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Identifying Patients for Nonstatin Therapy
Jennifer G Robinson1, Karol E Watson2
1Departments of Epidemiology & Medicine, University of Iowa College of Public Health and Carver College of Medicine, Iowa City, IA.
Insights
For patients with high atherosclerotic cardiovascular disease (ASCVD) risk despite statin therapy, non-statin options like ezetimibe and PCSK9 monoclonal antibodies (mAbs) offer benefits. Number-needed-to-treat (NNT) analysis helps identify which high-risk groups gain the most from these advanced therapies.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Risk Assessment
Background:
- Statins are the primary treatment for reducing atherosclerotic cardiovascular disease (ASCVD) risk.
- Some patients continue to have elevated ASCVD risk even with maximal statin therapy.
- Ezetimibe and PCSK9 monoclonal antibodies (mAbs) have demonstrated efficacy in reducing ASCVD events in clinical trials.
Purpose of the Study:
- To evaluate the number-needed-to-treat (NNT) for ezetimibe and PCSK9 mAbs in patients with persistent high ASCVD risk.
- To identify specific patient subgroups who may benefit from adding non-statin therapies to statin regimens.
- To inform clinical decision-making regarding the use of advanced lipid-lowering therapies.
Main Methods:
- Analysis of randomized trial data to calculate NNT for ASCVD event prevention.
- Stratification of patient groups based on ASCVD risk level (extremely high, very high, high) and low-density lipoprotein cholesterol (LDL-C) levels.
- Comparison of NNT values for PCSK9 mAbs and ezetimibe across different patient profiles.
Main Results:
- PCSK9 mAbs may be cost-effective for extremely high-risk patients (e.g., those with familial hypercholesterolemia, polyvascular disease, recurrent events) with LDL-C ≥70 mg/dL (NNT <25).
- Ezetimibe is a reasonable option for patient groups with NNTs <30, including extremely high-risk patients with LDL-C ≥130 mg/dL.
- Specific LDL-C thresholds for initiating non-statin therapy are defined for various risk categories.
Conclusions:
- NNT analysis provides a framework for selecting patients who will derive the greatest benefit from non-statin therapies.
- Ezetimibe and PCSK9 mAbs are valuable additions to statin therapy for select high-risk ASCVD populations.
- Personalized treatment strategies based on risk stratification and LDL-C levels are crucial for optimizing ASCVD prevention.
Abstract:
Statins are first-line therapy for reducing atherosclerotic cardiovascular disease (ASCVD) risk. Some patients remain at high ASCVD risk despite maximizing statin therapy. Ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) have been shown to reduce ASCVD events in randomized trials and may be of benefit in selected high-risk patients with cardiovascular disease (CVD) or familial hypercholesterolemia (FH). Number-needed-to-treat (NNT) to prevent one ASCVD event can help identify groups of patients who may gain a net benefit from added nonstatin therapy. Patient groups with NNTs <25 (in whom PCSK9 mAbs may approach cost effectiveness with discounting) include extremely high-risk patients (those with CVD with FH, polyvascular disease, or recurrent ASCVD events) with lowdensity lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL, very high-risk patients (those with CVD with diabetes [and no polyvascular disease], chronic kidney disease, or acute coronary syndromes, or CVD or FH with poorly controlled risk factors) with LDL-C levels ≥100 mg/dL, and high-risk patients (those with CVD or FH with well-controlled risk factors) with LDL-C ≥130 mg/dL. Ezetimibe, which is generic in the United States, is reasonable for patient groups with NNTs <30, the level considered reasonable by most patients. This includes extremely high-risk patients with LDL-C levels ≥130 mg/dL, or very high-risk patients with LDL-C ≥190 mg/dL. All guidelines recommend statin therapy for the prevention of ASCVD.
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