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SOURCE LipoScience, Inc.
Data suggest lower risk of major adverse cardiovascular events and death, especially in patients with diabetes or prior coronary heart disease
ORLANDO, Fla., May 2, 2014 /PRNewswire/ -- LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced data suggesting that the use of a target low-density lipoprotein particle (LDL-P) number to guide statin therapy in at-risk patients can reduce the risk of major adverse cardiovascular events (MACE) and death, compared to using standard LDL cholesterol (LDL-C) targets as a guide to therapy. Such benefits are particularly pronounced in patients in whom LDL-P and LDL-C numbers disagree, as is common in people with diabetes mellitus or coronary heart disease (CHD).
The data, to be presented in a poster session at the 2014 National Lipid Association (NLA) Scientific Sessions, were generated by use of Evidera's Archimedes Model, a clinically detailed simulation model of human physiology, disease progression and healthcare delivery. The model, which has been validated in more than 50 clinical trials, incorporates person-specific data from real populations to create simulated populations that match individuals to demographic, risk factor and biomarker profiles over time.
"The Archimedes Model provides insight into likely health outcomes under various interventions and assumptions, allowing researchers to model populations over longer periods of time and with a greater number of patients than is possible in a clinical trial," said study co-investigator Richard Kahn, Ph.D., of the University of North Carolina at Chapel Hill. "In this study the Model generated results supporting the use of LDL particle information to guide statin therapy for patients at high risk of cardiovascular events, including individuals with diabetes or coronary heart disease."
Dr. Kahn and colleagues used the Archimedes Model to evaluate the efficacy of using LDL-C- versus LDL-P-guided therapy to prevent cardiovascular disease (CVD) events in patients with dyslipidemia. The Model accounted for inter-relationships of patients' baseline characteristics and risk factors, underlying physiological parameters and statin therapy effects to estimate CVD morbidity and mortality. The population simulated consisted of 1 million individuals representative of the general US population aged 20-84, which were derived from the National Health and Nutrition Examination Survey (NHANES) 1999-2006. The investigators also examined subpopulations of dyslipidemic individuals at moderate or high risk of CHD, patients with diagnosed diabetes, and those with prior CHD.
The simulated study had three arms:
The analysis showed that statin therapy in both the LDL-P Alone arm and the Dual arm reduced MACE (defined as fatal and nonfatal myocardial infarction [MI, or heart attack], fatal and nonfatal stroke, and CVD death) and death due to CVD (defined as CHD or stroke) to a greater extent than in the Control arm. However, a slightly greater effect was observed in the LDL-P arm than in the dual arm. In patients with established CHD, the relative reduction in risk of MACE relative to Controls was 6.2% in the Dual arm and 6.6% in the LDL-P Alone arm. In patients with diabetes, the relative risk reduction versus the Control Arm was 7.3% in the LDL-P Alone arm and 6.9% in the Dual Arm.
"This simulated study shows how LDL-P information can be used to make therapy more targeted to the needs of the individual patient, so that appropriate treatment will be given to the patients who need it most," said study principal investigator Henry Folse of Evidera in San Francisco, Calif. "The benefit of the use of LDL-P information is greatest for patients with discordantly high LDL-P relative to LDL-C, which is particularly common in patients with diabetes."
The poster presentation of the simulated outcomes data, "Using low-density lipoprotein (LDL) particle number (LDL-P) versus LDL cholesterol (LDL-C) to guide preventative therapy for cardiovascular disease," will be presented Friday, May 2 from 11:35 AM – 12:35 PM and on Saturday, May 3 from 12:00 PM – 1:00 PM during the NLA meeting at the Hyatt Regency Grand Cypress in Orlando.
"The Archimedes Modeling data provide a glimpse of how LDL-P targets can be used to manage high-risk patients on statin therapy," stated William C. Cromwell, MD, Chief Medical Officer of LipoScience. "We hope the findings stimulate further investigation and real-world use of LDL-P measurement as a guide to manage LDL-related risk for CVD."
The NLA Scientific Sessions also include the following poster presentations that support the clinical utility of NMR-based lipoprotein particle measurement. All will be presented on Friday, May 2 from 11:35 AM–12:35 PM and on Saturday, May 3 from 12:00 PM–1:00 PM.
About LipoScience, Inc.
LipoScience, Inc. (Nasdaq: LPDX) is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. The NMR LipoProfile® test, the Company's first proprietary test, is the only FDA-cleared blood test that directly quantifies LDL particles and provides physicians and their patients with actionable information to personalize management of heart disease. To date, more than 11 million NMR LipoProfile tests have been ordered. LipoScience is striving toward the NMR LipoProfile test becoming the preferred choice by physicians for the management of cardiovascular disease.
The Vantera® Clinical Analyzer is the first FDA-cleared platform that utilizes NMR technology. Its ease of use and quick turnaround time help maximize efficiency and throughput in the clinical laboratory. For further information on LipoScience, please visit www.liposcience.com.
Evidera, a wholly owned subsidiary of Symphony Technology Group, is one of the preeminent commercial entities analyzing effectiveness, establishing evidence, and substantiating the value of treatments within the global health industry through its market leading portfolio of health economics, outcomes research, market access, data analytics and epidemiology services. Evidera partners with life sciences organizations worldwide to optimize the market access and commercial success of their products by leveraging unparalleled knowledge of the global payer and regulator landscape and by developing, capturing and communicating the clinical and economic evidence that clients require to successfully market their products. Our research and consulting services are driven by world-class science and thought leadership and leverage a unique combination of capabilities. For more information, please visit www.evidera.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: our industry, business strategy, goals and expectations concerning our future operations, performance or results, profitability, capital expenditures, liquidity and capital resources, timing or anticipated results of our FDA submissions and other financial and operating information. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward -looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Expert Panel on Detection Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA 2001;285:2486-2497.
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