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Posted by on Jan 21, 2014 in Hypertension | 0 comments

In a nutshell

This trial investigated the efficiency and tolerability of evolocumab as a cholesterol reducing drug.

Some background

High blood cholesterol, or hypercholesterolemia, is an important factor in the development and progression of cardiovascular disease, such as high blood pressure. Reduction of LDL-C levels, commonly referred to as the "bad cholesterol", is known to significantly improve prognosis among cardiovascular patients. Evolocumab is a new drug that was shown to be effective at reducing LDL-C levels in a recent large scale phase II trial. However, the long term effects of this drug were not properly investigated. This large scale and long term randomized trial enrolled participants from the original evolocumab phase II study to continue receiving treatment for 52 additional weeks.

Methods & findings

Of the 1359 participants of the original phase II trial, 1104 elected to enroll in this study. Patients were randomized to receive either standard care (368 patients acting as a control group), or standard care plus evolocumab injections every 4 weeks (736 patients).

Patients in the evolocumab group showed a persistent reduction in LDL-C levels. At week 12 of the trial, 61.9% of the patients in the evolocumab group showed an LDL-C below the recommended level of 70mg/dl, compared to 0.3% of patients in the control group. At the end of the 52nd week of the trial, 62.5% of patients in the evolocumab group showed an LDL-C level of below 70mg/dl, compared to 1% of patients in the control group. Among patients receiving evolocumab for the first time an average reduction of 52.3% in LDL-C levels was seen by week 52. Discontinuation of evolocumab led to rapid return of LDL-C levels to those measured before the initiation of treatment.

The bottom line

This trial concluded that evolocumab appears to be extremely effective and well tolerated in the treatment of hypercholesterolemia.

The fine print

This trial was funded by Amgen Inc. which developed and manufactures evolocumab.

What’s next?

Consult with your physician regarding the importance of reducing blood cholesterol levels in the management of hypertension.

Published By :

Circulation

Date :

Nov 19, 2013

Original Title :

Efficacy and Safety of Longer-Term Administration of Evolocumab (AMG 145) in Patients With Hypercholesterolemia: 52-Week Results From the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) Randomized Trial.

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