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["Soft" and "hard" end points in the example of hypertension]
1Medizinische Poliklinik, Universitätsklinikum Bonn.
Insights
Antihypertensive treatment reduces major cardiovascular events. Newer trials use surrogate markers like organ damage and new-onset diabetes to assess treatment effectiveness when hard endpoints show smaller differences.
Area of Science:
- Cardiology
- Clinical Trials
- Hypertension Research
Context:
- Hypertension is a chronic disease with significant long-term health consequences if left untreated.
- Early intervention trials confirmed antihypertensive treatment reduces major adverse cardiovascular events (MACE) compared to placebo.
- Current research focuses on comparing active treatment strategies, where differences in MACE are less pronounced.
Purpose:
- To evaluate the effectiveness of antihypertensive treatments in reducing both hard endpoints and intermediate/surrogate endpoints.
- To explore the predictive value of organ damage markers (e.g., left ventricular hypertrophy, microalbuminuria, intima-media thickness) in assessing treatment efficacy.
- To investigate the impact of antihypertensive therapies on the new occurrence of diabetes mellitus as a patient-relevant outcome.
Summary:
- First-phase intervention trials demonstrated that antihypertensive drugs significantly decrease hard endpoints like death, stroke, and myocardial infarction versus placebo.
- Second-phase trials, comparing active treatments, utilize surrogate markers of organ damage and new-onset diabetes due to smaller differences in hard endpoints.
- Surrogate markers, such as left ventricular hypertrophy and microalbuminuria, are increasingly incorporated into large trials to enhance predictive power.
Impact:
- Antihypertensive therapies are crucial for reducing mortality and morbidity associated with high blood pressure.
- The use of surrogate endpoints provides a more sensitive measure for evaluating new treatment strategies in hypertension.
- Understanding the impact on diabetes incidence offers a comprehensive view of antihypertensive treatment benefits beyond cardiovascular protection.
Abstract:
Hypertension is a disease with a long latency. Those afflicted will, if untreated, die earlier than an age-matched cohort within the general population. In a first phase of intervention trials it was demonstrated that anti-hypertensive treatment, in comparison with placebo, results in a reduction of so-called hard end points (death, stroke, myocardial infarction). In a second phase of clinical trials, which is still continuing, active treatment strategies are being compared. The problem in this phase is that differences in these hard end points are smaller than in placebo-controlled trials. For this reason signs of organ damage that occur in the time between the diagnosis of high blood pressure and the occurrence of hard end points (e.g. left ventricular hypertrophy, microalbuminuria, intima/media thickness) are used as additional end points. According to epidemiological data, these intermediate or surrogate end points are more or less predictive of hard end points. Systematic inclusion of such surrogates in large trials has been tried for some years in an attempt to raise the predictive power of these parameters. Another patient-relevant endpoint of antihypertensive treatment is the new occurrence of diabetes mellitus.
Related Concept Videos
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Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.
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