Effectiveness of valsartan for treatment of hypertension: patient profiling and hierarchical modeling of determinants and outcomes (the PREVIEW study).
BACKGROUND
Patient- and clinician-related factors may explain variability in blood pressure (BP) outcomes and the differences between real-world effectiveness and efficacy seen in randomized trials of antihypertensive agents.


OBJECTIVE
To examine the effectiveness of 90 days of second-line valsartan treatment and identify patient- and physician-level determinants that impact BP outcomes.


METHODS
A prospective, multicenter, multilevel pharmaco-epidemiological study was conducted in 3194 hypertensive patients (systolic BP [SBP] > or =140 mm Hg, diastolic BP [DBP] > or =90 mm Hg; for diabetic patients, > or =130 and > or =80 mm Hg, respectively) treated by 504 general practitioners (GPs). Statistical analysis included heuristic data mining, and hierarchical linear and logistic modeling.


RESULTS
With valsartan treatment, mean +/- SD SBP decreased from 154.4 +/- 15.5 mm Hg to 139.0 +/- 12.0 mm Hg and mean DBP decreased from 91.3 +/- 9.2 mm Hg to 82.6 +/- 7.4 mm Hg. SBP control rates increased from 9.0% to 38.6%, DBP from 25.5% to 65.5%, and combined SBP/DBP from 7.3% to 34.4%. A highly vulnerable cohort (n = 1063; 35.4%) of patients was identified. Twenty-four percent of variability in SBP and 25% of variability in DBP at 90 days were attributable to physician-related variables: guideline-compliant BP management, hypertension, practice patterns, hypertensive patient volume, and years in practice. The remaining 76% and 75% of variability in SBP and DBP, respectively, were due to patient factors, notably diabetes and related complications, vulnerability to uncontrolled BP, nonadherence, cardiovascular risk, and age. Similar factors increased the odds of treatment nonresponse, with diabetes being the single largest determinant of uncontrolled SBP (OR 8.99), DBP (OR 20.35), and combined SBP/DBP (OR = 18.64).


CONCLUSIONS
Valsartan is effective and well tolerated in a broad range of patients in whom first-line antihypertensive treatment failed or was not tolerated. Mitigating the impact of BP-elevating variables and optimizing the effect of BP-lowering factors provides therapeutic benefits incremental to valsartan's pharmacologic effect. Improving outcomes in hypertensive patients involves 3 steps: (1) identifying, intuitively rather than formally, patients less likely to achieve BP control; (2) targeting modifiable or manageable patient- and physician-level determinants with BP-elevating or BP-lowering effects; and (3) managing variables that increase the odds and optimizing those that lower the odds of uncontrolled BP.
Tutor in Internal Medicine, Department of Nephrology and Hypertension, Universitair Ziekenhuis Brussel, Brussel, Belgium.
Patricia
P
Van der Niepen
Annemie
A
Woestenburg
Heidi
H
Brié
Stefaan
S
Vancayzeele
Karen
K
MacDonald
Kris
K
Denhaerynck
Christopher
C
Lee
Christine
C
Hermans
Ivo
I
Abraham
D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000145:classification* / Q000188:drug therapy*; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D010349:Patient Compliance; D010818:Practice Patterns, Physicians'; D011361:Professional Competence; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
D000959:Antihypertensive Agents; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine