Re: HYVET stopped early

MarilynMann wrote:
1: Drugs Aging. 2001;18(3):151-64. Related Articles, Links

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

Bulpitt C, Fletcher A, Beckett N, Coope J, Gil-Extremera B, Forette F,
Nachev C, Potter J, Sever P, Staessen J, Swift C, Tuomilehto J.

Imperial College School of Medicine, Section of Elderly Care,
Hammersmith Hospital, London, England.

A number of trials and meta-analyses have demonstrated clear benefits
of blood pressure (BP) reduction in patients aged <80 years with
regard to the reduction in stroke and cardiovascular events. However,
a variety of studies have suggested that the positive relationship
between BP and cardiovascular mortality is weakened or indeed reversed
in the very elderly. Most intervention trials to date have either
excluded or not recruited sufficient patients aged > or =80 years to
determine whether there is a significant benefit from treatment in
this age group. A meta-analysis of intervention trials that recruited
patients aged > or =80 years has suggested a benefit in terms of
stroke reduction but has also raised the possibility of an increase in
total mortality. The benefit to risk ratio therefore needs to be
clearly established before recommendations can be made for treating
very elderly patients with hypertension. The Hypertension in the Very
Elderly Trial (HYVET) pilot recruited 1283 patients aged > or =80
years and showed the feasibility of performing such a trial in this
age group. It was a Prospective Randomised Open Blinded End-Points
(PROBE) design but the main trial has additional pharmaceutical
sponsorship to run a double-blind trial. Therefore, the main trial is
a randomised, double-blind, placebo-controlled trial designed to
assess the benefits of treating very elderly patients with
hypertension. It compares placebo with a low dose diuretic (indapamide
sustained release 1.5mg daily) and additional ACE inhibitor
(perindopril) therapy if required. As in the pilot trial, the primary
end-point is stroke events (fatal and non-fatal) and the trial is
designed to determine whether or not a 35% difference occurs between
placebo and active treatment. The main objective will be achieved with
90% power at the 1% level of significance. Secondary outcome measures
will include total mortality, cardiovascular mortality, cardiac
mortality, stroke mortality and skeletal fracture. 2100 patients aged

or =80 years are to be recruited and followed up for an average of 5

years. Entry BP criteria after 2 months of a single-blind placebo run-
in period are a sustained sitting systolic BP (SBP) of 160 to 199mm Hg
and a diastolic BP of 90 to 109mm Hg. The standing SBP must be >140mm
Hg. The trial will be carried out in accordance with the principles of
Good Clinical Practice. We describe in detail the protocol for the
main trial and discuss the reasons for the changes from the pilot, the
use of the drug regimen, and the BP criteria to be used in the trial.

* * *

It's still not clear to me if my mother (age 82) should be on BP
medication because her systolic BP is less than 160. I'm not clear on
the difference between sitting and standing BP but I assume they take
her BP when she is sitting.

Marilyn


I don't know anything in particular about this trial, but it looks less interesting than the initial press release. I think most doctors (at least in the US) already believed that prior trials had shown benefit to treating hypertension in the elderly if the SBP was above 160.

This new study doesn't seem to answer whether treating lower levels of hypertenion in the elderly is helpful.

--
David Rind
drind@xxxxxxxxxxxxxxxxxxxxx
.

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