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Cholesterol drug significantly reduced patients' risk of death in trial

13 March 2018

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

New research indicates that alirocumab (Praluent-Regeneron, Sanofi) reduced patients' risk of death by 15% in a major clinical trial. The 3-year study found that patients taking alirocumab were 15% less likely to experience a heart attack, stroke, or hospitalization compared with those taking placebo.

As federal officials struggle to tackle exorbitant pharmaceutical prices, at least one drug's manufacturers have pledged to slash prices of a potentially life-saving drug for its most at-risk patients. These results about Praluent is announced on Saturday at an American College of Cardiology conference in Florida. "With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients".

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Patients with higher baseline LDL-C levels (at or above 100 mg/dL) experienced a more pronounced effect from the drug, which reduced the risk of MACE by 24 percent, and cut the risk of death from any cause by 29 percent.

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor. The companies are specifically asking that insurers loosen restrictions only for patients at the highest risk of death-those who have had a heart attack or other serious coronary event in the past year, and whose cholesterol levels exceed the threshold recommended by doctors despite taking statins.

"The hard data from the Odyssey Outcomes trial confirms. that treatment with Praluent does lead to a reduction of both cardiovascular and all-cause deaths, particularly for the higher-risk patient population", said David Whitrap, a spokesman for ICER, which conducted the review.

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The drug, which is injected every two weeks or every four weeks based on strength, allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood.

For those in the Praluent treatment arm, an estimated 75% of patient time was on the 75 mg dose. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.

"We need to reset our expectations" and realize that benefits for any new drug are going to be fairly small when added to already good treatments such as statins, said Dr Jeffrey Kuvin, conference leader and cardiology chief at Dartmouth-Hitchcock Medical Centre. "Enough is enough. We're willing to work in their [price] range, providing that payers agree to reduce their burdensome barriers for patients". Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release. "This is the right thing to do for patients".

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Cholesterol drug significantly reduced patients' risk of death in trial