Novartis Pharmaceuticals Corporation Medical, East Hanover NJ, USA.
Curr Med Res Opin. 2010 Sep;26(9):2203-12. doi: 10.1185/03007995.2010.500883.
To compare blood pressure (BP) goal achievement associated with the use of valsartan-based single pill combinations (SPCs) vs. angiotensin II receptor blocker (ARB)-based free combinations (FCs) among adult hypertension patients.
Data were collected from physician-administered chart review of adult hypertension patients in the South Central region. All patients had uncontrolled BP before initiating one of the index therapies (SPCs: valsartan/amlodipine or valsartan/hydrochlorothiazide [HCTZ], FCs: ARB + calcium channel blocker [CCB] or ARB + HCTZ) between 07/2008 and 06/2009. Up to three BP measures were collected starting from 45 days after the therapy initiation. BP goal was <130/80 mmHg for patients with diabetes, chronic renal disease or coronary heart disease; or <140/90 mmHg for patients without these comorbidities. The Kaplan-Meier method with log-rank test was used to compare rates of BP goal achievement associated with valsartan-based SPCs vs. ARB-based FCs over time. Cox proportional hazard models were used to estimate the likelihood of BP goal achievement associated with SPCs vs. FCs, controlling for demographics, baseline BP, hypertension history, comorbidities, prior and concurrent use of anti-hypertensive medications, and physician specialty.
The study included 812 patients: 414 on valsartan-based SPCs (209 on valsartan/amlodipine and 205 on valsartan/HCTZ) and 398 on ARB-based FCs (200 on ARB + CCB and 198 on ARB + HCTZ). The ARBs in the FC group included valsartan, losartan, olmesartan, telmisartan, irbesartan and candesartan. In the ARB FC group, the most commonly used ARB and CCB were valsartan (29.1%) and amlodipine (81.5%), respectively. During the observation period (81 days for valsartan SPC patients and 90 days for ARB FC patients), 65.9% of valsartan SPC patients and 55.8% of the ARB FC patients achieved BP goal. Over time, the rates of BP goal achievement were consistently higher among valsartan SPC vs. ARB FC patients (p = 0.01): 31.1% vs. 28.9% and 69.1% vs. 59.2% at month 3 and 6 after therapy initiation, respectively. Cox regression confirmed that valsartan SPC patients were more likely to achieve BP goal (HR = 1.22; p = 0.05). A similar trend was observed in the subgroup analyses comparing SPC of valsartan/amlodipine vs. FCs of ARB + CCB and SPC of valsartan/HCTZ vs. FCs of ARB + HCTZ.
Non-randomization of treatments, limited generalizability, and no records of BP measures within 45 days.
Patients using valsartan-based SPCs were significantly more likely to achieve BP goal than those treated with ARB-based FCs in the real-world clinical practice in the South Central region. The significance was achieved at two-sided alpha = 0.05.
比较在南中地区的成年高血压患者中，使用缬沙坦为基础的单片复方制剂（SPC）与血管紧张素 II 受体阻滞剂（ARB）为基础的自由复方（FC）治疗时，血压（BP）目标的达成情况。
数据来自南中地区医生管理的成年高血压患者图表回顾。所有患者在 2008 年 7 月至 2009 年 6 月期间开始使用指数治疗（SPC：缬沙坦/氨氯地平或缬沙坦/氢氯噻嗪[HCTZ]，FC：ARB+钙通道阻滞剂[CCB]或 ARB+HCTZ）之前，血压均未得到控制。从治疗开始后 45 天开始，最多收集三次 BP 测量值。对于有糖尿病、慢性肾病或冠心病的患者，BP 目标为<130/80mmHg；对于没有这些合并症的患者，BP 目标为<140/90mmHg。使用 Kaplan-Meier 方法和对数秩检验比较缬沙坦为基础的 SPC 与 ARB 为基础的 FC 在不同时间点血压目标达成率。使用 Cox 比例风险模型估计 SPC 与 FC 相关的 BP 目标达成率，控制人口统计学、基线 BP、高血压病史、合并症、之前和同时使用的抗高血压药物以及医生专业。
该研究纳入了 812 名患者：414 名使用缬沙坦为基础的 SPC（209 名使用缬沙坦/氨氯地平，205 名使用缬沙坦/HCTZ）和 398 名使用 ARB 为基础的 FC（200 名使用 ARB+CCB，198 名使用 ARB+HCTZ）。FC 组中的 ARB 包括缬沙坦、氯沙坦、奥美沙坦、替米沙坦、厄贝沙坦和坎地沙坦。在 ARB FC 组中，最常用的 ARB 和 CCB 分别是缬沙坦（29.1%）和氨氯地平（81.5%）。在观察期间（缬沙坦 SPC 患者为 81 天，ARB FC 患者为 90 天），65.9%的缬沙坦 SPC 患者和 55.8%的 ARB FC 患者达到了 BP 目标。随着时间的推移，缬沙坦 SPC 患者的 BP 目标达成率始终高于 ARB FC 患者（p=0.01）：治疗后第 3 个月和第 6 个月分别为 31.1%和 28.9%，69.1%和 59.2%。Cox 回归证实缬沙坦 SPC 患者更有可能达到 BP 目标（HR=1.22；p=0.05）。在比较缬沙坦/氨氯地平 SPC 与 ARB+CCB FCs 以及缬沙坦/HCTZ SPC 与 ARB+HCTZ FCs 的亚组分析中，也观察到了类似的趋势。
治疗非随机化、有限的普遍性以及在 45 天内没有 BP 测量记录。
在南中地区的真实临床实践中，与使用 ARB 为基础的 FCs 相比，使用缬沙坦为基础的 SPCs 的患者更有可能达到 BP 目标。在双侧 alpha = 0.05 时达到显著水平。
