Clinical Trails Flashcards
The SPRINT Trial
A Randomized Trial of Intensive versus Standard BP Control
9361 participants
median of 3.33 years of follow-up
‒ Non diabetic, hypertensive patients >50y with increased cardiovascular risk
‒ Aim ‒ SBP<140 (standard treatment) ‒ SBP<120 (intensive treatment)
CONCLUSIONS
Among pts at high risk for cardiovascular events but without diabetes,
No Needed to Treat (NNT) to prevent a primary outcome = 61
‒ Reduced MI, ACS, CVA, CHF or death
‒ 2.19%/y standard vs 1.65%/y intensive Rx HR 0.75
‒ Mortality reduction HR 0.73 (0.60 – 0.90)
‒ Increased hypotension, syncope, acute kidney injury but not injurious falls
SBP in the Two Treatment Groups over the Course of the Trial.
The SBP target in the intensive-treatment group was <120 mm Hg, and the target in the standard-treatment group was < 140 mm Hg.
The mean number of medications is the number of BP medications administered at the exit of each visit.
I bars represent 95% confidence intervals.
Primary Outcome and Death from Any Cause.
Shown are the cumulative hazards for the primary outcome (a composite of MI, ACS, stroke, HF, or death from cardiovascular causes) (Panel A)
and for death from any cause (Panel B).
The inset in each panel shows the same data on an enlarged y axis. CI denotes confidence interval.
The HYVET Trial
Should antihypertensive treatment ever be stopped in older patients?
Treatment of HTN in Pts 80 Years of Age or Older
2008
https://www.youtube.com/watch?v=BIjlxCGPsCQ
3845 pts from Europe, China, Australasia, and Tunisia
mean age, 83.6 years
mean BP while sitting, 173.0/90.8 mm Hg
11.8% had a history of CVD.
Median follow-up was 1.8 years.
‒ SBP >160mmHg, DBP < 110mmHg
‒ Indapamide 1.5mg + Perindopril 2-4mg vs placebo
‒ Target BP 150/80
RESULTS
At 2 years, the mean BP while sitting was 15.0/6.1 mm Hg lower in the active-treatment group than in the placebo group.
In an intention-to-treat analysis, active treatment was associated with:
30% reduction in the rate of fatal or nonfatal stroke
39% reduction in the rate of death from stroke ( you only need 11 people to prevent stroke)
21% reduction in the rate of death from any cause
23% reduction in the rate of death from CV causes
64% reduction in the rate of heart failure
Fewer serious adverse events were reported in the active-treatment group
CONCLUSIONS
The results provide evidence that antihypertensive Rx with indapamide (sustained release), with or without perindopril, in persons 80 years of age or older is beneficial.
Mean BP
Measured while Pts were seated, in the intention-to-treat population,
- Acpording to study group.
Kaplan–Meier Estimates of the Rate of End Points, According to Study Group.
For the active-treatment group as compared with the placebo group, the unadjusted hazard ratios (95% CIs) were as follows:
- for fatal or nonfatal stroke, 0.70 (0.49 to 1.01) (Panel A);
- for death from any cause, 0.79 (0.65 to 0.95) (Panel B);
- for death from cardiovascular causes, 0.77 (0.60 to 1.01) (Panel C);
- for death from stroke, 0.61 (0.38 to 0.99) (Panel D);
- and for heart failure, 0.36 (0.22 to 0.58) (Panel E)
HTN trials - challenges and current directions - G.M.C. Rosano
Effect of Salt Substitution on Cardiovascular Events and Death
20,995 persons were enrolled
cluster-randomized trial involving persons from 600 villages in rural China
The participants had a Hx of stroke or were 60 years of age or older and had high BP
The mean age was 65.4 years, and 49.5% were female,
- 6% had a history of stroke
- 4% a history of HTN.
The mean duration of follow-up was 4.74 years.
RESULTS
The rate of stroke was lower with the salt substitute than with regular salt
- (29.14 events vs. 33.65 events per 1000 person-years)
The rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years)
- and death (39.28 events vs. 44.61 events per 1000 person-years)
The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years).
CONCLUSIONS
Among persons who had a history of stroke or were 60 years of age or older and had HTN, the rates of:
- stroke,
- major cardiovascular events,
- and death from any cause
were lower with the salt substitute than with regular salt
Effects of Salt Substitution on Trial Outcomes.
Shown are the effects of salt substitute, as compared with regular salt, on the primary outcome of stroke (Panel A),
the secondary outcomes of major adverse CV events (a composite of nonfatal stroke, nonfatal acute coronary syndrome, or death from vascular causes) (Panel B)
and death from any cause (Panel C),
and the safety outcome of hyperkalemia (Panel D).
ALLHAT Trial
Which Antihypertensive is Best?
‒ Chlorthalidone 12.5 – 25mg
‒ Amlodipine
‒ Lisinopril
‒ Doxazosin
