Treating hypertension in the oldest of the old reduces total mortality: results of the Hypertension in the Very Elderly Trial (HYVET).

TREATING HYPERTENSION IN THE OLDEST OF THE OLD REDUCES TOTAL MORTALITY: RESULTS OF THE HYPERTENSION IN THE VERY ELDERLY TRIAL (HYVET) the elderly, defined as individuals aged 65 years and older, represent the most rapidly growing segment of the population. in 1990, they accounted for 13% of the Us population and are expected to account for 20% of the population by the year 2040. the population of “old elderly” (ie, those older than 85) is also growing and is projected to reach 16 million by the middle of the 21st century. hypertension, defined as a systolic blood pressure (Bp) of ≥140 mm hg and/or a diastolic Bp of ≥90 mm hg will likely develop in approximately 90% of individuals reaching these extremes of age. although large prospective clinical trials conducted many years ago demonstrated the clear benefits of actively treating hypertension in the elderly, relatively few patients older than 80 years were included. a meta-analysis of the oldest old including these trials found that the reduced risk of stroke and heart failure may have been offset by an increase in total mortality, a finding that was replicated prospectively in the pilot phase of the hypertension in the Very Elderly trial (hyVEt). the main hyVEt study was designed to resolve these areas of uncertainty and to determine the relative benefits and risks of antihypertensive treatment in patients with hypertension aged 80 years or older. hyVEt was a prospective, randomized, double-blind, placebo-controlled trial performed in 195 centers from 13 countries in Europe, China, australasia, and North africa (tunisia). it was co-funded by the British heart foundation and the institut de recherches internationales servier. to be eligible, patients had to be at least 80 years old and have a systolic Bp of at least 160 mm hg on repeated measurements, as described below. Exclusion criteria included accelerated or secondary hypertension, a hemorrhagic stroke in the previous 6 months, heart failure requiring treatment, gout, clinical dementia, requirements for a nursing home, a contraindication to the use of the study medications, a serum creatinine level >1.7 mg/dL, or a serum potassium <3.5 mg/dL or >5.5 mg/dL. prior to randomization, potentially eligible patients were told to stop all antihypertensive treatment and take a single placebo tablet for at least 2 months. at the end of the placebo run-in phase, each patient had Bp measured twice in the seated and standing positions at 2 separate study visits at least 1 month apart. Most Bp measurements were performed using a validated automated device, although early in the trial use of a mercury device was allowed. inclusion in the randomized portion of the trial required that the mean of 4 systolic Bp measurements from each individual was between 160 and 190 mm hg. When the trial began in 2000, a mean baseline seated diastolic Bp between 90 and 109 mm hg was an inclusion criterion, but a protocol amendment in 2003 relaxed this criterion, allowing inclusion of patients with any mean diastolic Bp <110 mm hg. as such, the randomized population included patients with mixed systolic/diastolic hypertension as well as isolated systolic hypertension. after the placebo run-in phase, eligible patients were randomized to receive either the thiazide-type diuretic indapamide (sustained release, 1.5 mg) or matching placebo. randomization was stratified according to sex and age (80–89 years and 90 years or older). Of the 4761 patients who entered the From the Division of General Internal Medicine/ Division of Cardiology, University of Nevada School of Medicine, Reno, NV;1 the Risk Reduction Center, Saint Mary’s Regional Medical Center, Reno, NV;2 the Primary Care Service Line, Ralph H . Johnson VA Medical Center, Charleston, SC;3 and the Division of General Internal Medicine/Geriatrics, Medical University of South Carolina, Charleston, SC4 Address for correspondence: Michael J . Bloch, MD, Risk Reduction Center, Saint Mary’s Regional Medical Center, 645 North Arlington Street, Suite 460, Reno, NV 89503 E-mail: mbloch@aol .com