indications - national lipid association · when drug therapy fails™ the only fda-approved...

LIPOSORBER ® provides hope… When Drug Therapy Fails ™ The only FDA-approved treatment for patients with elevated Lipoprotein(a) (Lp(a)) with Functional Hypercholesterolemia The LIPOSORBER® LA-15 System is indicated for Functional Hypercholesterolemia patients with either established Coronary Artery Disease (CAD) or Peripheral Arterial Disease (PAD) 1) LDL-C≥100 mg/dl or 2) Lp(a)≥60 mg/dl and LDL-C≥100 mg/dl In combination with diet & maximum tolerable lipid-lowering drug therapies that failed to achieve the recommended therapeutic targets. 1 INDICATIONS ESTABLISHED THERAPEUTIC NEED EARLY, INTENSIVE INTERVENTION CAN PREVENT PREMATURE CARDIOVASCULAR EVENTS & DEATH Identifying Lp(a) as a risk factor in FH patients may have signiﬁcant impact on preventing premature cardiovascular events and/or death when early and intensive intervention is given. 4 Individuals of familial hypercholesterolemia with elevated Lp(a)≥50mg/dl are at 40% greater risk of getting premature Atherosclerotic Cardiovascular Disease (ASCVD) & death than individuals with FH or elevated Lp(a) alone. 2 Unfortunately, the majority of familial hypercholesterolemia individuals are not achieving the LDL-C therapeutic targets (52% of FH individuals with no history of CV disease didn’t achieve LDL-C<100mg/dl & 78% of FH individuals with a history of CV disease that didn’t achieve the targeted LDL-C<70 mg/dl) despite 66% of patients taking two or more lipid-lowering therapies. 3,4 NEW Adverse Events: The most common adverse events are hypo- tension (0.8%) , nausea/vomiting (0.5%) and ﬂushing/blotching (0.4%). Other adverse reactions include angina/chest pain, fainting, light-headedness and anemia. Contraindication: Angiotensin Converting Enzyme (ACE) Inhib- itors are contraindicated with Liposorber. Patient can replace an ACE with an Angiotensin Receptor Blocker (ARB) References: 1. April 21, 2020 FDA approval letter for LIPOSORBER® LA-15 System 2. Duell, P.B. et al. Atherosclerosis. 2019; 289: 85-93. 3. Padmanabhan, A. et al. Journal of Clinical Apheresis. 2019; 34:171-354. 4. Ellis, K.L. et al. J Am Coll Cardiol. 2019;73(9):1029–39.

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Page 1: INDICATIONS - National Lipid Association · When Drug Therapy Fails™ The only FDA-approved treatment for patients with elevated Lipoprotein(a) (Lp(a)) with Functional Hypercholesterolemia

LIPOSORBER® provides hope…When Drug Therapy Fails™

The only FDA-approved treatment for patients with elevated Lipoprotein(a) (Lp(a)) with Functional Hypercholesterolemia

NEW

INDICATION

The LIPOSORBER® LA-15 System is indicated for Functional Hypercholesterolemia patients with either established Coronary Artery Disease (CAD) or Peripheral Arterial Disease (PAD)

1) LDL-C≥100 mg/dl or 2) Lp(a)≥60 mg/dl and LDL-C≥100 mg/dl

In combination with diet & maximum tolerable lipid-lowering drug therapies that failed to achieve the recommended therapeutic targets.1

INDICATIONS

ESTABLISHED THERAPEUTIC NEED

EARLY, INTENSIVE INTERVENTION CAN PREVENT PREMATURE CARDIOVASCULAR EVENTS & DEATH Identifying Lp(a) as a risk factor in FH patients may have significant impact

on preventing premature cardiovascular events and/or death when early and intensive intervention is given.4

Individuals of familial hypercholesterolemia with elevated Lp(a)≥50mg/dl are at 40% greater risk of getting premature Atherosclerotic Cardiovascular Disease (ASCVD) & death than individuals with FH or elevated Lp(a) alone.2

Unfortunately, the majority of familial hypercholesterolemia individuals are not achieving the LDL-C therapeutic targets (52% of FH individuals with no

history of CV disease didn’t achieve LDL-C<100mg/dl & 78% of FH individuals with a history of CV disease that didn’t achieve the targeted LDL-C<70 mg/dl) despite 66% of patients taking two or more lipid-lowering therapies.3,4

NEW

Adverse Events: The most common adverse events are hypo-tension (0.8%) , nausea/vomiting (0.5%) and flushing/blotching (0.4%). Other adverse reactions include angina/chest pain, fainting, light-headedness and anemia.Contraindication: Angiotensin Converting Enzyme (ACE) Inhib-itors are contraindicated with Liposorber. Patient can replace an ACE with an Angiotensin Receptor Blocker (ARB)

References:1. April 21, 2020 FDA approval letter for LIPOSORBER® LA-15 System2. Duell, P.B. et al. Atherosclerosis. 2019; 289: 85-93.3. Padmanabhan, A. et al. Journal of Clinical Apheresis. 2019; 34:171-354.4. Ellis, K.L. et al. J Am Coll Cardiol. 2019;73(9):1029–39.

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