The Hypertension Optimal Treatment (HOT) Study: 12-month data on blood pressure and tolerability. With special reference to age and gender.

The Hypertension Optimal Treatment (HOT) Study is an ongoing prospective, randomized, multicenter trial conducted in 26 countries. Its two main aims are to evaluate the relationship between three levels of target diastolic blood pressure (< or = 90, < or = 85 or < or = 80 mmHg) and the incidence of cardiovascular morbidity and mortality in hypertensive patients and the effects on morbidity and mortality of a low dose, 75 mg daily, of acetylsalicylic acid (ASA, aspirin) compared with placebo. Altogether 19,193 patients have been recruited and randomized and one-year data are now available for all patients. This is a report on the blood pressures achieved, the tolerability and other available data after 12 months of follow-up of all patients. Special reference will be given to the subgroup of elderly patients (> or = 65 years, n = 6,113) as compared to younger patients (< 65 years, n = 13,080). On average, the target group < or = 90 mmHg in diastolic blood pressure has reached 86 mmHg, the target group < or = 85 mmHg has reached 83 mmHg and the target group < or = 80 mmHg has reached 81 mmHg. The percentage of patients that has obtained their target blood pressures is 84% in the target group < or = 90 mmHg, 72% in the target group < or = 85 mmHg and 57% in the target group < or = 80 mmHg at 12 months of follow-up. In the elderly subgroup (> or = 65 years of age) the percentage of patients at target is higher for all target groups, being 86, 76 and 61%, respectively, at 12 months. Antihypertensive treatment is initiated with a calcium antagonist, felodipine, at a dose of 5 mg once daily. If target blood pressure is not reached, additional antihypertensive therapy, with either an angiotensin converting enzyme (ACE) inhibitor or a beta-adrenoceptor blocking agent, is given. Further dose adjustments are made in accordance with a set protocol. As a fifth and final step a diuretic may be added. Side effects have been relatively few in this large multinational series of intensively treated hypertensive patients. Only ankle edema, 2.6% and 3.0%, and coughing, 1.3% and 0.8%, in young and elderly patients, respectively, exceed a frequency of 1%, and 88% of all patients are still taking their baseline therapy felodipine after one year. The one-year data presented here indicate that it should be possible to fulfill the primary aims of the HOT Study.