Results of the pilot study for the Hypertension in the Very Elderly Trial

J Hypertens. 2003 Dec;21(12):2409-17. doi: 10.1097/00004872-200312000-00030.

Abstract

Background: The risks and benefits of treating hypertension in individuals older than 80 years are uncertain. A meta-analysis has suggested that a reduction in stroke events of 36% may have to be balanced against a 14% increase in total mortality.

Objectives: To report the results of the pilot study of the Hypertension in the Very Elderly Trial (HYVET), which is in progress to address these issues.

Methods: The HYVET-Pilot was a multicentre international open pilot trial. In 10 European countries, 1283 patients older than 80 years and with a sustained blood pressure of 160-219/90-109 mmHg were allocated randomly to one of three treatments: a diuretic-based regimen (usually bendroflumethiazide; n = 426), an angiotensin-converting enzyme inhibitor regimen (usually lisinopril; n = 431) or no treatment (n = 426). The procedure permitted doses of the drug to be titrated and diltiazem slow-release to be added to active treatment. Target blood pressure was < 150/80 mmHg and mean follow-up was 13 months.

Results: In the combined actively treated groups, the reduction in stroke events relative hazard rate (RHR) was 0.47 [95% confidence interval (CI) 0.24 to 0.93] and the reduction in stroke mortality RHR was 0.57 (95% CI 0.25 to 1.32). However, the estimate of total mortality supported the possibility of excess deaths with active treatment (RHR 1.23, 95% CI 0.75 to 2.01).

Conclusions: The preliminary results support the need for the continuing main HYVET trial. It is possible that treatment of 1000 patients for 1 year may reduce stroke events by 19 (nine non-fatal), but may be associated with 20 extra non-stroke deaths.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / therapeutic use
  • Biomarkers / blood
  • Blood Pressure / drug effects
  • Calcium Channel Blockers / therapeutic use
  • Creatinine / blood
  • Diastole / drug effects
  • Diuretics / therapeutic use
  • Double-Blind Method
  • Europe / epidemiology
  • Female
  • Follow-Up Studies
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / epidemiology*
  • Hypertension / physiopathology
  • Male
  • Pilot Projects
  • Potassium / blood
  • Risk Factors
  • Survival Analysis
  • Systole / drug effects
  • Treatment Outcome

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Biomarkers
  • Calcium Channel Blockers
  • Diuretics
  • Creatinine
  • Potassium