Principal Findings:

Patients in the study were randomized into three groups, based on specific target diastolic blood pressure levels: ≤ 90 mm Hg, ≤ 85 mm Hg, and ≤ 80 mm Hg. Each group consisted of more than 6,000 patients, and all had similar baseline characteristics. If the target blood pressure was not reached, a low dose of an ACE inhibitor or a beta blocker was added. The third step, if necessary, was to double the dose of felodipine. The fourth step, if necessary, was to double the add-on treatment. If the target blood pressure still was not reached, a combination of felodipine, an ACE inhibitor and a beta blocker could be used, or hydrochlorothiazide could be added. At the end of the study, 78% of the patients were still on felodipine, and approximately 2/3 of the patients were on combined treatment.

The mean diastolic blood pressure from 6 months on showed a dramatic reduction. Target blood pressures were reached by 84%, 72%, and 57% of patients, respectively. For the target group of ≤ 90 mmHg, the average was 85 mm Hg; for the target group of ≤85 mm Hg, the average was 83 mm Hg; and for the target group of ≤80 mm Hg, the average was 81 mm Hg. In total, 92% of the patients in the study reached 90 mmHg or below.

The HOT investigators noted that there was poor separation between the three targets and that it was difficult to show significant differences between the three groups for major cardiovascular events and all MI.

There was a 16% decrease in all major cardiovascular events with aspirin compared to placebo. For all MI, there is a 36% difference in favor of aspirin, but no significant difference for stroke. Although the aspirin group did not show an increased risk of cerebral bleeding, other bleeds (gastrointestinal, nasal) were approximately twice as common in the aspirin group.