A. J. Palmer

The Hypertension in the Very Elderly Trial (HYVET). Rationale, methodology and comparison with previous trials

SummaryThe 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 treatment on stroke incidence in hypertensive patients over the age of 80 years. Secondary end-points include total cardiovascular mortality and morbidity.Entry criteria include a sustained sitting systolic blood pressure of 160 to 219mm Hg plus a sustained sitting diastolic pressure of 95 to 109mm Hg. Also required is a standing systolic blood pressure of at least 140mm Hg. Patients must give their informed consent, and be free of congestive heart failure requiring treatment, gout, renal failure or a recent cerebral haemorrhage. Patients are to be randomised to 3 groups — (i) no treatment; (ii) treatment with a diuretic [bendroflumethiazide (bendrofluazide)]; or (iii) treatment with an angiotensin converting enzyme (ACE) inhibitor (lisinopril).Starting dosage for bendroflumethiazide and lisinopril is 2.5 mg/day. In order to achieve goal sitting systolic and diastolic blood pressures (< 150/80mm Hg), a doubling of the dosage is allowed. Furthermore, slow release diltiazem (120 mg/day increasing to 240 mg/day if required) may be added to the medication of the actively treated groups. These drugs have been chosen as inexpensive and appropriate representatives of their therapeutic classes.700 patients in each group (a total of 2100) will be sufficient to detect a 40% difference in cerebrovascular events between no treatment and active treatment (α = 0.01, 1−β = 0.90). These numbers will also detect a difference in total mortality of 25% and in cardiovascular mortality of 35%.The pilot phase of the trial has been started with support from the British Heart Foundation. Centres which are interested in taking part should contact C. J. Bulpitt or any of the other authors.

Use of surrogate respondents in studies of stroke and dementia

A study was performed to determine the misclassification of information on exposure when surrogate informants are interviewed. Information from nondementia patients admitted to a geriatric ward was compared with that obtained from the patients family members or friends (informants). Thirty-seven patients were recruited (17 with current or previous stroke, and 20 no history of stroke). Information on past medical and family history, cigarette smoking and alcohol consumption was collected using a questionnaire that was administered independently to patients and informants. For nonstroke patients, agreement on smoking and alcohol consumption at different ages was generally good. Informants reported slightly lower smoking and alcohol intake than patients: 1.3 fewer total pack-years (95% CI, -3.8, +6.5) and 2.7 fewer units/week (95% CI, -1.5, +6.9), respectively. For stroke patients, informants tended to report a greater smoking consumption at all ages, and a slightly higher alcohol consumption. Informants reported an excess of 7.4 total pack-years (95% CI, -1.2, + 16.0) and 2.19 units/week (95% CI, -1.0, +5.3). Agreement for medical history was good, except for hypertension. There was poor agreement for family medical history. The impact of misclassification is discussed.