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First-of-Its-Kind Study Suggests Importance of Routine Mental Health Screening in the Care of Patients Suffering From Genetic Disease PKU
Date:3/18/2011

e to a PKU treatment plan."  

To measure neuropsychiatric impairment, patients already treated at PKU clinics were screened for psychiatric distress and cognitive impairment using standard neuropsychiatric assessment tools.  Individual test results were then correlated to patients' blood Phe levels.  The study found that patients who screened positive for psychiatric deficiencies had significantly higher blood Phe levels than patients who screened negative.

"Up until now, lowering blood Phe levels has been the only success measure in the treatment of PKU.  We believe ADAPT study results are an important step toward improving the overall care of PKU patients.  The data indicate that physicians have the opportunity to more easily identify those patients with neuropsychiatric and cognitive impairments, and better understand the impact of the link between Phe and these deficits, by simply incorporating mental health screening into the current standard of care," said Hank Fuchs, M.D., Chief Medical Officer of BioMarin.

Additional KUVAN Poster Presentations at ACMGOther presentations at ACMG describe ongoing studies designed to further examine the use of KUVAN® (sapropterin dihydrochloride) Tablets for PKU, with endpoints of neuropsychiatric effects and long-term safety in children. KUVAN is the first and only FDA approved treatment to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4-) responsive PKU, and is to be used in conjunction with a Phe-restricted diet.

  • PKU-016 / ASCEND Outcomes Study: Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in PKU Subjects – Clinical Study Design (S Stahl, et al, University of California, San Diego, Calf.)  [Poster 189 – March 18, 10:30-11:30 am]. The ongoing double-blind, placebo-controlled, randomized (1:1) 26-week outcomes study is evaluating the safety and efficacy of S
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  • SOURCE BioMarin Pharmaceutical Inc.
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