Background
Inability to tolerate statins because of muscle symptoms contributes to uncontrolled cholesterol levels and insufficient cardiovascular risk reduction. Bempedoic acid, a prodrug that is activated by a hepatic enzyme not present in skeletal muscle, inhibits
ATP
‐citrate lyase, an enzyme upstream of β‐hydroxy β‐methylglutaryl‐coenzyme A reductase in the cholesterol biosynthesis pathway.
Methods and Results
The phase 3, double‐blind, placebo‐controlled CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL‐Inhibiting Regimen) Serenity study randomized 345 patients with hypercholesterolemia and a history of intolerance to at least 2 statins (1 at the lowest available dose) 2:1 to bempedoic acid 180 mg or placebo once daily for 24 weeks. The primary end point was mean percent change from baseline to week 12 in low‐density lipoprotein cholesterol. The mean age was 65.2 years, mean baseline low‐density lipoprotein cholesterol was 157.6 mg/dL, and 93% of patients reported a history of statin‐associated muscle symptoms. Bempedoic acid treatment significantly reduced low‐density lipoprotein cholesterol from baseline to week 12 (placebo‐corrected difference, −21.4% [95% CI, −25.1% to −17.7%];
P
<0.001). Significant reductions with bempedoic acid versus placebo were also observed in non–high‐density lipoprotein cholesterol (−17.9%), total cholesterol (−14.8%), apolipoprotein B (−15.0%), and high‐sensitivity C‐reactive protein (−24.3%;
P
<0.001 for all comparisons). Bempedoic acid was safe and well tolerated. The most common muscle‐related adverse event, myalgia, occurred in 4.7% and 7.2% of patients who received bempedoic acid or placebo, respectively.
Conclusions
Bempedoic acid offers a safe and effective oral therapeutic option for lipid lowering in patients who cannot tolerate statins.
Clinical Trial Registration
URL
:
https://www.clinicaltrials.gov
. Unique identifier:
NCT
02988115.
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The demand for writing skills is becoming increasingly prevalent within the U.S. job market. Yet, the biggest barrier to developing successful writing skills, writing apprehension, has received very little attention from scholars in the past 30 years. The present study sought to identify the influence of instructional communicative behaviors on business students’ writing apprehension. Specifically, the study tested a model in which instructors’ immediate behaviors and clarity indirectly influenced students’ writing apprehension through the mediation of perceived immediacy. The data were consistent with the hypothesized model.
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