I meant Ezetimide as sole therapy

For ezetimibe as sole therapy in an obese 68-year-old woman with elevated lipids and no prior cardiovascular events, the evidence is thin and does not support starting it.

The evidence you have is almost entirely about ezetimibe combined with a statin, not ezetimibe alone. The 2024 meta-analysis of 106,358 participants [1] and the IMPROVE-IT trial of 18,144 patients [19] both tested ezetimibe added to a statin, never ezetimibe by itself. The few monotherapy studies are small, short, and measure only lab values, not real outcomes. One 2003 review found ezetimibe alone lowered LDL by about 17% [4, 6]. A 2008 study of 33 patients found a 16% LDL reduction and some antioxidant effects [2]. A 2004 trial of 892 patients found a 17.7% LDL reduction [6]. None of these studies tracked whether anyone had fewer heart attacks or lived longer.

The key question is whether lowering LDL with ezetimibe monotherapy prevents cardiovascular events. The answer is that no trial has ever tested this. The IMPROVE-IT trial showed that adding ezetimibe to simvastatin reduced events by about 6% over seven years [19], but that was in people who had already had a heart attack, and the benefit came on top of a statin. For primary prevention in a 68-year-old woman with no prior events, there is zero outcome data for ezetimibe alone.

The safety profile appears mild in short-term studies, but long-term safety data for monotherapy is absent. The 2024 meta-analysis found no increase in muscle or gastrointestinal side effects for the combination [1], but that does not tell you about ezetimibe alone over years.

My call: ezetimibe monotherapy lowers LDL on lab tests but has never been shown to prevent heart attacks or strokes in any population, let alone in primary prevention for an obese older woman. The evidence does not support starting it. Confidence: high.