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The Hypertension Optimal Treatment (HOT) Study investigated optimal diastolic blood pressure targets and aspirin
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Pharmacology
Background:
- Hypertension is a major risk factor for cardiovascular morbidity and mortality.
- Optimal blood pressure targets for antihypertensive treatment require further investigation.
- The role of low-dose aspirin in cardiovascular event prevention in hypertensive patients is not fully established.
Purpose of the Study:
- To determine the optimal target diastolic blood pressure for reducing cardiovascular events in hypertensive patients.
- To evaluate the efficacy of low-dose aspirin (75 mg daily) versus placebo in preventing cardiovascular events.
- To assess the safety and effectiveness of felodipine-based antihypertensive therapy.
Main Methods:
- Prospective, randomized, multicenter trial involving over 18,000 hypertensive patients aged 50-80.
- Patients randomized to target diastolic blood pressure goals of ≤90 mmHg, ≤85 mmHg, or ≤80 mmHg.
- Dual investigation: PROBE design for blood pressure targets and double-blind, placebo-controlled for aspirin.
Main Results:
- The study aimed to collect 1,100 clinical events over 2.5 years of follow-up.
- Felodipine 5 mg was used as basic treatment, with add-on beta-blockers or ACE inhibitors as needed.
- Data collection focused on cardiovascular morbidity and mortality outcomes.
Conclusions:
- The HOT study provides crucial data on achieving optimal blood pressure control in hypertension.
- Findings will inform clinical guidelines regarding target blood pressures and the use of aspirin.
- The study contributes to understanding the comprehensive management of hypertension and cardiovascular risk reduction.
Abstract:
The Hypertension Optimal Treatment (HOT) Study is a prospective, randomized, multicenter study which will be conducted in some 20 countries world-wide. Two major issues will be investigated: i) What is the optimal target diastolic blood pressure during antihypertensive treatment with regard to the reduction in cardiovascular morbidity and mortality? In order to address this question patients will be randomized to three different therapeutic goals: a diastolic blood pressure < or = 90 mmHg, < or = 85 mmHg or < or = 80 mmHg; ii) The second aim is to evaluate the effect of a low dose acetylsalicylic acid (ASA, aspirin) 75 mg o.d. in comparison with placebo on cardiovascular morbidity and mortality. The first aim will be investigated in accordance with the PROBE design (Prospective Randomized Open Blinded Endpoint evaluation), whereas the evaluation of aspirin versus placebo will be conducted under double blind conditions. It is estimated that 1,100 clinical events will be needed in order to answer the question regarding the relationship between target diastolic blood pressure and major cardiovascular events. The collection of these events will require the enrollment of at least 18,000 hypertensive men and women aged 50-80 years to be followed for 2.5 years (about 40,000 patient years). All patients will be given felodipine 5 mg o.d. as basic antihypertensive treatment with the addition of a beta-blocker or an ACE-inhibitor in a second step, with further predetermined increments in dosage as required in order to obtain the randomized therapeutic goal.