The hypertension optimal treatment (HOT) study-patient characteristics: Randomization, risk profiles, and early blood pressure results

L. Hansson, A. Zanchetti

Research output: Contribution to journalArticlepeer-review


The Hypertension Optimal Treatment (HOT) Study is a prospective, randomized, multicenter trial being conducted in 26 countries. Its main aim is to evaluate the relationship between three levels of target diastolic blood pressure (± 90, ± 85 or ± 80 mmHg) and cardiovascular morbidity and mortality in hypertensive patients. In addition, the study will examine the effects on morbidity and mortality of a low dose, 75 mg daily, of acetylsalicylic acid (ASA, aspirin) or placebo. In the HOT Study, basic antihypertensive treatment is initiated with the calcium antagonist felodipine at a dose of 5 mg daily. If target blood pressure is not reached, additional antihypertensive therapy with either an angiotensin converting enzyme (ACE) inhibitor or a βadrenoceptor blocking agent is given. Further dosage adjustments are made in accordance with a set protocol. As a fifth and final step, a diuretic may be added. Inclusion of patients was stopped on April 30, 1994. At that time 19196 patients had been randomized. There were 9, 055 (47% women and 10, 141 (53% men with an average age of 61.5 ± 7.5 (SD) years. At enrolment, 52% of patients were receiving antihypertensive treatment. These patients entered a wash-out period of at least 2 weeks before randomization. The average randomization blood pressure in untreated patients was 169 ± 14/106 ± 3 mmHg and in the treated patients 170 ± 14/105 ± 3 mmHg. On August 15, 1994, blood pressure data were available for 14, 710 and 10, 275 patients, who had completed 3 and 6 months treatment, respectively. The average reduction in diastolic blood pressure was 22 mmHg after 6 months. The average diastolic blood pressure after 3 months was 87 ± 7 mmHg in the ± 90 target group, 85 ± 8 mmHg in the ± 85 target group, and 83 ± 8 mmHg and in the ± 80 target group. After 6 months, the corresponding values were 86 ± 7 mmHg, in the ± 90 group, 84 ± 7 mmHg in the ± 85 target group, and 82 ±7 mmHg in the ± 80 target group. The goal of randomizing 18 000 patients in the HOT Study has been obtained and exceeded. The average age was 3.2 years lower than predicted, but more patients were smokers (15.8% and slightly more patients had diabetes mellitus (8.4% than predicted. Furthermore, an additional 1,000 patients were recruited. We expect that the higher prevalence of some cardiovascular risk factors and the larger number of recruited patients will counterbalance the lower age, and that the predicted number of events will occur, ensuring the statistical power of the study. The preliminary data presented here indicate that it will be possible to fulfill the primary aims of the HOT Study, and that a sufficient number of patient-years will have been accumulated by the end of 1996.

Original languageEnglish
Pages (from-to)322-327
Number of pages6
JournalBlood Pressure
Issue number5
Publication statusPublished - 1994


  • Aspirin
  • Felodipine
  • Hypertension
  • Treatment

ASJC Scopus subject areas

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine


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