Tolvaptan Trial Results Announced
At the American Society of Nephrology (ASN) meeting on 3 November 2012, Dr Vicente Torrres from the Mayo Clinic, together with research collaborators, reported the results of a 3 year global study known as TEMPO - Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease Outcomes.
Over 1400 ADPKD patients worldwide were randomly assigned to receive Tolvaptan or a placebo. Tolvaptan was shown to reduce the rate of increase in Total Kidney Volume (TKV), lessen symptoms such as pain and reduce the rate of kidney function decline, compared with the placebo. However patients who received Tolvaptan had more side effects related to thirst and frequent urination and some patients had raised liver-enzyme levels.
Tolvaptan was developed by Otsuka in Japan and, if approved by the medical regulatory agencies, could become the first commercially available drug treatment to slow down the rate of disease progression for ADPKD patients. The reduction in size and reduced pain may alos be good arguments for treatment in some patients with otherwise kidney function.
We will prepare a release on the implications for patients in the UK, as Tolvaptan is not currently licensed for ADPKD and we do not know whether it will be approved here.