RICHMOND, Virginia, May 18, 2015 – Barbara K. Zedler, MD, Chief Medical Officer of Venebio Group, LLC, attended the American Academy of Pain Medicine’s (AAPM) 2015 meeting to present recent advancements in a Risk Index for Overdose or Serious Opioid-Induced Respiratory Depression (RIOSORD) developed for Venebio’s client Kaleo, Inc.
RIOSORD was created using retrospective data from the U.S. Veterans Health Administration (VHA) to examine risk factors for serious side effects associated with opioids. RIOSORD is a clinical decision support tool – the first ever to provide real-time, evidence-based results for clinicians to identify patients at high-risk for life-threatening opioid emergencies such as overdose. RIOSORD provides a quantitative estimate of the risk of experiencing an event and the personalized risk factor profile for each patient. The physician can use this output to determine an alternate medication or dose for the patient, recommend clinical or behavioral changes, or prescribe an opioid antagonist for use in the event of an opioid emergency/overdose in high-risk patients.
RIOSORD was validated in a study of 18 million patients using opioids from the IMS PharMetrics Plus administrative claims database, the largest such database in the United States consisting of over 170 million records. 7,234 of these patients experienced an overdose or serious opioid-induced respiratory depression (OSORD) event. The variables which predicted OSORD in the IMS PharMetrics Plus study were consistent with those in the VHA data. RIOSORD had excellent accuracy in predicting which patients in both the VA and IMS populations actually experienced an event during the next six months.
Dr. Zedler discussed some of the 16 predictors in the RIOSORD algorithm at AAPM 2015 during an interview with Clinical Pain Advisor, a leading pain management publication. Half of the predictors are health conditions including substance use disorder, bipolar disorder, schizophrenia, and kidney, pulmonary or cerebrovascular disease. The other half are characteristics of prescriptions that the patient is consuming (opioids, benzodiazepines, or antidepressants).
The next step in the development of RIOSORD is to prospectively evaluate its performance in various clinical settings and patient subgroups.
View the abstract and poster, “Validation of a Screening Risk Index for Overdose or Serious Prescription Opioid-Induced Respiratory Depression” on painmed.org here.
View the article and video interview with Dr. Zedler in Clinical Pain Advisor here.
Venebio is a privately held research consultancy that provides cost-effective, custom solutions for complex life sciences problems. By integrating the expertise of a global network of scientists in a broad range of biomedical fields, Venebio delivers comprehensive project management and start-to-finish problem solving in genetic and molecular epidemiology, pharmacoepidemiology and pharmacovigilance, personalized medicine, bioinformatics, systems biology, biomarker discovery, and epidemiologic literature reviews and analysis. Venebio’s comprehensive services are offered to pharmaceutical companies, biotechnology and medical device companies, healthcare organizations, academic research centers, law firms, government entities and NGOs. Learn more at www.venebio.com.
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