Ezetimibe: Clinical and scientific meaning of the IMPROVE-IT study

After years of anxious wait, in June of the current year, the results of the clinical trial IMPROVE-IT were published in the New England Journal of Medicine.1 This was the first study to properly evaluate the clinical impact of adding ezetimibe to statin therapy. Until then, we had known that the combination of ezetimibe with statin enhanced the antihyperlipidemic effect of statins (surrogate endpoint). However, a positive surrogate marker does not necessarily have a guaranteed clinical impact on the therapy.2 Therefore, the IMPROVE-IT would fill a gap in the literature concerning the effect of ezetimibe on clinical outcomes.

The publication of the ENHANCE study in 2008 created uncertainty about the efficacy of the therapy with ezetimibe.3 In this randomized, clinical trial including patients with familial hypercholesterolemia, the therapy with ezetimibe added to 80 mg of simvastatin led to greater reductions in LDL cholesterol levels as compared with simvastatin alone. However, the effect was not accompanied by a greater reduction in atherosclerosis, measured by the carotid intima-media thickness (surrogate endpoint). At this point, it became evident that the industry was precipitate in promoting the use of a drug before its effects were demonstrated by clinical outcomes.

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In the same year, the New England Journal of Medicine published an article showing how the marketing to physicians and consumers had a positive impact on sales of ezetimibe in the American market, despite the absence of clinical evidence, differently from what was observed in Canada.4 The marketing was primarily aimed at substituting conventional therapeutic regimens with the combination of ezetimibe with statin at low doses. Nevertheless, in the lack of large studies to evaluate the impact on clinical outcomes, whether the substitution of low doses for high doses of statins (combined with ezetimibe) would lead to decreases in the pleiotropic effects of statins remained unknown.

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Thus, the results of the IMPROVE-IT study were awaited. They were first presented at the American Heart Association’s scientific sessions in November, 2014. In contrast to what usually occurs to large clinical trials, the study was not published on the day of presentation, which raised speculations that disagreements between authors and editors caused such delay in the publication, although the authors stressed that they had not submitted the study to the journal before the presentation at the meeting.

In this context, we will evaluate the dual meaning of this study, which demonstrated not only the efficacy of ezetimibe, but also only a slight decrease of the risk. This observation encourages us to have an intense debate over the relative risk reduction, the absolute risk reduction (ARR) and the number needed to treat (NNT) in the critical analysis of the scientific evidence.

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