New drug drastically lowers LDL cholesterol levels, stroke and heart attack risks
A new drug has been seen in initial tests to drastically reduce cholesterol levels and halve the risk of heart attacks and stroke compared to standard treatment.
The drug called evolocumab drives the LDL cholesterol levels so dramatically low that researchers expect to see quick benefits with modest intervention once the drug is cleared.
Lead study author Dr Marc Sabatine, a senior physician at Brigham and Women's Hospital in Boston, MA, and colleagues presented their findings at the American College of Cardiology's 64th Annual Scientific Session in San Diego.
Of the 4465 participants, 2,976 were randomised to receive an injection of evolocumab every two or four weeks plus standard therapy, while 1,489 patients received standard statin therapy alone.
The average follow-up duration was 11.1 months.
Participants were fully aware of the treatment they were receiving, as were the researchers but not the reviewing panel, writes Medical News Today.
At study baseline, the average LDL cholesterol level among participants was 120 mg/dL, the average level found among the general population.
Patients treated with evolocumab experienced an average 61% reduction in LDL cholesterol levels.
Within 12 weeks, LDL cholesterol levels reduced to less than 100 mg/dL - defined as the optimal range - in 90.2% of evolocumab-treated patients, while levels reached 70 mg/dL or less for 73.6% of patients who received the drug.
In comparison, only 26% of patients who received standard therapy alone saw their LDL cholesterol levels fall below 100 mg/dL, while only 3.8% had such levels fall below 70 mg/dL.
Those treated with evolocumab also showed a 53% reduction in cardiovascular events, including heart attack, stroke, hospitalisation, angioplasty and death.
Evolocumab was found to be largely well tolerated by patients.
Some limitations of study which was published in The New England Journal Of Medicine, include the small number of cardiovascular events.
The study was a one-year extension of 12 phase 2 and 3 clinical trials that had assessed evolocumab's ability to reduce levels of low-density lipoprotein (LDL) cholesterol.
Statin therapy is the standard treatment at present for high cholesterol. It works by blocking an enzyme in the liver that makes the cholesterol.
Evolocumab works differently by blocking a protein (PCSK9) that stops the liver from removing LDL cholesterol from the blood.
Once cleared, it is hoped that the drug can be used by patients who do not respond to statins or who are unable to tolerate them.
The results of the ongoing clinical trial involving more than 27,500 patients are expected in 2017.
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