i3 Drug Safety to Deliver 17 Presentations at ICPE 2008


One of the Largest Studies of Association Between Anti-Psychotic Medications and

Diabetes/Dyslipidemia in Adolescents Discussed

COPENHAGEN, Denmark,  Aug. 13, 2008 -- i3 Drug Safety epidemiologists will present the results of 17 key studies at the 24th annual International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) next week in Copenhagen, Denmark.  Most of these studies drew on information from the large, integrated health care claims database of i3’s parent company Ingenix, an industry leader in health information, technology and consulting.

The presentations include:

In one of the largest studies of its kind, Dr. Cheryl Enger and colleagues at i3 Drug Safety showed that adolescents with bipolar disorder or schizophrenia had an increased risk of developing diabetes or dyslipidemia compared with adolescents without these disorders in the general population.  Additionally those patients treated with antipsychotic medications were at higher risk of developing diabetes or dyslipidemia compared to untreated patients.
In this retrospective cohort study of insurance claims for either schizophrenia or bipolar disorder from 1997 through 2006, researchers identified 16,997 adolescents with bipolar disorder and 887 with schizophrenia; they developed a comparison group via random selection of 188,059 adolescents without claims evidence of these diagnoses or prescriptions of antipsychotic medication.  The researchers found a 67 percent higher risk of developing dyslipidemia in the mental disorder cohort compared to the general population, and a 3.3-fold higher risk of developing dyslipidemia in those treated with antipsychotics compared with those who are not.  Similarly, they found a 60 percent increase in diabetes in the mental disorder cohort compared to the general population, and a 2.6-fold increase in diabetes in those treated with antipsychotics compared with the untreated patients.

Poster Presentation: Monday, August 18 at 8:00 am to 6:00 pm Hall A1
Concurrent Session: Wednesday, August 20 at 8:30 am to 10:00 am Auditorium 12 

While long-acting beta agonists (LABAs) improve asthma symptoms in the short run, Drs. Tobias Kurth and John Seeger studied the claims data of 49,000 patients to determine whether LABAs may exacerbate the disease.  The study used regression modeling and propensity score matching to calculate the relative risk of emergency room (ER) visits, hospitalizations, intubations, and death among nearly 19,000 patients who had at least one dispensing of a LABA between 2000 and 2004 compared with those patients who did not use a LABA.  This study showed no increased risk of death or intubation for patients using LABAs, but did show a trend of increased ER visits.

Concurrent Session:  Monday, August 18 at 1:30 pm to 3:00 pm Room 20

To address concerns about the potential risks of malignancy, including lymphoma, associated with the use of topical calcineurin inhibitors, including pimecrolimus, Drs. Schneeweiss and Seeger identified nearly 93,000 pimecrolimus users who initiated treatment between 2002 and 2006. They identified 26 adjudicated cases of lymphoma that were confirmed through review of underlying medical records, yielding an incidence rate of 21 per 100,000 person-years. This incidence rate of lymphoma was similar to that among initiators of topical corticosteroids and tacrolimus, another topical calcineurin inhibitor. The study did not find any increase in the incidence of lymphoma among initiators of topical pimecrolimus relative to these comparators.

Concurrent Session:  Tuesday, August 19 at 11:00 am to 12:30 pm  Auditorium 12

About i3
i3, a global Ingenix company, provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.  It is composed of i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, engaged in pharmacovigilance and epidemiology; i3 Pharma Informatics, a data, science and technology provider of market analytics; i3 Statprobe, a leader in comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; and i3 Innovus, delivering the science and solutions to achieve marketplace success.  i3 helps companies gain sharper insights that lead to better patient care. For more information, visit www.i3global.com.
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Joan Schimml
(952) 833-6582


Posted: August 2008

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