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Evaluation of endpoints in hypertension
1Department of Geriatrics, University of Uppsala, Sweden.
Insights
Blood pressure is a key predictor of cardiovascular events like stroke. Despite this, many treated hypertension patients remain uncontrolled, highlighting a gap in cardiovascular risk management.
Area of Science:
- Cardiology
- Hypertension Research
- Clinical Trials
Background:
- Cardiovascular mortality, including myocardial infarction and stroke, are primary endpoints in hypertension trials.
- Hard endpoints are often unrealistic in short-term trials with low-risk patients or in daily clinical practice.
- Intermediate or surrogate endpoints, such as blood pressure, are frequently used as substitutes.
Purpose of the Study:
- To evaluate the effectiveness of blood pressure control in reducing hard cardiovascular endpoints.
- To assess the relationship between achieved blood pressure levels and outcomes like stroke and myocardial infarction.
- To highlight the importance of blood pressure as a surrogate endpoint in hypertension management.
Main Methods:
- Utilizing data from large-scale intervention trials, such as the Hypertension Optimal Treatment (HOT) Study.
- Analyzing the correlation between treated blood pressure levels and hard endpoints (fatal/non-fatal stroke, myocardial infarction).
- Reviewing epidemiological studies demonstrating the link between blood pressure and cardiovascular prognosis.
Main Results:
- Blood pressure is a strong predictor of cardiovascular risk, especially stroke.
- The Hypertension Optimal Treatment (HOT) Study specifically investigates blood pressure levels against hard outcomes.
- Recent reports indicate that only a minority of treated hypertensive patients achieve adequate blood pressure control.
Conclusions:
- Blood pressure is a crucial and practical surrogate endpoint for cardiovascular risk in hypertension.
- Effective blood pressure management is essential for reducing cardiovascular mortality and morbidity.
- There is a significant unmet need in achieving optimal blood pressure control in the hypertensive population.
Abstract:
Cardiovascular mortality is the undisputed "hard endpoint" in hypertension intervention trials. Non-fatal myocardial infarction and stroke are frequently included in this category as well. For obvious reasons, such hard endpoints are not always realistic in relatively short-term (3-5 years) trials comprising patients with a relatively low absolute risk, such as mild hypertension. Nor are they directly applicable in the daily clinical routine care of hypertensive patients. In most situations intermediate endpoints are used as substitutes for the hard endpoints. These intermediate or substitute endpoints are sometimes referred to as surrogate endpoints. The most frequently used intermediate endpoint is blood pressure itself. It is also a most relevant substitute endpoint, being easy to measure and evaluate in routine clinical practice. Blood pressure is obviously a very strong predictor of cardiovascular risks, particularly as regards stroke. An ongoing large intervention trial in hypertension, the Hypertension Optimal Treatment (HOT) Study is specifically designed to evaluate the obtained level of treated blood pressure in relation to hard endpoints such as fatal and non-fatal stroke and myocardial infarction as well as other cardiovascular mortality. In view of the strong link between blood pressure and prognosis in hypertension, as demonstrated in several epidemiologic studies, it is disappointing to note that several recent reports show that only a minority of treated hypertensive patients are well controlled.