Benefit of ezetimibe ‘unclear’
MedWire News: The benefit of ezetimibe for treating elevated cholesterol levels is "unclear," according to a report published by the German Institute for Quality and Efficiency in Health Care (IQWiG).
"In patients with hypercholesterolemia there is no proof of a benefit or harm from ezetimibe therapy compared with placebo," write the authors. "Likewise, there is no proof of an additional or lesser benefit, or for greater or lesser harm from ezetimibe compared with other lipid-lowering agents or with nondrug treatment interventions."
For the benefit assessment of treatment with ezetimibe, particularly in combination with statins, compared with treatment with placebo or other lipid-lowering drugs, the team searched the literature for randomized controlled trials published before 28 April 2011.
A total of two studies were identified as relevant for analysis: ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) and ARBITER-6-HALTS (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis). In both studies, all patients received a statin as basic therapy.
In the 24-month ENHANCE study (n=720), half of the patients received ezetimibe and half received placebo. In the 14-month ARBITER-6-HALTS study (n=363), treatment with ezetimibe was compared with niacin treatment.
The IQWiG reports no statistically significant difference in all-cause and vascular mortality, vascular morbidity, or the composite outcome of mortality and cardiovascular morbidity between patients treated with ezetimibe or placebo. Similarly, no significant differences were found between patients treated with ezetimibe or niacin.
In addition, there were no significant between-group differences for the following outcomes: health-related quality of life, adverse events, serious adverse events, or study discontinuation due to adverse events.
The IQWiG stated in a press release that these data show "proof is lacking that patients have a greater benefit if they take ezetimibe in addition to statins for the prevention of heart attacks."
It concluded: "The attention of healthcare professionals is currently focused on an ongoing study (IMPROVE-IT [Improved Reduction of Outcomes: Vytorin Efficacy International Trial]). It is the first study with the primary aim of comparing the effect of simvastatin plus ezetimibe versus simvastatin plus placebo on cardiovascular outcomes.
"The study includes high-risk patients with acute coronary syndrome whose condition has already been stabilized. The results are expected in 2013."
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Nikki Withers