Trials in coronary heart disease and hypertension with special reference to the elderly*

The risks of complications like death, myocardial infarction and stroke increase continuously with increasing age. Therefore, the chances of detecting effects of treatment in trials also increase when patients get older. The relationships between different end-points change with age, e.g. the ratio between stroke and MI increases with age. However, interventions not related to the interventions under study may also increase, causing dilution of effects. The older subject may also be more vulnerable to the side-effects of treatment. Side-effects, and quality-of-life measures, which indeed may vary with age, must be properly balanced against effects on 'hard' end-points. A review of trials in patients with hypertension and myocardial infarction shows that effects of various interventions have been at least as great in older as in younger patients. However, metabolic side effects such as impaired glucose metabolism, increased serum creatinine, and increased uric acid levels have not been negligible, and such effects may turn out to be more hazardous in the elderly than in younger patients. The balance between positive and negative effects must be properly assessed in relation to the prognosis of the untreated condition. Patients who have suffered a myocardial infarction have, in general, a more serious prognosis than most hypertensives, and more side-effects of treatment may therefore be accepted in patients with myocardial infarction.