Ezetimibe did not increase diabetes risk in IMPROVE-IT substudy
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Key takeaways:
- Ezetimibe conferred no increased risk for new-onset diabetes among IMPROVE-IT participants.
- The findings were consistent regardless of baseline characteristics and history of statin monotherapy.
Researchers observed no increased risk for new-onset diabetes among IMPROVE-IT participants assigned to ezetimibe plus statin therapy vs. statin monotherapy, according to a research letter.
A post hoc analysis of IMPROVE-IT, a randomized, double-blind, multicenter trial that evaluated whether simvastatin plus ezetimibe improved CV outcomes compared with statin monotherapy, was published in the Journal of the American Heart Association.
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“Our key takeaway from this study was the addition of ezetimibe to statin therapy was not associated with the development of new-onset diabetes. This held true for patients both with and without metabolic syndrome, which is a risk factor in the development of diabetes,” Nishant P. Shah, MD, FACC, assistant professor of medicine in cardiology at Duke Heart Center, Duke University School of Medicine and Duke Clinical Research Institute, told Healio. “The results of this study are strengthened by being obtained in the context of a large randomized clinical trial with 6 years of follow-up.”
As Healio previously reported, ezetimibe plus simvastatin improved clinical outcomes after ACS compared with simvastatin alone among 18,144 moderate- to high-risk patients within 10 days after ACS (mean age, 64 years; 25% women).
The present study included IMPROVE-IT participants without diabetes at baseline. The primary endpoint of new-onset diabetes was defined as the initiation of an antihyperglycemic medication or two consecutive blood glucose measurements of 126 mg/dL or more, according to the study.
Patients were evaluated at 30 days and every 4 months thereafter, with a median of 6 years of follow-up.
Overall, 14.9% of participants met the criteria for new-onset diabetes during follow-up.
Those who developed new-onset diabetes had elevated BMI, systolic BP, triglycerides and more criteria meeting the definition of metabolic syndrome according to the AHA compared with those who did not develop new-onset diabetes.
Among patients who developed new-onset diabetes, there were no differences in baseline characteristics between those who received simvastatin plus ezetimibe and those who received statin monotherapy, the researchers wrote.
Shah and colleagues reported no significant difference in risk for new-onset diabetes among patients treated with simvastatin plus ezetimibe compared with statin monotherapy (HR = 1.03; 95% CI, 0.93-1.15). This finding remained consistent across sensitivity analyses that used various definitions of new-onset diabetes.
Moreover, ezetimibe on top of statin therapy did not appear to impact risk for new-onset diabetes among patients with no history of statin therapy before trial enrollment or those who had taken statins before (P for interaction = .5).
Ezetimibe on top of statin therapy also did not affect risk for new-onset diabetes in patients with or without metabolic syndrome at baseline (P for interaction = .46), according to the study.
“Observing no increased risk of diabetes with ezetimibe is very important, as ezetimibe serves as another tool to lower LDL-C in addition to statins. Our results support the safety and efficacy of this medication as an adjunct to statin therapy. We have also seen data on how PCSK9 inhibitors also are not associated with diabetes. Thus, our results combined with PCSK9 inhibitor data could also be important for national guidelines,” Shah told Healio. “Several newer LDL-lowering agents are in development or recently been approved. It will be important to see if these agents are also not associated with diabetes.”
For more information:
Nishant Shah, MD, FACC, can be reached at nishant.shah@duke.edu. Twitter: @nishant_shahmd.
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