PCSK9 Inhibitor Shared Decision-Making Tool
Personalized risk visualization and printable patient handout for PCSK9 inhibitor therapy discussions. Select the clinical scenario and enter the current LDL-C to generate a patient-facing handout.
This shared decision-making tool is intended for use by licensed healthcare professionals during patient consultations. It is clinical decision support under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act and is not a medical device. All risk estimates are derived from published, peer-reviewed clinical trial data (CTT Collaborators, Lancet 2010; FOURIER, N Engl J Med 2017; ODYSSEY OUTCOMES, N Engl J Med 2018) and represent population-level data that may not reflect individual patient risk. This tool does not replace clinical judgment — the treating clinician is solely responsible for evaluating the applicability of these estimates and for all clinical decisions. No patient data is collected, stored, or transmitted; all calculations occur entirely in your browser. AI-HEART Lab, its affiliates, and contributors assume no liability for clinical decisions or patient outcomes. By using this tool, you agree to the AI-HEART Lab Terms of Service.
On maximally tolerated statin ± ezetimibe
Established coronary, cerebrovascular, or peripheral arterial disease, on maximally tolerated statin. Data source: FOURIER (median 2.2 years).
0/500 characters
Clinician Reference
ARR (median 2.2 years)
1.5%
NNT (median 2.2 years)
67
Scenario: Stable ASCVD. Primary endpoint: CV death, MI, stroke, UA hospitalization, or coronary revascularization. Source: Sabatine MS, et al. N Engl J Med 2017;376:1713-1722. LDL-C reduction: ~50-60% (class effect; FOURIER 59%, ODYSSEY 54.7%, ORION-10/11 50-52%). Safety: FOURIER-OLE through 8.4 years (O'Donoghue ML, et al. Circulation 2022;146:1109-1119). Neurocognitive: EBBINGHAUS (Giugliano RP, et al. N Engl J Med 2017;377:633-643).
EHR Documentation
Select a patient decision in the handout below to generate EHR text.
Patient Handout
Preview of the printable handout for your patient
Your Heart Health: Understanding PCSK9 Inhibitor Therapy
What is a PCSK9 inhibitor?
A PCSK9 inhibitoris a medicine that helps your body remove more "bad" cholesterol (LDL) from your blood. It works differently from a statin.
- It is given as an injection (a shot), not a pill
- You get the shot once or twice a month at home, or twice a year in the office
- It is usually added on top of your statin, not instead of it
- It can lower your bad cholesterol by about half beyond what your statin already does
Why is my doctor considering this?
Your doctor may suggest a PCSK9 inhibitor if:
- You have heart disease (prior heart attack, stroke, or blocked arteries)
- Your bad cholesterol is still too high despite taking a statin and ezetimibe
- You cannot take statins due to side effects
- You have a very high cholesterol condition that runs in your family
How much could this help?
In a large study of people with heart disease like yours, all already taking a statin, here is what happened over about 2 years:
Out of 100 people like you, over about 2 years:
- About 1 fewer heart attack, stroke, or other serious heart problem with the added medicine
- About 10 would still have a serious heart problem even with the added medicine
- About 89 would not have a serious heart problem either way
What does taking this medicine mean?
Possible benefits
- Lowers your chance of another heart attack or stroke
- Cuts bad cholesterol by about half beyond your statin
- Studied for over 7 years with no new safety concerns found
- No effect on memory or thinking in studies
Possible downsides
- Injection site redness or soreness in about 2 to 4 out of 100 people (usually mild)
- Flu-like symptoms in some people
- You need a shot every 2-4 weeks (at home) or twice a year (at the office)
- The medicine must be kept in the refrigerator
- Insurance approval is often needed before starting
How do I take it?
There are different PCSK9 inhibitor medicines. Your doctor will help you choose:
Self-injection at home
A small shot you give yourself under the skin, every 2 to 4 weeks. Uses a pre-filled pen (like an insulin pen). Most people learn quickly.
Office injection
A shot given by your doctor or nurse. First two shots are 3 months apart, then every 6 months. No self-injection needed.
My decision today
Questions for my doctor
My next steps
This handout is not medical advice. Always talk with your doctor about what is best for you.
Based on current heart health guidelines | AI-HEART Lab | ai-heart.org
Disclaimer: This shared decision-making tool is intended for use by licensed healthcare professionals during patient consultations. It is clinical decision support under Section 520(o)(1)(E) of the FD&C Act and is not a medical device. Risk estimates are derived from published, peer-reviewed trial data and represent population-level data that may not reflect individual patient risk. This tool does not replace clinical judgment. No patient data is collected, stored, or transmitted. AI-HEART Lab assumes no liability for clinical decisions or patient outcomes. Terms of Service