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Published on: December 11, 2017
American college of cardiology 57th scientific sessions, 2008
Insights
The ENHANCE trial showed disappointing results for ezetimibe and simvastatin combination therapy in familial hypercholesterolemia. This highlights the need for further research into statins and non-statin lipid-lowering drugs.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- The American College of Cardiology (ACC) Scientific Sessions are a key venue for presenting high-impact clinical trials.
- The ENHANCE trial, investigating combination therapy for familial hypercholesterolemia, faced scrutiny due to data delays.
- A special session was convened due to the trial's controversial nature and unexpected findings.
Purpose of the Study:
- To evaluate the effect of combination ezetimibe and high-dose simvastatin versus simvastatin alone on atherosclerosis progression.
- To assess the impact of this combination therapy in patients with Heterozygous Familial Hypercholesterolemia (HeFH).
Main Methods:
- The study involved patients with HeFH.
- Comparison of atherosclerosis progression between patients receiving combination therapy and those on high-dose simvastatin monotherapy.
Main Results:
- The ENHANCE trial yielded unexpectedly disappointing results.
- Data revealed that the combination therapy did not significantly alter the atherosclerotic process compared to simvastatin alone.
Conclusions:
- The findings raise questions about the efficacy of ezetimibe and simvastatin combination therapy in this patient population.
- The results spurred further interest in the non-lipid-lowering benefits of statins and alternative lipid-lowering agents.
Abstract:
The peak-interest clinical trials at the American College of Cardiology (ACC) Scientific Sessions, which took place from March 29 to April 2, 2008, are generally ushered into the high-profile Late-Breaking Clinical Trials sessions. This year, the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) was precluded from the "Late-Breakers" because a peek at the unexpectedly disappointing data had already been afforded in January.Amid pre-meeting publicity about allegedly inappropriate data delays (and a Congressional hearing delving into them), the ACC created a special plenary session "Showcase" presentation of the data with a review panel for comment. The ENHANCE findings intensified interest in both non-lipid-lowering benefits of statins and non-statins for lipid lowering. This 57th ACC conference hosted a record 29,000 attendees in Chicago, Illinois.
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