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A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe (Zetia, Vytorin with simvastatin).
The analysis was prompted by previous findings from very large meta-analyses of an increased risk for new onset diabetes associated with statins. This small but potentially troubling increase occurred in one person out of a thousand taking moderate-intensity statins and three persons out of a thousand taking high-intensity statins. Whether or not a similar risk exists for ezetimibe has been unknown.
of Duke University, presented the results of the IMPROVE-IT substudy on Tuesday afternoon at the European Society of Cardiology meeting in London.
The IMPROVE-IT investigators looked at the 12,254 patients in the trial who did not already have diabetes (5,284 patients entered the trial with diabetes). New onset diabetes was defined as the initiation of a diabetes drug or two consecutive fasting glucose levels of 7 mmol/L or higher.
During the course of the study, with a mean followup of 75 months, 1,414 patients (13.3% of the study population) developed diabetes. There was no significant difference between groups:
- 720 new cases on ezetimibe and simvastatin
- 694 cases on simvastatin alone
- Hazard ratio 1.04 (95% CI 0.94-1.15, P=0.46)
Similar findings were observed when the investigators performed four different sensitivity analyses using slightly different definitions for new onset diabetes.
Related story: IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics
From the American Heart Association: