BASKING RIDGE, NJ, August 21, 2006— Epidemiologists from i3 Drug Safety will present the results of 12 important studies at ICPE in Lisbon this week. All of these studies drew on a large, integrated database of health care claims maintained by Ingenix, i3’s parent company, to follow de-identified patients through their health care experiences. These presentations include:
1. No Difference in Serious Muscle, Kidney and Liver Conditions Between Crestor® (rosuvastatin) and Less Potent Statins To address concerns that the higher potency of Crestor may increase adverse muscle, kidney and liver events, i3 researchers followed the health of 11,249 Crestor users and 37,282 users of other statins for up to 18 months. This study showed no difference for kidney and liver dysfunction. The numbers for serious muscle conditions were too small to draw any conclusive comparisons.
2. Three Studies Validate the Use of Large-Scale Pregnancy Registries i3 Drug Safety studies on drugs used to treat asthma and depression in pregnancy are affirming the value of health insurance data for unbiased, large scale pregnancy research. Epidemiologists tracked adverse events in pregnant women and the frequency of malformation and other issues in their babies. They ruled out a connection between Wellbutrin® (buproprion) exposure and birth defects, and confirmed an increased relative risk of congenital malformation with the use of Paxil® (paroxetine).
3. Results of Two FDA-Mandated Studies Support Drugs In two FDA-mandated studies, i3 Drug Safety epidemiologists laid to rest concerns about the safety of Yasmin® (ethinylestradiol/drospirenone), whose anti-fluid retention properties were suspected to exacerbate potassium imbalances, and Zelnorm® (tegaserod), with regard to an increased incidence of gall bladder and abdominal/pelvic surgeries. In fact, the Zelnorm cohort had a lower incidence of surgeries.
About i3
i3, a global Ingenix company, provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It is composed of i3 Drug Safety, engaged in pharmacovigilence and epidemiology; i3 Research, a therapeutically specialized contract research organization; i3 Innovus, delivering the science and solutions to achieve marketplace success; i3 Statprobe, a leader in comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; and, i3 DLN, providing certified medical education. i3 helps companies gain sharper insights that lead to better patient care. For more information, visit www.i3global.com
