Patients Managed to Target LDL Particle Number Experience Fewer Cardiovascular Events Than Patients Managed to Target LDL Cholesterol, According to Study Data demonstrates that the NMR LipoProfile® test provides clinically reliable information to help reduce cardiovascular events, especially in patients with diabetes and those on statin therapy

WASHINGTON, March 31, 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 showing that patients managed to a target LDL particle (LDL-P) number, as measured by LipoScience's NMR LipoProfile test, achieved a 22 to 25 percent greater reduction in the risk of cardiovascular (CV) events over a three-year period compared to patients who attained LDL cholesterol (LDL-C) targets.

These data, presented in a poster session at the 63rd American College of Cardiology (ACC) Scientific Sessions in Washington, D.C., are derived from a real-world sample of commercially insured patients who were at a high risk of CV events, including patients with Coronary Heart Disease and Diabetes Mellitus. The investigators found that patients who achieved target LDL-P levels (<1000 nmol/L) received more aggressive lipid-lowering treatment than those reaching target LDL-C concentrations (<100 mg/dL).

Those treatment differences were associated with better outcomes (as measured by the reduction in CV event rates) over one to three years of follow-up. The study was sponsored by LipoScience and jointly designed by LipoScience and HealthCore, with clinical input from Terry A. Jacobson, MD, Professor of Medicine at Emory University, Atlanta, and Peter P. Toth, MD, PhD, Director of Preventive Cardiology at CGH Medical Center in Sterling, Ill.

"These new data add to the growing body of evidence suggesting that NMR measurement of LDL particle number, when used in conjunction with other lipid measurements, is a valuable cardiovascular risk management tool," commented Dr. Jacobson, the lead author of the study. "Due to the wide variance in the cholesterol content of LDL particles among individuals, measurements of LDL cholesterol and LDL particle number frequently disagree, especially in patients with insulin resistance and those treated with lipid-lowering therapies. When a disagreement between LDL-P and LDL-C is present, quantification of LDL particle number is a more clinically reliable measure of LDL and of treatment outcomes than measurement of LDL cholesterol."

Dr. Jacobson and colleagues analyzed data from more than 4,000  high-risk patients (over 2,000 with LDL-P < 1000 nmol/L and over 2,000 with LDL-C < 100 mg/dL) selected from the HealthCore Integrated Research DatabaseSM who were followed for as long as three years. Those who achieved LDL-P target <1000 nmol/L were more likely to receive higher-potency statin medications at baseline, compared to patients whose LDL-P levels were not measured but who achieved LDL-C concentrations below 100 mg/dL. As noted above, the risk of a CV event was 22 to 25 percent lower in the LDL-P target group than in the LDL-C target group over one to three years of follow-up.

Dr. Jacobson's poster, "Comparison of cardiovascular events between patients achieving low-density lipoprotein particle targets and patients achieving low-density lipoprotein cholesterol targets," will be presented Monday, March 31 from 9:30 a.m. to 12:30 p.m. in Hall C of the Washington Convention Center. The poster number is 150.

"The HealthCore data add an important, real-world, analysis to the ongoing discussion of how best to optimize individual patient management. These findings are consistent with the recommendations of various expert panels and organizations such as the National Lipid Association, the American Association for Clinical Chemistry, and the American Association of Clinical Endocrinologists, each of which advocates the use of LDL-P as a target of therapy in managing at-risk patients," stated William C. Cromwell, MD, Chief Medical Officer of LipoScience.  "We hope the findings encourage greater adoption by clinicians to manage their patients to an LDL-P target to reduce CVD events."

The ACC Scientific Session also includes the following poster presentations that support the clinical utility of NMR-based lipoprotein particle measurement:

  • Poster #143: May HT, et al. Utility of high-density lipoprotein cholesterol, particle concentration, and size in predicting future major adverse cardiovascular events among patients undergoing angiography: The Intermountain Heart Collaborative Study.
    • Saturday, March 29, 9:30am to 12:30pm, Hall C
  • Poster #146: Muhlestein JB, et al. GlycA and GlycB, novel NMR biomarkers of inflammation, strongly predict future cardiovascular events, but not the presence of coronary artery disease (CAD), among patients undergoing coronary angiography: The Intermountain Heart Collaborative Study.
    • Sunday, March 30, 9:30am to 12:30pm, Hall C
  • Poster #128: Koren MJ, et al. Effects of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, on lipoprotein particle concentrations determined by nuclear magnetic resonance: Substudy of a randomized double-blind phase II clinical trial.
    • Sunday, March 30, 9:30am to 12:30pm, Hall C
  • Poster #134: Xu R, et al. Effects of evolocumab on lipoprotein particles and subclasses in hypercholesterolemic and heterozygous familial hypercholesterolemia subjects on statin therapy
    • Sunday, March 30, 9:30am to 12:30pm, Hall C
  • Poster #141 Alexander V, An antisense inhibitor of apolipoprotein C-III significantly decreases apolipoprotein C-III, triglycerides, Very-Low-Density Lipoprotein cholesterol and particle number, and increases High-Density Lipoprotein cholesterol and particle number in hypertriglyceridemic patients on a fibrate.
    • Monday, March 31, 9:30am to 12:30pm, Hall C

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 helps maximize efficiency and throughput in the clinical laboratory. For further information on LipoScience, please visit www.liposcience.com.

About HealthCore, Inc.

HealthCore, based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint, Inc. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the "real world" safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to www.healthcore.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.

SOURCE LipoScience, Inc.



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