Reducing ldl with pcsk9 inhibitors–the clinical benefit of lipid drugs _ american pharmacists association

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Two new drugs, alirocumab (Praluent—Sanofi Aventis) and evolocumab (Repatha—Amgen), have been approved by FDA due to their ability to lower LDL cholesterol levels in patients at risk for cardiovascular disease. There is optimism that the drugs could reduce cardiovascular risks, although this has not yet been proven.

Two new drugs, alirocumab (Praluent—Sanofi Aventis) and evolocumab (Repatha—Amgen), have been approved by FDA due to their


ability to lower LDL cholesterol levels in patients at risk for cardiovascular disease. There is optimism that the drugs could reduce cardiovascular risks, although this has not yet been proven. When the drugs were submitted through the traditional FDA approval pathway, LDL cholesterol reduction was the surrogate measure of clinical benefit, and the FDA advisory committee had to consider whether this was enough evidence to substitute for demonstration of clinical cardiovascular benefit. There are both benefits and risks to using LDL cholesterol reduction as a surrogate endpoint for drug approval. When evaluating medications from any new drug class intended to reduce cardiovascular risks, it is important to establish evidence of improved outcomes. “As substantially as alirocumab and evolocumab reduce LDL cholesterol, definitive evidence of reduced cardiovascular event rates is essential,” the authors write. Ongoing trials should help to accomplish this.