. During treatment with tolvaptan, no significant aquaresis-related symptoms or hepatotoxicity were described. No serious adverse events, discontinuation, or deaths were reported during the study. CONCLUSION: Tolvaptan was well-tolerated without severe adverse events in patients with ADPKD who showed rapid disease progression criteria. Longer follow-up is required to learn about the long-term effects of this treatment.

Efficacy of a hepatitis B vaccination schedule with two cycles of four double doses of conventional vaccine and four doses of adjuvanted vaccine in chronic kidney disease patients evaluated for renal transplantation.

INTRODUCTION: The response to hepatitis B (HB) vaccine remains suboptimal among chronic kidney disease patients. The aim of this study was to analyze the efficacy of a hepatitis B vaccination schedule with two 4-double doses of conventional vaccine and four doses of adjuvant vaccine in chronic kidney disease patients evaluated for renal transplantation. METHODS: In this prospective study, we recruited chronic kidney disease patients evaluated for renal transplantation to receive four 40-µg doses of hepatitis B virus vaccine (0, 1, 2 and 6 months) and another four 40 µg doses of hepatitis B virus vaccine and four 20 µg doses of adjuvant vaccine if they were nonresponders. AntiHBs titers were analyzed before every vaccine dose and 1 month after the fourth dose. RESULTS: One hundred fifty-five patients were enrolled in the study. The response to the vaccination increased until the seventh dose: first dose, 5.4%; second, 29.5%; third, 66.7%; fourth, 75.9%; fifth, 83.3%; sixth, 87.3%; seventh, 92.5%; and eighth, 93.8%. AntiHBs titers after the first and second vaccination with Engerix were 10 to 99 mIU/mL in the 12% and 7.7%, 100 to 999 mIU/mL in the 30.1%, and 46.2%, and 1000 mIU/mL in the 34.9% and 15.4%, respectively. Fendrix was administrated in 6.2% of the patients and 75% of them obtained a response. AntiHBc-positive patients obtained a response with one vaccination cycle in the 71.4%. The response was influenced by age and was greater in women. Adverse events were found in 11.5% of the patients (inflammation and/or local pain), which were less frequent in men (8.9% versus 16.1%) and similar for both vaccines. CONCLUSION: The response to the hepatitis B vaccination with four double doses of conventional vaccine and revaccination with the same schedule and adjuvanted vaccine shows a high response rate in chronic kidney disease evaluated for renal transplantation.