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The risk of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (the first key secondary end point) was 15% lower with bempedoic acid than with placebo, and the ...
In the cardiovascular outcomes trial, the rates were 1.2% for bempedoic acid and 0.9% for placebo. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
CONCLUSION ― In one large clinical trial in statinintolerant patients who had or were at high-risk for cardiovascular disease, the oral adenosine triphosphate- citrate lyase (ACL) inhibitor bempedoic acid (Nexletol) modestly reduced the risk of a 4-component composite of major adverse cardiovascular events (MACE) compared to placebo.
In the cardiovascular outcomes trial, in which 7,001 patients were exposed to NEXLETOL and 6,964 patients were exposed to placebo for a median of 3.1 years [see Clinical Studies, (14.1)], adverse reactions led to discontinuation of treatment in 11% of NEXLETOL-treated patients and 10% of placebo-treated patients.