HYVET: HYpertension in the Very Elderly Trial

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HYVET HYpertension in the Very Elderly Trial

• Purpose
• To compare the benefits of the diuretic
  indapamide with placebo in the treatment of
  hypertension patients older than 80 years of age.
• Reference
• Beckett NS, Peters R, Fletcher AE, et al. for
  the HYVET Study Group. Treatment of hypertension
  in patients 80 years of age or older. N Engl J
  Med 200835818871898.

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HYVET HYpertension in the Very Elderly Trial-
TRIAL DESIGN -

• Design
• Multicenter, multinational, randomized,
  double-blind, placebo-controlled trial.
• Patients
• 3845 patients who were 80 years of age and who
  had a sustained systolic blood pressure of 160
  mm Hg.
• Treatment
• Indapamide 1.5 mg sustained release or matching
  placebo. Perindopril (2 or 4 mg) or matching
  placebo added if necessary for patient to achieve
  target blood pressure of 150/80 mm Hg.

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HYVET HYpertension in the Very Elderly Trial-
TRIAL DESIGN continued -

Baseline characteristics
Active treatment
Placebo
(n1933)
(n1912)
Mean age years
83.6
83.5
Female sex number ()
1174 (60.7)
1152 (60.3)
Blood pressure mm Hg
While sitting
173/91
173/91
While standing
168/89
168/89
1718 (89.9)
Previous hypertension number ()
1737 (89.9)
74.5
74.5
Heart rate beats/min
131 (6.9)
Stroke number ()
130 (6.7)
Myocardial infarction number ()
59 (3.1)
62 (3.2)
Beckett et al. N Eng J Med 200835818871898.
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HYVET HYpertension in the Very Elderly Trial-
RESULTS -

• Primary endpoint and follow-up
• The trial was terminated early because a planned
  interim analysis showed a significant reduction
  both in the primary endpoint of fatal and
  non-fatal stroke and in total mortality. In the
  final analysis, the primary endpoint was not
  significant (p0.06). Median follow-up was 1.8
  years.
• Secondary endpoints
• There were also significant reductions in the
  following
• Death from any cause
• Death from stroke
• Any heart failure
• Any cardiovascular event
• Other results
• There were fewer serious adverse events in the
  active-treatment group than in the placebo group
  (358 vs. 448, p0.001). Among patients followed
  for 2 years, there were no significant
  differences between the groups in terms of serum
  levels of potassium, uric acid, glucose or
  creatinine.

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HYVET HYpertension in the Very Elderly Trial-
RESULTS continued -

Primary and secondary outcomes
Unadjustedhazard ratio
Placebo (n1912) (n)
Indapamide (n1933) (n)
p value
(95 CI)
Primary endpoint
Fatal or non-fatal stroke
69
51
0.70 (0.49

0.101)
0.06




Secondary endpoints
Death from any cause
235
196
0.79 (0.65

0.95)
0.02
Death from stroke
42
27
0.61 (0.38

0.99)
0.046
Any heart failure
57
22
0.36 (0.22

0.58)
lt0.001




Any cardiovascular event
193
138
0.0004
0.79 (0.69

0.90)
Beckett et al. N Eng J Med 200835818871898.
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HYVET HYpertension in the Very Elderly Trial-
RESULTS continued -
No. at risk Placebo group Active-treatment group
Beckett et al. N Eng J Med 200835818871898.
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HYVET HYpertension in the Very Elderly Trial-
SUMMARY -

• In hypertensive individuals aged 80 years or
  older, treatment with the diuretic indapamide,
  with or without perindopril, reduced the relative
  risk of fatal or non-fatal stroke, but not
  significantly (p0.06).Active treatment reduced
  the risk of stroke and all-cause mortality in
  these patients, and there were also reductions in
  heart failure and any cardiovascular
  events.These results are evidence that this
  antihypertensive treatment regime is beneficial
  in people over the age of 80 years old.