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IMPROVE-IT: Ezetimibe plus simvastatin reduces total, recurrent CV events
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SAN DIEGO — High-risk patients with ACS assigned simvastatin plus ezetimibe had fewer total and recurrent events compared with those assigned simvastatin alone, according to new data from the IMPROVE-IT trial presented at the American College of Cardiology Scientific Sessions.
The researchers evaluated all events, not just the time of first event, of the primary composite endpoint — CV death, MI, unstable angina requiring hospitalization, stroke and coronary revascularization — that occurred during the median 6-year follow-up of the IMPROVE-IT trial, which compared high-risk ACS patients assigned simvastatin plus ezetimibe (Zetia, Merck) with those assigned simvastatin (Zocor, Merck) alone.
Sabina A. Murphy
Among the 18,144 patients, there were 9,545 total events of the composite primary endpoint during the study period (56% first events, 44% subsequent events), Sabina A. Murphy, MPH, director of biostatistics for the TIMI Study Group, Brigham and Women’s Hospital, said during a presentation. In patients with an event, the mean number of events was 1.8 (range, 1-14).
Compared with simvastatin alone, combined simvastatin/ezetimibe (Vytorin, Merck) was associated with a 9% reduction in total events (incidence rate ratio [IRR] = 0.91; 95% CI, 0.85-0.97) and a 12% reduction in subsequent events (IRR = 0.88; 95% CI, 0.79-0.98). The reduction in first events was previously reported at the American Heart Association Scientific Sessions in November 2014 (HR = 0.936; 95% CI, 0.887-0.988; number needed to treat = 50).
According to the researchers, the lower rate of total events associated with adding ezetimibe to simvastatin therapy was driven by decreases in nonfatal MI (IRR = 0.87; P = .004) and nonfatal stroke (IRR = 0.77; P = .005).
In addition, the rate of total CHD death, nonfatal MI and urgent revascularization events were reduced by 15% in the simvastatin/ezetimibe group (IRR = 0.85; P = .002).
Christopher P. Cannon
“This reinforces the idea that lowering cholesterol a lot is good,” researcher Christopher P. Cannon, MD, physician at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and executive director of cardiometabolic trials at Harvard Clinical Research Institute, told Cardiology Today. “Second, third and fourth events were all reduced in exactly the same rate as the first event.
“The benefit [of adding ezetimibe to simvastatin] is actually magnified in terms of the absolute benefit, and the number needed to treat to prevent one of these events was cut by more than half,” Cannon said. – by Erik Swain
Reference:
Murphy SA, et al. Featured Clinical Research II. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Disclosure: The study was funded by Merck. Cannon reports receiving consultant fees/honoraria from Bristol-Myers Squibb, Boehringer Ingelheim, CSL Behring, Essentialis, GlaxoSmithKline, Kowa, Lipimedix, Merck, Pfizer, Regeneron/Sanofi and Takeda, and research grants from Accumetrics, Arisaph, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Janssen Pharmaceuticals. Murphy reports receiving consultant fees/honoraria from Merck and research grants from AstraZeneca, Daiichi Sankyo, GlaxoSmithKline and Merck.
Perspective
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Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
This post-hoc analysis from IMPROVE-IT is reassuring in that the benefit we saw from the primary analysis is also applicable to recurrent events. However, it is not known if the same benefit with ezetimibe/simvastatin would have been observed if a high-intensity statin such as atorvastatin 80 mg were to be used, as recommended by the guidelines, instead of simvastatin 40 mg in the IMPROVE-IT trial.
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