HYVET TRIAL PDF

Keywords: elderly, hypertension, HYVET, older adults, treatment Despite this, a trend analysis from the EWPHE trial suggested that the. The Hypertension in the Very Elderly Trial (HYVET) is a multicentre, open, randomised, controlled trial. The aim of this trial is to investigate the effect of active. Drugs Aging. ;18(3) Hypertension in the Very Elderly Trial (HYVET): protocol for the main trial. Bulpitt C(1), Fletcher A, Beckett N, Coope J.

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Early trials in the field of hypertension focused on adults in their fifties and sixties. However, with the passage of time, a progressive effort has been made to expand the evidence base for treatment in older adults.

More recently, additional data from this cohort has been published suggesting that appropriate anti-hypertensive therapy may lead to a reduction in incident cognitive impairment and fractures, whilst a 1 year open label extension of the main study confirmed many of the original trial findings.

This review provides an overview of the Hypertension in the Very Elderly Trial whilst also discursively evaluating the latest data. The s saw publication of landmark data demonstrating the benefits of anti-hypertensive therapy [ 1 — 3 ].

Despite this, a trend analysis from the EWPHE trial suggested that the treatment of hypertension might be less effective or even harmful to the very old aged over 80 years [ 10 ]. Yet the authors of the meta-analysis noted that a single, randomized controlled trial demonstrating no benefit from anti-hypertensive therapy, in this cohort, would negate the apparent benefits seen across their meta-analysis [ 11 ].

Given this uncertainty, the Hypertension in the Very Elderly Trial HYVET was commissioned with an open label pilot undertaken to determine trial feasibility [ 1112 ]. Active treatment was associated with a reduction in all fatal and non-fatal cerebrovascular events with a relative hazard rate RHR of 0.

However there was a non-significant rise in all cause mortality RHR 1. A double-blind placebo-controlled trial with recruitment centres in 13 countries, HYVET prospectively analyzed data from older adults. The initial inclusion criteria demanded both systolic and diastolic hypertension SDH mean systolic BP — mmHg; mean diastolic BP 90— mmHgoff treatment, during a 2 month run in period.

This enhanced recruitment rates and led to the inclusion of subjects with isolated systolic hypertension ISH. Subjects were then randomized to one of two treatment arms, the thiazide like diuretic, indapamide sustained release, 1. The investigators also observed a non-significant reduction in the primary outcome measure, stroke, unadjusted hazard ratio HR 0. Whilst a statistically significant reduction in congestive cardiac failure was also observed unadjusted HR 0.

HYVET – Wiki Journal Club

Moreover, active treatment was well tolerated. At 2 years there were no significant changes in serum potassium, uric acid, glucose and creatinine between the trial arms [ 13 ]. In fact, serious adverse events SAEs were observed post-randomization in the placebo group. Furthermore, standing and seated BPs post-treatment were equivalent, suggesting that antihypertensive therapy was not associated with orthostatic hypotension [ 13 ]. Having recruited large rtial of patients from Eastern Europe and Hyver, the authors were criticized for not appreciating the increased prevalence of cerebrovascular events in these populations, when compared with adults from Western Europe — a factor which may exaggerate the potential benefit arising from active therapy [ 14 ].

In addition, it was notable that four centres closed in the first year due to data quality issues [ 13 ]. Equally, at the time of the second interim analysis July the relative risk of all stroke fatal and non-fatal amongst those receiving active treatment was 0. However, at the time of the final intention-to-treat analysis in Octoberthis significant reduction in the primary outcome measure failed to show statistical significance — the reasons for which have never been elaborated.

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HYVET also has a number of methodological issues, namely the protocol amendment which provided for the inclusion of subjects with ISH and the variable methods for measuring blood pressure.

jyvet Initially blood pressures were recorded with either a mercury sphygmomanometer or a validated automated device, but at the end of the trial a validated automated device was used in the majority of centres [ 13 ]. Given the log linear relationship between systolic blood pressure and clinical outcomes, the mortality tria, morbidity benefits seen in the trial might be a feature of systolic BP control, particularly in ISH, as opposed to achieved systolic and diastolic blood pressure.

In common with many other clinical trials in older people, the inclusion criteria also required that subjects be in relatively good physical and mental health individuals with dementia and those resident in nursing homes were excludedquestioning the applicability of the trial outcomes to the real life setting [ 1316 ].

The number of subjects who smoked cigarettes 2. Although waist circumference was not reported, hypertensive status was infrequently associated with other features of the metabolic syndrome in the trial population, aside from those subjects who had suffered a prior cardiovascular event [ 17 ]. More importantly, the early evidence of mortality benefit resulted in a relatively short duration of follow-up median 1.

