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HYVET Shows Benefits for Treating Hypertension in Healthy Very Old Patients

But, how this finding applies to typical patients outside of studies is unclear.

In most hypertension treatment trials, the focus has been on younger patients; even studies in which the cohort is reported as "elderly" have included patients as young as 60. In the Hypertension in the Very Elderly Trial (HYVET; funded by a manufacturer of the study drugs), 3845 generally healthy subjects older than 80 (mean age, 84) with hypertension (mean blood pressure, 171/91 mm Hg) were randomized to the diuretic indapamide (Lozol and generics) or to placebo for 2 years; the angiotensin-converting–enzyme inhibitor perindopril (Aceon) or a matching placebo could be added, if needed to achieve target BPs (JW Apr 17 2008).

In the indapamide group, systolic BP was lowered by a mean 15 mm Hg, and diastolic BP was lowered by 6 mm Hg. Fatal and nonfatal strokes were somewhat less common in the indapamide group (12.4 vs. 17.7 strokes per 1000 patient-years; P=0.06), with a number needed to treat of 100 to prevent 1 stroke by 2 years. All-cause mortality was significantly lower in the indapamide group (10% vs. 12%). Only two serious adverse events occurred, both in the indapamide group.

These results provide encouragement that strokes can be prevented by treating hypertension in very old patients, but the findings probably are too good to be true in general practice. Tightly controlled efficacy trials like this one often yield results that cannot be reproduced in usual practice, because inclusion criteria eliminate many typical patients, and because trial patients benefit from tight monitoring and follow-up that often cannot be reproduced in practice. For example, risk for drug-induced orthostatic hypotension and its potentially serious consequences (e.g., falls, hip fractures) is likely to be much higher in actual practice. Even with careful patient selection and monitoring, the number needed to treat to benefit one patient in the HYVET trial was still quite high. Typical patients who have serious medical comorbidities and take multiple medications are likely to benefit less and to have more adverse events than were those in the HYVET study.

— Thomas L. Schwenk, MD

Published in Journal Watch General Medicine December 29, 2008