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Alirocumab Added to High-Intensity Statin Therapy and Coronary Atherosclerosis in Patients With Acute Myocardial Infarction—Reply
In Reply Dr Benson expresses concerns about the selection of lipid-lowering treatment in the placebo group of our study and suggests that a higher dose of rosuvastatin (40 mg) in combination with ezetimibe should have been selected. In contrast to previous trials of PCSK9 inhibitors, in which patients typically underwent a lipid stabilization phase after screening and were already taking maximally tolerated statin therapy at the time of study enrollment, the PACMAN-AMI trial enrolled patients in the acute setting of acute myocardial infarction, and the majority of patients (88%) had not been taking any statin therapy at the time of enrollment. When designing our study, we were concerned that initiating a triple lipid-lowering therapy with the highest dose of rosuvastatin combined with a second oral medication (ezetimibe) and alirocumab might have created tolerability issues in a study population largely consisting of statin-naive patients. Although statin intolerance is relatively rare, it is dose dependent and may affect adherence to treatment. The PACMAN-AMI trial was a mechanistic imaging study aiming to compare the effects of standardized, guideline-recommended high-intensity statin therapy (ideally unchanged during the study) alone vs in combination with alirocumab. Notably, the control group in our study received higher doses of lipid-lowering therapy and had lower median LDL-C levels than in other recent studies of patients with acute myocardial infarction. For example, only 48% of patients in the SWEDEHEART registry were treated with a high-intensity statin and had a median LDL-C level of 77 mg/dL, and only 59% of patients in the placebo group of the GLAGOV trial used a high-intensity statin and had a median LDL-C level of 93 mg/dL.
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