As a result, yyvet remains unclear whether such benefits hhyvet or diminish over a longer time course and although the inclusion criteria allowed for the hyver of patients aged between 80 and years, most were 80 to 85 years old mean age; Hyve, the benefit of treatment above 85—90 years of age remains uncertain [ 1819 ].

Earlier this year, results from a 1 year open label active treatment extension of HYVET were published. Trial participants receiving double-blind treatment at their final visit within the main study were deemed eligible for inclusion.

Hypertension in the Very Elderly Trial (HYVET): protocol for the main trial.

However, those who had reached either primary or secondary end points during the main trial apart from myocardial infarction, heart failure and skeletal fracture were excluded. Again, differences were seen for all-cause mortality 47 deaths; HR 0.

Whilst these results strengthen the case for early benefit arising from anti-hypertensive therapy in octogenarians, the selective exclusion criteria are questionable. This hypothesis, that indapamide a thiazide-like diuretic reduces urinary calcium excretion and as a result may reduce fracture rates, was tested in a sub-study. When analyzing the 90 incident, validated fractures 38 in the active group; 52 in the placebo group and adjusting for baseline risk factors, a HR of 0.

Allowing for all fractures, regardless of whether they were incident, validated fractures or not, resulted in an adjusted HR of 0. Once again, the relative well being of the trial participants limits the potential applicability of these data to the general population.

Furthermore, a failure to routinely identify vertebral fractures and difficulties in data hyveh may be sources of error. The trial steering group also published an analysis evaluating the association of depression with cardiovascular mortality and morbidity, all-cause mortality and incident dementia. Whilst each additional GDS point at baseline also increased these risks, the study was not designed to evaluate this association. Thus, social and economic status were not adequately controlled for and reverse causality could not be excluded.

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Formal education was protective HR 0. This may reflect the relative physical well being of the trial population [ 24 ]. Thus, no significant difference was observed between the two trial arms HR 0. However using these data, a dynamic model of cognition that allowed all outcomes cognitive worsening, stability, improvement or death to be categorized simultaneously was developed.

This appeared to detect small differences between the two trial arms, in favour of treatment. Although the model requires further validation, it suggests that cognitive change in those aged over 80 years is small, depends on baseline cognitive function and the relative efficacy of anti-hypertensive treatment [ 25 ]. This treatment hgvet was tria, found to be associated with a large and significant reduction in heart failure, whilst proving particularly efficacious in the management of isolated systolic hypertension.

All authors have completed the Unified Competing Interest form at http: Triaal Center for Biotechnology InformationU. Br J Clin Pharmacol. Published online Aug Author information Hyveet notes Copyright and License information Disclaimer. Received Apr 30; Accepted Aug This article has been cited by other articles in PMC.

Abstract Early trials in the field of hypertension focused on adults in their fifties and sixties. Introduction The s saw publication of landmark data demonstrating the benefits of anti-hypertensive therapy [ 1 — 3 ].

Main study findings A double-blind placebo-controlled trial with recruitment centres in 13 countries, HYVET prospectively analyzed data from older adults. Conflict of interest statement All authors have completed the Unified Competing Interest form at http: Hypertension — treated and untreated. The role of blood pressure control in preventing complications of hypertension. Effects of treatment on morbidity in hypertension. Results in patients with diastolic blood pressures averaging through mm Hg.

Five-year findings of the hypertension Detection and Follow-up Program: Reduction in mortality of persons with high blood pressure, including mild hypertension.

Five-year findings of the Hypertension Detection and Follow-up Program: Mortality by race-sex and age. Prevention of stroke by antihypertensive drug treatment in hyevt persons with isolated systolic hypertension. Medical Research Council trial of treatment of hypertension in older adults: Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension.

Influence of antihypertensive drug treatment on morbidity and mortality in patients over the age of 60 years. Antihypertensive drugs in very old people: Results of the pilot study for the hypertension in the very elderly trial. Treatment of hypertension in patients 80 years of age or older.

Hypertension In The Very Elderly Trial (HYVET): Lower Is Better, But Not Too Low

N Engl J Med. Treatment of hypertension in the elderly. Mancia G, Grassi G. Treating very elderly hypertensive patients is rewarding: Immediate and late benefits of treating very elderly people with hypertension: Association of depression with subsequent mortality, cardiovascular morbidity and incident dementia in people aged 80 and over and suffering from hypertension.

Sociodemographic and lifestyle risk factors for incident dementia and cognitive decline in the HYVET. Support Center Support Center. Please review our privacy policy.