Tolvaptan's Ultimate Approval Is Promising For ADPKD Patients

Tolvaptan's Ultimate Approval Is Promising For ADPKD Patients

tolvaptanTolvaptan, CAS number 150683-30-0, is efficacious when treating patients who have hyponatremia, or those patients who do not enough sodium in their blood. Patients with heart failure, liver problems such as cirrhosis of the liver, and the syndrome of inappropriate antidiuretic hormone may have hyponatremia. Because the human body needs the chemical sodium to be able to function well, Tolvaptan is essential for helping the kidneys to maintain the right amount of sodium for the body. In a class of medications called vasopressin V2 receptor antagonists, Tolvaptan is also known as the brand name Samsca. By increasing the amount of water released from the body via urine, Tolvaptan is successful at lowering the level of sodium in the blood of patients in the form of a tolerable once daily tablet. Side effects of Tolvaptan are mild, and include nausea, constipation, weakness, dry mouth and loss of appetite.

ADPKDOn November 4, 2012 results from a clinical trial of Tolvaptan, coined TEMPO, were revealed at the Kidney Week 2012 event, which was held in San Diego and sponsored by the American Society of Nephrology. Tolvaptan was praised as being an effectual treatment which slowed the rate of kidney function decline. This placebo-controlled, multi-center, double-blind clinical trial took place over a three year period, and involved 1,445 patients with Autosomal Dominant Polycystic Kidney Disease, also known as ADPKD. The TEMPO study, which stands for The Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease Outcomes was declared successful, according to Dr. Vicente Torres, Professor of Medicine, Division of Nephrology and Hypertension at the Mayo Clinic.  Autosomal Dominant Polycystic Kidney Disease (ADPKD) is an inherited condition which causes cysts in the kidneys that destroy tissue, as well as causing the patient to experience pain, hypertension, and kidney failure. As current management of ADPKD have been focused on treating disease complications, and not on slowing the cyst development or preventing progression to kidney failure, the trial of Tolvaptan to treat this devastating disease was crucial. While Tolvaptan for the treatment of ADPKD is still technically in its investigational stage, and not yet approved by the FDA, signs of an ultimate approval look promising.  Conclusions from the TEMPO study show that when patients received Tolvaptan for three years they experienced not only a slowed increase in total kidney volume and decline in their kidney function, but they also endured a lowered frequency of ADPKD-related events. Specifically, the patients who were dosed with Tolvaptan were 61% less likely to experience a certain level of worsening kidney function, and they were also 36% less likely to experience marked kidney pain that required treatment. The current study of Tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease is sponsored by Otsuka Pharmaceuticals, which has already received FDA approval for Tolvaptan for the treatment of hyponatremia, under the brand name Samsca, in 2009. LGM Pharma provides API Tolvaptan for research and development purposes, and offers clients continued support throughout the R&D process.

Related News: FDA Warns of Liver Injury Risk with Tolvaptan


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