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British Journal of Cancer 09/2012; 107(6):901-3. · 5.04 Impact Factor
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I Abraham, K Macdonald,
M Song,
G Ciesielski,
C Pacheco,
C Lee,
M Cholette,
K Kinsey,
P Speaks,
C Hermans,
H Brié,
S Reel,
P Van der Niepen,
B Yee,
S Vancayzeele
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ABSTRACT: BACKGROUND AND AIMS: Obesity combined with hypertension places patients at greater risk for target-organ damage and cardiovascular disease. The purpose of this secondary analysis was to identify physician- and patient-levels determinants of blood pressure (BP) values and predictors of uncontrolled BP through subgroup analysis by body mass index (BMI). METHODS AND RESULTS: We conducted a subgroup analysis of 3006 patients with High-BMI (BMI >25kg/m(2); n=2124) and Normal-BMI (BMI<25kg/m(2); n=882) treated by 504 physicians and enrolled in PREVIEW, a Belgian prospective, multi-center, pharmaco-epidemiological study of 90-day second-line treatment with valsartan. Physician- and patient-level determinants of BP values and BP control were identified by means of hierarchical linear and logistic regression. Blood pressure values and control after 90 days of treatment were consistently lower for the High-BMI group. The 25.5% of variance in 90-day systolic and 28.3% of the variance in 90-day diastolic BP were attributable to physician-level determinants for the High-BMI group; versus 27.3% and 29.8% for the Normal-BMI group (ICC=0.273 and 0.298, respectively). Determinants of 90-day BP values and predictors of uncontrolled BP varied considerably by BMI status. CONCLUSION: Several common and unique patient- and physician-level determinants of BP values and control were identified for the High-BMI and Normal-BMI groups. These findings highlight the need for differentiating healthcare interventions to account for patient and physician variables, particularly with respect to effective BP management in vulnerable populations.
Nutrition, metabolism, and cardiovascular diseases: NMCD 09/2011; · 3.52 Impact Factor
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K MacDonald,
C S Lee,
H-C Chen,
M L Ko,
G E Fidel,
H Brié,
C Hermans,
S Vancayzeele,
S Reel,
P Van der Niepen,
I Abraham
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ABSTRACT: Gender-specific determinants of blood pressure (BP) values and control have not been the focus of clinical hypertension research. The purpose of this analysis was to identify gender-specific and multi-level (physician and patient) determinants of BP values and predictors of uncontrolled BP. We completed a subgroup analysis comparing men and women who participated in the Belgian PREVIEW study of second-line treatment effectiveness of valsartan, applying two-level hierarchical modelling of 90-day BP values and guideline-defined BP control. In total, 1665 women and 1525 men were treated by 504 general practitioners. Fewer women than men reached systolic BP (SBP) (P=0.015) and combined BP targets at 90 days (P=0.007). More than 26% of the variance in 90-day SBP (intra-class correlation coefficient (ICC)=0.270) and diastolic BP (DBP) (ICC=0.262) was attributable to physician-level factors for men; the physician-level ICCs for SBP and DBP were 0.259 and 0.268, respectively, for women. Determinants of 90-day BP values and predictors of uncontrolled BP varied considerably by gender. Many of the multi-level determinants of BP by gender are amenable to intervention, and the remainder can serve as warning signs to clinicians that patients may remain vulnerable to poor outcomes associated with sub-optimal BP control.
Journal of human hypertension 06/2011; 25(6):372-82. · 2.80 Impact Factor
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ABSTRACT: The 'DRIVER' study was designed to investigate the 'real-world' effectiveness of aliskiren-based treatment of hypertension. This article reports the 180-day blood pressure (BP) outcomes, and the multilevel (physician- and patient-level) determinants thereof.
DRIVER was a prospective, observational, open-label, multi-centre, pharmaco-epidemiologic study of hypertensive patients treated with aliskiren in whom prior treatment failed or was not tolerated. 2070 patients (enrolled by 426 physicians) were enrolled; 1695 patients (81.9%) completed the 180-day aliskiren treatment period. Mean patient age was 64.2 ± 12.1 years; 53.7% were men, 25.3% diabetic and 40.7% had a high or very high cardiovascular (CV) risk. At 180 days, the mean ± SD reductions in systolic and diastolic BP were -22.9 ± 16.7 mmHg and -10.5 ± 10.9 mmHg respectively (both p < .001). 2007 and 2009 guideline-defined BP control was achieved in 36.4% and 56.3% of patients, respectively (both p < .001). 64.2% of eligible patients had a reduction in CV risk (p < .001). A physician-level class effect was responsible for 22.8% and 28.1% of variability in systolic and diastolic BP, respectively, for 20.1% of variability in BP control, and for 16.1% of variability in the reduction of CV risk. Both patient- (e.g. adherence) and physician-related factors (e.g. age and knowledge) were significant in profiling best response to treatment with aliskiren. Adverse events reported in this article were consistent with the aliskiren scientific leaflet.
Aliskiren is safe and effective in reducing BP, improving BP control and reducing global CV risk in a 'real-world' setting and for patients in whom prior treatment failed or was not tolerated. Optimising treatment adherence and strategic medical education may be ways of improving BP outcomes in patients with hypertension.
