Van der Niepen Patricia, Woestenburg Annemie, Brié Heidi, Vancayzeele Stefaan, MacDonald Karen, Denhaerynck Kris, Lee Christopher, Hermans Christine, Abraham Ivo
Tutor in Internal Medicine, Department of Nephrology and Hypertension, Universitair Ziekenhuis Brussel, Brussel, Belgium.
Ann Pharmacother. 2009 May;43(5):849-61. doi: 10.1345/aph.1L576. Epub 2009 Apr 7.
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.
To examine the effectiveness of 90 days of second-line valsartan treatment and identify patient- and physician-level determinants that impact BP outcomes.
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.
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).
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.
患者相关因素和临床医生相关因素可能解释血压（BP）结果的变异性，以及抗高血压药物随机试验中观察到的现实世界有效性和疗效之间的差异。
研究二线缬沙坦治疗90天的有效性，并确定影响血压结果的患者和医生层面的决定因素。
对3194例高血压患者（收缩压[SBP]≥140mmHg，舒张压[DBP]≥90mmHg；糖尿病患者分别为≥130mmHg和≥80mmHg）进行了一项前瞻性、多中心、多层次的药物流行病学研究，这些患者由504名全科医生（GP）治疗。统计分析包括启发式数据挖掘以及分层线性和逻辑建模。
接受缬沙坦治疗后，平均±标准差SBP从154.4±15.5mmHg降至139.0±12.0mmHg，平均DBP从91.3±9.2mmHg降至82.6±7.4mmHg。SBP控制率从9.0%提高到38.6%，DBP从25.5%提高到65.5%，联合SBP/DBP从7.3%提高到34.4%。确定了一组高度易患人群（n = 1063；35.4%）。90天时SBP变异性的24%和DBP变异性的25%可归因于医生相关变量：符合指南的血压管理、高血压、执业模式、高血压患者数量和执业年限。SBP和DBP变异性的其余76%和75%分别归因于患者因素，特别是糖尿病及其相关并发症、血压控制不佳的易感性、不依从、心血管风险和年龄。类似因素增加了治疗无反应的几率，糖尿病是血压控制不佳的SBP（比值比8.99）、DBP（比值比20.35）和联合SBP/DBP（比值比 = 18.64）的单一最大决定因素。
缬沙坦在一线抗高血压治疗失败或不耐受的广泛患者中有效且耐受性良好。减轻血压升高变量的影响并优化降压因素的效果可提供超出缬沙坦药理作用的治疗益处。改善高血压患者的治疗效果包括三个步骤：（1）直观而非正式地识别不太可能实现血压控制的患者；（2）针对具有升高或降低血压作用的可改变或可管理的患者和医生层面的决定因素；（3）管理增加血压控制不佳几率的变量并优化降低该几率的变量。
