July 17, 2019
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High-intensity statin therapy confers improved outcomes in older patients with ACS

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High-intensity therapy with simvastatin and ezetimibe contributed to a greater benefit compared with monotherapy with simvastatin in patients hospitalized for ACS, especially in those aged 75 years or older, according to a secondary analysis of the IMPROVE-IT trial published in JAMA Cardiology.

“In light of these observations, continuing to treat elderly patients after an ACS with moderate- rather than higher-intensity therapy to lower lipid levels will represent a missed opportunity to incrementally improve long-term outcomes for this high-risk population,” Richard G. Bach, MD, FACC, professor of medicine in the cardiovascular division at Washington University School of Medicine in St. Louis, and colleagues wrote.

As Cardiology Today previously reported, the addition of ezetimibe to simvastatin was associated with better clinical outcomes in high-risk patients with ACS compared with simvastatin alone.

Secondary analysis

This secondary analysis included all 18,144 patients (mean age, 64 years; 76% men) that were enrolled in the trial who were hospitalized within 10 days for ACS, had an LDL of at least 50 mg/dL and a maximum of 125 mg/dL or 100 mg/dL depending on whether they were receiving prescription therapy. Patients were assigned 40 mg simvastatin with 10 mg ezetimibe once per day or 40 mg simvastatin once per day with placebo.

The primary efficacy endpoint was a composite of CVD death, nonfatal stroke or major adverse cardiac event, which was defined as unstable angina leading to hospitalization, nonfatal MI or coronary revascularization after 30 days.

Of the patients in the trial, 28.5% were aged 65 to 74 years and 15.4% were aged at least 75 years at randomization.

Patients younger than 65 years assigned simvastatin and ezetimibe had lower rates of the primary endpoint compared with those assigned simvastatin and placebo (0.9%; HR = 0.97; 95% CI, 0.9-1.05). This was also seen in patients aged 65 to 74 years (0.8%; HR = 0.96; 95% CI, 0.87-1.06). The greatest absolute risk reduction was in patients aged at least 75 years (8.7%; HR = 0.8; 95% CI, 0.7-0.9; P for interaction = .02).

High-intensity therapy with simvastatin and ezetimibe contributed to a greater benefit compared with monotherapy with simvastatin in patients hospitalized for ACS, especially in those aged 75 years or older, according to a secondary analysis of the IMPROVE-IT trial published in JAMA Cardiology.
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There was no increase in the rate of adverse events in younger or older patients when simvastatin and ezetimibe was compared with simvastatin and placebo.

“These results have implications for guideline recommendations regarding therapy to lower lipid levels in elderly individuals,” Bach and colleagues wrote.

Shared decision - making

“While the results reported by Bach et al are part of a post-hoc analysis, they provide valuable information for both the patient and the practitioner,” Antonio M. Gotto Jr., MD, DPhil, dean emeritus at Weill Cornell Medicine, wrote in a related editorial. “They strongly support the benefit of intensive therapy to reduce LDL-C levels in elderly individuals with atherosclerotic cardiovascular disease.” – by Darlene Dobkowski

Disclosures: The IMPROVE-IT trial was supported by Merck and Co. Bach reports he received grants from CSL Behring, Merck & Co. and Myokardia and personal fees from Armaron Bio, Novo Nordisk and Pharmacosmos. Gotto reports he received personal fees from Esperion Therapeutics, consults for Kowa Pharmaceuticals and serves on the data safety monitoring board for Akcea Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures.