InsightRX Presents Research Evaluating Effectiveness of Model-Informed Precision Dosing for Heparin at Annual Anticoagulation Forum Meeting

SAN FRANCISCO, April 4, 2023 –InsightRX – which provides cloud-based precision medicine software to optimize treatment decisions – presented research comparing model-informed precision dosing (MIPD) to a hospital dosing nomogram for therapeutic heparin dosing at the 17^th National Conference on Anticoagulation Therapy held April 1-3 in San Francisco.

The research, titled “Anti-Xa target attainment & dose selection: comparison of pharmacokinetic model-guided dosing versus institutional practice,” was presented during a one-hour poster session on Saturday, April 1, at the San Francisco Marriott Marquis. Jonathan D. Faldasz, Pharm.D., BCPS, senior director of product and customer experience at InsightRX, was the presenter.

MIPD has proven clinically beneficial in achieving therapeutic drug exposure and decreasing the need for dosing adjustment, yet there has been little research on the application of MIPD to the dosing of unfractionated heparin (UFH). An InsightRX team recently conducted a simulation from which it concluded that an initial therapeutic heparin dosing strategy using MIPD may enable more accurate dosing than would an average hospital dosing nomogram (a flow chart for calculating the correct dosage for a specific patient). 

Heparin is an anticoagulant used therapeutically to prevent or slow the development and growth of blood clots in people with certain medical conditions or patients undergoing high-risk medical procedures. 

Unfortunately, anticoagulants have been “consistently identified as the most common cause of adverse drug events (ADEs)” in healthcare settings. And despite advances in therapeutic heparin dosing and monitoring, determining the right dosage can be extremely challenging because each patient eliminates heparin at their own rate, based on variables such as their size, blood composition, and underlying disease state. This undermines the effectiveness of standardized dosing guidelines and introduces some risk to patients. 

Heparin levels below the target range for a patient can result in further and worsening clot formation, with potential for embolic organ failure, embolic stroke and death, while levels above the target range can trigger major bleeding, with serious consequences including hemorrhagic stroke, organ failure and death. It is essential, therefore, to closely monitor the effect that heparin is having on a patient.  The two most common measures of heparins activity are the antifactory-Xa assay (anti-Xa) and activated partial thromboplastic time (aPTT).

InsightRX researchers conducted a digital twin study in which they assembled real-world covariate weight distributions from a sample of 2,000 de-identified adult patients from the InsightRX database. The researchers then combined that data with synthesized data generated according to inter-patient variation as defined by a model describing the pharmacokinetic/pharmacodynamics of heparin developed by Delavenne et al. An initial dose was calculated according to a typical hospital nomogram (both low and high dose) and as predicted by two pharmacokinetic (PK) models (Delavenne et al and Brunet et al) to achieve steady-state anti-Xa concentration in the desired therapeutic range of 0.3-0.7 units/mL. 

Results of the simulation show that initial heparin dosing using MIPD is more likely to result in target dosage attainment than would a hospital nomogram. This is significant because more accurate initial heparin dosing will reduce the number of patients whose doses must be adjusted and will minimize the likelihood of an ADE that could be life-threatening or life-changing to a patient. 

“This is a promising development in improving the ability of hospitals to ensure patients receiving heparin injections are being administered safe and effective dosages,” said Sirj Goswami, CEO and co-founder of InsightRX. “Our study shows that, used with the right dosing model, MIPD can potentially be used to drive better outcomes for patients being treated with heparin.”

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