P0331ASSESSMENT OF DELIVERY OF NICE APPROVED USE OF TOLVAPTAN (JINARC) IN ADULTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE IN A UK RENAL CENTRE

Abstract

Background and Aims: Until recently, the management of ADPKD has largely been limited to lifestyle changes (smoking cessation, salt avoidance and diet with weight loss) and tight blood pressure control, in addition to kidney pain management and prompt treatment of complications such as infections. The approval of Tolvaptan, a highly selective vasopressin V2 receptor antagonist, by NICE, following the pivotal TEMPO 3:4 trial provides clinicians with an opportunity to modify the progression of ADPKD and preserve kidney function. Tolvaptan works by slowing cyst growth patients with ADPKD (and therefore potentially reducing kidney pain, urinary tract infections and haematuria). During the TEMPO 3:4 trial, a reversible elevation (> 3X upper limit) of liver enzymes was observed in 4.4% patients taking tolvaptan vs 1% on placebo. The onset of liver injury was between 3 -14 months of initiation of tolvaptan; therefore, monthly blood tests are required to mitigate the potential injury associated with the increase in liver enzymes. The main side effects are polyuria and thirst. The aims for the audit were • To assess compliance of tolvaptan therapy • To assess the tolerability of the side effects of tolvaptan • To assess the feasibility of a pharmacist led, consultant backed tolvaptan clinic • To measure the retention rate among patients on tolvaptan therapy Method: We carried out a prospective questionnaire-based study on all patients who were on tolvaptan therapy. All patients received a comprehensive explanation of the merits and side-effects of Tolvaptan with written literature and a copy of their initial assessment consultation prior to commencement of therapy. In addition, we reviewed patients' clinic attendances, relevant biochemical results and liver function test as per licence agreement tolvaptan therapy. This was approved by the Hull University Teaching Hospitals (HUTH) NHS Trust Audit department with a signed Clinical Governance Form 1. Results: In total, 27 patients, consisting of 18 males and 9 females [mean age 44.5yrs] and all Caucasian on tolvaptan therapy were evaluated. The median duration of treatment was 10months. Two patients [7.4%] dropped out of treatment: one patient opted out of treatment due to the polyuria interfering with his job requirements and the other had relocated to another country; giving HUTHa retention rate of 92.6%. 55.5% of patients responded to not having missed a dose of drug at any time at any time despite a significant number experiencing side-affects (Figure1). Some purposely missed medication due to a social event. Although 100% of patients did respond to experiencing side effects of tolvaptan, 74% of patients said it did not interfere with their quality of life. 88.8% of patients were on the full dose of 90mg in the morning and 30mg after 8 hours. The Tolvaptan clinic in HUTH is run as a pharmacist led with consultant oversight. Currently no issues have arisen but the patients' view of a pharmacist led-clinic is currently being studied. Conclusion: This study demonstrates that despite a number of expected side-affects; with good patient education and follow-up, few patients stopped therapy and most patients remain compliant to tolvaptan therapy. Currently a pharmacist led, consultant backed tolvaptan clinic has not adversely affected this success. (Figure Presented).