Schmieder Roland E, Ott Christian, Schmid Axel, Friedrich Stefanie, Kistner Iris, Ditting Tilmann, Veelken Roland, Uder Michael, Toennes Stefan W
Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany
Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
Adherence to medication has been repeatedly proposed to represent a major cause of treatment-resistant hypertension (TRH); however, treatment decisions such as treating TRH with renal denervation depend on accurate judgment of adherence. We carefully analyzed adherence rates to medication before and after renal denervation and its effect on blood pressure (BP) control.
Eighty patients with TRH were included in 2 prospective observational studies that assessed the difference of potential antihypertensive and nephroprotective effects of renal denervation. To compare prescribed with actual medication intake (representing a measure of adherence), we analyzed urine samples collected at baseline and at 6 months after renal denervation for antihypertensive compounds or metabolites (by liquid chromatography-mass spectrometry). In addition to office BP, 24-hour ambulatory BP and central hemodynamics (central systolic pressure, central pulse pressure) were assessed. Informed consent for analyses of urine metabolites was obtained from 79 of 80 patients. Actual intake of all antihypertensive drugs was detected at baseline and at 6 months after renal denervation in 44 (56%) and 52 (66%) patients, respectively; 1 drug was missing in 22 (28%) and 17 (22%) patients, respectively, and ≥2 drugs were missing in 13 (16%) and 10 (13%) patients, respectively. At baseline, 24-hour ambulatory BP (P=0.049) and central systolic BP (P=0.012) were higher in nonadherent patients. Adherence did not significantly change overall (McNemar-Bowker test, P=0.362). An increase in adherence was observed in 21 patients, and a decrease was observed in 11 patients. The decrease in 24-hour ambulatory BP was not different in those with stable adherence 6 months after renal denervation (n=41, -7±13 mm Hg) compared with those with increased adherence (n=21, -10±13 mm Hg) and decreased adherence (n=11, -7±14 mm Hg) (P>0.20). Our study is limited by the relatively small sample size and potentially by the specific health environment of our university center (Northern Bavaria, Germany).
Nonadherence to medication among patients with TRH was relatively low: ≈1 of 6 patients with TRH did not take ≥2 of the prescribed drugs. Adherence pattern did not change significantly after renal denervation and had no impact on the overall observed BP changes, supporting the concept that renal denervation is an effective treatment in patients with TRH.
URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00888433, NCT01442883 and NCT01687725.
坚持服药一直被认为是治疗抵抗性高血压(TRH)的主要原因;然而,诸如用肾去神经支配治疗TRH等治疗决策取决于对依从性的准确判断。我们仔细分析了肾去神经支配前后的服药依从率及其对血压(BP)控制的影响。
80例TRH患者纳入2项前瞻性观察性研究,评估肾去神经支配潜在的降压和肾保护作用差异。为比较处方用药与实际药物摄入情况(代表依从性指标),我们分析了在基线和肾去神经支配后6个月采集的尿样中的抗高血压化合物或代谢物(采用液相色谱 - 质谱法)。除诊室血压外,还评估了24小时动态血压和中心血流动力学(中心收缩压、中心脉压)。80例患者中有79例获得了尿代谢物分析的知情同意。在基线和肾去神经支配后6个月,分别在44例(56%)和52例(66%)患者中检测到所有抗高血压药物的实际摄入情况;分别有22例(28%)和17例(22%)患者漏服1种药物,分别有13例(16%)和10例(13%)患者漏服≥2种药物。在基线时,未坚持服药的患者24小时动态血压(P = 0.049)和中心收缩压(P = 0.012)较高。总体而言,依从性没有显著变化(McNemar - Bowker检验,P = 0.362)。观察到21例患者依从性增加,11例患者依从性降低。肾去神经支配后6个月依从性稳定的患者(n = 41,-7±13 mmHg)与依从性增加的患者(n = 21,-10±13 mmHg)和依从性降低的患者(n = 11,-7±14 mmHg)相比,24小时动态血压的下降无差异(P>0.20)。我们的研究受到样本量相对较小以及可能受我们大学中心(德国巴伐利亚北部)特定健康环境的限制。
TRH患者中不服药的情况相对较少:约每6例TRH患者中有1例未服用≥2种处方药物。肾去神经支配后依从性模式没有显著变化,对总体观察到的血压变化没有影响,支持肾去神经支配是TRH患者有效治疗方法的观点。
网址:https://www.clinicaltrials.gov。唯一标识符:NCT00888433、NCT01442883和NCT01687725。