International Journal of Clinical Practice 01/2011; 65(1):54-63. · 2.41 Impact Factor
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ABSTRACT: Ivo Abraham1,2, Karen MacDonald2, Christine Hermans3, Ann Aerts3, Christopher Lee2,4, Heidi Brié3, Stefaan Vancayzeele31Center for Health Outcomes and Pharmacoeconomic Research, and Department of Pharmacy Practice and Science, College of Pharmacy, The University of Arizona, Tucson, AZ, USA; 2Matrix45, Earlysville, VA, USA; 3Novartis Pharma, Vilvoorde, Belgium; 4School of Nursing, Oregon Health and Science University, Portland, OR, USAAbstract: The pharmacological efficacy of various monotherapy, single pill, and combination therapies of the angiotensin II receptor blocker valsartan have been established, mainly through randomized controlled trials that used similar methodological and statistical platforms and thus enabled synthesis of evidence. The real world effectiveness of valsartan has been studied extensively, but the relative lack of scientific and technical congruence of these studies render synthesis virtually impossible. To date, all have focused on blood pressure outcomes, despite evidence-based calls to grade antihypertensive treatment to patients' total cardiovascular risk. We review a T3 translational research program of seven studies involving valsartan monotherapy as well as single and separate pill combinations, and the determinants and effect on blood pressure and total cardiovascular risk outcomes. All seven studies examined not only the impact of valsartan-based regimens on blood pressure values and control, but also, within a statistical hierarchical approach, the physician- and patient-related determinants of these blood pressure outcomes. Two studies also investigated the determinants and outcomes of valsartan-based treatment on total cardiovascular risk – among the first studies to use this risk coefficient as an outcome rather than only a determinant. These seven studies included a total of 19,533 patients, contributed by 3434 physician-investigators in Belgium – a country particularly well-suited for observational effectiveness studies because of demographics and epidemiology. Each study used the same methodological and statistical platform. We summarize the impact of various valsartan regimens on such outcomes as blood pressure values and control, change in total cardiovascular risk, and reduction in risk by at least one category. We also review the results of statistical multilevel and logistic modeling of physician- and patient-related determinants on these outcomes, including the proportion of variance attributable to a physician class effect before patients enter the equation. In its different formulations, valsartan has major real-world benefits in lowering blood pressure and total cardiovascular risk within a 90-day period. It is essential to understand the physician- and patient-related determinants of blood pressure and total cardiovascular risk outcomes associated with valsartan treatment. Antihypertensive research should expand its historical focus on lowering blood pressure with an emphasis on lowering total cardiovascular research.Keywords: valsartan, angiotensin II receptor blocker, hypertension, total cardiovascular risk, effectiveness, pharmaco-epidemiology
Vascular Health and Risk Management. 01/2011;
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G Brusselle,
A Michils,
R Louis,
L Dupont,
B Van de Maele,
A Delobbe,
C Pilette,
C S Lee,
S Gurdain,
S Vancayzeele,
P Lecomte,
C Hermans, K MacDonald,
M Song,
I Abraham
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ABSTRACT: To evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium.
Effectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations.
The sample (n=158) had a mean age of 48.17+/-17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values <0.001), >82% had an improvement in total AQLQ scores of > or =0.5 points (P<0.001), and >91% were severe exacerbation-free (P<0.001). At 52 weeks, >72% had a good/excellent GETE rating (P<0.001), >84% had improvements in total AQLQ score of > or =0.5 points (P<0.001), >56% had minimally important improvements in EQ-5D utility scores (P=0.012), and >65% were severe exacerbation-free (P<0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted.
The PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma.
Respiratory medicine 08/2009; 103(11):1633-42. · 2.33 Impact Factor
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ABSTRACT: In anemic cancer patients treated with erythropoiesis-stimulating agent (ESA), (i) to examine the proportion of variance in hemoglobin (Hb) outcomes attributable to patients versus center, country, and region and (ii) to develop predictive models of treatment response.
Retrospective study with a minimum of three visits at 1-month intervals. Three hundred and seven centers in 13 European countries contributed 2192 anemic ESA-treated cancer patients. Treatment response criteria included: Hb increase > or =1 g/dl, Hb increase > or =1 g/dl within 8 weeks, hematopoietic response (Hb increase > or =2 g/dl or Hb > or = 12 g/dl), Hb increase > or =2 g/dl, and Hb between 12 and 13 g/dl.
Hb increased from 9.54 +/- 0.95 g/dl (baseline) to 10.88 +/- 1.49 g/dl (visit 3). Hb change from visits 1 to 2 (index of relative immediacy of response to ESA) averaged 0.81 +/- 1.17 g/dl. The proportion of variance in Hb outcomes attributable to center was 11.8%-34.3%, country 2.9%-20.7%, and region 0.0%-7.6%. Immediacy of response to ESA was the most prevalent predictor of treatment response, followed by diagnosis of hematological malignancy and age <70 years.
. Hb outcomes are determined significantly by the treating center and less so by country or region. The remaining majority variance was attributable to patient-related factors. Immediacy of response to ESA is the single most important predictor of treatment. When used according to guidelines, ESAs are effective in managing anemia in cancer patients and improving treatment outcomes.
Annals of Oncology 08/2009; 20(10):1714-21. · 6.43 Impact Factor
