STEPS

New Drug Reviews

Alirocumab (Praluent) for the Treatment of Hyperlipidemia

 


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Am Fam Physician. 2016 Aug 15;94(4):310-311.

Alirocumab (Praluent) is a monoclonal antibody labeled for the treatment of hyperlipidemia in patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need additional lowering of low-density lipoprotein (LDL) cholesterol despite treatment with diet and maximally tolerated doses of statins.1 It is one of two inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK-9), a protein that binds LDL-receptors on hepatocytes, leading to enhanced clearing of serum LDL by free LDL receptors.

View/Print Table

DrugDosageDose formCost*

Alirocumab (Praluent)

75 mg via subcutaneous injection every two weeks, increasing to 150 mg every two weeks if needed

Prefilled 75-mg or 150-mg syringe/pen

$1,164*


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 6, 2016).

DrugDosageDose formCost*

Alirocumab (Praluent)

75 mg via subcutaneous injection every two weeks, increasing to 150 mg every two weeks if needed

Prefilled 75-mg or 150-mg syringe/pen

$1,164*


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 6, 2016).

SAFETY

In an 18-month randomized controlled trial, 2,341 patients taking alirocumab did not have increased all-cause mortality, cardiovascular mortality, stroke, or heart failure compared with those taking placebo.1,2 Alirocumab has been shown to increase adverse neurocognitive effects such as amnesia, memory impairment, and confusional state, but these are rare (number needed to harm [NNH] = 170). Serious adverse effects leading to discontinuation are similar to those with placebo and are infrequent (7.2%).

TOLERABILITY

Common adverse effects of alirocumab include localized injection-site reactions, nasopharyngitis, and flulike illness (4% to 11%).1 Additionally, myalgia is more common with alirocumab than with placebo (NNH = 40). When alirocumab is used alone, one in 20 patients will discontinue therapy because of adverse effects. However, when combined

Address correspondence to Kathleen A. Barry, MD, at kathleen.anne.barry@gmail.com. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

1. U.S. National Library of Medicine/National Institutes of Health. Drug label information. Praluent–alirocumab injection, solution. https://www.dailymed.nlm.nih.gov. Accessed December 28, 2016.

2. Robinson JG, Farnier M, Krempf M, et al.; ODYSSEY Long Term Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489–1499.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.



 

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