Richmond, Va. - April 13, 2017 - A recent study published in Pain Medicine validates the strong performance of Venebio Group's risk index tool -- Venebio Opioid Advisor (VOA) -- at predicting the likelihood of a life-threatening overdose in patients taking a prescription opioid.
Prescription opioid sales quadrupled in the United States between 1999 and 2010[FOOTNOTE 1], and deaths from prescription opioid overdose have increased in near parallel proportions, from 4,030 in 1999 to more than 15,000 in 2015.[FOOTNOTE 2][FOOTNOTE 3]
VOA is the only validated risk index and clinical decision support tool that calculates a patient's likelihood of experiencing a life-threatening overdose from a prescription opioid, determines their personalized risk factor profile and gives individualized guidance regarding interventions that health care professionals can consider to reduce the patient's risk of overdose.
"VOA was designed and intended to fill a practical need for a relatively brief and simple screening instrument with high predictive performance in a typically busy clinical practice or in screening a population of patients treated with opioids," said Lenn Murrelle, MSPH, Ph.D., president and CEO of Venebio.
"Pain and its management are complex and multidimensional, and the risk of an opioid overdose is likewise dependent on many factors," added Barbara Zedler, M.D., lead author and chief medical officer of Venebio. "Primary care professionals express concern about prescription opioid misuse and find managing patients with chronic pain to be stressful. Many feel inadequately trained in prescribing opioids and treating or managing opioid use disorder or addiction."
VOA originally included the 15 factors most strongly associated with a life-threatening opioid overdose based on administrative health care claims data from the 1.9 million patients in the U.S. Veterans Health Administration (VHA) population who were prescribed an opioid. VOA demonstrated excellent predictive performance, with an 88-percent probability of correctly differentiating VHA opioid users with and without an overdose. Further, the observed incidence of overdose matched well with VOA's average predicted probability of overdose in each risk class, or grouping of the prescription opioid users by their VOA-predicted level of risk.
VOA's strong predictive performance in the VHA patient population was replicated in this latest study of 18.3 million patients treated with opioids in a U.S. commercial health plan database (IMS PharMetrics Plus) from 2009-13. VOA again had unusually strong predictive performance, with a 90-percent probability of correctly distinguishing opioid users in the commercially insured population with and without an overdose. In addition, the actual occurrence of overdose very closely matched VOA's average predicted probability of overdose by risk class. The researchers identified 7,234 cases of opioid overdose in this commercially insured population, which is the largest such case series to date among U.S. medical users of prescription opioids.
Further development of VOA focuses on prospective studies that are underway, supported by a $1.5-million grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH).
To establish and monitor a patient's risk for opioid overdose, a baseline overdose risk score can be calculated before starting treatment and reassessed and tracked over time during chronic opioid treatment. VOA can monitor changes in risk level due to changes in treatment or from fluctuations in a patient's clinical condition or other medications.
VOA creates a uniquely practical opportunity for recurring education and supports clinical decision-making by providing frontline health care professionals information personalized for each patient and based on current best practices of comprehensive pain management and opioid prescribing.
"VOA offers proven and personalized information that can reduce the number of life-threatening prescription opioid overdoses," added Murrelle.
The study, "Validation of a Screening Risk Index for Serious Prescription Opioid-induced Respiratory Depression or Overdose in a U.S. Commercial Health Plan Claims Database," was funded by Kaléo, Inc., a privately held pharmaceutical company. The full study can be read at: https:/
Venebio is a 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, health care organizations, academic research centers, law firms, government entities and NGOs. Learn more at http://www.
Footnote 1: Paulozzi L, Jones C, Mack KA, Rudd R. Vital signs: Overdoses of prescription opioid pain relievers - United States, 1999-2008. MMWR Morb Mortal Wkly Rep 2011;60(43):1487-92.
Footnote 2: CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016. Available at: http://wonder.
Footnote 3: CDC. Prescription opioid overdose data. 2016.