Академический Документы
Профессиональный Документы
Культура Документы
DOI 10.1007/s11739-011-0669-5
SYMPOSIUM WHAT INTERVENTION TRIALS DONT TELL US: THE RESIDUAL RISK
SIMI 2011
D. Vanuzzo (&)
Cardiovascular Prevention Centre, Health Unit 4 Medio
Friuli, P.le Santa Maria Misericordia, 33100 Udine, Italy
e-mail: diego.vanuzzo@mediofriuli.it
123
S46
123
S47
123
S48
123
Final considerations
To understand the results of the intervention trials and of
the observational PRIME study, some hypotheses can be
considered.
1.
S49
Table 1 Results of Cox regressions, best model for men and women aged 3569 years free of previous cardiovascular disease at baseline. The
CUORE project samples
Men
b
Women
p value
HR more
adverse
levela
HR more
favourable
levelb
p value
HR more
adverse
levela
HR more
favourable
levelb
Age (years)
b1
0.076
\0.0001
2.01
0.50
0.079
\0.0001
1.95
0.51
b2
0.013
\0.0001
1.31
0.76
0.016
\0.0001
1.41
0.71
b3
0.006
\0.0001
1.31
0.76
0.003
0.0362
1.14
0.88
HDL-cholesterol (mg/dl)
b4
-0.013
\0.0001
1.60
0.60
-0.015
0.0002
1.26
0.80
b5
0.508
\0.0001
1.66
0.60
0.773
\0.0001
2.17
0.46
Diabetes, yesno
b6
0.462
0.0005
1.59
0.63
0.339
0.0859
1.40
0.71
b7
0.490
\0.0001
1.63
0.61
0.590
\0.0001
1.80
0.55
G (l)
6.583
6.016
0.953
0.989
For continuous variables, hazard ratio with level 1 standard deviation higher (see Table 1); for dichotomized variables, yes versus no
For continuous variables, hazard ratio with level 1 standard deviation lower (see Table 1); for dichotomized variables, no versus yes
G(l) is the linear combination of the risk factor averages or of the prevalence in each category for the corresponding b1 coefficients
S(t) is 10-year survival evaluated at mean value of risk factors
Risk equation is: 1[S(t)]^{EXP[b1 9 age ? b2 9 SBP ? b3 9 TC ? b4 9 HDL-C ? b5 (if smoker) ? b6 (if diabetic) ? b7 (if under
hypertension treatment)G(l)]}, where SBP is systolic blood pressure, TC is total cholesterol, HDL-C is HDL-cholesterol
2.
3.
The compliance with drug treatment is rather disappointing, even in clinical trials, and part of the residual risk can
be attributed to dose reduction or periodical interruption.
In observational studies the drug treatment is generally
recorded only at baseline and there is no specific
follow-up.
123
S50
4.
5.
123
None.
References
1. Hermans MP, Fruchart JC (2010) Reducing Residual Vascular
Risk in Patients with Atherogenic Dyslipidemia: Where do we go
from here? Clin Lipidology. 5(6):811826
2. Vandenbroucke JP (2004) When are observational studies as
credible as randomised trials? Lancet 363:17281731
3. Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology:
The Essentials. 3rd edn. Baltimore, Md: Williams & Wilkins;
1996:2
4. Lauer MS (2001) Medical therapy for coronary artery disease
works, even (especially) in the real world. Am J Med 110:497498
5. MacMahon S, Peto R, Cutler J, Collins R, Sorlie P, Neaton J et al
(1990) Blood pressure, stroke, and coronary heart disease. Part 1,
prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet
335:765774
6. Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, Eberlein
KA et al (1990) Blood pressure, stroke and coronary heart disease. Part 2, short term reductions in blood pressure: overview of
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
S51
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
123