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Posted by on Jun 27, 2015 in Coronary artery disease | 0 comments

In a nutshell

This paper studied whether adding alirocumab (Praluent) to statin treatment is effective and safe in patients with high levels of cholesterol.

Some background

Statins are a group of drugs that reduce levels of low-density lipoprotein cholesterol (LDL, the "bad" type of cholesterol). However, some patients already receive the maximum allowed dose of statins. Thus, other treatments are needed to further reduce levels of cholesterol. Alirocumab has shown to be able to reduce cholesterol in patients who have high levels even after statin therapy.

Methods & findings

The current study examined the long-term safety and effectiveness of alirocumab. Patients who had high levels of cholesterol and were at risk of cardiovascular diseases were studied. 205 patients who received alirocumab and 106 patients who received a placebo (drug that has no real effect) were analyzed. All patients received the maximum allowed statin treatment. The change in cholesterol levels were measured.

After 24 weeks of treatment, the estimated average decrease in LDL cholesterol levels was 48.2% among patients receiving alirocumab and 2.3% among patients receiving placebo. The dosage of alirocumab was increased in 16.8% of patients at week 12 because their LDL cholesterol level at week 8 was greater than 70 mg/dL. 75% of patients receiving alirocumab achieved an LDL cholesterol level of less than 70 mg/dL at week 24, compared to 9% of patients receiving placebo.

The rate of adverse events (undesired effect of treatment) was similar between patients receiving alirocumab and patients receiving placebo. It was uncommon for patients to stop taking medication due to adverse events. 5.3% of patients receiving alirocumab and 2.8% of patients receiving placebo had a mild injection site reaction (redness or damage to skin surrounding where drug was injected). 8.7% of patients receiving alirocumab had a potential general allergic reaction. 6.5% of patients receiving placebo had a potential general allergic reaction.

The bottom line

The authors concluded that alirocumab treatment led to a greater decrease in levels of low density lipoprotein cholesterol in patients who had high cholesterol levels.

The fine print

This study was sponsored by Sanofi and Regeneron Pharmaceuticals, the developers of alirocumab. Alirocumab has not yet been approved by the Food and Drug Administration (FDA). 

What’s next?

Talk to your doctor about your treatment options if your are recieving the maximum dose of statins. 

Published By :

American heart journal

Date :

Jun 01, 2015

Original Title :

Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study.

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