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MAASTRICHT, The Netherlands--The significant combined effect of bempedoic acid and ezetimibe on LDL-C in patients at high risk for CV events may suggest a new era of non-statin therapy.
MAASTRICHT, The Netherlands -a fixed-dose combination of 2 lipid-lowering agents with complementary mechanisms of action is effective for high-risk cardiovascular patients who fail to meet lipid goals with conventional statin therapies. The ATP citrate lyase inhibitor bempedoic acid, delivered in combination with the cholesterol absorption inhibitor ezetimibe (typically used as an add-on to statin therapy) lowered low-density lipoprotein (LDL) cholesterol by 38% compared to placebo, according to lead author Christie Ballantyne, MD, of Baylor College of Medicine in Houston, Texas, who presented the results of the phase 3 trial at the European Atherosclerosis Society 2019 Congress on May 27th.
A total of 301 patients at high risk for heart attack or stroke (measured as clinical disease with a history of familial hypercholesterolemia and LDL levels above 2.6 mmol/L, or no clinical disease, with multiple risk factors and LDL above 3.4 mmol/L) were randomized to the combination therapy, either agent alone, or placebo. The majority of patients (65%) were already taking a statin, many at the maximal dose.
At the end of 12 weeks, the combination of bempedoic acid/ezetimibe (180 mg/10 mg) reduced LDL-C by 36.2%, which was significantly greater than ezetimibe alone (23.2%), bempedoic acid alone (17.2%), or placebo, which actually increased LDL by 1.8%. The fixed combination also demonstrated greater reduction in non-high-density lipoprotein and high sensitivity C-reactive protein than either agent alone or placebo.
“The results of this study show that a fixed combination of bempedoic acid and ezetimibe, two oral lipid-lowering agents with complementary mechanisms of action, has the potential to meet the needs of high risk patients who are unable to attain LDL cholesterol goal with currently available therapies,” Dr. Ballantyne said.
The efficacy of the 2-agent combination is also supported by data from a phase 2 trial that showed additional LDL-C lowering when bempedoic acid was added to ongoing treatment with ezetimibe. (ref)
Bempedoic acid/ezetimibe was well tolerated and presents a good therapeutic option for patients who are unable to tolerate conventional statin therapies, in addition to those who are already taking statins. “The fixed combination is also a convenient once-daily option for patients,” Dr. Ballantyne added.
Reference: Ballantyne C, Laufs U, Ray KK, et al. Efficacy and safety of bempedoic acid + ezetimibe fixed-dose combination in patients at high CVD risk and with elevated LDL-C receiving maximally tolerated statin therapy. Paper presented at 87th EAS Congress: May 26-29, 2019; Maastricht, The Netherlands. Abstract EAS19-1133.