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The Study

Evolocumab in Patients without a Previous Myocardial Infarction or Stroke.

In simple terms

This study is like a fair test where half the people got a new medicine and half got a sugar pill, and no one knew who got what. After years of watching, the people who got the real medicine had fewer heart problems. So we can say the medicine probably helped — but only for people like those in the study.

74%

Analysis score

74/ 90

Maximum 90 for a randomized controlled trial.

Where the score came from

Reporting0
Methodology100
Publication100
Statistical77
Study type (basis of the score)
Randomized Controlled Trial
Level 1b - Individual RCT
What’s the bottom line?

This study tested a monthly injection called evolocumab in people with high cholesterol and heart disease or diabetes but no prior heart attack or stroke.

Where does this study sit?

Reviews of RCTs (Meta-analyses)

Max 100

Randomized Trials

Max 90

Reviews of Cohort Studies

Max 85

Cohort Studies

Max 72

Reviews of Case-Control Studies

Max 63

Case-Control Studies

Max 58

Cross-Sectional & Case Series

Max 50

Expert Opinion

Max 5
StrongerWeaker
Randomized Trials
Level 1b
74

74 / 100

Quality score

Participants are randomly assigned to treatment or control groups, minimizing bias. The gold standard for testing whether an intervention causes an effect.

Can establish causation

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Key takeaways

Summary

Based on the study abstract and findings.

  1. 1For every 56 people treated for 5 years, one major heart or brain event was prevented — a meaningful benefit for those at high risk.
  2. 2Over 5 years, 6.2% of people who got the shot had a first heart attack, stroke, or death from heart disease, compared to 8.0% who got a placebo — that’s 18 fewer events per 1,000 people.
  3. 3The shot also cut the need for heart procedures by 19%.

Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data

Publication

Journal

The New England journal of medicine

Year

2025

Authors

E. Bohula, N. Marston, Ajay K. Bhatia, Gaetano M. De Ferrari, Lawrence A. Leiter, José C. Nicolau, Jeong-Gun Park, J. Kuder, Sabina A. Murphy, E. Walsh, H. Wang, Vladimir Blaha, Andrzej Budaj, J. Cornel, A. Goudev, R. Kiss, A. Lorenzatti, A. Parkhomenko, M. Cyrille, G. Paiva da Silva Lima, E. Ohman, R. Giugliano, M. Sabatine

41 citations
Analysis v5

Related Content

Claims (6)

Assertion

Evolocumab lowers the risk of first major heart or blood vessel events by 25% in high-risk patients who have not had a heart attack or stroke, and does not increase side effects over 4.6 years of use.

Quantitative
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Assertion

In adults with high cholesterol, atherosclerosis, or diabetes who have not had a heart attack or stroke, receiving evolocumab injections every two weeks for about 4.6 years reduces the rate of first heart attacks, strokes, or deaths from heart disease by 25% compared to no treatment.

Causal
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Assertion

In adults with atherosclerosis or diabetes and high LDL cholesterol but no prior heart attack or stroke, monthly injections of evolocumab for about 4.6 years lower the rate of first major cardiovascular events, including procedures to restore blood flow, by 19% compared to no treatment.

Causal
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Assertion

In adults with atherosclerosis or diabetes and high LDL cholesterol but no prior heart attack or stroke, taking evolocumab does not lead to more serious adverse events than taking a placebo over 4.6 years.

Causal
Read analysis
Assertion

In adults with atherosclerosis or diabetes and LDL cholesterol of at least 90 mg/dL who have not had a heart attack or stroke, taking evolocumab for five years lowers the chance of a first major cardiovascular event from 8.0% to 6.2%.

Quantitative
Read analysis
Assertion

Evolocumab lowers the risk of cardiovascular events in middle-aged and older adults with atherosclerosis or diabetes and high LDL cholesterol, but this benefit has only been observed in a population that is mostly White and not in younger or more racially diverse groups.

Causal
Read analysis
Fit Body Science verdict — we translate health studies into clear verdicts backed by peer-reviewed research.

Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.