VALUE: Valsartan Antihypertensive Longterm Use Evaluation

1
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation

• Purpose
• To test the hypothesis that, for the same blood
  pressure control, valsartan would reduce cardiac
  morbidity and mortality more than amlodipine in
  hypertensive patients at high cardiovascular risk
• Reference
• Julius S, Kjeldsen SE, Weber M, et al. Outcomes
  in hypertensive patients at high cardiovascular
  risk treated with regimens based on valsartan or
  amlodipine the VALUE randomised trial. Lancet
  200436320222031.

2
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - TRIAL DESIGN -

• Design
• Multicenter, multinational, randomized,
  double-blind
• Patients
• 15,245 patients 50 yrs with treated or
  untreated hypertension and high risk of
  cardiovascular events
• Follow up and primary endpoint
• First event a composite of cardiac morbidity
  and mortality.
• Treatment
• Treatment initiated with valsartan (80 mg), or
  amlodipine (5 mg) and titrated upwards until a BP
  lt 140/90 mmHg was achieved other
  antihypertensive drugs other than ACE inhibitors
  or calcium antagonists, could be added if
  necessary

3
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - TRIAL DESIGN continued-
Baseline characteristics
4
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - RESULTS -

• No significant difference was observed in
  cardiac morbidity and mortality between the two
  groups
• There was a trend for greater heart failure
  reductions in the valsartan arm, although this
  was not statistically significant

5
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - RESULTS -

• At 72 months, valsartan (80/160 mg per day)
  and amlodipine (5/10 mg per day) both produced
  similar blood pressure levels (139.3/79.2 mm Hg
  vs 137.5/77.7 mm Hg, plt0.0001)
• Amlodipine (5/10 mg per day) was more
  efficacious than valsartan (80/160 mg per day) at
  reducing BP in the early months
• At 1 month BP in the amlodipine arm was reduced
  more than in the valsartan arm (4.0/2.1 mm Hg)
• At 6 months BP in the amlodipine arm was reduced
  more than in the valsartan arm (2.1/1.6 mm Hg)

6
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - RESULTS continued -

7
VALUE Valsartan Anti-hypertensive Long-term Use
Evaluation - SUMMARY -

• The valsartan group had a higher incidence of
  myocardial infarction than the amlodipine group,
  whereas the latter experienced a significantly
  higher incidence of new onset diabetes