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Comparative effectiveness studies of medications
Current Opinion in Investigational Drugs (London, England : 2000)
|August 24, 2010
Summary
Studies comparing cardiovascular drugs should focus on the presence of atherosclerosis, not just vascular event risk. This shift, enabled by advanced imaging, improves patient stratification for more accurate drug trials.
Area of Science:
- Cardiovascular medicine
- Pharmacology
- Medical imaging
Background:
- Comparative effectiveness studies, especially in oncology, utilize prognostic criteria like tissue diagnosis and disease staging.
- Cardiology drug trials historically stratify patients based on vascular event risk (e.g., coronary heart disease risk).
- New imaging technologies, including coronary calcium scoring, now allow for atherosclerosis screening in asymptomatic individuals.
Discussion:
- Current stratification methods in cardiovascular drug trials may not fully capture disease presence.
- The development of advanced imaging techniques offers a more direct measure of underlying cardiovascular disease.
- Shifting trial criteria to disease presence (atherosclerosis) aligns with oncological stratification approaches.
Key Insights:
- Cardiovascular research can enhance drug trial precision by adopting disease-based stratification.
- Coronary calcium scoring and similar imaging modalities provide objective measures of atherosclerosis.
- Stratifying by atherosclerosis presence, rather than event risk, may lead to more relevant safety and efficacy comparisons.
Outlook:
- Future cardiovascular drug studies should prioritize stratification based on confirmed atherosclerosis.
- This approach promises more accurate comparative effectiveness and safety evaluations for cardiovascular therapies.
- Integration of imaging-based disease detection will refine clinical trial design and patient selection.
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