PIMS PhyzioTypeTM System: Psychotropic-Induced Metabolic Symptoms

MENTAL ILLNESS, Thought Disorders: Atypical Antipsychotic Drugs (AAPs)

The PIMS PhyzioType System provides the physician with the patient’s risk profile for weight- and lipid-related side effects for the major atypical antipsychotics (AAPs), olanzapine, quetiapine, and risperidone. The PIMS product enables DNA-guided drug selection and clinical management of the AAPs. The PIMS PhyzioType System consists of 4 tests predicting weight gain, triglycerides, HDL/ LDL cholesterol and blood glucose abnormalities induced by AAPs on a class-wide and drug-specific basis. The PIMS PhyzioType System is covered by U.S. Patents 8,389,247 and 8,012,718 (Physiogenomic Methods for Predicting Psychotropic Induced Diabetes and Metabolic Syndromes).

All AAPs are under scrutiny for metabolic side effects. In September 2003, the FDA required the labels for aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone to specify the potential risk of diabetes complications as a result of treatment with these drugs. The labels now state: “Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics... Epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics.”

In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study, it was shown that 74% of patients on antipsychotics discontinue therapy within 18 months of treatment initiation. Among the AAPs, olanzapine had the least discontinuation (64%), and quetiapine the most (82%) while risperidone (74%) and ziprasidone (79%) were intermediate. Olanzapine was associated with the highest incidence of weight gain and side effects of glucose and lipid metabolism. The observed variability among AAPs and their effects on patients highlight the need for personalized recommendations of drug choice to minimize potential side effects.

The PIMS PhyzioType system provides the physician with the patient’s risk profile for weight- and lipid-related side effects for the major psychotropics in the class, Risperdal®, Seroquel® and Zyprexa®. The PIMS product enables DNA-guided drug selection and clinical management of the AAPs.

Beyond CATIE, other studies suggest that the drop-off rate at one year for AAPs is closer to 57% and there is a significant amount of drug switching that occurs during that time period. Psychiatric services surveys have also shown that high risk patients compliant with antipsychotic medications have a significantly lower risk of hospitalization (14%) than those who are non-adherent (35%) or partially adherent (24%).

In the US alone, 58 million people suffered a diagnosable mental disorder in 2004, up from 44 million (+30%) in 2001. An estimated 14 million suffer chronic mental disorders associated with schizophrenia, bipolar disorder, obsessive-compulsive disorder and generalized anxiety disorder. In the US, Atypical antipsychotic (AAP) drugs comprise an estimated $9 Billion market, reaching 3 million patients. Within this group, estimates of individuals at risk of drug-induced pre-diabetes are 15 to 18% with those at risk of drug-induced metabolic symptoms as high as 30%



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